Article

This edition of Rare Diseases Report: Cancers highlights the latest breakthroughs and remaining unmet needs in the management of rare cancers. In addition to celebrating the great progress that has been made in recent years, we also discuss new challenges, such as how the healthcare system can prepare to manage the growing number of rare cancer survivors who are living longer due to improvements in disease management. 

INTRODUCTION

NORD: Making Progress Through Collaboration
By Katie Kowalski, MPH

IN THIS ISSUE

The Complex Challenge of Survival After HPV-Associated Oropharyngeal Cancer
By Vlad C. Sandulache, MD, PhD

Progress in Ovarian Cancer: Discovery of Fallopian Tube Involvement
By Ronny Drapkin, MD, PhD

An Evolving Understanding of Adenosquamous Carcinoma of the Lung
By Rajwanth Veluswamy, MD, MSCR

Gastrointestinal Stromal Tumor: Reflecting on 2 Decades of Clinical Advancements
By Jason K. Sicklick, MD, FACS

Progress in Treating Testicular Cancer
By Liang Cheng, MD

Strategies to Improve Long-Term Outcomes in Younger Patients with Hodgkin Lymphoma
By Ann LaCasce, MD, MMSc

Targeted Therapies in Younger and Older Patients with Mantle Cell Lymphoma
By Reem Karmali, MD, MS

Advances in Management of Relapsed/Refractory Hairy Cell Leukemia
By Robert J. Kreitman, MD

Treatment Needs of Older Adults With Newly Diagnosed Acute Myeloid Leukemia
By Harry Erba, MD, PhD

Progress in Management of Advanced Acute Lymphocytic Leukemia in Children
By Susan Colace, MD, MSCI

This edition of Rare Diseases Report: Cancers highlights the latest breakthroughs and remaining unmet needs in the management of rare cancers. In addition to celebrating the great progress that has been made in recent years, we also discuss new challenges, such as how the healthcare system can prepare to manage the growing number of rare cancer survivors who are living longer due to improvements in disease management. 

INTRODUCTION

NORD: Making Progress Through Collaboration
By Katie Kowalski, MPH

IN THIS ISSUE

The Complex Challenge of Survival After HPV-Associated Oropharyngeal Cancer
By Vlad C. Sandulache, MD, PhD

Progress in Ovarian Cancer: Discovery of Fallopian Tube Involvement
By Ronny Drapkin, MD, PhD

An Evolving Understanding of Adenosquamous Carcinoma of the Lung
By Rajwanth Veluswamy, MD, MSCR

Gastrointestinal Stromal Tumor: Reflecting on 2 Decades of Clinical Advancements
By Jason K. Sicklick, MD, FACS

Progress in Treating Testicular Cancer
By Liang Cheng, MD

Strategies to Improve Long-Term Outcomes in Younger Patients with Hodgkin Lymphoma
By Ann LaCasce, MD, MMSc

Targeted Therapies in Younger and Older Patients with Mantle Cell Lymphoma
By Reem Karmali, MD, MS

Advances in Management of Relapsed/Refractory Hairy Cell Leukemia
By Robert J. Kreitman, MD

Treatment Needs of Older Adults With Newly Diagnosed Acute Myeloid Leukemia
By Harry Erba, MD, PhD

Progress in Management of Advanced Acute Lymphocytic Leukemia in Children
By Susan Colace, MD, MSCI

This edition of Rare Diseases Report: Cancers highlights the latest breakthroughs and remaining unmet needs in the management of rare cancers. In addition to celebrating the great progress that has been made in recent years, we also discuss new challenges, such as how the healthcare system can prepare to manage the growing number of rare cancer survivors who are living longer due to improvements in disease management. 

INTRODUCTION

NORD: Making Progress Through Collaboration
By Katie Kowalski, MPH

IN THIS ISSUE

The Complex Challenge of Survival After HPV-Associated Oropharyngeal Cancer
By Vlad C. Sandulache, MD, PhD

Progress in Ovarian Cancer: Discovery of Fallopian Tube Involvement
By Ronny Drapkin, MD, PhD

An Evolving Understanding of Adenosquamous Carcinoma of the Lung
By Rajwanth Veluswamy, MD, MSCR

Gastrointestinal Stromal Tumor: Reflecting on 2 Decades of Clinical Advancements
By Jason K. Sicklick, MD, FACS

Progress in Treating Testicular Cancer
By Liang Cheng, MD

Strategies to Improve Long-Term Outcomes in Younger Patients with Hodgkin Lymphoma
By Ann LaCasce, MD, MMSc

Targeted Therapies in Younger and Older Patients with Mantle Cell Lymphoma
By Reem Karmali, MD, MS

Advances in Management of Relapsed/Refractory Hairy Cell Leukemia
By Robert J. Kreitman, MD

Treatment Needs of Older Adults With Newly Diagnosed Acute Myeloid Leukemia
By Harry Erba, MD, PhD

Progress in Management of Advanced Acute Lymphocytic Leukemia in Children
By Susan Colace, MD, MSCI

Background

Hodgkin lymphoma occurs in fewer than 9,000 individuals in the United States each year,¹ but it is one of the most common types of cancer in AYAs.² For the purposes of cHL, AYA is typically defined as an age range of 18 to 39 years, which covers the first of 2 bimodal peaks in incidence but stops short of the second.^3,4 The first of these peaks occurs between the ages of 15 and 34 years, while the second begins at about age 55.⁵ Children younger than 15 years of age can also develop Hodgkin lymphoma, but it is less common.⁶

In AYAs and in adults, more than 90% of patients with Hodgkin lymphoma have cHL.⁷ Most AYAs present with the nodular sclerosis subtype, but cHL is managed differently in pediatric patients versus in adult centers.^8,9 Evidence suggests that the specific risks of common treatment protocols, although similar, are not the same in AYAs as in adults.^10,11 Even though the literature evaluating the presentation and management of AYA cHL has been growing since 2005, when the AYA Oncology Progress Review Group called for AYAs to be recognized
as a distinct group, clinical trials specific to AYA cHL remain limited.⁹

Major Hodgkin lymphoma guidelines only partially address AYAs as a distinct group. In guidelines issued by the National Cancer Institute, the differences in clinical presentation of AYAs are described for young children, AYAs, and older adults, but there are no treatment recommendations specific to AYAs.¹² Guidelines from the EuroNet Paediatric Hodgkin Lymphoma Group offer recommendations for relapsed and refractory Hodgkin lymphoma, but do not differentiate between children and adolescents.¹³ The National Comprehensive Cancer Network (NCCN) provides separate treatment recommendations for patients 18 years or younger and those who are older than 18.^14,15 For Hodgkin lymphoma, AYA is not addressed as a separate category even though the NCCN has provided general guidelines for treatment of malignancies in AYA.¹⁶

First-line therapies are effective in children, AYAs, and adults. Survival rates at 5 years have increased steadily, approaching or exceeding 90% across age groups even for patients with unfavorable risk characteristics.¹⁷ This success has permitted greater focus on developing strategies that preserve efficacy with lower acute and long-term risks.

Risk-Adapted Therapies

While the potential for new and novel therapies to reduce the risk of long-term toxicities continues to be explored, adjusting existing regimens to reduce these risks has proven to be a viable strategy. This adjustment is a standard of care in the pediatric setting based on results from such studies as German GPOH-HD 95, which suggested that doses of radiotherapy, a major contributor to late toxicities,¹⁸ can be omitted in patients with a complete response after chemotherapy.¹¹ This pediatric trial contained both younger children and adolescents, but subsequent secondary analyses looking specifically at AYAs in this and other trials have suggested that efficacy is similarly preserved with risk-adapted strategies.⁹

However, due to AYA patients with cHL being treated using both pediatric and adult approaches, the persistent debate about optimal therapies in this age group complicates the effort to define a well-accepted strategy for risk adjustment. While risk-adapted strategies that rely on interim positron emission tomography (PET) to calibrate treatment intensity are now being used routinely across age stratifications, other initiatives are creating additional opportunities to gauge the impact on late effects in AYAs. These include strategies to improve collaboration across groups of trialists and data generated by observational cohorts, which can evaluate late effects not captured in time-limited clinical trials.

Among recent data supporting risk-adjusted therapy, the toxicity outcomes from a multicenter trial of PET-guided intensive treatment in patients with newly diagnosed advanced cHL were presented at the 2022 annual meeting of the American Society of Hematology.¹⁹ This phase 3 trial enrolled patients younger than 60 years, 79% of whom were younger than 45 years. Building on previous evidence that PET guidance improves the safety of eBEACOPP (escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), nearly 1,500 patients were randomized to this strategy or to PET-guided BrECADD, a modified eBEACOPP in which the antibody conjugate brentuximab vedotin (BV) was substituted for bleomycin. For an adjudicated endpoint of treatment-related morbidity, the experimental BrECAAD regimen reduced the risk by nearly 30% (hazard ratio [HR] 0.72). It is unclear whether this strategy will be used in the United States, where trials have been built on ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) rather than BEACOPP.

Efficacy data from this trial are not yet available, and these data will be important. There is concern that PET-directed therapy might result in lower toxicity at a cost of reduced rates of disease control. It is possible that the serious consequences of late toxicities—including infertility, compromised cardiovascular function, secondary cancers, and other organ damage—might need to be balanced against some loss of efficacy.

Novel Targeted Therapies

The goal of reducing late toxicities of cHL therapy in AYAs is also likely to be advanced by novel therapies. Research endeavors include a multicenter collaboration between US and Canadian investigators that is exploring the combination of nivolumab (a checkpoint inhibitor) plus BV.²⁰ The trial recently completed accrual and includes both adult and pediatric patients. If novel agents prove effective for improving efficacy while reducing the risk of late complications in AYAs, they are expected to have a profound effect on clinical practice.

Arguably, the era of targeted and novel therapies in cHL was initiated more than 10 years ago with the introduction of BV for the treatment of advanced disease in older adults.²¹ BV was moved into the front line for patients 18 years of age or older with advanced cHL in a trial that compared the standard of ABVD to the same drugs with BV substituted for bleomycin.²² In this study, the BV-containing regimen was associated with a significantly improved progression-free survival (PFS) (P = .04) and a lower rate of adverse events, including pulmonary toxicity (1% vs 3%) after 2 years of follow-up.

A similar study recently associated a BV-containing regimen with even greater efficacy in pediatric high-risk cHL.²³ In this multicenter study with 600 treatment-naïve patients ranging in age from 2 to 21 years, the standard pediatric regimen of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide was compared to the same regimen with BV substituted for bleomycin. With event-free survival as the primary endpoint, the experimental regimen was associated with a nearly 60% reduction in the risk of an adverse event or death (HR 0.41). However, no substantial differences were noted in toxicity after a follow-up of 42 months. It not yet clear whether the elimination of bleomycin will translate into less late toxicity, such as pulmonary or cardiovascular morbidity.

In the era of targeted therapies, the experience with BV has been a step toward more effective treatments using novel mechanisms of action to improve outcomes when used in the first-line treatment of patients with high-risk disease. Historically, many regimens and treatments that have demonstrated efficacy in relapsed and refractory cHL have found their way into the first-line setting. This trend might also be true of the checkpoint inhibitors, which have been tested extensively in relapsed/refractory cHL. In AYA patients with cHL, the rationale for these treatments might not only include a poor predicted response to current regimens, but a reduced risk of late toxicities if long-term follow-up demonstrates these treatments reduce late complications, such as secondary malignancies, which are associated with standard strategies, particularly those that include radiotherapy.

If targeted therapies do preserve efficacy and reduce risk of late complications, strategies to individualize therapy will remain relevant. Many of the emerging targeted therapies involve challenging and costly treatment protocols that demand selective application. Efforts to develop simpler and more precise biomarkers might streamline this task. Of promising developments in this area, cell-free DNA (cfDNA) appears to be near routine clinical application. A small study of cfDNA conducted in 121 patients found that minimal residual disease assessment by repeat cfDNA sequencing predicted response and PFS when performed as early as a week after treatment initiation.²⁴ If larger studies confirm accuracy, this biomarker strategy might prove simpler and more convenient than PET imaging.

Summary

In the treatment of hematologic malignancies, cHL is widely regarded as a success story with high rates of extended survival among children, AYAs, and older adults. This level of success does not obviate the need for even more effective treatments, and also permits more attention to be directed to reducing the risk of late toxicities. For the AYA population, which represents a large group with cHL, the current directions of clinical research offer the promise of imminent changes in how the disease is controlled and a reduction in treatment-related late morbidity and mortality.

Click to read more from 2023 Rare Diseases Report: Cancers

Background

Hodgkin lymphoma occurs in fewer than 9,000 individuals in the United States each year,¹ but it is one of the most common types of cancer in AYAs.² For the purposes of cHL, AYA is typically defined as an age range of 18 to 39 years, which covers the first of 2 bimodal peaks in incidence but stops short of the second.^3,4 The first of these peaks occurs between the ages of 15 and 34 years, while the second begins at about age 55.⁵ Children younger than 15 years of age can also develop Hodgkin lymphoma, but it is less common.⁶

In AYAs and in adults, more than 90% of patients with Hodgkin lymphoma have cHL.⁷ Most AYAs present with the nodular sclerosis subtype, but cHL is managed differently in pediatric patients versus in adult centers.^8,9 Evidence suggests that the specific risks of common treatment protocols, although similar, are not the same in AYAs as in adults.^10,11 Even though the literature evaluating the presentation and management of AYA cHL has been growing since 2005, when the AYA Oncology Progress Review Group called for AYAs to be recognized
as a distinct group, clinical trials specific to AYA cHL remain limited.⁹

Major Hodgkin lymphoma guidelines only partially address AYAs as a distinct group. In guidelines issued by the National Cancer Institute, the differences in clinical presentation of AYAs are described for young children, AYAs, and older adults, but there are no treatment recommendations specific to AYAs.¹² Guidelines from the EuroNet Paediatric Hodgkin Lymphoma Group offer recommendations for relapsed and refractory Hodgkin lymphoma, but do not differentiate between children and adolescents.¹³ The National Comprehensive Cancer Network (NCCN) provides separate treatment recommendations for patients 18 years or younger and those who are older than 18.^14,15 For Hodgkin lymphoma, AYA is not addressed as a separate category even though the NCCN has provided general guidelines for treatment of malignancies in AYA.¹⁶

First-line therapies are effective in children, AYAs, and adults. Survival rates at 5 years have increased steadily, approaching or exceeding 90% across age groups even for patients with unfavorable risk characteristics.¹⁷ This success has permitted greater focus on developing strategies that preserve efficacy with lower acute and long-term risks.

Risk-Adapted Therapies

While the potential for new and novel therapies to reduce the risk of long-term toxicities continues to be explored, adjusting existing regimens to reduce these risks has proven to be a viable strategy. This adjustment is a standard of care in the pediatric setting based on results from such studies as German GPOH-HD 95, which suggested that doses of radiotherapy, a major contributor to late toxicities,¹⁸ can be omitted in patients with a complete response after chemotherapy.¹¹ This pediatric trial contained both younger children and adolescents, but subsequent secondary analyses looking specifically at AYAs in this and other trials have suggested that efficacy is similarly preserved with risk-adapted strategies.⁹

However, due to AYA patients with cHL being treated using both pediatric and adult approaches, the persistent debate about optimal therapies in this age group complicates the effort to define a well-accepted strategy for risk adjustment. While risk-adapted strategies that rely on interim positron emission tomography (PET) to calibrate treatment intensity are now being used routinely across age stratifications, other initiatives are creating additional opportunities to gauge the impact on late effects in AYAs. These include strategies to improve collaboration across groups of trialists and data generated by observational cohorts, which can evaluate late effects not captured in time-limited clinical trials.

Among recent data supporting risk-adjusted therapy, the toxicity outcomes from a multicenter trial of PET-guided intensive treatment in patients with newly diagnosed advanced cHL were presented at the 2022 annual meeting of the American Society of Hematology.¹⁹ This phase 3 trial enrolled patients younger than 60 years, 79% of whom were younger than 45 years. Building on previous evidence that PET guidance improves the safety of eBEACOPP (escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), nearly 1,500 patients were randomized to this strategy or to PET-guided BrECADD, a modified eBEACOPP in which the antibody conjugate brentuximab vedotin (BV) was substituted for bleomycin. For an adjudicated endpoint of treatment-related morbidity, the experimental BrECAAD regimen reduced the risk by nearly 30% (hazard ratio [HR] 0.72). It is unclear whether this strategy will be used in the United States, where trials have been built on ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) rather than BEACOPP.

Efficacy data from this trial are not yet available, and these data will be important. There is concern that PET-directed therapy might result in lower toxicity at a cost of reduced rates of disease control. It is possible that the serious consequences of late toxicities—including infertility, compromised cardiovascular function, secondary cancers, and other organ damage—might need to be balanced against some loss of efficacy.

Novel Targeted Therapies

The goal of reducing late toxicities of cHL therapy in AYAs is also likely to be advanced by novel therapies. Research endeavors include a multicenter collaboration between US and Canadian investigators that is exploring the combination of nivolumab (a checkpoint inhibitor) plus BV.²⁰ The trial recently completed accrual and includes both adult and pediatric patients. If novel agents prove effective for improving efficacy while reducing the risk of late complications in AYAs, they are expected to have a profound effect on clinical practice.

Arguably, the era of targeted and novel therapies in cHL was initiated more than 10 years ago with the introduction of BV for the treatment of advanced disease in older adults.²¹ BV was moved into the front line for patients 18 years of age or older with advanced cHL in a trial that compared the standard of ABVD to the same drugs with BV substituted for bleomycin.²² In this study, the BV-containing regimen was associated with a significantly improved progression-free survival (PFS) (P = .04) and a lower rate of adverse events, including pulmonary toxicity (1% vs 3%) after 2 years of follow-up.

A similar study recently associated a BV-containing regimen with even greater efficacy in pediatric high-risk cHL.²³ In this multicenter study with 600 treatment-naïve patients ranging in age from 2 to 21 years, the standard pediatric regimen of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide was compared to the same regimen with BV substituted for bleomycin. With event-free survival as the primary endpoint, the experimental regimen was associated with a nearly 60% reduction in the risk of an adverse event or death (HR 0.41). However, no substantial differences were noted in toxicity after a follow-up of 42 months. It not yet clear whether the elimination of bleomycin will translate into less late toxicity, such as pulmonary or cardiovascular morbidity.

In the era of targeted therapies, the experience with BV has been a step toward more effective treatments using novel mechanisms of action to improve outcomes when used in the first-line treatment of patients with high-risk disease. Historically, many regimens and treatments that have demonstrated efficacy in relapsed and refractory cHL have found their way into the first-line setting. This trend might also be true of the checkpoint inhibitors, which have been tested extensively in relapsed/refractory cHL. In AYA patients with cHL, the rationale for these treatments might not only include a poor predicted response to current regimens, but a reduced risk of late toxicities if long-term follow-up demonstrates these treatments reduce late complications, such as secondary malignancies, which are associated with standard strategies, particularly those that include radiotherapy.

If targeted therapies do preserve efficacy and reduce risk of late complications, strategies to individualize therapy will remain relevant. Many of the emerging targeted therapies involve challenging and costly treatment protocols that demand selective application. Efforts to develop simpler and more precise biomarkers might streamline this task. Of promising developments in this area, cell-free DNA (cfDNA) appears to be near routine clinical application. A small study of cfDNA conducted in 121 patients found that minimal residual disease assessment by repeat cfDNA sequencing predicted response and PFS when performed as early as a week after treatment initiation.²⁴ If larger studies confirm accuracy, this biomarker strategy might prove simpler and more convenient than PET imaging.

Summary

In the treatment of hematologic malignancies, cHL is widely regarded as a success story with high rates of extended survival among children, AYAs, and older adults. This level of success does not obviate the need for even more effective treatments, and also permits more attention to be directed to reducing the risk of late toxicities. For the AYA population, which represents a large group with cHL, the current directions of clinical research offer the promise of imminent changes in how the disease is controlled and a reduction in treatment-related late morbidity and mortality.

Click to read more from 2023 Rare Diseases Report: Cancers

Background

Hodgkin lymphoma occurs in fewer than 9,000 individuals in the United States each year,¹ but it is one of the most common types of cancer in AYAs.² For the purposes of cHL, AYA is typically defined as an age range of 18 to 39 years, which covers the first of 2 bimodal peaks in incidence but stops short of the second.^3,4 The first of these peaks occurs between the ages of 15 and 34 years, while the second begins at about age 55.⁵ Children younger than 15 years of age can also develop Hodgkin lymphoma, but it is less common.⁶

In AYAs and in adults, more than 90% of patients with Hodgkin lymphoma have cHL.⁷ Most AYAs present with the nodular sclerosis subtype, but cHL is managed differently in pediatric patients versus in adult centers.^8,9 Evidence suggests that the specific risks of common treatment protocols, although similar, are not the same in AYAs as in adults.^10,11 Even though the literature evaluating the presentation and management of AYA cHL has been growing since 2005, when the AYA Oncology Progress Review Group called for AYAs to be recognized
as a distinct group, clinical trials specific to AYA cHL remain limited.⁹

Major Hodgkin lymphoma guidelines only partially address AYAs as a distinct group. In guidelines issued by the National Cancer Institute, the differences in clinical presentation of AYAs are described for young children, AYAs, and older adults, but there are no treatment recommendations specific to AYAs.¹² Guidelines from the EuroNet Paediatric Hodgkin Lymphoma Group offer recommendations for relapsed and refractory Hodgkin lymphoma, but do not differentiate between children and adolescents.¹³ The National Comprehensive Cancer Network (NCCN) provides separate treatment recommendations for patients 18 years or younger and those who are older than 18.^14,15 For Hodgkin lymphoma, AYA is not addressed as a separate category even though the NCCN has provided general guidelines for treatment of malignancies in AYA.¹⁶

First-line therapies are effective in children, AYAs, and adults. Survival rates at 5 years have increased steadily, approaching or exceeding 90% across age groups even for patients with unfavorable risk characteristics.¹⁷ This success has permitted greater focus on developing strategies that preserve efficacy with lower acute and long-term risks.

Risk-Adapted Therapies

While the potential for new and novel therapies to reduce the risk of long-term toxicities continues to be explored, adjusting existing regimens to reduce these risks has proven to be a viable strategy. This adjustment is a standard of care in the pediatric setting based on results from such studies as German GPOH-HD 95, which suggested that doses of radiotherapy, a major contributor to late toxicities,¹⁸ can be omitted in patients with a complete response after chemotherapy.¹¹ This pediatric trial contained both younger children and adolescents, but subsequent secondary analyses looking specifically at AYAs in this and other trials have suggested that efficacy is similarly preserved with risk-adapted strategies.⁹

However, due to AYA patients with cHL being treated using both pediatric and adult approaches, the persistent debate about optimal therapies in this age group complicates the effort to define a well-accepted strategy for risk adjustment. While risk-adapted strategies that rely on interim positron emission tomography (PET) to calibrate treatment intensity are now being used routinely across age stratifications, other initiatives are creating additional opportunities to gauge the impact on late effects in AYAs. These include strategies to improve collaboration across groups of trialists and data generated by observational cohorts, which can evaluate late effects not captured in time-limited clinical trials.

Among recent data supporting risk-adjusted therapy, the toxicity outcomes from a multicenter trial of PET-guided intensive treatment in patients with newly diagnosed advanced cHL were presented at the 2022 annual meeting of the American Society of Hematology.¹⁹ This phase 3 trial enrolled patients younger than 60 years, 79% of whom were younger than 45 years. Building on previous evidence that PET guidance improves the safety of eBEACOPP (escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), nearly 1,500 patients were randomized to this strategy or to PET-guided BrECADD, a modified eBEACOPP in which the antibody conjugate brentuximab vedotin (BV) was substituted for bleomycin. For an adjudicated endpoint of treatment-related morbidity, the experimental BrECAAD regimen reduced the risk by nearly 30% (hazard ratio [HR] 0.72). It is unclear whether this strategy will be used in the United States, where trials have been built on ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) rather than BEACOPP.

Efficacy data from this trial are not yet available, and these data will be important. There is concern that PET-directed therapy might result in lower toxicity at a cost of reduced rates of disease control. It is possible that the serious consequences of late toxicities—including infertility, compromised cardiovascular function, secondary cancers, and other organ damage—might need to be balanced against some loss of efficacy.

Novel Targeted Therapies

The goal of reducing late toxicities of cHL therapy in AYAs is also likely to be advanced by novel therapies. Research endeavors include a multicenter collaboration between US and Canadian investigators that is exploring the combination of nivolumab (a checkpoint inhibitor) plus BV.²⁰ The trial recently completed accrual and includes both adult and pediatric patients. If novel agents prove effective for improving efficacy while reducing the risk of late complications in AYAs, they are expected to have a profound effect on clinical practice.

Arguably, the era of targeted and novel therapies in cHL was initiated more than 10 years ago with the introduction of BV for the treatment of advanced disease in older adults.²¹ BV was moved into the front line for patients 18 years of age or older with advanced cHL in a trial that compared the standard of ABVD to the same drugs with BV substituted for bleomycin.²² In this study, the BV-containing regimen was associated with a significantly improved progression-free survival (PFS) (P = .04) and a lower rate of adverse events, including pulmonary toxicity (1% vs 3%) after 2 years of follow-up.

A similar study recently associated a BV-containing regimen with even greater efficacy in pediatric high-risk cHL.²³ In this multicenter study with 600 treatment-naïve patients ranging in age from 2 to 21 years, the standard pediatric regimen of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide was compared to the same regimen with BV substituted for bleomycin. With event-free survival as the primary endpoint, the experimental regimen was associated with a nearly 60% reduction in the risk of an adverse event or death (HR 0.41). However, no substantial differences were noted in toxicity after a follow-up of 42 months. It not yet clear whether the elimination of bleomycin will translate into less late toxicity, such as pulmonary or cardiovascular morbidity.

In the era of targeted therapies, the experience with BV has been a step toward more effective treatments using novel mechanisms of action to improve outcomes when used in the first-line treatment of patients with high-risk disease. Historically, many regimens and treatments that have demonstrated efficacy in relapsed and refractory cHL have found their way into the first-line setting. This trend might also be true of the checkpoint inhibitors, which have been tested extensively in relapsed/refractory cHL. In AYA patients with cHL, the rationale for these treatments might not only include a poor predicted response to current regimens, but a reduced risk of late toxicities if long-term follow-up demonstrates these treatments reduce late complications, such as secondary malignancies, which are associated with standard strategies, particularly those that include radiotherapy.

If targeted therapies do preserve efficacy and reduce risk of late complications, strategies to individualize therapy will remain relevant. Many of the emerging targeted therapies involve challenging and costly treatment protocols that demand selective application. Efforts to develop simpler and more precise biomarkers might streamline this task. Of promising developments in this area, cell-free DNA (cfDNA) appears to be near routine clinical application. A small study of cfDNA conducted in 121 patients found that minimal residual disease assessment by repeat cfDNA sequencing predicted response and PFS when performed as early as a week after treatment initiation.²⁴ If larger studies confirm accuracy, this biomarker strategy might prove simpler and more convenient than PET imaging.

Summary

In the treatment of hematologic malignancies, cHL is widely regarded as a success story with high rates of extended survival among children, AYAs, and older adults. This level of success does not obviate the need for even more effective treatments, and also permits more attention to be directed to reducing the risk of late toxicities. For the AYA population, which represents a large group with cHL, the current directions of clinical research offer the promise of imminent changes in how the disease is controlled and a reduction in treatment-related late morbidity and mortality.

Click to read more from 2023 Rare Diseases Report: Cancers

REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.

REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.

REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

There is a tremendous amount of atopic dermatitis (AD) research underway. This month, we have several interesting articles to present.

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

I love articles like this one from Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

There is a tremendous amount of atopic dermatitis (AD) research underway. This month, we have several interesting articles to present.

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

I love articles like this one from Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

There is a tremendous amount of atopic dermatitis (AD) research underway. This month, we have several interesting articles to present.

Silverberg and colleagues described a very well-designed, vehicle-controlled, randomized 8-week study of a topical formulation of a purified strain of Nitrosomonas eutropha, an ammonia-oxidizing bacterium. In theory, this bacterium may reduce Staphylococcus aureus. The study compared two concentrations of the bacterium vs vehicle delivered as a spray twice per day. Study participants were adults with AD affecting 10%-40% of body surface area.

The study found "meaningful" improvements in itch and objective signs of disease, with clear separation between both doses of the bacterial spray compared with vehicle. At week 4, about 23% of participants treated with the bacterium were clear or almost clear (with a 2-point improvement) compared with 12% in the vehicle group (for comparison, in a phase 2 study comparing topical ruxolitinib with 0.1% triamcinolone cream, there was a 25% clear or almost clear rate [with 2-point improvement] in the triamcinolone-treated individuals).

Though an "all-natural" bacterial approach to managing AD may be appealing to some, it sounded like magic to me. But this well-done study makes it seem like the bacterial approach could be more promising than I had thought. This study also reported about twice as many adverse events (including gastrointestinal issues) with the bacterium-treated participants compared with those who received vehicle, adding to my belief that the bacterial product has efficacy. Whether any other topical will be more effective and safer than is topical triamcinolone remains to be seen. I'm still pessimistic about topicals because of patients' poor adherence to topical treatment, but perhaps an easy-to-use spray that isn't associated with patients' fear of "steroids" will be helpful.

I love articles like this one from Chen and colleagues. They analyzed data on hundreds of thousands of patients with and without AD. Adults with AD had a "significantly increased risk" of developing venous thromboembolism compared with adults without AD. The huge sample size of their study seems compelling. That huge sample size allows detection of effects so small that they may be clinically insignificant.

They report that patients with AD had a venous thromboembolism at a rate of 1.05/1000 patients-years; the rate was 0.82 for patients without AD. From that, we can calculate that there would be an additional 23 patients with venous thromboembolism for every 100,000 patient-years or about one more venous thromboembolism in the AD group in every 4000 patient-years. Though the finding was statistically significant, I don't think it is clinically meaningful.

The authors correctly conclude that "vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients with AD who present with relevant symptoms (eg, unexplained dyspnea, chest tightness, and limb swelling)." But it is probably also true that vascular examination and consultation with the emergency department, cardiologists, or pulmonologists are indicated for patients without AD who present with those symptoms. I think the authors might have been on solid ground if they had concluded that there was a statistically significant but clinically insignificant increased risk for venous thromboembolism in patients with AD.

Eichenfeld and colleagues examined the use of topical crisaborole once per day as a maintenance treatment for patients with mild to moderate AD. The study compared patients given topical crisaborole with those randomly assigned to vehicle. The active treatment was effective because topical crisaborole treated patients had longer times to the first flare following treatment and fewer flares over the 1 year of treatment. The differences were not huge, but I think they were clinically meaningful. I'm guessing that the topical crisaborole maintenance treatment would have been even more effective had it been used regularly. The study did not, as far as I could tell, assess how well the treatment was used.

An interesting aspect of this study is that it began with nearly 500 participants who started on twice daily topical crisaborole. The 270 patients who responded to the treatment (achieving clear or almost clear with at least a 2-point improvement) were enrolled in the 1-year maintenance phase. Thus, the participants in the maintenance phase were preselected for patients who respond to topical crisaborole. We don't know why they were responders (I, of course, expect it is because they selected for patients who are better than others are at using a topical treatment), but it may be best not to try to generalize these results and assume this form of maintenance treatment would work equally well in a population who achieve initial success with an oral therapy regimen (for example, a quick course of oral prednisone).

Dupilumab was a revolutionary treatment for AD. I didn't think that I'd ever see a more effective treatment. It's so safe too! It has been a first-line treatment for AD since its introduction. Now, we also have oral Janus kinase inhibitor options. Blauvelt and colleagues examined what happens when patients who have been on dupilumab are switched to a high dose (30 mg/d) of upadacitinib (the standard starting dose of upadacitinib is 15 mg/d). Though dupilumab is very effective, upadacitinib is more so. After 4 weeks of switching to upadacitinib, nearly half the patients were completely clear of AD compared with only 16.0% after 24 weeks of dupilumab! The authors point out, optimistically, that "No new safety risks were observed." Though there were no cancers, gastrointestinal perforations, major adverse cardiovascular events, or venous thromboembolic events, there were cases of eczema herpeticum and zoster in patients treated with upadacitinib. Having upadacitinib available for patients who fail dupilumab is a clear benefit; the role of upadacitinib before dupilumab seems less clear.

Patients doing great on dupilumab for AD may be wondering: Do I still need to take it every 2 weeks? Spekhorst and colleagues may have the answer. They describe the response to tapering dupilumab in patients who had been on the drug for at least 1 year with well-controlled disease for at least 6 months. Patients in the study then continued dupilumab with the longest possible dosing interval while maintaining control of their AD.

Generally, patients maintained good control of their AD, with only a small increase in mean disease severity and in concomitant use of topical steroids. For the patients who attempted prolongation, 83% successfully continued dupilumab treatment with a prolonged interval. Not at all surprisingly, the authors calculated that prolonging the interval between dosing led to large savings in cost.

One of the nice features of dupilumab treatment is that loss of response over time seems unusual. Perhaps there is a low propensity for forming antidrug antibodies when dupilumab is used in the standard every 2-week dosing regimen. I don't know whether antidrug antibodies would be more likely with the intermittent dosing regimen. But now that we have other good systemic treatment options for AD, losing dupilumab efficacy would not be as critical a problem as it used to be. I also want to point out that patients' adherence to injection treatment, though better than adherence to topicals, is far from perfect. It's likely that many patients have already been prolonging the interval between taking their treatments. If you want to know, just ask them. The way I like to phrase the question is: "Are you keeping the extra injectors you've accumulated refrigerated like you are supposed to?"

AUSTIN, TEX. – Self-treatment of migraines using cannabis can be effective but comes at risk of significant side effects, according to results from a randomized, controlled trial of cannabis products in migraine. The study also suggests that typical recreational doses may be higher than needed, and that products with a mixture of THC and CBD might limit adverse effects, according to lead author Nathaniel Schuster, MD.

“Patients are using cannabis on their own, treating themselves without us having known whether this is effective in a placebo-controlled study. Knowing that there’s a lot of interest in THC and CBD, [it would be useful to know] whether one or both might be effective, as well as a mix,” said Dr. Schuster in an interview. He presented the results at the annual meeting of the American Headache Society.

Dr. Schuster and colleagues tested a cannabis product with 6% THC based on prior studies showing efficacy of that concentration for other pain conditions, according to Dr. Schuster, who is an associate professor and associate clinical director at the University of California, San Diego, center for pain medicine. He added that the study is the first randomized, controlled trial of cannabis in migraine patients that he is aware of. “It’s just hard to do this research. It’s very regulated. We had to go through a lot of government approvals to do this,” he said.

The study produced a key message. “I think one of the really important things for patients to take from this is that recreational doses are probably not necessary. The doses that we studied are lower than people use recreationally. Patients who are self-treating on their own right now are probably using higher doses than they need for the purpose of treating migraine,” said Dr. Schuster.

He also pointed out that the results offer potential insight into reducing side effects. “If [patients] are using THC only, they can hopefully have less of the side effects and tolerate it better by using a THC-CBD mix,” said Dr. Schuster.
 

Four therapies tested

Participants in the study could self-treat up to four migraine attacks. They were instructed to treat each migraine with one of four therapies, which were provided in a randomized, double-blind order: These included a 6% THC formulation; a mix of THC (6%) and CBD (11%); a CBD 11% formulation; and placebo cannabis with THC and CBD removed by alcohol extraction. Participants filled out a questionnaire 2 hours after treatment, and were then allowed to use rescue treatments if needed, but not additional cannabis. The age range was from 21 to 65, and inclusion criteria included 2-23 migraine days per month. Exclusion criteria included a positive urine test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment.

The study included 73 patients who treated a migraine during the study period. There were 247 migraine attacks treated. Among participants, the median age was 41, 82.6% were female and 17.4% were male, and the median body mass index was 26.0 kg/m². Participants experienced a median of 15 headache days per month and 6 migraine days per month, and 27.2% had chronic migraine.

At 2 hours, pain relief occurred in 48.3% of placebo treatments, 54.4% of the CBD treatments, 70.5% of the THC treatments (P = .007 versus placebo), and 69.0% of the THC/CBD treatments (P = .014 versus placebo). At 2 hours, pain freedom occurred in 15.5% of the placebo treatments, 24.6% of the CBD treatments, 29.5% of the THC treatments, and 36.2% of the THC/CBD treatments (P = .010 versus placebo). At 2 hours, freedom from most bothersome symptoms (MBS) occurred in 36.2% of the placebo treatments, 43.9% of the CBD treatments, 49.2% of the THC treatments, and 62.1% of the THC/CBD treatments (P = .004 versus placebo).

To achieve at least a 20% improvement in pain relief, compared with placebo, the number needed to treat (NNT) with THC/CBD was five. For at least a 20% improvement in pain freedom, the NNT was five, and for a 20% improvement in freedom from most bothersome symptoms, the NNT was four.

Treatment with THC was associated with the highest frequency of any adverse event (31.0%), followed by CBD and THC/CBD (19.6% each), and placebo (5.0%). At 2 hours, 18.0% of the THC treatments had an adverse event, compared with 7.0% of the CBD treatments, 6.9% of the THC/CBD treatments, and 5.2% of placebo treatments.

The number needed to treat of five for pain relief was encouraging, according to Dr. Schuster. “It’s better than some other things, but at the expense of side effects. The side effects that we see are certainly higher with cannabis than it is with other migraine treatments that patients certainly should be using beforehand. There’s also a risk of addiction, which is a concern,” said Dr. Schuster.
 

Useful data but questions remain

Having a clinical trial will be useful for physicians, said Ali Ezzati, MD, who attended the session. “I think it was an impressive study. Obviously, there are some challenges with cannabis studies in the medical world because of the stigma that comes with it and also the possibility of inducing addiction [and] promoting that to patients. But at the end of the day, it’s very, very common for our patients to ask us about cannabinoid use, and we really don’t have data on it. I’m glad that there are people who are running these studies so we will be able at least to answer our patients,” said Dr. Ezzati, who is an associate professor of neurology at University of California, Irvine.

Dr. Ezzati also noted that clinical trials have investigated cannabinoid use for other types of pain, such as arthritic or generalized pain. Although he said that there are some clinical similarities between other types of pain and migraine, the pathophysiology appears to be unique, which means that more work needs to be done. “It will probably take 5 or 10 years to have sufficient data to give patients a direct path for using (cannabinoids),” said Dr. Ezzati.

The study was funded by the Migraine Research Foundation. Dr. Schuster has consulted with Schedule 1 Therapeutics and Vectura Fertin. Dr. Ezzati has no relevant financial disclosures.

AUSTIN, TEX. – Self-treatment of migraines using cannabis can be effective but comes at risk of significant side effects, according to results from a randomized, controlled trial of cannabis products in migraine. The study also suggests that typical recreational doses may be higher than needed, and that products with a mixture of THC and CBD might limit adverse effects, according to lead author Nathaniel Schuster, MD.

“Patients are using cannabis on their own, treating themselves without us having known whether this is effective in a placebo-controlled study. Knowing that there’s a lot of interest in THC and CBD, [it would be useful to know] whether one or both might be effective, as well as a mix,” said Dr. Schuster in an interview. He presented the results at the annual meeting of the American Headache Society.

Dr. Schuster and colleagues tested a cannabis product with 6% THC based on prior studies showing efficacy of that concentration for other pain conditions, according to Dr. Schuster, who is an associate professor and associate clinical director at the University of California, San Diego, center for pain medicine. He added that the study is the first randomized, controlled trial of cannabis in migraine patients that he is aware of. “It’s just hard to do this research. It’s very regulated. We had to go through a lot of government approvals to do this,” he said.

The study produced a key message. “I think one of the really important things for patients to take from this is that recreational doses are probably not necessary. The doses that we studied are lower than people use recreationally. Patients who are self-treating on their own right now are probably using higher doses than they need for the purpose of treating migraine,” said Dr. Schuster.

He also pointed out that the results offer potential insight into reducing side effects. “If [patients] are using THC only, they can hopefully have less of the side effects and tolerate it better by using a THC-CBD mix,” said Dr. Schuster.
 

Four therapies tested

Participants in the study could self-treat up to four migraine attacks. They were instructed to treat each migraine with one of four therapies, which were provided in a randomized, double-blind order: These included a 6% THC formulation; a mix of THC (6%) and CBD (11%); a CBD 11% formulation; and placebo cannabis with THC and CBD removed by alcohol extraction. Participants filled out a questionnaire 2 hours after treatment, and were then allowed to use rescue treatments if needed, but not additional cannabis. The age range was from 21 to 65, and inclusion criteria included 2-23 migraine days per month. Exclusion criteria included a positive urine test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment.

The study included 73 patients who treated a migraine during the study period. There were 247 migraine attacks treated. Among participants, the median age was 41, 82.6% were female and 17.4% were male, and the median body mass index was 26.0 kg/m². Participants experienced a median of 15 headache days per month and 6 migraine days per month, and 27.2% had chronic migraine.

At 2 hours, pain relief occurred in 48.3% of placebo treatments, 54.4% of the CBD treatments, 70.5% of the THC treatments (P = .007 versus placebo), and 69.0% of the THC/CBD treatments (P = .014 versus placebo). At 2 hours, pain freedom occurred in 15.5% of the placebo treatments, 24.6% of the CBD treatments, 29.5% of the THC treatments, and 36.2% of the THC/CBD treatments (P = .010 versus placebo). At 2 hours, freedom from most bothersome symptoms (MBS) occurred in 36.2% of the placebo treatments, 43.9% of the CBD treatments, 49.2% of the THC treatments, and 62.1% of the THC/CBD treatments (P = .004 versus placebo).

To achieve at least a 20% improvement in pain relief, compared with placebo, the number needed to treat (NNT) with THC/CBD was five. For at least a 20% improvement in pain freedom, the NNT was five, and for a 20% improvement in freedom from most bothersome symptoms, the NNT was four.

Treatment with THC was associated with the highest frequency of any adverse event (31.0%), followed by CBD and THC/CBD (19.6% each), and placebo (5.0%). At 2 hours, 18.0% of the THC treatments had an adverse event, compared with 7.0% of the CBD treatments, 6.9% of the THC/CBD treatments, and 5.2% of placebo treatments.

The number needed to treat of five for pain relief was encouraging, according to Dr. Schuster. “It’s better than some other things, but at the expense of side effects. The side effects that we see are certainly higher with cannabis than it is with other migraine treatments that patients certainly should be using beforehand. There’s also a risk of addiction, which is a concern,” said Dr. Schuster.
 

Useful data but questions remain

Having a clinical trial will be useful for physicians, said Ali Ezzati, MD, who attended the session. “I think it was an impressive study. Obviously, there are some challenges with cannabis studies in the medical world because of the stigma that comes with it and also the possibility of inducing addiction [and] promoting that to patients. But at the end of the day, it’s very, very common for our patients to ask us about cannabinoid use, and we really don’t have data on it. I’m glad that there are people who are running these studies so we will be able at least to answer our patients,” said Dr. Ezzati, who is an associate professor of neurology at University of California, Irvine.

Dr. Ezzati also noted that clinical trials have investigated cannabinoid use for other types of pain, such as arthritic or generalized pain. Although he said that there are some clinical similarities between other types of pain and migraine, the pathophysiology appears to be unique, which means that more work needs to be done. “It will probably take 5 or 10 years to have sufficient data to give patients a direct path for using (cannabinoids),” said Dr. Ezzati.

The study was funded by the Migraine Research Foundation. Dr. Schuster has consulted with Schedule 1 Therapeutics and Vectura Fertin. Dr. Ezzati has no relevant financial disclosures.

AUSTIN, TEX. – Self-treatment of migraines using cannabis can be effective but comes at risk of significant side effects, according to results from a randomized, controlled trial of cannabis products in migraine. The study also suggests that typical recreational doses may be higher than needed, and that products with a mixture of THC and CBD might limit adverse effects, according to lead author Nathaniel Schuster, MD.

“Patients are using cannabis on their own, treating themselves without us having known whether this is effective in a placebo-controlled study. Knowing that there’s a lot of interest in THC and CBD, [it would be useful to know] whether one or both might be effective, as well as a mix,” said Dr. Schuster in an interview. He presented the results at the annual meeting of the American Headache Society.

Dr. Schuster and colleagues tested a cannabis product with 6% THC based on prior studies showing efficacy of that concentration for other pain conditions, according to Dr. Schuster, who is an associate professor and associate clinical director at the University of California, San Diego, center for pain medicine. He added that the study is the first randomized, controlled trial of cannabis in migraine patients that he is aware of. “It’s just hard to do this research. It’s very regulated. We had to go through a lot of government approvals to do this,” he said.

The study produced a key message. “I think one of the really important things for patients to take from this is that recreational doses are probably not necessary. The doses that we studied are lower than people use recreationally. Patients who are self-treating on their own right now are probably using higher doses than they need for the purpose of treating migraine,” said Dr. Schuster.

He also pointed out that the results offer potential insight into reducing side effects. “If [patients] are using THC only, they can hopefully have less of the side effects and tolerate it better by using a THC-CBD mix,” said Dr. Schuster.
 

Four therapies tested

Participants in the study could self-treat up to four migraine attacks. They were instructed to treat each migraine with one of four therapies, which were provided in a randomized, double-blind order: These included a 6% THC formulation; a mix of THC (6%) and CBD (11%); a CBD 11% formulation; and placebo cannabis with THC and CBD removed by alcohol extraction. Participants filled out a questionnaire 2 hours after treatment, and were then allowed to use rescue treatments if needed, but not additional cannabis. The age range was from 21 to 65, and inclusion criteria included 2-23 migraine days per month. Exclusion criteria included a positive urine test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment.

The study included 73 patients who treated a migraine during the study period. There were 247 migraine attacks treated. Among participants, the median age was 41, 82.6% were female and 17.4% were male, and the median body mass index was 26.0 kg/m². Participants experienced a median of 15 headache days per month and 6 migraine days per month, and 27.2% had chronic migraine.

At 2 hours, pain relief occurred in 48.3% of placebo treatments, 54.4% of the CBD treatments, 70.5% of the THC treatments (P = .007 versus placebo), and 69.0% of the THC/CBD treatments (P = .014 versus placebo). At 2 hours, pain freedom occurred in 15.5% of the placebo treatments, 24.6% of the CBD treatments, 29.5% of the THC treatments, and 36.2% of the THC/CBD treatments (P = .010 versus placebo). At 2 hours, freedom from most bothersome symptoms (MBS) occurred in 36.2% of the placebo treatments, 43.9% of the CBD treatments, 49.2% of the THC treatments, and 62.1% of the THC/CBD treatments (P = .004 versus placebo).

To achieve at least a 20% improvement in pain relief, compared with placebo, the number needed to treat (NNT) with THC/CBD was five. For at least a 20% improvement in pain freedom, the NNT was five, and for a 20% improvement in freedom from most bothersome symptoms, the NNT was four.

Treatment with THC was associated with the highest frequency of any adverse event (31.0%), followed by CBD and THC/CBD (19.6% each), and placebo (5.0%). At 2 hours, 18.0% of the THC treatments had an adverse event, compared with 7.0% of the CBD treatments, 6.9% of the THC/CBD treatments, and 5.2% of placebo treatments.

The number needed to treat of five for pain relief was encouraging, according to Dr. Schuster. “It’s better than some other things, but at the expense of side effects. The side effects that we see are certainly higher with cannabis than it is with other migraine treatments that patients certainly should be using beforehand. There’s also a risk of addiction, which is a concern,” said Dr. Schuster.
 

Useful data but questions remain

Having a clinical trial will be useful for physicians, said Ali Ezzati, MD, who attended the session. “I think it was an impressive study. Obviously, there are some challenges with cannabis studies in the medical world because of the stigma that comes with it and also the possibility of inducing addiction [and] promoting that to patients. But at the end of the day, it’s very, very common for our patients to ask us about cannabinoid use, and we really don’t have data on it. I’m glad that there are people who are running these studies so we will be able at least to answer our patients,” said Dr. Ezzati, who is an associate professor of neurology at University of California, Irvine.

Dr. Ezzati also noted that clinical trials have investigated cannabinoid use for other types of pain, such as arthritic or generalized pain. Although he said that there are some clinical similarities between other types of pain and migraine, the pathophysiology appears to be unique, which means that more work needs to be done. “It will probably take 5 or 10 years to have sufficient data to give patients a direct path for using (cannabinoids),” said Dr. Ezzati.

The study was funded by the Migraine Research Foundation. Dr. Schuster has consulted with Schedule 1 Therapeutics and Vectura Fertin. Dr. Ezzati has no relevant financial disclosures.

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, highlights key abstracts on early breast cancer from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first reports on exciting results from the phase 3 NATALEE trial, which compared adjuvant use of CDK4/6 inhibitor ribociclib plus endocrine therapy (ET) vs ET alone in patients with HR+/HER2- early breast cancer and found that the combination lowered risk for recurrence.  

The results of NATALEE, together with the recent findings of the monarchE trial, provide strong evidence that the addition of a CDK4/6 inhibitor to ET is useful in the adjuvant setting. Dr Burstein suggests that these findings may point to an emerging treatment paradigm in HR+/HER2- patients, particularly those with higher-risk breast cancers. 

Dr Burstein next discusses important data from the Early Breast Cancer Trialists Collaborative Group (EBCTCG). Their meta-analysis of 25 randomized trials on ovarian ablation in premenopausal women showed that ovarian ablation provided a substantial reduction in 15-year risk for recurrence and death. 

Finally, Dr Burstein reports on data from an analysis of patients enrolled in the PENELOPE-B trial to assess the value of circulating tumor DNA (ctDNA) in predicting clinical relapse. Dr Burstein reports that the results indicated that ctDNA was a strong prognostic factor for disease recurrence. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, highlights key abstracts on early breast cancer from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first reports on exciting results from the phase 3 NATALEE trial, which compared adjuvant use of CDK4/6 inhibitor ribociclib plus endocrine therapy (ET) vs ET alone in patients with HR+/HER2- early breast cancer and found that the combination lowered risk for recurrence.  

The results of NATALEE, together with the recent findings of the monarchE trial, provide strong evidence that the addition of a CDK4/6 inhibitor to ET is useful in the adjuvant setting. Dr Burstein suggests that these findings may point to an emerging treatment paradigm in HR+/HER2- patients, particularly those with higher-risk breast cancers. 

Dr Burstein next discusses important data from the Early Breast Cancer Trialists Collaborative Group (EBCTCG). Their meta-analysis of 25 randomized trials on ovarian ablation in premenopausal women showed that ovarian ablation provided a substantial reduction in 15-year risk for recurrence and death. 

Finally, Dr Burstein reports on data from an analysis of patients enrolled in the PENELOPE-B trial to assess the value of circulating tumor DNA (ctDNA) in predicting clinical relapse. Dr Burstein reports that the results indicated that ctDNA was a strong prognostic factor for disease recurrence. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, highlights key abstracts on early breast cancer from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first reports on exciting results from the phase 3 NATALEE trial, which compared adjuvant use of CDK4/6 inhibitor ribociclib plus endocrine therapy (ET) vs ET alone in patients with HR+/HER2- early breast cancer and found that the combination lowered risk for recurrence.  

The results of NATALEE, together with the recent findings of the monarchE trial, provide strong evidence that the addition of a CDK4/6 inhibitor to ET is useful in the adjuvant setting. Dr Burstein suggests that these findings may point to an emerging treatment paradigm in HR+/HER2- patients, particularly those with higher-risk breast cancers. 

Dr Burstein next discusses important data from the Early Breast Cancer Trialists Collaborative Group (EBCTCG). Their meta-analysis of 25 randomized trials on ovarian ablation in premenopausal women showed that ovarian ablation provided a substantial reduction in 15-year risk for recurrence and death. 

Finally, Dr Burstein reports on data from an analysis of patients enrolled in the PENELOPE-B trial to assess the value of circulating tumor DNA (ctDNA) in predicting clinical relapse. Dr Burstein reports that the results indicated that ctDNA was a strong prognostic factor for disease recurrence. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, presents key abstracts on metastatic breast cancer (mBC) from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first highlights results from the SONIA study, which compared endocrine therapy followed by a CDK4/6 inhibitor in the second-line with the use of a CDK4/6 inhibitor in the first line. Although the CDK4/6 inhibitor in first-line improved progression-free survival, overall survival remained unchanged.  

Dr Burstein next discusses results from the CANKADO trial, which randomized patients with mBC to report symptoms via a smartphone app. The app users reported fewer adverse events and better quality of life. 

Dr Burstein reports on the potentially practice-changing results of the X-7/7 trial comparing a fixed dose of capecitabine (7/7) with the standard dose (14/7). Although both dosing schedules showed similar overall survival results, the fixed dose was better tolerated.  

Finally, Dr Burstein turns to advances in the use of antibody-drug conjugates (ADCs), starting with an update from the TROPiCS-02 study comparing sacituzumab govitecan (SG) with standard chemotherapy. The 12.75-month follow-up showed an overall survival benefit when using SG in third- or fourth-line treatment.  

He also highlights phase 2 trial results with another ADC, HER3-DXd (patritumab deruxtecan), which showed significant response rates across a broad range of HER3 expression levels. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, presents key abstracts on metastatic breast cancer (mBC) from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first highlights results from the SONIA study, which compared endocrine therapy followed by a CDK4/6 inhibitor in the second-line with the use of a CDK4/6 inhibitor in the first line. Although the CDK4/6 inhibitor in first-line improved progression-free survival, overall survival remained unchanged.  

Dr Burstein next discusses results from the CANKADO trial, which randomized patients with mBC to report symptoms via a smartphone app. The app users reported fewer adverse events and better quality of life. 

Dr Burstein reports on the potentially practice-changing results of the X-7/7 trial comparing a fixed dose of capecitabine (7/7) with the standard dose (14/7). Although both dosing schedules showed similar overall survival results, the fixed dose was better tolerated.  

Finally, Dr Burstein turns to advances in the use of antibody-drug conjugates (ADCs), starting with an update from the TROPiCS-02 study comparing sacituzumab govitecan (SG) with standard chemotherapy. The 12.75-month follow-up showed an overall survival benefit when using SG in third- or fourth-line treatment.  

He also highlights phase 2 trial results with another ADC, HER3-DXd (patritumab deruxtecan), which showed significant response rates across a broad range of HER3 expression levels. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Dr Harold J. Burstein, of the Dana-Farber Cancer Institute in Boston, Massachusetts, presents key abstracts on metastatic breast cancer (mBC) from the 2023 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr Burstein first highlights results from the SONIA study, which compared endocrine therapy followed by a CDK4/6 inhibitor in the second-line with the use of a CDK4/6 inhibitor in the first line. Although the CDK4/6 inhibitor in first-line improved progression-free survival, overall survival remained unchanged.  

Dr Burstein next discusses results from the CANKADO trial, which randomized patients with mBC to report symptoms via a smartphone app. The app users reported fewer adverse events and better quality of life. 

Dr Burstein reports on the potentially practice-changing results of the X-7/7 trial comparing a fixed dose of capecitabine (7/7) with the standard dose (14/7). Although both dosing schedules showed similar overall survival results, the fixed dose was better tolerated.  

Finally, Dr Burstein turns to advances in the use of antibody-drug conjugates (ADCs), starting with an update from the TROPiCS-02 study comparing sacituzumab govitecan (SG) with standard chemotherapy. The 12.75-month follow-up showed an overall survival benefit when using SG in third- or fourth-line treatment.  

He also highlights phase 2 trial results with another ADC, HER3-DXd (patritumab deruxtecan), which showed significant response rates across a broad range of HER3 expression levels. 

--

Harold J. Burstein, MD, PhD, Professor, Department of Medicine, Harvard Medical School; Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts 

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. 

Work-related musculoskeletal disorders (WMSDs) are “musculoskeletal disorders (injuries or disorders of the muscles, nerves, tendons, joints, cartilage, and spinal discs) in which the work environment and performance of work contribute significantly to the condition; and/or the condition is made worse or persists longer due to work conditions.”¹ The health care industry has one of the highest rates of WMSDs, even when compared with traditional labor-intensive occupations, such as coal mining. In 2017, the health care industry reported more than a half million incidents of work-related injury and illness.^2,3 In particular, surgeons are at increased risk for WMSDs, since they repetitively perform the classic tenets of poor ergonomics, including operating in static, extreme, and awkward positions and for prolonged periods of time.³

Gynecologic surgeons face unique ergonomic challenges. Operating in the pelvis requires an oblique approach that adds complexity and inhibits appropriate ergonomic positioning.⁴ All modalities of surgery incur their own challenges and risks to the surgeon, including minimally invasive gynecologic surgery (MIGS), which has become the standard of care for most conditions. Although MIGS has several benefits for the patient, a survey of gynecologic oncologists found that 88% of respondents reported discomfort related to MIGS.⁵ Several factors contribute to the development of WMSDs in surgery, including lack of ergonomic awareness, suboptimal ergonomic education and training,^5,6 and ergonomically poor operating room (OR) equipment and instrument design.⁷ Furthermore, surgical culture does not generally prioritize ergonomics in the OR or requests for ergonomic accommodations.^7,8

Within 5 years, a physician workforce shortage is projected for the United States.⁹ WMSDs contribute to workforce issues as they are associated with decreased productivity; time off needed for pain and treatment, including short-term disability; and possibly early retirement (as those who are older and have more work experience may be more likely to seek medical attention).¹⁰ In a 2013 study of vaginal surgeons, 14% missed work; 21% modified their work hours, work type, or amount of surgery; and 29% modified their surgical technique because of injury.¹⁰ Work-related pain also can negatively affect mental health, sleep, relationships, and quality of life.⁶

Recently, awareness has increased regarding WMSDs and their consequences, which has led to significant strides in the study of ergonomics among surgeons, a growing body of research on the topic, and guidance for optimizing ergonomics in the OR.

Risk factors for ergonomic strain

Several factors contribute to ergonomic strain and, subsequently, the development of WMSDs. Recognizing these factors can direct strategies for injury prevention.

Patient factors

The prevalence of obesity in the United States increased from 30.5% in 1999–2000 to 41.9% between 2017 and 2020.¹¹ As the average patient’s body mass index (BMI) has increased, there is concern for a parallel increase in the ergonomic strain on laparoscopic surgeons.

A study of simulated laparoscopic tasks at varying model BMI levels demonstrated increased surgeon postural stress and workload at higher model BMIs (50 kg/m²) when compared with lower model BMIs (20 and 30 kg/m²).¹¹ This result was supported in another study, which demonstrated both increased muscle activity and increased time needed to complete a surgical task with laparoscopic surgery; interestingly, when the same study measured these parameters for robotic surgery, this association was not seen.¹² This suggests that a robotic rather than a laparoscopic approach may avoid some of the ergonomic strain associated with increased patient BMI.

Continue to: Surgeon factors...

Surgeon factors

Various surgeon characteristics have been shown to influence ergonomics in the OR. Surgeons with smaller hand sizes, for example, reported greater physical discomfort and demonstrated greater ergonomic workload when operating laparoscopically.^13-15 In particular, those with a glove size of 6.5 or smaller have more difficulty using laparoscopic instruments, and those with a glove size smaller than 7 demonstrate a larger decline in grip strength when using laparoscopic instruments repeatedly.^14,16

Surgeon height also can affect the amount of time spent in high-risk, nonergonomic positions. In a study that evaluated video recordings of surgeon posture during gynecologic laparoscopy, shorter surgeons were noted to use greater degrees of neck rotation to look at the monitor.¹⁷ Furthermore, surgeons with shorter arm lengths experienced more “extreme positions” of the nondominant shoulder and elbow.¹⁷ This trend also was seen in open and robotic surgery, where surgeons with a height of 66 cm or less reported increased pain scores after operating.¹⁸

Surgical instruments and OR setup

Surgical instrument characteristics can contribute to ergonomic strain, especially when the instruments have been designed with a one-size-fits-all mentality.^8,19 In an examination of the anthropometric measurements of surgeon hand sizes and their correlation with difficulty when using a “standard” laparoscopic instrument, surgeons with smaller finger and hand spans had trouble using these instruments.¹⁹ Another study compared surgeon grip strength and ergonomic workloads after using 3 laparoscopic advanced bipolar instruments.¹⁶ Gender and hand size aside, the authors found that use of several of the laparoscopic devices led to greater decline in grip strength.¹⁶

The setup of the OR also can have a profound effect on the surgeon’s ergonomics. Monitor placement, for example, is crucial to ergonomic success. One study found that positioning the monitor directly in front of the surgeon at eye level was associated with the lowest neck muscle activity during a simulated task.²⁰

Route of surgery

Each surgical approach has intrinsic ergonomic risks. With laparoscopy, surgeons often remain in straight head and back positions without much trunk motion, especially when compared with open surgery.²¹ In one study, laparoscopic surgeons spent more than 60% of a case in a static position and more than 80% of a case in a high-risk, “demanding” neck position.²²

Robotic surgery, in contrast to laparoscopy, often has been cited as being more “ergonomic.” While robotic surgery has less of an effect on the neck, shoulders, arms, and legs than laparoscopy²³ and often is associated with less physical discomfort than either open or laparoscopic surgery,^23,24 robotic surgery still maintains its own innate ergonomic risks. Of robotic surgeons surveyed, 56.1% reported neck stiffness, finger fatigue, and eye symptoms in one study.²⁵ In another survey study, more robotic surgeons (72%) reported physical symptoms than laparoscopic (57%) and open (49%) surgeons.²⁶Vaginal surgery also puts surgeons at ergonomic risk. A majority of surgeons (87.2%) who completed more than 50% of their cases vaginally reported a history of WMSDs.¹⁰ Vaginal surgery places surgeons in awkward positions of the neck, shoulder, and trunk frequently and for longer durations.²⁷

Continue to: Strategies for preventing WMSDs...

Strategies for preventing WMSDs

As factors that contribute to the development of WMSDs are identified, preventive strategies can be targeted to these individual factors. Research has focused on appropriate setup of the OR, surgeon posture, intraoperative microbreaks, and stretching both in and outside of the OR.

1. OR setup and positioning of the surgeon by MIGS route

The route of MIGS affects OR setup and surgeon posture. Ergonomic recommendations for laparoscopy, robotic surgery, and vaginal surgery are all unique to the risks posed by each particular approach.

Laparoscopic surgery. Laparoscopic monitors should face the surgeon directly, with the screen just below eye level to maintain the surgeon’s neck in a neutral position.²⁸ The table height should be set for the tallest surgeon, and shorter surgeons should stand on steps as needed.²⁸ The table height also should allow for the surgeon’s hands to be at elbow height, with the elbows bent at 90 degrees with the wrists straight.²⁹ Foot pedals should be placed at the surgeons’ foot level and should be reached easily.²⁸ Additionally, the patient’s arms should be tucked at their sides to allow surgeons a larger operative space.²⁹ When using laparoscopic instruments, locking and ratcheting features should be used whenever possible to reduce prolonged grip or squeeze forces.²⁸ The laparoscopic camera should be held in the palm with the wrist in a neutral position.²⁹

Robotic surgery. Positioning and setup of the robotic console is a main focus of ergonomic recommendations. The surgeon’s chair should be brought as close to the console as possible, and the knees positioned in a 90-degree angle.³⁰ The foot pedals should be brought toward the surgeon to maintain this angle of the knees.³⁰ The console should be rotated toward the surgeon and then the height adjusted so that the surgeon can look through the eyepiece while sitting upright and can maintain the neck in a neutral position.^28,30 The surgeon’s forehead should rest comfortably on the headrest.²⁹ The forearms should rest on the armrest while the arms are maintained in a neutral position and the shoulders remain relaxed while the surgeon holds the robotic controls.³⁰ It is important to utilize the armrest often to relieve stress on the arm while operating.²⁸ Frequent use of the clutch function can keep the robotic controls in the center of the workspace.²⁸

Vaginal surgery. Both seated and standing positions are associated with high-risk positioning of the trunk and bilateral shoulders, respectively, in vaginal surgery.³¹ However, surgeons who stand while operating vaginally reported more discomfort in the bilateral wrists, thighs, and lower legs than those who operated while seated.³¹ This suggests a potential ergonomic advantage to the seated position for vaginal surgery. Chair height should be adjusted so the surgeon can look straight ahead with the neck in a neutral position.³² Surgeons should consider using a headlamp, as this may prevent repetitive awkward movements to adjust overhead lights.³² For standing surgery, the table height should be adjusted for the tallest surgeon, and shorter surgeons or assistants should use steps as needed.³

Surgical assistants should switch sides during the course of the case to avoid excessive unilateral upper-extremity strain.³² The addition of a table-mounted vaginal retractor system may be useful in relieving physical strain for surgical assistants, but data currently are lacking to demonstrate this ergonomic benefit.³³ Further studies are needed, especially since many surgeons take on the role of surgical assist in the teaching environment and subsequently report more WMSDs than their colleagues who do not work in teaching environments.^10,34

2. Pain relief from individual ergonomic positioning devices

Apart from adjusting how the OR equipment is arranged or how the surgeons adjust their positioning, several devices that assist with surgeon positioning—including gel mats or insoles, exoskeletons, and “augmented reality” glasses—are being studied.

The use of gel mats or insoles in the OR has mixed evidence in the literature.^35-37

Exoskeletons, external devices that support a surgeon’s posture and positioning, have been studied thus far in simulated nonsterile surgical environments. Preliminarily, it appears that use of an exoskeleton can decrease muscle activity and time spent in static positions, with a reported decrease in post-task user discomfort.^38,39 More data are needed to determine if exoskeletons can be used in the sterile setting and for longer durations as may occur in actual OR cases.

Augmented reality glasses project the laparoscopic monitor image to the glasses, which frees the surgeon to place the “monitor” in a more neutral, ergonomic position. In one study, use of augmented reality glasses was associated with decreased muscle activity and a reduction in Rapid Entire Body Assessment (REBA) scores when compared with use of the conventional laparoscopic monitor.⁴⁰More data are needed on these emerging technologies to determine whether adverse effects occur with prolonged use.

Continue to: 3. Implementing intraoperative microbreaks and stretching...

The American College of Surgeons (ACS) recommends that surgeons avoid prolonged static postures during procedures.²⁸ One strategy for preventing sustained positioning is to incorporate breaks with associated stretching routinely during surgery.²⁸

Microbreaks. In a landmark study by Park and colleagues in 2017, 120-second long targeted stretching microbreaks (TSMBs) were completed every 20 to 40 minutes during a surgery, and results demonstrated improved postoperative surgeon pain scores without an associated increase in the length of the case.⁴¹ These surgeons reported improved pain in the neck, bilateral shoulders, bilateral hands, and lower back. Eighty-eight percent of surgeons reported either improvement or “no change” in their mental focus, and 100% reported improvement or “no change” in their physical performance after TSMBs were implemented.⁴² Of surveyed surgeons, 87% wanted TSMBs incorporated routinely.^41,42

Stretches. Multiple resources, such as the ACS and the Mayo Clinic, for intraoperative stretches are available. The ACS recommends performing neck and shoulder stretches during intraoperative microbreaks, including a range-of-movement neck exercise, deep cervical flexor training, and standing scapular retraction.²⁸ The ACS also demonstrates lumbrical stretches for the fingers and passive wrist extension exercises to be used intraoperatively (or between cases) (FIGURE 1).²⁸ The Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR Stretch Instructional Video” in which the surgeon is guided through several different short stretches, including shoulder shrugging and side bends, that can be used during surgery.⁴³

Both the ACS and the Mayo Clinic provide examples of pertinent stretch exercises for use when not in the sterile environment, between cases or after cases are complete. The ACS recommends several neck and shoulder stretches for the trapezius, levator scapulae, and pectoralis and recommends the use of a foam roller to improve thoracic mobility (FIGURE 2).²⁸ As above, the Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR-Stretch Between Surgery Stretches Video” in which the surgeon is guided through several short stretches that are done in a seated position, including stretches for the hamstring, lower back, and arms (FIGURE 3).⁴³

Many of the above-mentioned stretches were designed for use in the context of open, laparoscopic, or robotic surgery. For the vaginal surgeon, the intraoperative ergonomic stressors differ from those of other routes of surgery, and thus stretches tailored to the positioning during vaginal surgery are necessary. In a video recently published by the Society of Gynecologic Surgeons, several stretches are reviewed that target high-risk positions often held by the surgeon or assistant when operating vaginally.⁴⁴ These stretches include cervical retraction, thoracic extension, external arm rotation, cervical side bending, and lumbar extension (FIGURE 4).⁴⁴ The recommendation is to complete these exercises 2 times per day, with 8 to 10 repetitions per set.⁴⁴

Prioritizing ergonomic awareness and training

As caregivers, it is not uncommon for us to prioritize the needs of others before those of ourselves. However, WMSDs are prevalent, and their downstream effects may cause catastrophic professional and personal losses. Cumulatively, the global impact of WMSDs is a significant issue for the health care workforce and its longevity.

To prevent WMSDs, it is imperative that surgeons are aware of the factors that contribute to injury development and the appropriate, accessible modifications for these factors. While each surgical modality confers its own ergonomic challenges, these risks can be mitigated through increased awareness of OR setup, surgeon positioning, and incorporation of microbreaks and stretching exercises during and after surgical procedures.

Formal training in surgical ergonomics is lacking across specialties, including gynecology.⁴⁵ Multiple educational interventions have been proposed and studied to help fill this training gap.^30,46-49When used, these interventions have been associated with increased knowledge of surgical ergonomic principles or reduction in surgeon pain scores, including trainees.⁵⁰ As we become more cognizant of WMSDs, standardized resident curricula should be developed in an effort to reduce the prevalence of these potentially career-ending injuries.

In addition to education, cultivating a culture in which ergonomics is prioritized is essential. Although most surgeons report work-related pain, very few report their injuries to occupational health. For example, while 29% of gynecologic oncologists reported seeking treatment for a WMSD, only 1% had reported their injury to their employer.⁵ In a study of ACS members, only 19% of injuries were reported, 30% of surgeons stated that they did not know how to report an injury, and 21% felt that the resources for surgeons during and after an injury were inadequate.⁶

As we prioritize the health and safety of our patients, we also need to promote ergonomic awareness in the OR, respect the need for accommodations, encourage injury reporting, support surgeons who need to take time away for medical treatment, and partner with industry to develop new instruments and technology with effective ergonomic features. ●

Work-related musculoskeletal disorders (WMSDs) are “musculoskeletal disorders (injuries or disorders of the muscles, nerves, tendons, joints, cartilage, and spinal discs) in which the work environment and performance of work contribute significantly to the condition; and/or the condition is made worse or persists longer due to work conditions.”¹ The health care industry has one of the highest rates of WMSDs, even when compared with traditional labor-intensive occupations, such as coal mining. In 2017, the health care industry reported more than a half million incidents of work-related injury and illness.^2,3 In particular, surgeons are at increased risk for WMSDs, since they repetitively perform the classic tenets of poor ergonomics, including operating in static, extreme, and awkward positions and for prolonged periods of time.³

Gynecologic surgeons face unique ergonomic challenges. Operating in the pelvis requires an oblique approach that adds complexity and inhibits appropriate ergonomic positioning.⁴ All modalities of surgery incur their own challenges and risks to the surgeon, including minimally invasive gynecologic surgery (MIGS), which has become the standard of care for most conditions. Although MIGS has several benefits for the patient, a survey of gynecologic oncologists found that 88% of respondents reported discomfort related to MIGS.⁵ Several factors contribute to the development of WMSDs in surgery, including lack of ergonomic awareness, suboptimal ergonomic education and training,^5,6 and ergonomically poor operating room (OR) equipment and instrument design.⁷ Furthermore, surgical culture does not generally prioritize ergonomics in the OR or requests for ergonomic accommodations.^7,8

Within 5 years, a physician workforce shortage is projected for the United States.⁹ WMSDs contribute to workforce issues as they are associated with decreased productivity; time off needed for pain and treatment, including short-term disability; and possibly early retirement (as those who are older and have more work experience may be more likely to seek medical attention).¹⁰ In a 2013 study of vaginal surgeons, 14% missed work; 21% modified their work hours, work type, or amount of surgery; and 29% modified their surgical technique because of injury.¹⁰ Work-related pain also can negatively affect mental health, sleep, relationships, and quality of life.⁶

Recently, awareness has increased regarding WMSDs and their consequences, which has led to significant strides in the study of ergonomics among surgeons, a growing body of research on the topic, and guidance for optimizing ergonomics in the OR.

Risk factors for ergonomic strain

Several factors contribute to ergonomic strain and, subsequently, the development of WMSDs. Recognizing these factors can direct strategies for injury prevention.

Patient factors

The prevalence of obesity in the United States increased from 30.5% in 1999–2000 to 41.9% between 2017 and 2020.¹¹ As the average patient’s body mass index (BMI) has increased, there is concern for a parallel increase in the ergonomic strain on laparoscopic surgeons.

A study of simulated laparoscopic tasks at varying model BMI levels demonstrated increased surgeon postural stress and workload at higher model BMIs (50 kg/m²) when compared with lower model BMIs (20 and 30 kg/m²).¹¹ This result was supported in another study, which demonstrated both increased muscle activity and increased time needed to complete a surgical task with laparoscopic surgery; interestingly, when the same study measured these parameters for robotic surgery, this association was not seen.¹² This suggests that a robotic rather than a laparoscopic approach may avoid some of the ergonomic strain associated with increased patient BMI.

Continue to: Surgeon factors...

Surgeon factors

Various surgeon characteristics have been shown to influence ergonomics in the OR. Surgeons with smaller hand sizes, for example, reported greater physical discomfort and demonstrated greater ergonomic workload when operating laparoscopically.^13-15 In particular, those with a glove size of 6.5 or smaller have more difficulty using laparoscopic instruments, and those with a glove size smaller than 7 demonstrate a larger decline in grip strength when using laparoscopic instruments repeatedly.^14,16

Surgeon height also can affect the amount of time spent in high-risk, nonergonomic positions. In a study that evaluated video recordings of surgeon posture during gynecologic laparoscopy, shorter surgeons were noted to use greater degrees of neck rotation to look at the monitor.¹⁷ Furthermore, surgeons with shorter arm lengths experienced more “extreme positions” of the nondominant shoulder and elbow.¹⁷ This trend also was seen in open and robotic surgery, where surgeons with a height of 66 cm or less reported increased pain scores after operating.¹⁸

Surgical instruments and OR setup

Surgical instrument characteristics can contribute to ergonomic strain, especially when the instruments have been designed with a one-size-fits-all mentality.^8,19 In an examination of the anthropometric measurements of surgeon hand sizes and their correlation with difficulty when using a “standard” laparoscopic instrument, surgeons with smaller finger and hand spans had trouble using these instruments.¹⁹ Another study compared surgeon grip strength and ergonomic workloads after using 3 laparoscopic advanced bipolar instruments.¹⁶ Gender and hand size aside, the authors found that use of several of the laparoscopic devices led to greater decline in grip strength.¹⁶

The setup of the OR also can have a profound effect on the surgeon’s ergonomics. Monitor placement, for example, is crucial to ergonomic success. One study found that positioning the monitor directly in front of the surgeon at eye level was associated with the lowest neck muscle activity during a simulated task.²⁰

Route of surgery

Each surgical approach has intrinsic ergonomic risks. With laparoscopy, surgeons often remain in straight head and back positions without much trunk motion, especially when compared with open surgery.²¹ In one study, laparoscopic surgeons spent more than 60% of a case in a static position and more than 80% of a case in a high-risk, “demanding” neck position.²²

Robotic surgery, in contrast to laparoscopy, often has been cited as being more “ergonomic.” While robotic surgery has less of an effect on the neck, shoulders, arms, and legs than laparoscopy²³ and often is associated with less physical discomfort than either open or laparoscopic surgery,^23,24 robotic surgery still maintains its own innate ergonomic risks. Of robotic surgeons surveyed, 56.1% reported neck stiffness, finger fatigue, and eye symptoms in one study.²⁵ In another survey study, more robotic surgeons (72%) reported physical symptoms than laparoscopic (57%) and open (49%) surgeons.²⁶Vaginal surgery also puts surgeons at ergonomic risk. A majority of surgeons (87.2%) who completed more than 50% of their cases vaginally reported a history of WMSDs.¹⁰ Vaginal surgery places surgeons in awkward positions of the neck, shoulder, and trunk frequently and for longer durations.²⁷

Continue to: Strategies for preventing WMSDs...

Strategies for preventing WMSDs

As factors that contribute to the development of WMSDs are identified, preventive strategies can be targeted to these individual factors. Research has focused on appropriate setup of the OR, surgeon posture, intraoperative microbreaks, and stretching both in and outside of the OR.

1. OR setup and positioning of the surgeon by MIGS route

The route of MIGS affects OR setup and surgeon posture. Ergonomic recommendations for laparoscopy, robotic surgery, and vaginal surgery are all unique to the risks posed by each particular approach.

Laparoscopic surgery. Laparoscopic monitors should face the surgeon directly, with the screen just below eye level to maintain the surgeon’s neck in a neutral position.²⁸ The table height should be set for the tallest surgeon, and shorter surgeons should stand on steps as needed.²⁸ The table height also should allow for the surgeon’s hands to be at elbow height, with the elbows bent at 90 degrees with the wrists straight.²⁹ Foot pedals should be placed at the surgeons’ foot level and should be reached easily.²⁸ Additionally, the patient’s arms should be tucked at their sides to allow surgeons a larger operative space.²⁹ When using laparoscopic instruments, locking and ratcheting features should be used whenever possible to reduce prolonged grip or squeeze forces.²⁸ The laparoscopic camera should be held in the palm with the wrist in a neutral position.²⁹

Robotic surgery. Positioning and setup of the robotic console is a main focus of ergonomic recommendations. The surgeon’s chair should be brought as close to the console as possible, and the knees positioned in a 90-degree angle.³⁰ The foot pedals should be brought toward the surgeon to maintain this angle of the knees.³⁰ The console should be rotated toward the surgeon and then the height adjusted so that the surgeon can look through the eyepiece while sitting upright and can maintain the neck in a neutral position.^28,30 The surgeon’s forehead should rest comfortably on the headrest.²⁹ The forearms should rest on the armrest while the arms are maintained in a neutral position and the shoulders remain relaxed while the surgeon holds the robotic controls.³⁰ It is important to utilize the armrest often to relieve stress on the arm while operating.²⁸ Frequent use of the clutch function can keep the robotic controls in the center of the workspace.²⁸

Vaginal surgery. Both seated and standing positions are associated with high-risk positioning of the trunk and bilateral shoulders, respectively, in vaginal surgery.³¹ However, surgeons who stand while operating vaginally reported more discomfort in the bilateral wrists, thighs, and lower legs than those who operated while seated.³¹ This suggests a potential ergonomic advantage to the seated position for vaginal surgery. Chair height should be adjusted so the surgeon can look straight ahead with the neck in a neutral position.³² Surgeons should consider using a headlamp, as this may prevent repetitive awkward movements to adjust overhead lights.³² For standing surgery, the table height should be adjusted for the tallest surgeon, and shorter surgeons or assistants should use steps as needed.³

Surgical assistants should switch sides during the course of the case to avoid excessive unilateral upper-extremity strain.³² The addition of a table-mounted vaginal retractor system may be useful in relieving physical strain for surgical assistants, but data currently are lacking to demonstrate this ergonomic benefit.³³ Further studies are needed, especially since many surgeons take on the role of surgical assist in the teaching environment and subsequently report more WMSDs than their colleagues who do not work in teaching environments.^10,34

2. Pain relief from individual ergonomic positioning devices

Apart from adjusting how the OR equipment is arranged or how the surgeons adjust their positioning, several devices that assist with surgeon positioning—including gel mats or insoles, exoskeletons, and “augmented reality” glasses—are being studied.

The use of gel mats or insoles in the OR has mixed evidence in the literature.^35-37

Exoskeletons, external devices that support a surgeon’s posture and positioning, have been studied thus far in simulated nonsterile surgical environments. Preliminarily, it appears that use of an exoskeleton can decrease muscle activity and time spent in static positions, with a reported decrease in post-task user discomfort.^38,39 More data are needed to determine if exoskeletons can be used in the sterile setting and for longer durations as may occur in actual OR cases.

Augmented reality glasses project the laparoscopic monitor image to the glasses, which frees the surgeon to place the “monitor” in a more neutral, ergonomic position. In one study, use of augmented reality glasses was associated with decreased muscle activity and a reduction in Rapid Entire Body Assessment (REBA) scores when compared with use of the conventional laparoscopic monitor.⁴⁰More data are needed on these emerging technologies to determine whether adverse effects occur with prolonged use.

Continue to: 3. Implementing intraoperative microbreaks and stretching...

The American College of Surgeons (ACS) recommends that surgeons avoid prolonged static postures during procedures.²⁸ One strategy for preventing sustained positioning is to incorporate breaks with associated stretching routinely during surgery.²⁸

Microbreaks. In a landmark study by Park and colleagues in 2017, 120-second long targeted stretching microbreaks (TSMBs) were completed every 20 to 40 minutes during a surgery, and results demonstrated improved postoperative surgeon pain scores without an associated increase in the length of the case.⁴¹ These surgeons reported improved pain in the neck, bilateral shoulders, bilateral hands, and lower back. Eighty-eight percent of surgeons reported either improvement or “no change” in their mental focus, and 100% reported improvement or “no change” in their physical performance after TSMBs were implemented.⁴² Of surveyed surgeons, 87% wanted TSMBs incorporated routinely.^41,42

Stretches. Multiple resources, such as the ACS and the Mayo Clinic, for intraoperative stretches are available. The ACS recommends performing neck and shoulder stretches during intraoperative microbreaks, including a range-of-movement neck exercise, deep cervical flexor training, and standing scapular retraction.²⁸ The ACS also demonstrates lumbrical stretches for the fingers and passive wrist extension exercises to be used intraoperatively (or between cases) (FIGURE 1).²⁸ The Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR Stretch Instructional Video” in which the surgeon is guided through several different short stretches, including shoulder shrugging and side bends, that can be used during surgery.⁴³

Both the ACS and the Mayo Clinic provide examples of pertinent stretch exercises for use when not in the sterile environment, between cases or after cases are complete. The ACS recommends several neck and shoulder stretches for the trapezius, levator scapulae, and pectoralis and recommends the use of a foam roller to improve thoracic mobility (FIGURE 2).²⁸ As above, the Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR-Stretch Between Surgery Stretches Video” in which the surgeon is guided through several short stretches that are done in a seated position, including stretches for the hamstring, lower back, and arms (FIGURE 3).⁴³

Many of the above-mentioned stretches were designed for use in the context of open, laparoscopic, or robotic surgery. For the vaginal surgeon, the intraoperative ergonomic stressors differ from those of other routes of surgery, and thus stretches tailored to the positioning during vaginal surgery are necessary. In a video recently published by the Society of Gynecologic Surgeons, several stretches are reviewed that target high-risk positions often held by the surgeon or assistant when operating vaginally.⁴⁴ These stretches include cervical retraction, thoracic extension, external arm rotation, cervical side bending, and lumbar extension (FIGURE 4).⁴⁴ The recommendation is to complete these exercises 2 times per day, with 8 to 10 repetitions per set.⁴⁴

Prioritizing ergonomic awareness and training

As caregivers, it is not uncommon for us to prioritize the needs of others before those of ourselves. However, WMSDs are prevalent, and their downstream effects may cause catastrophic professional and personal losses. Cumulatively, the global impact of WMSDs is a significant issue for the health care workforce and its longevity.

To prevent WMSDs, it is imperative that surgeons are aware of the factors that contribute to injury development and the appropriate, accessible modifications for these factors. While each surgical modality confers its own ergonomic challenges, these risks can be mitigated through increased awareness of OR setup, surgeon positioning, and incorporation of microbreaks and stretching exercises during and after surgical procedures.

Formal training in surgical ergonomics is lacking across specialties, including gynecology.⁴⁵ Multiple educational interventions have been proposed and studied to help fill this training gap.^30,46-49When used, these interventions have been associated with increased knowledge of surgical ergonomic principles or reduction in surgeon pain scores, including trainees.⁵⁰ As we become more cognizant of WMSDs, standardized resident curricula should be developed in an effort to reduce the prevalence of these potentially career-ending injuries.

In addition to education, cultivating a culture in which ergonomics is prioritized is essential. Although most surgeons report work-related pain, very few report their injuries to occupational health. For example, while 29% of gynecologic oncologists reported seeking treatment for a WMSD, only 1% had reported their injury to their employer.⁵ In a study of ACS members, only 19% of injuries were reported, 30% of surgeons stated that they did not know how to report an injury, and 21% felt that the resources for surgeons during and after an injury were inadequate.⁶

As we prioritize the health and safety of our patients, we also need to promote ergonomic awareness in the OR, respect the need for accommodations, encourage injury reporting, support surgeons who need to take time away for medical treatment, and partner with industry to develop new instruments and technology with effective ergonomic features. ●

Work-related musculoskeletal disorders (WMSDs) are “musculoskeletal disorders (injuries or disorders of the muscles, nerves, tendons, joints, cartilage, and spinal discs) in which the work environment and performance of work contribute significantly to the condition; and/or the condition is made worse or persists longer due to work conditions.”¹ The health care industry has one of the highest rates of WMSDs, even when compared with traditional labor-intensive occupations, such as coal mining. In 2017, the health care industry reported more than a half million incidents of work-related injury and illness.^2,3 In particular, surgeons are at increased risk for WMSDs, since they repetitively perform the classic tenets of poor ergonomics, including operating in static, extreme, and awkward positions and for prolonged periods of time.³

Gynecologic surgeons face unique ergonomic challenges. Operating in the pelvis requires an oblique approach that adds complexity and inhibits appropriate ergonomic positioning.⁴ All modalities of surgery incur their own challenges and risks to the surgeon, including minimally invasive gynecologic surgery (MIGS), which has become the standard of care for most conditions. Although MIGS has several benefits for the patient, a survey of gynecologic oncologists found that 88% of respondents reported discomfort related to MIGS.⁵ Several factors contribute to the development of WMSDs in surgery, including lack of ergonomic awareness, suboptimal ergonomic education and training,^5,6 and ergonomically poor operating room (OR) equipment and instrument design.⁷ Furthermore, surgical culture does not generally prioritize ergonomics in the OR or requests for ergonomic accommodations.^7,8

Within 5 years, a physician workforce shortage is projected for the United States.⁹ WMSDs contribute to workforce issues as they are associated with decreased productivity; time off needed for pain and treatment, including short-term disability; and possibly early retirement (as those who are older and have more work experience may be more likely to seek medical attention).¹⁰ In a 2013 study of vaginal surgeons, 14% missed work; 21% modified their work hours, work type, or amount of surgery; and 29% modified their surgical technique because of injury.¹⁰ Work-related pain also can negatively affect mental health, sleep, relationships, and quality of life.⁶

Recently, awareness has increased regarding WMSDs and their consequences, which has led to significant strides in the study of ergonomics among surgeons, a growing body of research on the topic, and guidance for optimizing ergonomics in the OR.

Risk factors for ergonomic strain

Several factors contribute to ergonomic strain and, subsequently, the development of WMSDs. Recognizing these factors can direct strategies for injury prevention.

Patient factors

The prevalence of obesity in the United States increased from 30.5% in 1999–2000 to 41.9% between 2017 and 2020.¹¹ As the average patient’s body mass index (BMI) has increased, there is concern for a parallel increase in the ergonomic strain on laparoscopic surgeons.

A study of simulated laparoscopic tasks at varying model BMI levels demonstrated increased surgeon postural stress and workload at higher model BMIs (50 kg/m²) when compared with lower model BMIs (20 and 30 kg/m²).¹¹ This result was supported in another study, which demonstrated both increased muscle activity and increased time needed to complete a surgical task with laparoscopic surgery; interestingly, when the same study measured these parameters for robotic surgery, this association was not seen.¹² This suggests that a robotic rather than a laparoscopic approach may avoid some of the ergonomic strain associated with increased patient BMI.

Continue to: Surgeon factors...

Surgeon factors

Various surgeon characteristics have been shown to influence ergonomics in the OR. Surgeons with smaller hand sizes, for example, reported greater physical discomfort and demonstrated greater ergonomic workload when operating laparoscopically.^13-15 In particular, those with a glove size of 6.5 or smaller have more difficulty using laparoscopic instruments, and those with a glove size smaller than 7 demonstrate a larger decline in grip strength when using laparoscopic instruments repeatedly.^14,16

Surgeon height also can affect the amount of time spent in high-risk, nonergonomic positions. In a study that evaluated video recordings of surgeon posture during gynecologic laparoscopy, shorter surgeons were noted to use greater degrees of neck rotation to look at the monitor.¹⁷ Furthermore, surgeons with shorter arm lengths experienced more “extreme positions” of the nondominant shoulder and elbow.¹⁷ This trend also was seen in open and robotic surgery, where surgeons with a height of 66 cm or less reported increased pain scores after operating.¹⁸

Surgical instruments and OR setup

Surgical instrument characteristics can contribute to ergonomic strain, especially when the instruments have been designed with a one-size-fits-all mentality.^8,19 In an examination of the anthropometric measurements of surgeon hand sizes and their correlation with difficulty when using a “standard” laparoscopic instrument, surgeons with smaller finger and hand spans had trouble using these instruments.¹⁹ Another study compared surgeon grip strength and ergonomic workloads after using 3 laparoscopic advanced bipolar instruments.¹⁶ Gender and hand size aside, the authors found that use of several of the laparoscopic devices led to greater decline in grip strength.¹⁶

The setup of the OR also can have a profound effect on the surgeon’s ergonomics. Monitor placement, for example, is crucial to ergonomic success. One study found that positioning the monitor directly in front of the surgeon at eye level was associated with the lowest neck muscle activity during a simulated task.²⁰

Route of surgery

Each surgical approach has intrinsic ergonomic risks. With laparoscopy, surgeons often remain in straight head and back positions without much trunk motion, especially when compared with open surgery.²¹ In one study, laparoscopic surgeons spent more than 60% of a case in a static position and more than 80% of a case in a high-risk, “demanding” neck position.²²

Robotic surgery, in contrast to laparoscopy, often has been cited as being more “ergonomic.” While robotic surgery has less of an effect on the neck, shoulders, arms, and legs than laparoscopy²³ and often is associated with less physical discomfort than either open or laparoscopic surgery,^23,24 robotic surgery still maintains its own innate ergonomic risks. Of robotic surgeons surveyed, 56.1% reported neck stiffness, finger fatigue, and eye symptoms in one study.²⁵ In another survey study, more robotic surgeons (72%) reported physical symptoms than laparoscopic (57%) and open (49%) surgeons.²⁶Vaginal surgery also puts surgeons at ergonomic risk. A majority of surgeons (87.2%) who completed more than 50% of their cases vaginally reported a history of WMSDs.¹⁰ Vaginal surgery places surgeons in awkward positions of the neck, shoulder, and trunk frequently and for longer durations.²⁷

Continue to: Strategies for preventing WMSDs...

Strategies for preventing WMSDs

As factors that contribute to the development of WMSDs are identified, preventive strategies can be targeted to these individual factors. Research has focused on appropriate setup of the OR, surgeon posture, intraoperative microbreaks, and stretching both in and outside of the OR.

1. OR setup and positioning of the surgeon by MIGS route

The route of MIGS affects OR setup and surgeon posture. Ergonomic recommendations for laparoscopy, robotic surgery, and vaginal surgery are all unique to the risks posed by each particular approach.

Laparoscopic surgery. Laparoscopic monitors should face the surgeon directly, with the screen just below eye level to maintain the surgeon’s neck in a neutral position.²⁸ The table height should be set for the tallest surgeon, and shorter surgeons should stand on steps as needed.²⁸ The table height also should allow for the surgeon’s hands to be at elbow height, with the elbows bent at 90 degrees with the wrists straight.²⁹ Foot pedals should be placed at the surgeons’ foot level and should be reached easily.²⁸ Additionally, the patient’s arms should be tucked at their sides to allow surgeons a larger operative space.²⁹ When using laparoscopic instruments, locking and ratcheting features should be used whenever possible to reduce prolonged grip or squeeze forces.²⁸ The laparoscopic camera should be held in the palm with the wrist in a neutral position.²⁹

Robotic surgery. Positioning and setup of the robotic console is a main focus of ergonomic recommendations. The surgeon’s chair should be brought as close to the console as possible, and the knees positioned in a 90-degree angle.³⁰ The foot pedals should be brought toward the surgeon to maintain this angle of the knees.³⁰ The console should be rotated toward the surgeon and then the height adjusted so that the surgeon can look through the eyepiece while sitting upright and can maintain the neck in a neutral position.^28,30 The surgeon’s forehead should rest comfortably on the headrest.²⁹ The forearms should rest on the armrest while the arms are maintained in a neutral position and the shoulders remain relaxed while the surgeon holds the robotic controls.³⁰ It is important to utilize the armrest often to relieve stress on the arm while operating.²⁸ Frequent use of the clutch function can keep the robotic controls in the center of the workspace.²⁸

Vaginal surgery. Both seated and standing positions are associated with high-risk positioning of the trunk and bilateral shoulders, respectively, in vaginal surgery.³¹ However, surgeons who stand while operating vaginally reported more discomfort in the bilateral wrists, thighs, and lower legs than those who operated while seated.³¹ This suggests a potential ergonomic advantage to the seated position for vaginal surgery. Chair height should be adjusted so the surgeon can look straight ahead with the neck in a neutral position.³² Surgeons should consider using a headlamp, as this may prevent repetitive awkward movements to adjust overhead lights.³² For standing surgery, the table height should be adjusted for the tallest surgeon, and shorter surgeons or assistants should use steps as needed.³

Surgical assistants should switch sides during the course of the case to avoid excessive unilateral upper-extremity strain.³² The addition of a table-mounted vaginal retractor system may be useful in relieving physical strain for surgical assistants, but data currently are lacking to demonstrate this ergonomic benefit.³³ Further studies are needed, especially since many surgeons take on the role of surgical assist in the teaching environment and subsequently report more WMSDs than their colleagues who do not work in teaching environments.^10,34

2. Pain relief from individual ergonomic positioning devices

Apart from adjusting how the OR equipment is arranged or how the surgeons adjust their positioning, several devices that assist with surgeon positioning—including gel mats or insoles, exoskeletons, and “augmented reality” glasses—are being studied.

The use of gel mats or insoles in the OR has mixed evidence in the literature.^35-37

Exoskeletons, external devices that support a surgeon’s posture and positioning, have been studied thus far in simulated nonsterile surgical environments. Preliminarily, it appears that use of an exoskeleton can decrease muscle activity and time spent in static positions, with a reported decrease in post-task user discomfort.^38,39 More data are needed to determine if exoskeletons can be used in the sterile setting and for longer durations as may occur in actual OR cases.

Augmented reality glasses project the laparoscopic monitor image to the glasses, which frees the surgeon to place the “monitor” in a more neutral, ergonomic position. In one study, use of augmented reality glasses was associated with decreased muscle activity and a reduction in Rapid Entire Body Assessment (REBA) scores when compared with use of the conventional laparoscopic monitor.⁴⁰More data are needed on these emerging technologies to determine whether adverse effects occur with prolonged use.

Continue to: 3. Implementing intraoperative microbreaks and stretching...

The American College of Surgeons (ACS) recommends that surgeons avoid prolonged static postures during procedures.²⁸ One strategy for preventing sustained positioning is to incorporate breaks with associated stretching routinely during surgery.²⁸

Microbreaks. In a landmark study by Park and colleagues in 2017, 120-second long targeted stretching microbreaks (TSMBs) were completed every 20 to 40 minutes during a surgery, and results demonstrated improved postoperative surgeon pain scores without an associated increase in the length of the case.⁴¹ These surgeons reported improved pain in the neck, bilateral shoulders, bilateral hands, and lower back. Eighty-eight percent of surgeons reported either improvement or “no change” in their mental focus, and 100% reported improvement or “no change” in their physical performance after TSMBs were implemented.⁴² Of surveyed surgeons, 87% wanted TSMBs incorporated routinely.^41,42

Stretches. Multiple resources, such as the ACS and the Mayo Clinic, for intraoperative stretches are available. The ACS recommends performing neck and shoulder stretches during intraoperative microbreaks, including a range-of-movement neck exercise, deep cervical flexor training, and standing scapular retraction.²⁸ The ACS also demonstrates lumbrical stretches for the fingers and passive wrist extension exercises to be used intraoperatively (or between cases) (FIGURE 1).²⁸ The Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR Stretch Instructional Video” in which the surgeon is guided through several different short stretches, including shoulder shrugging and side bends, that can be used during surgery.⁴³

Both the ACS and the Mayo Clinic provide examples of pertinent stretch exercises for use when not in the sterile environment, between cases or after cases are complete. The ACS recommends several neck and shoulder stretches for the trapezius, levator scapulae, and pectoralis and recommends the use of a foam roller to improve thoracic mobility (FIGURE 2).²⁸ As above, the Mayo Clinic Hallbeck Human Factors Engineering Laboratories has a publicly available “OR-Stretch Between Surgery Stretches Video” in which the surgeon is guided through several short stretches that are done in a seated position, including stretches for the hamstring, lower back, and arms (FIGURE 3).⁴³

Many of the above-mentioned stretches were designed for use in the context of open, laparoscopic, or robotic surgery. For the vaginal surgeon, the intraoperative ergonomic stressors differ from those of other routes of surgery, and thus stretches tailored to the positioning during vaginal surgery are necessary. In a video recently published by the Society of Gynecologic Surgeons, several stretches are reviewed that target high-risk positions often held by the surgeon or assistant when operating vaginally.⁴⁴ These stretches include cervical retraction, thoracic extension, external arm rotation, cervical side bending, and lumbar extension (FIGURE 4).⁴⁴ The recommendation is to complete these exercises 2 times per day, with 8 to 10 repetitions per set.⁴⁴

Prioritizing ergonomic awareness and training

As caregivers, it is not uncommon for us to prioritize the needs of others before those of ourselves. However, WMSDs are prevalent, and their downstream effects may cause catastrophic professional and personal losses. Cumulatively, the global impact of WMSDs is a significant issue for the health care workforce and its longevity.

To prevent WMSDs, it is imperative that surgeons are aware of the factors that contribute to injury development and the appropriate, accessible modifications for these factors. While each surgical modality confers its own ergonomic challenges, these risks can be mitigated through increased awareness of OR setup, surgeon positioning, and incorporation of microbreaks and stretching exercises during and after surgical procedures.

Formal training in surgical ergonomics is lacking across specialties, including gynecology.⁴⁵ Multiple educational interventions have been proposed and studied to help fill this training gap.^30,46-49When used, these interventions have been associated with increased knowledge of surgical ergonomic principles or reduction in surgeon pain scores, including trainees.⁵⁰ As we become more cognizant of WMSDs, standardized resident curricula should be developed in an effort to reduce the prevalence of these potentially career-ending injuries.

In addition to education, cultivating a culture in which ergonomics is prioritized is essential. Although most surgeons report work-related pain, very few report their injuries to occupational health. For example, while 29% of gynecologic oncologists reported seeking treatment for a WMSD, only 1% had reported their injury to their employer.⁵ In a study of ACS members, only 19% of injuries were reported, 30% of surgeons stated that they did not know how to report an injury, and 21% felt that the resources for surgeons during and after an injury were inadequate.⁶

As we prioritize the health and safety of our patients, we also need to promote ergonomic awareness in the OR, respect the need for accommodations, encourage injury reporting, support surgeons who need to take time away for medical treatment, and partner with industry to develop new instruments and technology with effective ergonomic features. ●

The theme of the 49th Annual Scientific Meeting of the Society of Gynecologic Surgeons was Impact Factor—an allusion to scientific journal impact factor, as well as how we as gynecologic surgeons have a societal impact through our innovation, education, equity, and enterprise-level efforts. This theme and the diverse roster of speakers and presentations on contemporary and controversial issues impacting today’s gynecologic surgeons clearly resonated, breaking the prior registration record with more than 200 additional attendees than the previous year.

As always, the preconference postgraduate courses delivered relevant content that spanned the educational and surgical spectrum, including: “Innovations in training gynecologic surgeons”; “Urologic surgery for the gynecologic surgeon”; the social media workshop “Gynfluencing: Using social media to find your digital voice”; and “The sim factor: Making an impact in surgical education.” This also marked the first year of offering a specific SGS Fellows/Young Attendings’ course. The featured speaker of the SGS Equity Council was Patty Brisben, philanthropist, CEO, and founder of Pure Romance.

Dr. Beri Ridgeway, Cleveland Clinic Chief of Staff, delivered the Mark D. Walters Lecture, “Surgeon in the C-suite,” on leading approximately 5,000 physicians and the importance of surgeons and specifically ObGyns having a seat at the table. The TeLinde lecturer, Dr. Pam Moalli, Professor and Division Director for Urogynecology at the University of Pittsburgh Magee Womens Hospital, spoke on “Biomaterials for gynecologic surgeons: Toward bioinspired biomimetic devices.” The panel on the “Ergonomics of gynecologic surgery” was moderated by Dr. Amanda Fader and Dr. Kim Kho, who shared their experiences with work-related musculoskeletal injury, and featured esteemed panelists Dr. Noor Abu-Alnadi from UNC, Dr. Sue Hallbeck from Mayo Clinic, and Dr. Ladin Yurteri-Kaplan from Columbia University.

The conference also featured a new format of Ted Med Talks:

• Dr. Jason Wright, Editor-in-Chief, Obstetrics & Gynecology, and Division Director of Gynecologic Oncology at Columbia University, who spoke on “Surgical volume and outcomes for gynecologic surgery: Is more always better?”
• Dr. Kelly Wright, Division Director, Minimally Invasive Gynecologic Surgery, Cedars Sinai, on “Climate change starts at 7:15”
• Dr. Ebony Carter, Associate Editor, Equity, Obstetrics & Gynecology, and Division Director, Maternal Fetal Medicine, Washington University, on “Centering equity in reproductive health research.”

In this special section, several of these talks are presented. Additionally, Dr. Laura Homewood and her coauthors will discuss gender and racial biases in a large multi-institutional sample of more than 15,000 Press Ganey patient satisfaction surveys.

Dr. Cheryl Iglesia, SGS former president, and I hope that you will consider attending #SGS2024 in Orlando, Florida, led by Dr. Suzie As-Sanie, program chair, and Dr. Rosanne Kho, current SGS president, which promises to be another exciting meeting. ●

The theme of the 49th Annual Scientific Meeting of the Society of Gynecologic Surgeons was Impact Factor—an allusion to scientific journal impact factor, as well as how we as gynecologic surgeons have a societal impact through our innovation, education, equity, and enterprise-level efforts. This theme and the diverse roster of speakers and presentations on contemporary and controversial issues impacting today’s gynecologic surgeons clearly resonated, breaking the prior registration record with more than 200 additional attendees than the previous year.

As always, the preconference postgraduate courses delivered relevant content that spanned the educational and surgical spectrum, including: “Innovations in training gynecologic surgeons”; “Urologic surgery for the gynecologic surgeon”; the social media workshop “Gynfluencing: Using social media to find your digital voice”; and “The sim factor: Making an impact in surgical education.” This also marked the first year of offering a specific SGS Fellows/Young Attendings’ course. The featured speaker of the SGS Equity Council was Patty Brisben, philanthropist, CEO, and founder of Pure Romance.

Dr. Beri Ridgeway, Cleveland Clinic Chief of Staff, delivered the Mark D. Walters Lecture, “Surgeon in the C-suite,” on leading approximately 5,000 physicians and the importance of surgeons and specifically ObGyns having a seat at the table. The TeLinde lecturer, Dr. Pam Moalli, Professor and Division Director for Urogynecology at the University of Pittsburgh Magee Womens Hospital, spoke on “Biomaterials for gynecologic surgeons: Toward bioinspired biomimetic devices.” The panel on the “Ergonomics of gynecologic surgery” was moderated by Dr. Amanda Fader and Dr. Kim Kho, who shared their experiences with work-related musculoskeletal injury, and featured esteemed panelists Dr. Noor Abu-Alnadi from UNC, Dr. Sue Hallbeck from Mayo Clinic, and Dr. Ladin Yurteri-Kaplan from Columbia University.

The conference also featured a new format of Ted Med Talks:

• Dr. Jason Wright, Editor-in-Chief, Obstetrics & Gynecology, and Division Director of Gynecologic Oncology at Columbia University, who spoke on “Surgical volume and outcomes for gynecologic surgery: Is more always better?”
• Dr. Kelly Wright, Division Director, Minimally Invasive Gynecologic Surgery, Cedars Sinai, on “Climate change starts at 7:15”
• Dr. Ebony Carter, Associate Editor, Equity, Obstetrics & Gynecology, and Division Director, Maternal Fetal Medicine, Washington University, on “Centering equity in reproductive health research.”

In this special section, several of these talks are presented. Additionally, Dr. Laura Homewood and her coauthors will discuss gender and racial biases in a large multi-institutional sample of more than 15,000 Press Ganey patient satisfaction surveys.

Dr. Cheryl Iglesia, SGS former president, and I hope that you will consider attending #SGS2024 in Orlando, Florida, led by Dr. Suzie As-Sanie, program chair, and Dr. Rosanne Kho, current SGS president, which promises to be another exciting meeting. ●

The theme of the 49th Annual Scientific Meeting of the Society of Gynecologic Surgeons was Impact Factor—an allusion to scientific journal impact factor, as well as how we as gynecologic surgeons have a societal impact through our innovation, education, equity, and enterprise-level efforts. This theme and the diverse roster of speakers and presentations on contemporary and controversial issues impacting today’s gynecologic surgeons clearly resonated, breaking the prior registration record with more than 200 additional attendees than the previous year.

As always, the preconference postgraduate courses delivered relevant content that spanned the educational and surgical spectrum, including: “Innovations in training gynecologic surgeons”; “Urologic surgery for the gynecologic surgeon”; the social media workshop “Gynfluencing: Using social media to find your digital voice”; and “The sim factor: Making an impact in surgical education.” This also marked the first year of offering a specific SGS Fellows/Young Attendings’ course. The featured speaker of the SGS Equity Council was Patty Brisben, philanthropist, CEO, and founder of Pure Romance.

Dr. Beri Ridgeway, Cleveland Clinic Chief of Staff, delivered the Mark D. Walters Lecture, “Surgeon in the C-suite,” on leading approximately 5,000 physicians and the importance of surgeons and specifically ObGyns having a seat at the table. The TeLinde lecturer, Dr. Pam Moalli, Professor and Division Director for Urogynecology at the University of Pittsburgh Magee Womens Hospital, spoke on “Biomaterials for gynecologic surgeons: Toward bioinspired biomimetic devices.” The panel on the “Ergonomics of gynecologic surgery” was moderated by Dr. Amanda Fader and Dr. Kim Kho, who shared their experiences with work-related musculoskeletal injury, and featured esteemed panelists Dr. Noor Abu-Alnadi from UNC, Dr. Sue Hallbeck from Mayo Clinic, and Dr. Ladin Yurteri-Kaplan from Columbia University.

The conference also featured a new format of Ted Med Talks:

• Dr. Jason Wright, Editor-in-Chief, Obstetrics & Gynecology, and Division Director of Gynecologic Oncology at Columbia University, who spoke on “Surgical volume and outcomes for gynecologic surgery: Is more always better?”
• Dr. Kelly Wright, Division Director, Minimally Invasive Gynecologic Surgery, Cedars Sinai, on “Climate change starts at 7:15”
• Dr. Ebony Carter, Associate Editor, Equity, Obstetrics & Gynecology, and Division Director, Maternal Fetal Medicine, Washington University, on “Centering equity in reproductive health research.”

In this special section, several of these talks are presented. Additionally, Dr. Laura Homewood and her coauthors will discuss gender and racial biases in a large multi-institutional sample of more than 15,000 Press Ganey patient satisfaction surveys.

Dr. Cheryl Iglesia, SGS former president, and I hope that you will consider attending #SGS2024 in Orlando, Florida, led by Dr. Suzie As-Sanie, program chair, and Dr. Rosanne Kho, current SGS president, which promises to be another exciting meeting. ●