NATIONAL HARBOR, MD. – The combination of bempegaldesleukin and nivolumab produced durable responses in a phase 1/2 trial of patients with previously untreated metastatic melanoma.

Jennifer Smith/MDedge News

The overall response rate was 53%, and most responders were still in response at a median follow-up of about 19 months. The median progression-free survival was not reached, and the combination was considered well tolerated.

Adi Diab, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented these results from the PIVOT-02 study at the annual meeting of the Society for Immunotherapy of Cancer.

Dr. Diab explained that bempegaldesleukin (bempeg) is a CD122-preferential interleukin-2 pathway agonist, and earlier results from the PIVOT-02 trial showed that adding bempeg to nivolumab can convert baseline tumors from programmed death–ligand 1 (PD-L1) negative to PD-L1 positive (SITC 2018, Abstract O4).

Dr. Diab presented updated results from PIVOT-02 (NCT02983045) in 41 patients with metastatic melanoma who received bempeg plus nivolumab as first-line treatment. The patients had a median age of 63 years (range, 22-80 years) at baseline, and 58.5% were male. Most patients (58.5%) were PD-L1 positive, although PD-L1 status was unknown in 7.3% of patients.

Patients received bempeg at 0.006 mg/kg and nivolumab at 360 mg every 3 weeks. They received a median of nine cycles (range, 1-34), and the median follow-up was 18.6 months.

Efficacy

In the 38 patients who were evaluable for efficacy, the overall response rate was 53% (n = 20), and the complete response rate was 34% (n = 13). The median time to response was 2.0 months, and the median time to complete response was 7.9 months.

Dr. Diab noted that responses were seen regardless of PD-L1 expression at baseline. The response rate was 39% among PD-L1-negative patients, 64% among PD-L1-positive patients, and 33% among patients whose PD-L1 status was unknown.

Dr. Diab also pointed out that responses were durable and deepened over time. The median duration of response was not reached, and 17 of the 20 responders had ongoing responses at last follow-up. The median progression-free survival has not been reached.

Safety

“This combination is safe and tolerable, there’s no overlapping immune-related adverse events, and the most common side effects are grade 1/2 flu-like symptoms,” Dr. Diab said.

The most common grade 1/2 treatment-related adverse events (AEs) were flu-like symptoms (80.5%), rash (70.7%), fatigue (65.9%), pruritus (48.8%), nausea (46.3%), arthralgia (43.9%), decreased appetite (36.6%), and myalgia (36.6%).

Dr. Diab noted that cytokine-related AEs (flu-like symptoms, rash, and pruritus) were easily managed with NSAIDs; decreased with subsequent cycles of treatment; and did not necessitate dose delays, reductions, or discontinuations.

Grade 3/4 treatment-related AEs included two cases of acute kidney injury, two cases of atrial fibrillation, one case of dizziness, one case of dyspnea, one case of hypoxia, one case of hyperglycemia, and one case of hypernatremia.

Five patients discontinued treatment because of related AEs, including cerebrovascular accident, peripheral edema, blood creatinine increase, malaise, and pharyngitis. There were no treatment-related deaths.

Dr. Diab said these results were used to support the recent breakthrough therapy designation granted to bempeg in combination with nivolumab. The results have also prompted a phase 3 trial in which researchers are comparing the combination with nivolumab alone (NCT03635983).

The phase 1/2 trial is sponsored by Nektar Therapeutics in collaboration with Bristol-Myers Squibb. Dr. Diab reported relationships with Nektar, Celgene, CureVac, Idera, and Pfizer.

SOURCE: Diab A et al. SITC 2019, Abstract O35.

NATIONAL HARBOR, MD. – The combination of bempegaldesleukin and nivolumab produced durable responses in a phase 1/2 trial of patients with previously untreated metastatic melanoma.

Jennifer Smith/MDedge News

The overall response rate was 53%, and most responders were still in response at a median follow-up of about 19 months. The median progression-free survival was not reached, and the combination was considered well tolerated.

Adi Diab, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented these results from the PIVOT-02 study at the annual meeting of the Society for Immunotherapy of Cancer.

Dr. Diab explained that bempegaldesleukin (bempeg) is a CD122-preferential interleukin-2 pathway agonist, and earlier results from the PIVOT-02 trial showed that adding bempeg to nivolumab can convert baseline tumors from programmed death–ligand 1 (PD-L1) negative to PD-L1 positive (SITC 2018, Abstract O4).

Dr. Diab presented updated results from PIVOT-02 (NCT02983045) in 41 patients with metastatic melanoma who received bempeg plus nivolumab as first-line treatment. The patients had a median age of 63 years (range, 22-80 years) at baseline, and 58.5% were male. Most patients (58.5%) were PD-L1 positive, although PD-L1 status was unknown in 7.3% of patients.

Patients received bempeg at 0.006 mg/kg and nivolumab at 360 mg every 3 weeks. They received a median of nine cycles (range, 1-34), and the median follow-up was 18.6 months.

Efficacy

In the 38 patients who were evaluable for efficacy, the overall response rate was 53% (n = 20), and the complete response rate was 34% (n = 13). The median time to response was 2.0 months, and the median time to complete response was 7.9 months.

Dr. Diab noted that responses were seen regardless of PD-L1 expression at baseline. The response rate was 39% among PD-L1-negative patients, 64% among PD-L1-positive patients, and 33% among patients whose PD-L1 status was unknown.

Dr. Diab also pointed out that responses were durable and deepened over time. The median duration of response was not reached, and 17 of the 20 responders had ongoing responses at last follow-up. The median progression-free survival has not been reached.

Safety

“This combination is safe and tolerable, there’s no overlapping immune-related adverse events, and the most common side effects are grade 1/2 flu-like symptoms,” Dr. Diab said.

The most common grade 1/2 treatment-related adverse events (AEs) were flu-like symptoms (80.5%), rash (70.7%), fatigue (65.9%), pruritus (48.8%), nausea (46.3%), arthralgia (43.9%), decreased appetite (36.6%), and myalgia (36.6%).

Dr. Diab noted that cytokine-related AEs (flu-like symptoms, rash, and pruritus) were easily managed with NSAIDs; decreased with subsequent cycles of treatment; and did not necessitate dose delays, reductions, or discontinuations.

Grade 3/4 treatment-related AEs included two cases of acute kidney injury, two cases of atrial fibrillation, one case of dizziness, one case of dyspnea, one case of hypoxia, one case of hyperglycemia, and one case of hypernatremia.

Five patients discontinued treatment because of related AEs, including cerebrovascular accident, peripheral edema, blood creatinine increase, malaise, and pharyngitis. There were no treatment-related deaths.

Dr. Diab said these results were used to support the recent breakthrough therapy designation granted to bempeg in combination with nivolumab. The results have also prompted a phase 3 trial in which researchers are comparing the combination with nivolumab alone (NCT03635983).

The phase 1/2 trial is sponsored by Nektar Therapeutics in collaboration with Bristol-Myers Squibb. Dr. Diab reported relationships with Nektar, Celgene, CureVac, Idera, and Pfizer.

SOURCE: Diab A et al. SITC 2019, Abstract O35.

NATIONAL HARBOR, MD. – The combination of bempegaldesleukin and nivolumab produced durable responses in a phase 1/2 trial of patients with previously untreated metastatic melanoma.

Jennifer Smith/MDedge News

The overall response rate was 53%, and most responders were still in response at a median follow-up of about 19 months. The median progression-free survival was not reached, and the combination was considered well tolerated.

Adi Diab, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented these results from the PIVOT-02 study at the annual meeting of the Society for Immunotherapy of Cancer.

Dr. Diab explained that bempegaldesleukin (bempeg) is a CD122-preferential interleukin-2 pathway agonist, and earlier results from the PIVOT-02 trial showed that adding bempeg to nivolumab can convert baseline tumors from programmed death–ligand 1 (PD-L1) negative to PD-L1 positive (SITC 2018, Abstract O4).

Dr. Diab presented updated results from PIVOT-02 (NCT02983045) in 41 patients with metastatic melanoma who received bempeg plus nivolumab as first-line treatment. The patients had a median age of 63 years (range, 22-80 years) at baseline, and 58.5% were male. Most patients (58.5%) were PD-L1 positive, although PD-L1 status was unknown in 7.3% of patients.

Patients received bempeg at 0.006 mg/kg and nivolumab at 360 mg every 3 weeks. They received a median of nine cycles (range, 1-34), and the median follow-up was 18.6 months.

Efficacy

In the 38 patients who were evaluable for efficacy, the overall response rate was 53% (n = 20), and the complete response rate was 34% (n = 13). The median time to response was 2.0 months, and the median time to complete response was 7.9 months.

Dr. Diab noted that responses were seen regardless of PD-L1 expression at baseline. The response rate was 39% among PD-L1-negative patients, 64% among PD-L1-positive patients, and 33% among patients whose PD-L1 status was unknown.

Dr. Diab also pointed out that responses were durable and deepened over time. The median duration of response was not reached, and 17 of the 20 responders had ongoing responses at last follow-up. The median progression-free survival has not been reached.

Safety

“This combination is safe and tolerable, there’s no overlapping immune-related adverse events, and the most common side effects are grade 1/2 flu-like symptoms,” Dr. Diab said.

The most common grade 1/2 treatment-related adverse events (AEs) were flu-like symptoms (80.5%), rash (70.7%), fatigue (65.9%), pruritus (48.8%), nausea (46.3%), arthralgia (43.9%), decreased appetite (36.6%), and myalgia (36.6%).

Dr. Diab noted that cytokine-related AEs (flu-like symptoms, rash, and pruritus) were easily managed with NSAIDs; decreased with subsequent cycles of treatment; and did not necessitate dose delays, reductions, or discontinuations.

Grade 3/4 treatment-related AEs included two cases of acute kidney injury, two cases of atrial fibrillation, one case of dizziness, one case of dyspnea, one case of hypoxia, one case of hyperglycemia, and one case of hypernatremia.

Five patients discontinued treatment because of related AEs, including cerebrovascular accident, peripheral edema, blood creatinine increase, malaise, and pharyngitis. There were no treatment-related deaths.

Dr. Diab said these results were used to support the recent breakthrough therapy designation granted to bempeg in combination with nivolumab. The results have also prompted a phase 3 trial in which researchers are comparing the combination with nivolumab alone (NCT03635983).

The phase 1/2 trial is sponsored by Nektar Therapeutics in collaboration with Bristol-Myers Squibb. Dr. Diab reported relationships with Nektar, Celgene, CureVac, Idera, and Pfizer.

SOURCE: Diab A et al. SITC 2019, Abstract O35.

Amith Skandhan, MD, SFHM, has been announced as Southeast Health Statera Network’s (Dothan, Ala.) director of physician integration, and chairman of the network’s Physicians Participation Committee. Dr. Skandhan is senior lead hospitalist with Southeast Health, where he has worked for nearly a decade. He also champions the medical group’s clinical documentation improvement faction.

One of just 10 hospitalists in the nation to receive Top Hospitalist recognition by the American College of Physicians in 2018, Dr. Skandhan is also an assistant professor at Alabama College of Osteopathic Medicine and is one of Southeast Health’s Internal Medicine Residency Program’s core faculty members.
 

Ruby Sahoo, DO, has been promoted by Team Health (Knoxville, Tenn.) as regional performance director of its hospitalist services performance improvement team. Dr. Sahoo joined Team Health in 2016 and has most recently served as medical director and chief of staff at Grand Strand Medical Center (Myrtle Beach, S.C.).

Dr. Sahoo is a highly decorated internist and hospitalist. She was Team Health’s Medical Director of the Year for Hospital Medicine 2018, and a Frist Humanitarian Award winner in 2017. Additionally, Dr. Sahoo is a member of the Society of Hospital Medicine, the American College of Physicians, and the American Association of Physician Leadership.
 

David Vandenberg, MD, SFHM, recently was elevated to chief medical officer at St. Joseph Mercy Hospital (Ann Arbor and Livingston, Mich.). The hospitalist and senior fellow of hospital medicine previously has been St. Joseph’s vice chair of internal medicine and medical director of care management and documentation integrity. Dr. Vandenberg has spent 20 years as an employee at St. Joseph’s.

Cristian Andrade, MD, has been elevated to vice president of medical affairs with St. Joseph’s Health (Syracuse, N.Y.). A 16-year veteran with St. Joseph’s, Dr. Andrade has been a hospitalist with the system since 2006, and most recently has served as chief of hospitalist services.

Dr. Andrade now will provide guidance focusing on improving length of stay, as well as staff governance, utilization review, and the hospitalist program in general.
 

Paul DeJac, MD, has received a promotion to chief of hospitalist medicine at Roswell Park Comprehensive Cancer Center (Buffalo, N.Y.). Dr. DeJac was hired at Roswell Park in 2016, becoming lead hospitalist in 2017. He will look to boost professional development on the hospitalist team with a focus on improving patient care.

Independent Emergency Physicians (Farmington, Mich.), which provides hospitalist physicians, ED physicians, scribes, and more at a handful of hospitals in Michigan, has added urgent care facilities in Southfield, Mich., and Novi, Mich., to its portfolio. In addition, IEP has joined with Healthy Urgent Care to create a network of up to 15 urgent care centers in Southeast Michigan.

This is IEP’s first foray into urgent care. The company was founded in 1997 and practices at Ascension Health, Trinity Health, and Henry Ford Health System, covering four different hospitals.

Private hospitalist management provider Sound Physicians (Tacoma, Wash.) has grown once again, acquiring Indigo Health Partners (Traverse City, Mich.), one of Michigan’s largest private hospitalist groups. The new company will be known as Indigo, a division of Sound Inpatient Physicians.

Indigo’s approximately 150 providers are included in the transaction, which includes professionals in hospitals, skilled nursing facilities, and assisted living facilities. Indigo was previously known as Hospitalists of Northwest Michigan, based out of Munson Medical Center.

Amith Skandhan, MD, SFHM, has been announced as Southeast Health Statera Network’s (Dothan, Ala.) director of physician integration, and chairman of the network’s Physicians Participation Committee. Dr. Skandhan is senior lead hospitalist with Southeast Health, where he has worked for nearly a decade. He also champions the medical group’s clinical documentation improvement faction.

One of just 10 hospitalists in the nation to receive Top Hospitalist recognition by the American College of Physicians in 2018, Dr. Skandhan is also an assistant professor at Alabama College of Osteopathic Medicine and is one of Southeast Health’s Internal Medicine Residency Program’s core faculty members.
 

Ruby Sahoo, DO, has been promoted by Team Health (Knoxville, Tenn.) as regional performance director of its hospitalist services performance improvement team. Dr. Sahoo joined Team Health in 2016 and has most recently served as medical director and chief of staff at Grand Strand Medical Center (Myrtle Beach, S.C.).

Dr. Sahoo is a highly decorated internist and hospitalist. She was Team Health’s Medical Director of the Year for Hospital Medicine 2018, and a Frist Humanitarian Award winner in 2017. Additionally, Dr. Sahoo is a member of the Society of Hospital Medicine, the American College of Physicians, and the American Association of Physician Leadership.
 

David Vandenberg, MD, SFHM, recently was elevated to chief medical officer at St. Joseph Mercy Hospital (Ann Arbor and Livingston, Mich.). The hospitalist and senior fellow of hospital medicine previously has been St. Joseph’s vice chair of internal medicine and medical director of care management and documentation integrity. Dr. Vandenberg has spent 20 years as an employee at St. Joseph’s.

Cristian Andrade, MD, has been elevated to vice president of medical affairs with St. Joseph’s Health (Syracuse, N.Y.). A 16-year veteran with St. Joseph’s, Dr. Andrade has been a hospitalist with the system since 2006, and most recently has served as chief of hospitalist services.

Dr. Andrade now will provide guidance focusing on improving length of stay, as well as staff governance, utilization review, and the hospitalist program in general.
 

Paul DeJac, MD, has received a promotion to chief of hospitalist medicine at Roswell Park Comprehensive Cancer Center (Buffalo, N.Y.). Dr. DeJac was hired at Roswell Park in 2016, becoming lead hospitalist in 2017. He will look to boost professional development on the hospitalist team with a focus on improving patient care.

Independent Emergency Physicians (Farmington, Mich.), which provides hospitalist physicians, ED physicians, scribes, and more at a handful of hospitals in Michigan, has added urgent care facilities in Southfield, Mich., and Novi, Mich., to its portfolio. In addition, IEP has joined with Healthy Urgent Care to create a network of up to 15 urgent care centers in Southeast Michigan.

This is IEP’s first foray into urgent care. The company was founded in 1997 and practices at Ascension Health, Trinity Health, and Henry Ford Health System, covering four different hospitals.

Private hospitalist management provider Sound Physicians (Tacoma, Wash.) has grown once again, acquiring Indigo Health Partners (Traverse City, Mich.), one of Michigan’s largest private hospitalist groups. The new company will be known as Indigo, a division of Sound Inpatient Physicians.

Indigo’s approximately 150 providers are included in the transaction, which includes professionals in hospitals, skilled nursing facilities, and assisted living facilities. Indigo was previously known as Hospitalists of Northwest Michigan, based out of Munson Medical Center.

Amith Skandhan, MD, SFHM, has been announced as Southeast Health Statera Network’s (Dothan, Ala.) director of physician integration, and chairman of the network’s Physicians Participation Committee. Dr. Skandhan is senior lead hospitalist with Southeast Health, where he has worked for nearly a decade. He also champions the medical group’s clinical documentation improvement faction.

One of just 10 hospitalists in the nation to receive Top Hospitalist recognition by the American College of Physicians in 2018, Dr. Skandhan is also an assistant professor at Alabama College of Osteopathic Medicine and is one of Southeast Health’s Internal Medicine Residency Program’s core faculty members.
 

Ruby Sahoo, DO, has been promoted by Team Health (Knoxville, Tenn.) as regional performance director of its hospitalist services performance improvement team. Dr. Sahoo joined Team Health in 2016 and has most recently served as medical director and chief of staff at Grand Strand Medical Center (Myrtle Beach, S.C.).

Dr. Sahoo is a highly decorated internist and hospitalist. She was Team Health’s Medical Director of the Year for Hospital Medicine 2018, and a Frist Humanitarian Award winner in 2017. Additionally, Dr. Sahoo is a member of the Society of Hospital Medicine, the American College of Physicians, and the American Association of Physician Leadership.
 

David Vandenberg, MD, SFHM, recently was elevated to chief medical officer at St. Joseph Mercy Hospital (Ann Arbor and Livingston, Mich.). The hospitalist and senior fellow of hospital medicine previously has been St. Joseph’s vice chair of internal medicine and medical director of care management and documentation integrity. Dr. Vandenberg has spent 20 years as an employee at St. Joseph’s.

Cristian Andrade, MD, has been elevated to vice president of medical affairs with St. Joseph’s Health (Syracuse, N.Y.). A 16-year veteran with St. Joseph’s, Dr. Andrade has been a hospitalist with the system since 2006, and most recently has served as chief of hospitalist services.

Dr. Andrade now will provide guidance focusing on improving length of stay, as well as staff governance, utilization review, and the hospitalist program in general.
 

Paul DeJac, MD, has received a promotion to chief of hospitalist medicine at Roswell Park Comprehensive Cancer Center (Buffalo, N.Y.). Dr. DeJac was hired at Roswell Park in 2016, becoming lead hospitalist in 2017. He will look to boost professional development on the hospitalist team with a focus on improving patient care.

Independent Emergency Physicians (Farmington, Mich.), which provides hospitalist physicians, ED physicians, scribes, and more at a handful of hospitals in Michigan, has added urgent care facilities in Southfield, Mich., and Novi, Mich., to its portfolio. In addition, IEP has joined with Healthy Urgent Care to create a network of up to 15 urgent care centers in Southeast Michigan.

This is IEP’s first foray into urgent care. The company was founded in 1997 and practices at Ascension Health, Trinity Health, and Henry Ford Health System, covering four different hospitals.

Private hospitalist management provider Sound Physicians (Tacoma, Wash.) has grown once again, acquiring Indigo Health Partners (Traverse City, Mich.), one of Michigan’s largest private hospitalist groups. The new company will be known as Indigo, a division of Sound Inpatient Physicians.

Indigo’s approximately 150 providers are included in the transaction, which includes professionals in hospitals, skilled nursing facilities, and assisted living facilities. Indigo was previously known as Hospitalists of Northwest Michigan, based out of Munson Medical Center.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The combination of atezolizumab plus bevacizumab may offer some benefit to patients with advanced renal cell carcinoma, especially those who are positive for programmed death-ligand 1 (PD-L1), investigators report.

The overall response rate (ORR) among such patients was 60%, compared with 19% in PD-L1–negative patients, Bradley A. McGregor, MD, clinical director for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, and colleagues reported in the Journal of Clinical Oncology.

The data were presented last summer at the American Society of Clinical Oncology Annual Meeting in Chicago.

The phase 2 study comprised 60 patients, 42 of whom had variant histology RCC, and 18 of whom had clear cell RCC (ccRCC ) with at least 20% sarcomatoid differentiation. All patients had advanced renal cell carcinoma of various histologies, including papillary (12), chromophobe (10), unclassified (9), TFE3 translocation (5), collecting duct (5), and medullary (1). Most (65%) had not received prior systemic therapy.

They all received infusions of atezolizumab 1,200 mg plus bevacizumab 15 mg/kg every 3 weeks. No dose modifications were allowed. Dose delays were allowed, and patients could also drop one agent and continue with the other. Treatment continued until disease progression, toxicity, or intolerable side effects.

The median number of cycles was 9.5, although the range was wide (1-42). At analysis, 15 were still on the treatment, but 45 had dropped out. Reasons were disease progression (34), death (1), toxicity (5), or unspecified (8). Six patients delayed bevacizumab doses, half because of adverse events.

After a median follow-up of 13 months, the ORR was 33%. Those with ccRCC with sarcomatoid differentiation responded best to the combination (ORR, 50%). Those with variant-histology RCC responded less robustly (ORR, 26%).

ORR varied by baseline risk category, being 33% in favorable-, 45% in intermediate-, and 11% in poor-risk patients. Median time to response was 2.7 months, median response duration was 8.9 months, and median progression-free survival was 8.3 months.

PD-L1 status was determined in 36 patients; 15 were positive. Among the positive patents, ORR was 60%, compared with 19% in PD-L1 negative patients. Response rates varied with tumor characteristics. Among patients with ccRCC with sarcomatoid differentiation, the ORR was 50% in PD-L1–positive patients and 29% in negative patients. In patients with variant histology RCC, the ORR was also better in PD-L1 positive patients (67% vs. 14%).

The most common treatment-related side effects were fatigue (35%), proteinuria (35%), musculoskeletal pain (33%), diarrhea (22%), rash (20%), hypertension (18%), pruritus (18%), thyroid dysfunction (17%), hepatitis (15%), fever (13%), and mucositis (12%). Thirty-four patients developed at least one grade 3 adverse event; there were no grade 4 or 5 toxicities. One patient died, presumably because of disease progression.

Quality of life scores were largely stable during treatment.

“The combination demonstrated responses across several subtypes of RCC, including collecting duct and medullary carcinoma, histologies that are often treated with cytotoxic chemotherapy,” the authors said. “This is notable given the generally poor prognosis and low response rate associated with variant histology RCC in trials to date.”

The study also suggests the PD-L1 status might be “intriguing as a biomarker for response to atezolizumab and bevacizumab in variant histology RCC. We plan to conduct additional correlative work, including genomic profiling and assessment of the immune microenvironment, to better elucidate markers of response and resistance,” the authors wrote.

SOURCE: McGregor BA et al. J Clin Oncol. 2019 Nov 13. doi: 10.1200/JCO.19.01882.

The combination of atezolizumab plus bevacizumab may offer some benefit to patients with advanced renal cell carcinoma, especially those who are positive for programmed death-ligand 1 (PD-L1), investigators report.

The overall response rate (ORR) among such patients was 60%, compared with 19% in PD-L1–negative patients, Bradley A. McGregor, MD, clinical director for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, and colleagues reported in the Journal of Clinical Oncology.

The data were presented last summer at the American Society of Clinical Oncology Annual Meeting in Chicago.

The phase 2 study comprised 60 patients, 42 of whom had variant histology RCC, and 18 of whom had clear cell RCC (ccRCC ) with at least 20% sarcomatoid differentiation. All patients had advanced renal cell carcinoma of various histologies, including papillary (12), chromophobe (10), unclassified (9), TFE3 translocation (5), collecting duct (5), and medullary (1). Most (65%) had not received prior systemic therapy.

They all received infusions of atezolizumab 1,200 mg plus bevacizumab 15 mg/kg every 3 weeks. No dose modifications were allowed. Dose delays were allowed, and patients could also drop one agent and continue with the other. Treatment continued until disease progression, toxicity, or intolerable side effects.

The median number of cycles was 9.5, although the range was wide (1-42). At analysis, 15 were still on the treatment, but 45 had dropped out. Reasons were disease progression (34), death (1), toxicity (5), or unspecified (8). Six patients delayed bevacizumab doses, half because of adverse events.

After a median follow-up of 13 months, the ORR was 33%. Those with ccRCC with sarcomatoid differentiation responded best to the combination (ORR, 50%). Those with variant-histology RCC responded less robustly (ORR, 26%).

ORR varied by baseline risk category, being 33% in favorable-, 45% in intermediate-, and 11% in poor-risk patients. Median time to response was 2.7 months, median response duration was 8.9 months, and median progression-free survival was 8.3 months.

PD-L1 status was determined in 36 patients; 15 were positive. Among the positive patents, ORR was 60%, compared with 19% in PD-L1 negative patients. Response rates varied with tumor characteristics. Among patients with ccRCC with sarcomatoid differentiation, the ORR was 50% in PD-L1–positive patients and 29% in negative patients. In patients with variant histology RCC, the ORR was also better in PD-L1 positive patients (67% vs. 14%).

The most common treatment-related side effects were fatigue (35%), proteinuria (35%), musculoskeletal pain (33%), diarrhea (22%), rash (20%), hypertension (18%), pruritus (18%), thyroid dysfunction (17%), hepatitis (15%), fever (13%), and mucositis (12%). Thirty-four patients developed at least one grade 3 adverse event; there were no grade 4 or 5 toxicities. One patient died, presumably because of disease progression.

Quality of life scores were largely stable during treatment.

“The combination demonstrated responses across several subtypes of RCC, including collecting duct and medullary carcinoma, histologies that are often treated with cytotoxic chemotherapy,” the authors said. “This is notable given the generally poor prognosis and low response rate associated with variant histology RCC in trials to date.”

The study also suggests the PD-L1 status might be “intriguing as a biomarker for response to atezolizumab and bevacizumab in variant histology RCC. We plan to conduct additional correlative work, including genomic profiling and assessment of the immune microenvironment, to better elucidate markers of response and resistance,” the authors wrote.

SOURCE: McGregor BA et al. J Clin Oncol. 2019 Nov 13. doi: 10.1200/JCO.19.01882.

The combination of atezolizumab plus bevacizumab may offer some benefit to patients with advanced renal cell carcinoma, especially those who are positive for programmed death-ligand 1 (PD-L1), investigators report.

The overall response rate (ORR) among such patients was 60%, compared with 19% in PD-L1–negative patients, Bradley A. McGregor, MD, clinical director for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, and colleagues reported in the Journal of Clinical Oncology.

The data were presented last summer at the American Society of Clinical Oncology Annual Meeting in Chicago.

The phase 2 study comprised 60 patients, 42 of whom had variant histology RCC, and 18 of whom had clear cell RCC (ccRCC ) with at least 20% sarcomatoid differentiation. All patients had advanced renal cell carcinoma of various histologies, including papillary (12), chromophobe (10), unclassified (9), TFE3 translocation (5), collecting duct (5), and medullary (1). Most (65%) had not received prior systemic therapy.

They all received infusions of atezolizumab 1,200 mg plus bevacizumab 15 mg/kg every 3 weeks. No dose modifications were allowed. Dose delays were allowed, and patients could also drop one agent and continue with the other. Treatment continued until disease progression, toxicity, or intolerable side effects.

The median number of cycles was 9.5, although the range was wide (1-42). At analysis, 15 were still on the treatment, but 45 had dropped out. Reasons were disease progression (34), death (1), toxicity (5), or unspecified (8). Six patients delayed bevacizumab doses, half because of adverse events.

After a median follow-up of 13 months, the ORR was 33%. Those with ccRCC with sarcomatoid differentiation responded best to the combination (ORR, 50%). Those with variant-histology RCC responded less robustly (ORR, 26%).

ORR varied by baseline risk category, being 33% in favorable-, 45% in intermediate-, and 11% in poor-risk patients. Median time to response was 2.7 months, median response duration was 8.9 months, and median progression-free survival was 8.3 months.

PD-L1 status was determined in 36 patients; 15 were positive. Among the positive patents, ORR was 60%, compared with 19% in PD-L1 negative patients. Response rates varied with tumor characteristics. Among patients with ccRCC with sarcomatoid differentiation, the ORR was 50% in PD-L1–positive patients and 29% in negative patients. In patients with variant histology RCC, the ORR was also better in PD-L1 positive patients (67% vs. 14%).

The most common treatment-related side effects were fatigue (35%), proteinuria (35%), musculoskeletal pain (33%), diarrhea (22%), rash (20%), hypertension (18%), pruritus (18%), thyroid dysfunction (17%), hepatitis (15%), fever (13%), and mucositis (12%). Thirty-four patients developed at least one grade 3 adverse event; there were no grade 4 or 5 toxicities. One patient died, presumably because of disease progression.

Quality of life scores were largely stable during treatment.

“The combination demonstrated responses across several subtypes of RCC, including collecting duct and medullary carcinoma, histologies that are often treated with cytotoxic chemotherapy,” the authors said. “This is notable given the generally poor prognosis and low response rate associated with variant histology RCC in trials to date.”

The study also suggests the PD-L1 status might be “intriguing as a biomarker for response to atezolizumab and bevacizumab in variant histology RCC. We plan to conduct additional correlative work, including genomic profiling and assessment of the immune microenvironment, to better elucidate markers of response and resistance,” the authors wrote.

SOURCE: McGregor BA et al. J Clin Oncol. 2019 Nov 13. doi: 10.1200/JCO.19.01882.

Cancer-related pain was more common among patients in 2019 than in 2018, as was the use of prescription opioids, according to the American Society of Clinical Oncology.

Patients who have/had cancer were significantly more likely to report that they were currently experiencing cancer-related pain in 2019 (19%) than in 2018 (12%), but there was only a slight increase in patients who said that they had experienced cancer-related pain in the past, the society reported in its National Cancer Opinion Survey.

When asked about methods used to manage pain, nausea, and other symptoms, patients diagnosed with cancer most often said that they had not used anything in the last 12 months, although this response was significantly less common in 2019 (48%) than in 2018 (55%). Over-the-counter pain relievers were the most common method used (24% in 2019 and 22% in 2018), followed by vitamins/minerals/herbs (18% in 2019 and 17% in 2018), ASCO said.

Prescription opioids were the third most popular choice for symptom management both years, but use was significantly higher in 2019 (17%) than in 2018 (12%). Also showing a significant increase from 2018 to 2019 was use of medical marijuana, which went from 5% to 10%, ASCO said.

The survey was conducted online for ASCO by the Harris Poll from July 9 to Aug. 10, 2019. The total sample consisted of 4,815 U.S. adults, of whom 1,009 had been diagnosed with cancer.

[email protected]

Cancer-related pain was more common among patients in 2019 than in 2018, as was the use of prescription opioids, according to the American Society of Clinical Oncology.

Patients who have/had cancer were significantly more likely to report that they were currently experiencing cancer-related pain in 2019 (19%) than in 2018 (12%), but there was only a slight increase in patients who said that they had experienced cancer-related pain in the past, the society reported in its National Cancer Opinion Survey.

When asked about methods used to manage pain, nausea, and other symptoms, patients diagnosed with cancer most often said that they had not used anything in the last 12 months, although this response was significantly less common in 2019 (48%) than in 2018 (55%). Over-the-counter pain relievers were the most common method used (24% in 2019 and 22% in 2018), followed by vitamins/minerals/herbs (18% in 2019 and 17% in 2018), ASCO said.

Prescription opioids were the third most popular choice for symptom management both years, but use was significantly higher in 2019 (17%) than in 2018 (12%). Also showing a significant increase from 2018 to 2019 was use of medical marijuana, which went from 5% to 10%, ASCO said.

The survey was conducted online for ASCO by the Harris Poll from July 9 to Aug. 10, 2019. The total sample consisted of 4,815 U.S. adults, of whom 1,009 had been diagnosed with cancer.

[email protected]

Cancer-related pain was more common among patients in 2019 than in 2018, as was the use of prescription opioids, according to the American Society of Clinical Oncology.

Patients who have/had cancer were significantly more likely to report that they were currently experiencing cancer-related pain in 2019 (19%) than in 2018 (12%), but there was only a slight increase in patients who said that they had experienced cancer-related pain in the past, the society reported in its National Cancer Opinion Survey.

When asked about methods used to manage pain, nausea, and other symptoms, patients diagnosed with cancer most often said that they had not used anything in the last 12 months, although this response was significantly less common in 2019 (48%) than in 2018 (55%). Over-the-counter pain relievers were the most common method used (24% in 2019 and 22% in 2018), followed by vitamins/minerals/herbs (18% in 2019 and 17% in 2018), ASCO said.

Prescription opioids were the third most popular choice for symptom management both years, but use was significantly higher in 2019 (17%) than in 2018 (12%). Also showing a significant increase from 2018 to 2019 was use of medical marijuana, which went from 5% to 10%, ASCO said.

The survey was conducted online for ASCO by the Harris Poll from July 9 to Aug. 10, 2019. The total sample consisted of 4,815 U.S. adults, of whom 1,009 had been diagnosed with cancer.

[email protected]

A study has found that consistent occupational exposure to disinfectants is associated with an increased risk of chronic obstructive pulmonary disease (COPD).

“Clinicians should be aware of this new risk factor and systematically look for sources of exposure to cleaning products and disinfectants in addition to other occupational exposures in patients with COPD,” wrote Orianne Dumas, PhD, of the Université de Versailles St-Quentin-en-Yvelines (France) and coauthors. The study was published in JAMA Network Open.

To determine if regular use of disinfectants had a negative impact on respiratory health, the researchers analyzed data from 73,262 active female nurses who had no history of COPD and completed questionnaires every 2 years for the Nurses’ Health Study II. Their mean age at baseline was 54.7. Exposure to commonly used disinfectants was evaluated by a job-task-exposure matrix (JTEM) specific to nurses.

Between 2009 and 2015, 582 nurses reported incident physician-diagnosed COPD. Weekly use of disinfectants was associated with COPD incidence (adjusted hazard ratio 1.35; 95% confidence interval, 1.14-1.59). Additional associations were found in nurses who used disinfectants to clean surfaces (AHR, 1.38; 95% CI, 1.13-1.68) and to clean medical instruments (AHR, 1.31; 95% CI, 1.07-1.61). High-level exposure to certain disinfectants – including glutaraldehyde, bleach, hydrogen peroxide, alcohol, and quaternary ammonium compounds – were significantly associated with increased risk of COPD incidence.

The authors acknowledged their study’s limitations, including the JTEM only assessing exposure to seven of the major cleaning products commonly used in health care. In addition, detailed data on exposure to disinfectants was not available before 2009. However, they added that, because the study has been ongoing since 1989, it could be expected that women who had been nurses for decades had “already accumulated a long history of exposure.”

The study was supported in part by grants from the Centers for Disease Control and Prevention and the National Institutes of Health. Five of the authors reported receiving grants from the CDC’s National Institute for Occupational Safety and Health (NIOSH); one additional author reported being a consultant on a NIOSH grant and receiving personal fees from a health care system. No other conflicts of interest were reported.

SOURCE: Dumas O et al. JAMA Netw Open. 2019 Oct 18. doi: 10.1001/jamanetworkopen.2019.13563.

A study has found that consistent occupational exposure to disinfectants is associated with an increased risk of chronic obstructive pulmonary disease (COPD).

“Clinicians should be aware of this new risk factor and systematically look for sources of exposure to cleaning products and disinfectants in addition to other occupational exposures in patients with COPD,” wrote Orianne Dumas, PhD, of the Université de Versailles St-Quentin-en-Yvelines (France) and coauthors. The study was published in JAMA Network Open.

To determine if regular use of disinfectants had a negative impact on respiratory health, the researchers analyzed data from 73,262 active female nurses who had no history of COPD and completed questionnaires every 2 years for the Nurses’ Health Study II. Their mean age at baseline was 54.7. Exposure to commonly used disinfectants was evaluated by a job-task-exposure matrix (JTEM) specific to nurses.

Between 2009 and 2015, 582 nurses reported incident physician-diagnosed COPD. Weekly use of disinfectants was associated with COPD incidence (adjusted hazard ratio 1.35; 95% confidence interval, 1.14-1.59). Additional associations were found in nurses who used disinfectants to clean surfaces (AHR, 1.38; 95% CI, 1.13-1.68) and to clean medical instruments (AHR, 1.31; 95% CI, 1.07-1.61). High-level exposure to certain disinfectants – including glutaraldehyde, bleach, hydrogen peroxide, alcohol, and quaternary ammonium compounds – were significantly associated with increased risk of COPD incidence.

The authors acknowledged their study’s limitations, including the JTEM only assessing exposure to seven of the major cleaning products commonly used in health care. In addition, detailed data on exposure to disinfectants was not available before 2009. However, they added that, because the study has been ongoing since 1989, it could be expected that women who had been nurses for decades had “already accumulated a long history of exposure.”

The study was supported in part by grants from the Centers for Disease Control and Prevention and the National Institutes of Health. Five of the authors reported receiving grants from the CDC’s National Institute for Occupational Safety and Health (NIOSH); one additional author reported being a consultant on a NIOSH grant and receiving personal fees from a health care system. No other conflicts of interest were reported.

SOURCE: Dumas O et al. JAMA Netw Open. 2019 Oct 18. doi: 10.1001/jamanetworkopen.2019.13563.

A study has found that consistent occupational exposure to disinfectants is associated with an increased risk of chronic obstructive pulmonary disease (COPD).

“Clinicians should be aware of this new risk factor and systematically look for sources of exposure to cleaning products and disinfectants in addition to other occupational exposures in patients with COPD,” wrote Orianne Dumas, PhD, of the Université de Versailles St-Quentin-en-Yvelines (France) and coauthors. The study was published in JAMA Network Open.

To determine if regular use of disinfectants had a negative impact on respiratory health, the researchers analyzed data from 73,262 active female nurses who had no history of COPD and completed questionnaires every 2 years for the Nurses’ Health Study II. Their mean age at baseline was 54.7. Exposure to commonly used disinfectants was evaluated by a job-task-exposure matrix (JTEM) specific to nurses.

Between 2009 and 2015, 582 nurses reported incident physician-diagnosed COPD. Weekly use of disinfectants was associated with COPD incidence (adjusted hazard ratio 1.35; 95% confidence interval, 1.14-1.59). Additional associations were found in nurses who used disinfectants to clean surfaces (AHR, 1.38; 95% CI, 1.13-1.68) and to clean medical instruments (AHR, 1.31; 95% CI, 1.07-1.61). High-level exposure to certain disinfectants – including glutaraldehyde, bleach, hydrogen peroxide, alcohol, and quaternary ammonium compounds – were significantly associated with increased risk of COPD incidence.

The authors acknowledged their study’s limitations, including the JTEM only assessing exposure to seven of the major cleaning products commonly used in health care. In addition, detailed data on exposure to disinfectants was not available before 2009. However, they added that, because the study has been ongoing since 1989, it could be expected that women who had been nurses for decades had “already accumulated a long history of exposure.”

The study was supported in part by grants from the Centers for Disease Control and Prevention and the National Institutes of Health. Five of the authors reported receiving grants from the CDC’s National Institute for Occupational Safety and Health (NIOSH); one additional author reported being a consultant on a NIOSH grant and receiving personal fees from a health care system. No other conflicts of interest were reported.

SOURCE: Dumas O et al. JAMA Netw Open. 2019 Oct 18. doi: 10.1001/jamanetworkopen.2019.13563.

Kaposi sarcoma (KS) is a low-grade vascular tumor that is rare among the general US population, with an incidence rate of less than 1 per 100,000.¹ The tumor is more common among certain groups of individuals due to geographic differences in the prevalence of KS-associated herpesvirus (also referred to as human herpesvirus 8) as well as host immune factors.² Kaposi sarcoma often is defined by the patient's predisposing characteristics yielding the following distinct epidemiologic subtypes: (1) classic KS is a rare disease affecting older men of Mediterranean descent; (2) African KS is an endemic cancer with male predominance in sub-Saharan Africa; (3) AIDS-associated KS is an often aggressive AIDS-defining illness; and (4) iatrogenic KS occurs in patients on immunosuppressive therapy.³ When evaluating a patient without any of these risk factors, the clinical suspicion for KS may be low. We report a patient with postpolio syndrome (PPS) who presented with KS of the right leg, ankle, and foot. 

A 77-year-old man with a distant history of paralytic poliomyelitis presented for an annual skin examination with concern for a new lesion on the right ankle. The patient had a history of PPS primarily affecting the right leg. Physical examination revealed residual weakness in an atrophic right lower extremity with a mottled appearance and mild pitting edema to the knee. Two red, dome-shaped, vascular papules were appreciated on the medial aspect of the right ankle (Figure 1), and a shave biopsy of the larger papule was performed. Microscopic examination of the biopsy specimen was consistent with KS (Figure 2). This patient had no history of human immunodeficiency virus or immunosuppressive therapy and was not of Mediterranean descent. 

Because KS is a radiosensitive vascular neoplasm and radiation therapy (RT) alone can achieve local control,⁴ the patient was treated with 6 megaelectron-volt electron-beam RT. He received 30 Gy in 10 fractions to the affected area of the medial ankle. The patient tolerated RT well. Three weeks after completing treatment, he was found to have mild lichenification on the right medial ankle with no clinical evidence of disease. Four months later, he presented with multiple additional vascular papules on the right third toe and in the interdigital web space (Figure 3). Shave biopsy of one of these lesions was consistent with KS. Contrast computed tomography of the chest, abdomen, and pelvis was performed, revealing no evidence of metastatic disease. The patient was treated with 30 Gy in 15 fractions using opposed lateral 6 megaelectron-volt photon fields to the entire right lower extremity below the knee to treat all of the skin affected by the PPS. His posttreatment course was complicated by edema in the affected leg that resolved after daily pneumatic compression. He had no evidence of residual or recurrent disease 6 months after completing RT (Figure 4). 

Cutaneous KS is a human herpesvirus 8-positive tumor of endothelial origin typically seen in older men of Mediterranean or African descent and among immunosuppressed patients.⁴ Our patient did not have any classic risk factors for KS, but his disease did arise in the setting of a right lower extremity that was notably affected by PPS. Postpolio syndrome is characterized by muscle atrophy due to denervation of the motor unit.⁵ Bruno et al⁶ found that such deficits in motor innervation could lead to impairments in venous outflow causing cutaneous venous congestion. Acroangiodermatitis clinically resembles KS but is a benign reactive vasoproliferative disorder and is well known to occur in the lower extremities as a sequela of chronic venous insufficiency.⁷ A case of bilateral lower extremity pseudo-KS was reported in a patient with notable PPS.⁸ A report of 2 patients describes KS arising in the setting of chronic venous insufficiency without any classic risk factors.⁹ Therefore, patients with PPS characterized by venous insufficiency may represent a population at increased risk for KS. 
 

Kaposi sarcoma (KS) is a low-grade vascular tumor that is rare among the general US population, with an incidence rate of less than 1 per 100,000.¹ The tumor is more common among certain groups of individuals due to geographic differences in the prevalence of KS-associated herpesvirus (also referred to as human herpesvirus 8) as well as host immune factors.² Kaposi sarcoma often is defined by the patient's predisposing characteristics yielding the following distinct epidemiologic subtypes: (1) classic KS is a rare disease affecting older men of Mediterranean descent; (2) African KS is an endemic cancer with male predominance in sub-Saharan Africa; (3) AIDS-associated KS is an often aggressive AIDS-defining illness; and (4) iatrogenic KS occurs in patients on immunosuppressive therapy.³ When evaluating a patient without any of these risk factors, the clinical suspicion for KS may be low. We report a patient with postpolio syndrome (PPS) who presented with KS of the right leg, ankle, and foot. 

A 77-year-old man with a distant history of paralytic poliomyelitis presented for an annual skin examination with concern for a new lesion on the right ankle. The patient had a history of PPS primarily affecting the right leg. Physical examination revealed residual weakness in an atrophic right lower extremity with a mottled appearance and mild pitting edema to the knee. Two red, dome-shaped, vascular papules were appreciated on the medial aspect of the right ankle (Figure 1), and a shave biopsy of the larger papule was performed. Microscopic examination of the biopsy specimen was consistent with KS (Figure 2). This patient had no history of human immunodeficiency virus or immunosuppressive therapy and was not of Mediterranean descent. 

Because KS is a radiosensitive vascular neoplasm and radiation therapy (RT) alone can achieve local control,⁴ the patient was treated with 6 megaelectron-volt electron-beam RT. He received 30 Gy in 10 fractions to the affected area of the medial ankle. The patient tolerated RT well. Three weeks after completing treatment, he was found to have mild lichenification on the right medial ankle with no clinical evidence of disease. Four months later, he presented with multiple additional vascular papules on the right third toe and in the interdigital web space (Figure 3). Shave biopsy of one of these lesions was consistent with KS. Contrast computed tomography of the chest, abdomen, and pelvis was performed, revealing no evidence of metastatic disease. The patient was treated with 30 Gy in 15 fractions using opposed lateral 6 megaelectron-volt photon fields to the entire right lower extremity below the knee to treat all of the skin affected by the PPS. His posttreatment course was complicated by edema in the affected leg that resolved after daily pneumatic compression. He had no evidence of residual or recurrent disease 6 months after completing RT (Figure 4). 

Cutaneous KS is a human herpesvirus 8-positive tumor of endothelial origin typically seen in older men of Mediterranean or African descent and among immunosuppressed patients.⁴ Our patient did not have any classic risk factors for KS, but his disease did arise in the setting of a right lower extremity that was notably affected by PPS. Postpolio syndrome is characterized by muscle atrophy due to denervation of the motor unit.⁵ Bruno et al⁶ found that such deficits in motor innervation could lead to impairments in venous outflow causing cutaneous venous congestion. Acroangiodermatitis clinically resembles KS but is a benign reactive vasoproliferative disorder and is well known to occur in the lower extremities as a sequela of chronic venous insufficiency.⁷ A case of bilateral lower extremity pseudo-KS was reported in a patient with notable PPS.⁸ A report of 2 patients describes KS arising in the setting of chronic venous insufficiency without any classic risk factors.⁹ Therefore, patients with PPS characterized by venous insufficiency may represent a population at increased risk for KS. 
 

Kaposi sarcoma (KS) is a low-grade vascular tumor that is rare among the general US population, with an incidence rate of less than 1 per 100,000.¹ The tumor is more common among certain groups of individuals due to geographic differences in the prevalence of KS-associated herpesvirus (also referred to as human herpesvirus 8) as well as host immune factors.² Kaposi sarcoma often is defined by the patient's predisposing characteristics yielding the following distinct epidemiologic subtypes: (1) classic KS is a rare disease affecting older men of Mediterranean descent; (2) African KS is an endemic cancer with male predominance in sub-Saharan Africa; (3) AIDS-associated KS is an often aggressive AIDS-defining illness; and (4) iatrogenic KS occurs in patients on immunosuppressive therapy.³ When evaluating a patient without any of these risk factors, the clinical suspicion for KS may be low. We report a patient with postpolio syndrome (PPS) who presented with KS of the right leg, ankle, and foot. 

A 77-year-old man with a distant history of paralytic poliomyelitis presented for an annual skin examination with concern for a new lesion on the right ankle. The patient had a history of PPS primarily affecting the right leg. Physical examination revealed residual weakness in an atrophic right lower extremity with a mottled appearance and mild pitting edema to the knee. Two red, dome-shaped, vascular papules were appreciated on the medial aspect of the right ankle (Figure 1), and a shave biopsy of the larger papule was performed. Microscopic examination of the biopsy specimen was consistent with KS (Figure 2). This patient had no history of human immunodeficiency virus or immunosuppressive therapy and was not of Mediterranean descent. 

Because KS is a radiosensitive vascular neoplasm and radiation therapy (RT) alone can achieve local control,⁴ the patient was treated with 6 megaelectron-volt electron-beam RT. He received 30 Gy in 10 fractions to the affected area of the medial ankle. The patient tolerated RT well. Three weeks after completing treatment, he was found to have mild lichenification on the right medial ankle with no clinical evidence of disease. Four months later, he presented with multiple additional vascular papules on the right third toe and in the interdigital web space (Figure 3). Shave biopsy of one of these lesions was consistent with KS. Contrast computed tomography of the chest, abdomen, and pelvis was performed, revealing no evidence of metastatic disease. The patient was treated with 30 Gy in 15 fractions using opposed lateral 6 megaelectron-volt photon fields to the entire right lower extremity below the knee to treat all of the skin affected by the PPS. His posttreatment course was complicated by edema in the affected leg that resolved after daily pneumatic compression. He had no evidence of residual or recurrent disease 6 months after completing RT (Figure 4). 

Cutaneous KS is a human herpesvirus 8-positive tumor of endothelial origin typically seen in older men of Mediterranean or African descent and among immunosuppressed patients.⁴ Our patient did not have any classic risk factors for KS, but his disease did arise in the setting of a right lower extremity that was notably affected by PPS. Postpolio syndrome is characterized by muscle atrophy due to denervation of the motor unit.⁵ Bruno et al⁶ found that such deficits in motor innervation could lead to impairments in venous outflow causing cutaneous venous congestion. Acroangiodermatitis clinically resembles KS but is a benign reactive vasoproliferative disorder and is well known to occur in the lower extremities as a sequela of chronic venous insufficiency.⁷ A case of bilateral lower extremity pseudo-KS was reported in a patient with notable PPS.⁸ A report of 2 patients describes KS arising in the setting of chronic venous insufficiency without any classic risk factors.⁹ Therefore, patients with PPS characterized by venous insufficiency may represent a population at increased risk for KS. 
 

Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.

Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.

“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.

As a combination of olanzapine and samidorphan, ALKS 3831 is designed to maintain the clinical efficacy of olanzapine and mitigate the substantial weight gain that often results from taking antipsychotics. Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.

Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.

Find the full press release on the Alkermes website.

[email protected]

Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.

Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.

“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.

As a combination of olanzapine and samidorphan, ALKS 3831 is designed to maintain the clinical efficacy of olanzapine and mitigate the substantial weight gain that often results from taking antipsychotics. Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.

Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.

Find the full press release on the Alkermes website.

[email protected]

Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.

Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.

“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.

As a combination of olanzapine and samidorphan, ALKS 3831 is designed to maintain the clinical efficacy of olanzapine and mitigate the substantial weight gain that often results from taking antipsychotics. Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.

Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.

Find the full press release on the Alkermes website.

[email protected]

References

1. Final update summary: breast cancer: medication use to reduce risk. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-medications-for-risk-reduction1 Updated October 2019. Accessed November 25, 2019.
2. Final update summary: BRCA-related cancer: risk assessment, genetic counseling, and genetic testing. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing1. Updated August 2019. Accessed November 25, 2019.
3. Campos-Outcalt D. USPSTF BRCA testing recs: 2 more groups require attention. J Fam Pract. 2019;68:audio. https://www.mdedge.com/familymedicine/article/208085/womens-health/uspstf-brca-testing-recs-2-more-groups-require-attention?channel=60894. Accessed November 25, 2019.

References

1. Final update summary: breast cancer: medication use to reduce risk. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-medications-for-risk-reduction1 Updated October 2019. Accessed November 25, 2019.
2. Final update summary: BRCA-related cancer: risk assessment, genetic counseling, and genetic testing. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing1. Updated August 2019. Accessed November 25, 2019.
3. Campos-Outcalt D. USPSTF BRCA testing recs: 2 more groups require attention. J Fam Pract. 2019;68:audio. https://www.mdedge.com/familymedicine/article/208085/womens-health/uspstf-brca-testing-recs-2-more-groups-require-attention?channel=60894. Accessed November 25, 2019.

References

1. Final update summary: breast cancer: medication use to reduce risk. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-medications-for-risk-reduction1 Updated October 2019. Accessed November 25, 2019.
2. Final update summary: BRCA-related cancer: risk assessment, genetic counseling, and genetic testing. U.S. Preventive Services Task Force Web Site. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing1. Updated August 2019. Accessed November 25, 2019.
3. Campos-Outcalt D. USPSTF BRCA testing recs: 2 more groups require attention. J Fam Pract. 2019;68:audio. https://www.mdedge.com/familymedicine/article/208085/womens-health/uspstf-brca-testing-recs-2-more-groups-require-attention?channel=60894. Accessed November 25, 2019.