BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

Multiple myeloma, an incurable plasma cell malignancy, has an average age of diagnosis over 65 years. For transplant-eligible patients, high-dose melphalan 200 mg/m2 (MEL200), followed by autologous stem cell rescue (ASCR) is the standard in consolidation therapy. Most clinical trials evaluating MEL200 with ASCR excluded patients over 65 due to concerns for toxicity and treatment-related mortality, leading to use of reduced dose melphalan 140 mg/m2 (MEL140) in clinical practice for older patients. As this dose has limited studies surrounding its reduction, the purpose of this study was to compare outcomes and toxicities of MEL140 in patients over the age of 65 to MEL200 in patients 65 and under.

METHODS

This single-center institutional review board approved retrospective study was conducted at VA Tennessee Valley Healthcare System. All multiple myeloma patients greater than 18 years of age who received melphalan with ASCR from January 1, 2018, to December 31, 2021, were included. Patients were divided into two arms: age < 65 treated with MEL200 and age >65 treated with MEL140. The primary endpoint was oneyear progression-free survival (PFS). The secondary endpoints were one-year overall survival (OS), treatment related mortality, time to neutrophil engraftment, and toxicities including febrile neutropenia, diarrhea, mucositis, infection, and intensive care unit transfers.

RESULTS

A total of 222 patients were included, 114 patients in the MEL200 arm and 108 patients in the MEL140 arm. The primary endpoint of one-year PFS had no significant difference, with 103 (90.4%) patients in the MEL200 group compared to 99 (91.7%) patients in the MEL140 group (p=0.732). Similarly, there was no statistically significant difference in the secondary endpoint of one-year OS with 112 (98.3%) patients in the MEL200 group compared to 106 (98.2%) in the MEL140 group (p=0.956). Toxicities were similar; however, grade 3 mucositis was higher in the MEL200 arm.

CONCLUSIONS

Our study found no difference in oneyear PFS or one-year OS when comparing MEL140 to MEL200 with minimal differences in regimen-related toxicities. Although not powered to detect statistical difference, results suggests that dose reduction with MEL140 in patients >65 years does not impact one-year PFS when compared to patients <65 receiving standard MEL200.

BACKGROUND

Multiple myeloma, an incurable plasma cell malignancy, has an average age of diagnosis over 65 years. For transplant-eligible patients, high-dose melphalan 200 mg/m2 (MEL200), followed by autologous stem cell rescue (ASCR) is the standard in consolidation therapy. Most clinical trials evaluating MEL200 with ASCR excluded patients over 65 due to concerns for toxicity and treatment-related mortality, leading to use of reduced dose melphalan 140 mg/m2 (MEL140) in clinical practice for older patients. As this dose has limited studies surrounding its reduction, the purpose of this study was to compare outcomes and toxicities of MEL140 in patients over the age of 65 to MEL200 in patients 65 and under.

METHODS

This single-center institutional review board approved retrospective study was conducted at VA Tennessee Valley Healthcare System. All multiple myeloma patients greater than 18 years of age who received melphalan with ASCR from January 1, 2018, to December 31, 2021, were included. Patients were divided into two arms: age < 65 treated with MEL200 and age >65 treated with MEL140. The primary endpoint was oneyear progression-free survival (PFS). The secondary endpoints were one-year overall survival (OS), treatment related mortality, time to neutrophil engraftment, and toxicities including febrile neutropenia, diarrhea, mucositis, infection, and intensive care unit transfers.

RESULTS

A total of 222 patients were included, 114 patients in the MEL200 arm and 108 patients in the MEL140 arm. The primary endpoint of one-year PFS had no significant difference, with 103 (90.4%) patients in the MEL200 group compared to 99 (91.7%) patients in the MEL140 group (p=0.732). Similarly, there was no statistically significant difference in the secondary endpoint of one-year OS with 112 (98.3%) patients in the MEL200 group compared to 106 (98.2%) in the MEL140 group (p=0.956). Toxicities were similar; however, grade 3 mucositis was higher in the MEL200 arm.

CONCLUSIONS

Our study found no difference in oneyear PFS or one-year OS when comparing MEL140 to MEL200 with minimal differences in regimen-related toxicities. Although not powered to detect statistical difference, results suggests that dose reduction with MEL140 in patients >65 years does not impact one-year PFS when compared to patients <65 receiving standard MEL200.

BACKGROUND

Multiple myeloma, an incurable plasma cell malignancy, has an average age of diagnosis over 65 years. For transplant-eligible patients, high-dose melphalan 200 mg/m2 (MEL200), followed by autologous stem cell rescue (ASCR) is the standard in consolidation therapy. Most clinical trials evaluating MEL200 with ASCR excluded patients over 65 due to concerns for toxicity and treatment-related mortality, leading to use of reduced dose melphalan 140 mg/m2 (MEL140) in clinical practice for older patients. As this dose has limited studies surrounding its reduction, the purpose of this study was to compare outcomes and toxicities of MEL140 in patients over the age of 65 to MEL200 in patients 65 and under.

METHODS

This single-center institutional review board approved retrospective study was conducted at VA Tennessee Valley Healthcare System. All multiple myeloma patients greater than 18 years of age who received melphalan with ASCR from January 1, 2018, to December 31, 2021, were included. Patients were divided into two arms: age < 65 treated with MEL200 and age >65 treated with MEL140. The primary endpoint was oneyear progression-free survival (PFS). The secondary endpoints were one-year overall survival (OS), treatment related mortality, time to neutrophil engraftment, and toxicities including febrile neutropenia, diarrhea, mucositis, infection, and intensive care unit transfers.

RESULTS

A total of 222 patients were included, 114 patients in the MEL200 arm and 108 patients in the MEL140 arm. The primary endpoint of one-year PFS had no significant difference, with 103 (90.4%) patients in the MEL200 group compared to 99 (91.7%) patients in the MEL140 group (p=0.732). Similarly, there was no statistically significant difference in the secondary endpoint of one-year OS with 112 (98.3%) patients in the MEL200 group compared to 106 (98.2%) in the MEL140 group (p=0.956). Toxicities were similar; however, grade 3 mucositis was higher in the MEL200 arm.

CONCLUSIONS

Our study found no difference in oneyear PFS or one-year OS when comparing MEL140 to MEL200 with minimal differences in regimen-related toxicities. Although not powered to detect statistical difference, results suggests that dose reduction with MEL140 in patients >65 years does not impact one-year PFS when compared to patients <65 receiving standard MEL200.

BACKGROUND

In 2017, the Thoracic Tumor Board realized that there were patients whose lung resections had critical review of the slides and reports prior to presentation. Errors were found which resulted in a change of the pathology Tumor Nodal Metastases (pTNM) staging for the patient. The impacts were important for determining appropriate therapy. It was decided to systematically review all lung cancer resections for accuracy before determining definitive therapy recommendations.

METHODS

All lung resections for malignancy were examined prior and up to 2 days of completion for accuracy of tumor type, tumor size, tumor grade, lymph node metastases and pathologic stage (pTNM). Any errors found were given to the original pathologist for a change in the report before release or for a modified report to be issued.

RESULTS

From June 2017 to December 2020, there were 91 lung resections with 28 (30.77%) errors. Errors included: 16 incorrect pathologic staging, 5 missed tumors in lung and lymph nodes, 2 unexamined stapled surgical margins, 1 wrong site, 1 incorrect lymph node number and 2 missed tumor vascular invasion.

IMPLICATIONS

Quality improvement (QI) review of lung resections by a second pathologist is important and may clearly improve pathologic staging for lung cancer patients. It can be added to QI programs currently used in Surgical Pathology. It is important in directing appropriate postsurgical therapies.

BACKGROUND

In 2017, the Thoracic Tumor Board realized that there were patients whose lung resections had critical review of the slides and reports prior to presentation. Errors were found which resulted in a change of the pathology Tumor Nodal Metastases (pTNM) staging for the patient. The impacts were important for determining appropriate therapy. It was decided to systematically review all lung cancer resections for accuracy before determining definitive therapy recommendations.

METHODS

All lung resections for malignancy were examined prior and up to 2 days of completion for accuracy of tumor type, tumor size, tumor grade, lymph node metastases and pathologic stage (pTNM). Any errors found were given to the original pathologist for a change in the report before release or for a modified report to be issued.

RESULTS

From June 2017 to December 2020, there were 91 lung resections with 28 (30.77%) errors. Errors included: 16 incorrect pathologic staging, 5 missed tumors in lung and lymph nodes, 2 unexamined stapled surgical margins, 1 wrong site, 1 incorrect lymph node number and 2 missed tumor vascular invasion.

IMPLICATIONS

Quality improvement (QI) review of lung resections by a second pathologist is important and may clearly improve pathologic staging for lung cancer patients. It can be added to QI programs currently used in Surgical Pathology. It is important in directing appropriate postsurgical therapies.

BACKGROUND

In 2017, the Thoracic Tumor Board realized that there were patients whose lung resections had critical review of the slides and reports prior to presentation. Errors were found which resulted in a change of the pathology Tumor Nodal Metastases (pTNM) staging for the patient. The impacts were important for determining appropriate therapy. It was decided to systematically review all lung cancer resections for accuracy before determining definitive therapy recommendations.

METHODS

All lung resections for malignancy were examined prior and up to 2 days of completion for accuracy of tumor type, tumor size, tumor grade, lymph node metastases and pathologic stage (pTNM). Any errors found were given to the original pathologist for a change in the report before release or for a modified report to be issued.

RESULTS

From June 2017 to December 2020, there were 91 lung resections with 28 (30.77%) errors. Errors included: 16 incorrect pathologic staging, 5 missed tumors in lung and lymph nodes, 2 unexamined stapled surgical margins, 1 wrong site, 1 incorrect lymph node number and 2 missed tumor vascular invasion.

IMPLICATIONS

Quality improvement (QI) review of lung resections by a second pathologist is important and may clearly improve pathologic staging for lung cancer patients. It can be added to QI programs currently used in Surgical Pathology. It is important in directing appropriate postsurgical therapies.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

INTRODUCTION

Prostate cancer rarely metastasizes to the pituitary gland and the close relationship of these sellar masses to cavernous sinuses and major vessels makes management challenging. We describe a unique case of complete reversal of ptosis in metastatic prostate cancer presenting as cavernous sinus syndrome

CASE REPORT

A 76-year-old male presented with left diplopia, ptosis, and facial numbness. Examination showed left oculomotor palsy and numbness in the V1 and V2 distribution of trigeminal nerve. MRI revealed an 11 × 26 × 17 mm posterior sellar mass extending into the left cavernous sinus. Prolactin was slightly elevated, but rest of the pituitary hormones were normal. Resection of the sellar mass showed metastatic prostatic adenocarcinoma positive for NKX-3.1 and prostate-specific antigen (PSA), and Gleason score 4. PSA was elevated at 32 ng/ mL. Positron emission tomography (PET) showed lesions in the left prostatic lobe, pelvic lymph nodes, L5 spine, and right femoral head. FoundationOne testing found no actionable mutations. He was started on leuprorelin-docetaxel and received radiation for the brain and bony lesions. He is currently being maintained on leuprorelin-abiraterone and prednisone, which he is tolerating well.

DISCUSSION

Pituitary metastases (PMs) from prostate cancer are rare and are usually confined to the posterior pituitary. The close relationship of pituitary masses to the cavernous sinuses and internal carotid artery can lead to catastrophic neurovascular consequences. Imaging has limited sensitivity for differentiating non-invasive metastases from adenomas. Older age, new-onset diabetes insipidus, invasive masses, and rapidly growing lesions should raise suspicion for PMs. Intracranial prostatic metastases indicate poor prognosis with a reported median survival of 6-10 months. Timely diagnosis and management can prevent permanent neurologic damage as illustrated by our case in which ptosis and extraocular symptoms were completely resolved by surgery and radiation. Such unique cases underline the significance of suspecting metastatic disease in appropriate demographic groups and the crucial role of multidisciplinary care for oncologic patients.

CONCLUSIONS

A high index of suspicion for PMs in elderly people with new-onset sellar symptoms and early involvement of multidisciplinary teams can lead to prevention and even reversal of serious neurologic symptoms.

INTRODUCTION

Prostate cancer rarely metastasizes to the pituitary gland and the close relationship of these sellar masses to cavernous sinuses and major vessels makes management challenging. We describe a unique case of complete reversal of ptosis in metastatic prostate cancer presenting as cavernous sinus syndrome

CASE REPORT

A 76-year-old male presented with left diplopia, ptosis, and facial numbness. Examination showed left oculomotor palsy and numbness in the V1 and V2 distribution of trigeminal nerve. MRI revealed an 11 × 26 × 17 mm posterior sellar mass extending into the left cavernous sinus. Prolactin was slightly elevated, but rest of the pituitary hormones were normal. Resection of the sellar mass showed metastatic prostatic adenocarcinoma positive for NKX-3.1 and prostate-specific antigen (PSA), and Gleason score 4. PSA was elevated at 32 ng/ mL. Positron emission tomography (PET) showed lesions in the left prostatic lobe, pelvic lymph nodes, L5 spine, and right femoral head. FoundationOne testing found no actionable mutations. He was started on leuprorelin-docetaxel and received radiation for the brain and bony lesions. He is currently being maintained on leuprorelin-abiraterone and prednisone, which he is tolerating well.

DISCUSSION

Pituitary metastases (PMs) from prostate cancer are rare and are usually confined to the posterior pituitary. The close relationship of pituitary masses to the cavernous sinuses and internal carotid artery can lead to catastrophic neurovascular consequences. Imaging has limited sensitivity for differentiating non-invasive metastases from adenomas. Older age, new-onset diabetes insipidus, invasive masses, and rapidly growing lesions should raise suspicion for PMs. Intracranial prostatic metastases indicate poor prognosis with a reported median survival of 6-10 months. Timely diagnosis and management can prevent permanent neurologic damage as illustrated by our case in which ptosis and extraocular symptoms were completely resolved by surgery and radiation. Such unique cases underline the significance of suspecting metastatic disease in appropriate demographic groups and the crucial role of multidisciplinary care for oncologic patients.

CONCLUSIONS

A high index of suspicion for PMs in elderly people with new-onset sellar symptoms and early involvement of multidisciplinary teams can lead to prevention and even reversal of serious neurologic symptoms.

INTRODUCTION

Prostate cancer rarely metastasizes to the pituitary gland and the close relationship of these sellar masses to cavernous sinuses and major vessels makes management challenging. We describe a unique case of complete reversal of ptosis in metastatic prostate cancer presenting as cavernous sinus syndrome

CASE REPORT

A 76-year-old male presented with left diplopia, ptosis, and facial numbness. Examination showed left oculomotor palsy and numbness in the V1 and V2 distribution of trigeminal nerve. MRI revealed an 11 × 26 × 17 mm posterior sellar mass extending into the left cavernous sinus. Prolactin was slightly elevated, but rest of the pituitary hormones were normal. Resection of the sellar mass showed metastatic prostatic adenocarcinoma positive for NKX-3.1 and prostate-specific antigen (PSA), and Gleason score 4. PSA was elevated at 32 ng/ mL. Positron emission tomography (PET) showed lesions in the left prostatic lobe, pelvic lymph nodes, L5 spine, and right femoral head. FoundationOne testing found no actionable mutations. He was started on leuprorelin-docetaxel and received radiation for the brain and bony lesions. He is currently being maintained on leuprorelin-abiraterone and prednisone, which he is tolerating well.

DISCUSSION

Pituitary metastases (PMs) from prostate cancer are rare and are usually confined to the posterior pituitary. The close relationship of pituitary masses to the cavernous sinuses and internal carotid artery can lead to catastrophic neurovascular consequences. Imaging has limited sensitivity for differentiating non-invasive metastases from adenomas. Older age, new-onset diabetes insipidus, invasive masses, and rapidly growing lesions should raise suspicion for PMs. Intracranial prostatic metastases indicate poor prognosis with a reported median survival of 6-10 months. Timely diagnosis and management can prevent permanent neurologic damage as illustrated by our case in which ptosis and extraocular symptoms were completely resolved by surgery and radiation. Such unique cases underline the significance of suspecting metastatic disease in appropriate demographic groups and the crucial role of multidisciplinary care for oncologic patients.

CONCLUSIONS

A high index of suspicion for PMs in elderly people with new-onset sellar symptoms and early involvement of multidisciplinary teams can lead to prevention and even reversal of serious neurologic symptoms.

The rapid rise of chimeric antigen receptor T (CAR T-cell) therapy has allowed hematologists to make great strides in treating aggressive cases of multiple myeloma and several types of lymphoma and leukemia. But patients with chronic lymphocytic leukemia (CLL), the most common leukemia in adults, have been left out.

Now there are encouraging signs that CLL could join the list of blood cancers that can be effectively treated by CAR T therapy. On another front, bispecific antibodies – which just received FDA approval to treat B-cell lymphoma – are being tested as treatments for CLL.

“These are the two immunotherapies that have the most potential right now,” said Ohio State University, Columbus, hematologist Kerry A. Rogers, MD, in an interview. She went on to say that these treatments could be a boon for patients with CLL who don’t respond well to targeted therapy drugs or are so young that those medications may not retain effectiveness throughout the patients’ lifespans.

As the American Cancer Society explains, CAR T therapy is a way to get T cells “to fight cancer by changing them in the lab so they can find and destroy cancer cells.” The cells are then returned to the patient.

As the National Cancer Institute says, “If all goes as planned, the CAR T cells will continue to multiply in the patient’s body and, with guidance from their engineered receptor, recognize and kill any cancer cells that harbor the target antigen on their surfaces.”

According to Dr. Rogers, CAR T therapy is less toxic than stem cell transplantation, a related treatment. That means older people can better tolerate it, including many CLL patients in their late 60s and beyond, she said. (Side effects of CAR T therapy include cytokine release syndrome, nervous system impairment, and weakening of the immune system.)

Thus far, CAR T therapy has been approved by the U.S. Food and Drug Administration to treat lymphomas, some forms of leukemia, and multiple myeloma. “Despite the excitement around these therapies, they lead to long-term survival in fewer than half of the patients treated,” cautions the National Cancer Institute, which also notes their high cost: more than $450,000 in one case.

CAR T therapy is not FDA-approved for CLL. “There are many reasons why CAR T is less effective in patients with CLL versus other lymphomas,” said Lee Greenberger, PhD, chief scientific officer of the Leukemia & Lymphoma Society, in an interview. “For one, many patients with heavily pretreated CLL – prior to any use of CAR T – have mutations that are known to be difficult to treat. Dysfunctional T cells are also common in patients with CLL, and there’s often a lower number of available T-cells to manufacture.”

The results of a phase 1/2 trial released in August 2023 offered new insight about CAR T for CLL. In the open-label trial reported in The Lancet, 117 U.S. patients with CLL or small lymphocytic lymphoma underwent a form of CAR T therapy called lisocabtagene maraleucel after failing treatment with two lines of therapy, including a Bruton´s tyrosine kinase inhibitor. Among 49 patients at a specific dose, “the rate of complete response or remission (including with incomplete marrow recovery) was statistically significant at 18%,” the researchers reported. A total of 51 patients in the entire study died.

The rate of undetectable minimal residual disease blood was 64%. That rate is impressive, said University of Texas MD Anderson Cancer Center leukemia specialist Nitin Jain, MD, in an interview. It’s not nearly as high as researchers have seen in other disease settings, but it’s “a good, good thing for these patients. We’ll have to see in the longer follow-up how these patients fare 2, 3, or 4 years down the line.”

Dr. Rogers, the Ohio physician, said doctors had hoped durable benefit in the Lancet study would be more impressive. An important factor limiting its value may be the aggressiveness of the disease in patients who have already failed several treatments, she said. “The efficacy of CAR T might be improved by giving it as an earlier line of therapy before the CLL has become this aggressive. But it’s difficult to propose that you should use this before a Bruton´s tyrosine kinase inhibitor or venetoclax because it’s expensive and difficult.”

What’s next for CART T research in CLL? Understanding the best timing for treatment will be key, Dr. Rogers said.

The Leukemia & Lymphoma Society’s Dr. Greenberger predicted that “we will begin to see CAR T explored in CLL patients whose disease has a high risk of failing approved agents, such as Bruton´s tyrosine kinase and B cell lymphoma 2 inhibitors. However, CLL patients may still receive prior therapy with more effective Bruton’s tyrosine kinase or B cell lymphoma 2 inhibitors in the future before using CAR T. This will likely be heightened as more Bruton´s tyrosine kinase inhibitors become generic in the next 5 to 10 years and, hopefully, less expensive than CAR T therapy.”

In the big picture, he said, “treatment of CLL with CAR T is possible, but still needs significant improvements if it is to become a mainline therapy in the future.”

CAR T therapy remains available via clinical trials, and Dr. Rogers said it is “currently an important option for patients whose CLL has become resistant to standard targeted agents. We can certainly expect to extend someone’s expected survival by years if they have a favorable response.” She acknowledged that the cost is quite high, but noted that targeted therapies are also expensive, especially over the long term. They can run to $10,000-$20,000 a month. Bispecific antibodies are also being explored as potential therapy for CLL. “They’re really exciting,” Dr. Rogers said, with the potential to spur responses similar to those from CAR T therapy.

A 2022 review described these drugs as “molecules that combine antibody-directed therapies with cellular mediated immunotherapy.” The FDA explains that “by targeting two antigens or epitopes, they can cause multiple physiological or antitumor responses, which may be independent or connected.”

According to Dr. Greenberger, many bispecifics are in clinical trials now. However, “in the context of CLL, actually, the data is actually very, very limited. The development is just starting, and there are phase 1 and phase 2 trials ongoing.”

But data from lymphoma trials are encouraging, he said, and bispecifics “are actually looking as good as CAR T in some settings.”

Regimens can be a challenge for patients taking bispecifics, Dr. Greenberger said. “Repeat dosing with a step-up dosing approach to start is typically required when treating lymphoma.”

On the other hand, Dr. Rogers noted that antibody treatment can be easier for hematologists to arrange than CAR T therapy and stem cell transplants. “From an administrative side, there’s not as many things you need to have set up. So it’s able to be administered in a wider variety of settings,” she said,

Bispecific side effects include cytokine release syndrome and neurotoxicity as well as infusion reactions, Dr. Greenberger said, adding that “I would not exclude cost as a challenge.”

According to Formulary Watch, the bispecific Columvi (glofitamab-gxbm), which recently gained FDA approval to treat diffuse large B-cell lymphoma, is estimated to cost $350,000 for an 8.5-month round of treatment. Reuters reported that the bispecific Talvey (talquetamab-tgvs), which just received FDA approval to treat multiple myeloma, is estimated to cost $270,000-$360,000 for 6-8 months of treatment.

For now, bispecific trials “are mostly now reserved for patients with CLL who become resistant to our current standard targeted agents,” Dr. Rogers said. “It’s a little unclear if you can do CAR T therapy first and then bispecifics, or bispecifics and then CAR T therapy.”

What’s coming next for bispecifics? “On the horizon is better ease of administration, which is already being addressed by subcutaneous dosing for some bispecifics in lymphomas,” Dr. Greenberger said. “There’s also the possibility of combining bispecifics with conventional therapy.”

Dr. Rogers discloses ties with Genentech, AbbVie, Novartis, AstraZeneca, Janssen, Pharmacyclics, Beigene, and LOXO@Lilly. Dr. Greenberger discloses employment with the Leukemia & Lymphoma Society, which supports academic grants and a venture philanthropy via the Therapy Acceleration Program.

Dr. Jain reports ties with Pharmacyclics, AbbVie, Genentech, AstraZeneca, Pfizer, and numerous other disclosures.
 

The rapid rise of chimeric antigen receptor T (CAR T-cell) therapy has allowed hematologists to make great strides in treating aggressive cases of multiple myeloma and several types of lymphoma and leukemia. But patients with chronic lymphocytic leukemia (CLL), the most common leukemia in adults, have been left out.

Now there are encouraging signs that CLL could join the list of blood cancers that can be effectively treated by CAR T therapy. On another front, bispecific antibodies – which just received FDA approval to treat B-cell lymphoma – are being tested as treatments for CLL.

“These are the two immunotherapies that have the most potential right now,” said Ohio State University, Columbus, hematologist Kerry A. Rogers, MD, in an interview. She went on to say that these treatments could be a boon for patients with CLL who don’t respond well to targeted therapy drugs or are so young that those medications may not retain effectiveness throughout the patients’ lifespans.

As the American Cancer Society explains, CAR T therapy is a way to get T cells “to fight cancer by changing them in the lab so they can find and destroy cancer cells.” The cells are then returned to the patient.

As the National Cancer Institute says, “If all goes as planned, the CAR T cells will continue to multiply in the patient’s body and, with guidance from their engineered receptor, recognize and kill any cancer cells that harbor the target antigen on their surfaces.”

According to Dr. Rogers, CAR T therapy is less toxic than stem cell transplantation, a related treatment. That means older people can better tolerate it, including many CLL patients in their late 60s and beyond, she said. (Side effects of CAR T therapy include cytokine release syndrome, nervous system impairment, and weakening of the immune system.)

Thus far, CAR T therapy has been approved by the U.S. Food and Drug Administration to treat lymphomas, some forms of leukemia, and multiple myeloma. “Despite the excitement around these therapies, they lead to long-term survival in fewer than half of the patients treated,” cautions the National Cancer Institute, which also notes their high cost: more than $450,000 in one case.

CAR T therapy is not FDA-approved for CLL. “There are many reasons why CAR T is less effective in patients with CLL versus other lymphomas,” said Lee Greenberger, PhD, chief scientific officer of the Leukemia & Lymphoma Society, in an interview. “For one, many patients with heavily pretreated CLL – prior to any use of CAR T – have mutations that are known to be difficult to treat. Dysfunctional T cells are also common in patients with CLL, and there’s often a lower number of available T-cells to manufacture.”

The results of a phase 1/2 trial released in August 2023 offered new insight about CAR T for CLL. In the open-label trial reported in The Lancet, 117 U.S. patients with CLL or small lymphocytic lymphoma underwent a form of CAR T therapy called lisocabtagene maraleucel after failing treatment with two lines of therapy, including a Bruton´s tyrosine kinase inhibitor. Among 49 patients at a specific dose, “the rate of complete response or remission (including with incomplete marrow recovery) was statistically significant at 18%,” the researchers reported. A total of 51 patients in the entire study died.

The rate of undetectable minimal residual disease blood was 64%. That rate is impressive, said University of Texas MD Anderson Cancer Center leukemia specialist Nitin Jain, MD, in an interview. It’s not nearly as high as researchers have seen in other disease settings, but it’s “a good, good thing for these patients. We’ll have to see in the longer follow-up how these patients fare 2, 3, or 4 years down the line.”

Dr. Rogers, the Ohio physician, said doctors had hoped durable benefit in the Lancet study would be more impressive. An important factor limiting its value may be the aggressiveness of the disease in patients who have already failed several treatments, she said. “The efficacy of CAR T might be improved by giving it as an earlier line of therapy before the CLL has become this aggressive. But it’s difficult to propose that you should use this before a Bruton´s tyrosine kinase inhibitor or venetoclax because it’s expensive and difficult.”

What’s next for CART T research in CLL? Understanding the best timing for treatment will be key, Dr. Rogers said.

The Leukemia & Lymphoma Society’s Dr. Greenberger predicted that “we will begin to see CAR T explored in CLL patients whose disease has a high risk of failing approved agents, such as Bruton´s tyrosine kinase and B cell lymphoma 2 inhibitors. However, CLL patients may still receive prior therapy with more effective Bruton’s tyrosine kinase or B cell lymphoma 2 inhibitors in the future before using CAR T. This will likely be heightened as more Bruton´s tyrosine kinase inhibitors become generic in the next 5 to 10 years and, hopefully, less expensive than CAR T therapy.”

In the big picture, he said, “treatment of CLL with CAR T is possible, but still needs significant improvements if it is to become a mainline therapy in the future.”

CAR T therapy remains available via clinical trials, and Dr. Rogers said it is “currently an important option for patients whose CLL has become resistant to standard targeted agents. We can certainly expect to extend someone’s expected survival by years if they have a favorable response.” She acknowledged that the cost is quite high, but noted that targeted therapies are also expensive, especially over the long term. They can run to $10,000-$20,000 a month. Bispecific antibodies are also being explored as potential therapy for CLL. “They’re really exciting,” Dr. Rogers said, with the potential to spur responses similar to those from CAR T therapy.

A 2022 review described these drugs as “molecules that combine antibody-directed therapies with cellular mediated immunotherapy.” The FDA explains that “by targeting two antigens or epitopes, they can cause multiple physiological or antitumor responses, which may be independent or connected.”

According to Dr. Greenberger, many bispecifics are in clinical trials now. However, “in the context of CLL, actually, the data is actually very, very limited. The development is just starting, and there are phase 1 and phase 2 trials ongoing.”

But data from lymphoma trials are encouraging, he said, and bispecifics “are actually looking as good as CAR T in some settings.”

Regimens can be a challenge for patients taking bispecifics, Dr. Greenberger said. “Repeat dosing with a step-up dosing approach to start is typically required when treating lymphoma.”

On the other hand, Dr. Rogers noted that antibody treatment can be easier for hematologists to arrange than CAR T therapy and stem cell transplants. “From an administrative side, there’s not as many things you need to have set up. So it’s able to be administered in a wider variety of settings,” she said,

Bispecific side effects include cytokine release syndrome and neurotoxicity as well as infusion reactions, Dr. Greenberger said, adding that “I would not exclude cost as a challenge.”

According to Formulary Watch, the bispecific Columvi (glofitamab-gxbm), which recently gained FDA approval to treat diffuse large B-cell lymphoma, is estimated to cost $350,000 for an 8.5-month round of treatment. Reuters reported that the bispecific Talvey (talquetamab-tgvs), which just received FDA approval to treat multiple myeloma, is estimated to cost $270,000-$360,000 for 6-8 months of treatment.

For now, bispecific trials “are mostly now reserved for patients with CLL who become resistant to our current standard targeted agents,” Dr. Rogers said. “It’s a little unclear if you can do CAR T therapy first and then bispecifics, or bispecifics and then CAR T therapy.”

What’s coming next for bispecifics? “On the horizon is better ease of administration, which is already being addressed by subcutaneous dosing for some bispecifics in lymphomas,” Dr. Greenberger said. “There’s also the possibility of combining bispecifics with conventional therapy.”

Dr. Rogers discloses ties with Genentech, AbbVie, Novartis, AstraZeneca, Janssen, Pharmacyclics, Beigene, and LOXO@Lilly. Dr. Greenberger discloses employment with the Leukemia & Lymphoma Society, which supports academic grants and a venture philanthropy via the Therapy Acceleration Program.

Dr. Jain reports ties with Pharmacyclics, AbbVie, Genentech, AstraZeneca, Pfizer, and numerous other disclosures.
 

The rapid rise of chimeric antigen receptor T (CAR T-cell) therapy has allowed hematologists to make great strides in treating aggressive cases of multiple myeloma and several types of lymphoma and leukemia. But patients with chronic lymphocytic leukemia (CLL), the most common leukemia in adults, have been left out.

Now there are encouraging signs that CLL could join the list of blood cancers that can be effectively treated by CAR T therapy. On another front, bispecific antibodies – which just received FDA approval to treat B-cell lymphoma – are being tested as treatments for CLL.

“These are the two immunotherapies that have the most potential right now,” said Ohio State University, Columbus, hematologist Kerry A. Rogers, MD, in an interview. She went on to say that these treatments could be a boon for patients with CLL who don’t respond well to targeted therapy drugs or are so young that those medications may not retain effectiveness throughout the patients’ lifespans.

As the American Cancer Society explains, CAR T therapy is a way to get T cells “to fight cancer by changing them in the lab so they can find and destroy cancer cells.” The cells are then returned to the patient.

As the National Cancer Institute says, “If all goes as planned, the CAR T cells will continue to multiply in the patient’s body and, with guidance from their engineered receptor, recognize and kill any cancer cells that harbor the target antigen on their surfaces.”

According to Dr. Rogers, CAR T therapy is less toxic than stem cell transplantation, a related treatment. That means older people can better tolerate it, including many CLL patients in their late 60s and beyond, she said. (Side effects of CAR T therapy include cytokine release syndrome, nervous system impairment, and weakening of the immune system.)

Thus far, CAR T therapy has been approved by the U.S. Food and Drug Administration to treat lymphomas, some forms of leukemia, and multiple myeloma. “Despite the excitement around these therapies, they lead to long-term survival in fewer than half of the patients treated,” cautions the National Cancer Institute, which also notes their high cost: more than $450,000 in one case.

CAR T therapy is not FDA-approved for CLL. “There are many reasons why CAR T is less effective in patients with CLL versus other lymphomas,” said Lee Greenberger, PhD, chief scientific officer of the Leukemia & Lymphoma Society, in an interview. “For one, many patients with heavily pretreated CLL – prior to any use of CAR T – have mutations that are known to be difficult to treat. Dysfunctional T cells are also common in patients with CLL, and there’s often a lower number of available T-cells to manufacture.”

The results of a phase 1/2 trial released in August 2023 offered new insight about CAR T for CLL. In the open-label trial reported in The Lancet, 117 U.S. patients with CLL or small lymphocytic lymphoma underwent a form of CAR T therapy called lisocabtagene maraleucel after failing treatment with two lines of therapy, including a Bruton´s tyrosine kinase inhibitor. Among 49 patients at a specific dose, “the rate of complete response or remission (including with incomplete marrow recovery) was statistically significant at 18%,” the researchers reported. A total of 51 patients in the entire study died.

The rate of undetectable minimal residual disease blood was 64%. That rate is impressive, said University of Texas MD Anderson Cancer Center leukemia specialist Nitin Jain, MD, in an interview. It’s not nearly as high as researchers have seen in other disease settings, but it’s “a good, good thing for these patients. We’ll have to see in the longer follow-up how these patients fare 2, 3, or 4 years down the line.”

Dr. Rogers, the Ohio physician, said doctors had hoped durable benefit in the Lancet study would be more impressive. An important factor limiting its value may be the aggressiveness of the disease in patients who have already failed several treatments, she said. “The efficacy of CAR T might be improved by giving it as an earlier line of therapy before the CLL has become this aggressive. But it’s difficult to propose that you should use this before a Bruton´s tyrosine kinase inhibitor or venetoclax because it’s expensive and difficult.”

What’s next for CART T research in CLL? Understanding the best timing for treatment will be key, Dr. Rogers said.

The Leukemia & Lymphoma Society’s Dr. Greenberger predicted that “we will begin to see CAR T explored in CLL patients whose disease has a high risk of failing approved agents, such as Bruton´s tyrosine kinase and B cell lymphoma 2 inhibitors. However, CLL patients may still receive prior therapy with more effective Bruton’s tyrosine kinase or B cell lymphoma 2 inhibitors in the future before using CAR T. This will likely be heightened as more Bruton´s tyrosine kinase inhibitors become generic in the next 5 to 10 years and, hopefully, less expensive than CAR T therapy.”

In the big picture, he said, “treatment of CLL with CAR T is possible, but still needs significant improvements if it is to become a mainline therapy in the future.”

CAR T therapy remains available via clinical trials, and Dr. Rogers said it is “currently an important option for patients whose CLL has become resistant to standard targeted agents. We can certainly expect to extend someone’s expected survival by years if they have a favorable response.” She acknowledged that the cost is quite high, but noted that targeted therapies are also expensive, especially over the long term. They can run to $10,000-$20,000 a month. Bispecific antibodies are also being explored as potential therapy for CLL. “They’re really exciting,” Dr. Rogers said, with the potential to spur responses similar to those from CAR T therapy.

A 2022 review described these drugs as “molecules that combine antibody-directed therapies with cellular mediated immunotherapy.” The FDA explains that “by targeting two antigens or epitopes, they can cause multiple physiological or antitumor responses, which may be independent or connected.”

According to Dr. Greenberger, many bispecifics are in clinical trials now. However, “in the context of CLL, actually, the data is actually very, very limited. The development is just starting, and there are phase 1 and phase 2 trials ongoing.”

But data from lymphoma trials are encouraging, he said, and bispecifics “are actually looking as good as CAR T in some settings.”

Regimens can be a challenge for patients taking bispecifics, Dr. Greenberger said. “Repeat dosing with a step-up dosing approach to start is typically required when treating lymphoma.”

On the other hand, Dr. Rogers noted that antibody treatment can be easier for hematologists to arrange than CAR T therapy and stem cell transplants. “From an administrative side, there’s not as many things you need to have set up. So it’s able to be administered in a wider variety of settings,” she said,

Bispecific side effects include cytokine release syndrome and neurotoxicity as well as infusion reactions, Dr. Greenberger said, adding that “I would not exclude cost as a challenge.”

According to Formulary Watch, the bispecific Columvi (glofitamab-gxbm), which recently gained FDA approval to treat diffuse large B-cell lymphoma, is estimated to cost $350,000 for an 8.5-month round of treatment. Reuters reported that the bispecific Talvey (talquetamab-tgvs), which just received FDA approval to treat multiple myeloma, is estimated to cost $270,000-$360,000 for 6-8 months of treatment.

For now, bispecific trials “are mostly now reserved for patients with CLL who become resistant to our current standard targeted agents,” Dr. Rogers said. “It’s a little unclear if you can do CAR T therapy first and then bispecifics, or bispecifics and then CAR T therapy.”

What’s coming next for bispecifics? “On the horizon is better ease of administration, which is already being addressed by subcutaneous dosing for some bispecifics in lymphomas,” Dr. Greenberger said. “There’s also the possibility of combining bispecifics with conventional therapy.”

Dr. Rogers discloses ties with Genentech, AbbVie, Novartis, AstraZeneca, Janssen, Pharmacyclics, Beigene, and LOXO@Lilly. Dr. Greenberger discloses employment with the Leukemia & Lymphoma Society, which supports academic grants and a venture philanthropy via the Therapy Acceleration Program.

Dr. Jain reports ties with Pharmacyclics, AbbVie, Genentech, AstraZeneca, Pfizer, and numerous other disclosures.
 

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

TOPLINE:

Nonalcoholic fatty liver disease (NAFLD) is an independent risk factor for precancerous colorectal adenomatous polyps in men and women, according to results of a large study.

METHODOLOGY:

• Researchers conducted a retrospective review of the medical records of adults who underwent abdominal ultrasound and colonoscopy at a single hospital in China from January 2018 to December 2022 to determine NAFLD status and presence of polyps.
• Multivariate logistic regression analysis was used to detect associations between NAFLD and adenomatous and nonadenomatous polyps.

TAKEAWAY:

• Overall, 36.6% of the 3,028 patients had adenomatous polyps, 10.7% had nonadenomatous polyps, and 52.7% were polyp free.
• The higher frequency of NAFLD was significant in adults with adenomatous polyps (66.9%) but not in patients with nonadenomatous polyps (57%) vs. adults with no polyps (52.3%).
• In the fully adjusted model, NAFLD was a significant independent risk factor for adenomatous polyps (odds ratio [OR], 1.6; P < .0001) but not for nonadenomatous polyps (OR, 1.0; P = .813).
• The association between NAFLD and adenomatous polyps was statistically significant in both men (OR, 1.8) and women (OR, 1.4).

IN PRACTICE:

“Our results clearly demonstrated that NAFLD is associated with the development of colorectal adenomatous polyps in males and females, but is not associated with an increased risk of nonadenomatous polyps. The findings provide new insight into the prevention of colorectal cancer in NAFLD patients,” the authors wrote.

SOURCE:

The study was co-led by Yingxue Yang and Yajie Teng, The First People’s Hospital of Kunshan, Suzhou, China. It was published online in the European Journal of Gastroenterology & Hepatology. The study had no specific funding.

LIMITATIONS:

The diagnosis of NAFLD was by ultrasound rather than by liver biopsy. The study’s cross-sectional design precludes conclusions about causality between NAFLD and the risk for colorectal adenomatous polyps. The study involved a single center.

DISCLOSURES:

The authors have disclosed no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

Nonalcoholic fatty liver disease (NAFLD) is an independent risk factor for precancerous colorectal adenomatous polyps in men and women, according to results of a large study.

METHODOLOGY:

• Researchers conducted a retrospective review of the medical records of adults who underwent abdominal ultrasound and colonoscopy at a single hospital in China from January 2018 to December 2022 to determine NAFLD status and presence of polyps.
• Multivariate logistic regression analysis was used to detect associations between NAFLD and adenomatous and nonadenomatous polyps.

TAKEAWAY:

• Overall, 36.6% of the 3,028 patients had adenomatous polyps, 10.7% had nonadenomatous polyps, and 52.7% were polyp free.
• The higher frequency of NAFLD was significant in adults with adenomatous polyps (66.9%) but not in patients with nonadenomatous polyps (57%) vs. adults with no polyps (52.3%).
• In the fully adjusted model, NAFLD was a significant independent risk factor for adenomatous polyps (odds ratio [OR], 1.6; P < .0001) but not for nonadenomatous polyps (OR, 1.0; P = .813).
• The association between NAFLD and adenomatous polyps was statistically significant in both men (OR, 1.8) and women (OR, 1.4).

IN PRACTICE:

“Our results clearly demonstrated that NAFLD is associated with the development of colorectal adenomatous polyps in males and females, but is not associated with an increased risk of nonadenomatous polyps. The findings provide new insight into the prevention of colorectal cancer in NAFLD patients,” the authors wrote.

SOURCE:

The study was co-led by Yingxue Yang and Yajie Teng, The First People’s Hospital of Kunshan, Suzhou, China. It was published online in the European Journal of Gastroenterology & Hepatology. The study had no specific funding.

LIMITATIONS:

The diagnosis of NAFLD was by ultrasound rather than by liver biopsy. The study’s cross-sectional design precludes conclusions about causality between NAFLD and the risk for colorectal adenomatous polyps. The study involved a single center.

DISCLOSURES:

The authors have disclosed no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

Nonalcoholic fatty liver disease (NAFLD) is an independent risk factor for precancerous colorectal adenomatous polyps in men and women, according to results of a large study.

METHODOLOGY:

• Researchers conducted a retrospective review of the medical records of adults who underwent abdominal ultrasound and colonoscopy at a single hospital in China from January 2018 to December 2022 to determine NAFLD status and presence of polyps.
• Multivariate logistic regression analysis was used to detect associations between NAFLD and adenomatous and nonadenomatous polyps.

TAKEAWAY:

• Overall, 36.6% of the 3,028 patients had adenomatous polyps, 10.7% had nonadenomatous polyps, and 52.7% were polyp free.
• The higher frequency of NAFLD was significant in adults with adenomatous polyps (66.9%) but not in patients with nonadenomatous polyps (57%) vs. adults with no polyps (52.3%).
• In the fully adjusted model, NAFLD was a significant independent risk factor for adenomatous polyps (odds ratio [OR], 1.6; P < .0001) but not for nonadenomatous polyps (OR, 1.0; P = .813).
• The association between NAFLD and adenomatous polyps was statistically significant in both men (OR, 1.8) and women (OR, 1.4).

IN PRACTICE:

“Our results clearly demonstrated that NAFLD is associated with the development of colorectal adenomatous polyps in males and females, but is not associated with an increased risk of nonadenomatous polyps. The findings provide new insight into the prevention of colorectal cancer in NAFLD patients,” the authors wrote.

SOURCE:

The study was co-led by Yingxue Yang and Yajie Teng, The First People’s Hospital of Kunshan, Suzhou, China. It was published online in the European Journal of Gastroenterology & Hepatology. The study had no specific funding.

LIMITATIONS:

The diagnosis of NAFLD was by ultrasound rather than by liver biopsy. The study’s cross-sectional design precludes conclusions about causality between NAFLD and the risk for colorectal adenomatous polyps. The study involved a single center.

DISCLOSURES:

The authors have disclosed no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

AMSTERDAM – For patients hospitalized for acute heart failure, initiating treatment with the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) before hospital discharge was safe, it appeared to improve diuresis and natriuresis while reducing the administered diuretic dose, and it meant quicker initiation of guideline-directed therapy in a controlled study of 238 patients.

Treatment with dapagliflozin was begun for people with heart failure on their first day of hospitalization for an acute episode. Such treatment “can be safely started to optimize a key medication,” Zachary Cox, PharmD, said at the annual congress of the European Society of Cardiology. It improved fluid removal, as evidenced in the “totality of diuretic measures,” it resulted in reduced doses of IV diuretics, and it shortened length of stay in the hospital.

In current U.S. practice, about 80% of people hospitalized with heart failure do not initially receive treatment with a sodium-glucose cotransporter 2 (SGLT2) inhibitor during their hospital stay when they are not already taking an agent from the class, noted Dr. Cox, professor of pharmacy at Lipscomb University College of Pharmacy in Nashville, Tenn.

Physicians are often uncomfortable changing a patient’s medications on the first day of a hospitalization, he noted. “Our results should embolden physicians” to begin treatment with an SGLT2 inhibitor early during hospitalization and to then continue it chronically, Dr. Cox said in a press briefing.

“Despite the messaging [from guidelines], we still see hesitancy. We hope more evidence of safety will improve uptake.” The study’s “key message is to start guideline-directed medical therapy early,” prior to hospital discharge, Dr. Cox concluded.
 

“Some support” for SGLT2 inhibitors

The study results “provide some support for SGLT2 inhibitors facilitating decongestion and hospital discharge without observed safety issues,” said Stephen D. Wiviott, MD, designated discussant for the report and a cardiologist and professor at Harvard Medical School in Boston.

While initiation of an SGLT2 inhibitor during an acute heart failure hospitalization received endorsement as a top management priority in both the 2023 heart failure guidelines of the European Society of Cardiology and in 2022 U.S. guidelines, evidence of the safety and efficacy of this approach has been scanty, Dr. Wiviott noted.

Two prior studies addressed the issue. The SOLOIST-WHF trial tested the combined SGLT1 and SGLT2 inhibitor sotagliflozin (Inpefa, Lexicon) for patients recently hospitalized for heart failure, but only 142 of the 596 participants who were randomly assigned to receive sotagliflozin began receiving it at least a day before hospital discharge; for the remaining 454, treatment with sotagliflozin began on their discharge day, noted Dr. Wiviott.

In the EMPULSE trial, 530 people hospitalized for acute heart failure were randomly assigned to initially receive empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) or placebo during hospitalization. The primary endpoint was largely driven by an improvement in the patient-reported outcome, as assessed on the basis of the Kansas City Cardiomyopathy Questionnaire Total Symptom Score, Dr. Wiviott added.

The DICTATE-AHF study included 238 adults who were within 24 hours of first presenting to any of six participating U.S. hospitals with hypervolemic acute heart failure. All patients underwent a standard treatment protocol with IV loop diuretics, and half received additional, open-label treatment with a daily 10-mg dose of dapagliflozin.

The average age of the patients was 65 years, 71% had type 2 diabetes (the study excluded people with type 1 diabetes), and about half had a left ventricular ejection fraction of 40% or less.
 

Similar weight loss with lower diuretics dose

The study’s primary outcome was a measure of diuretic efficiency, calculated as a person’s cumulative weight change divided by the cumulative dose of loop diuretics.

Both treatment arms experienced nearly identical weight loss, but for the people who received dapagliflozin, this occurred with a lower cumulative dose of diuretics. The diuretic efficiency with dapagliflozin produced comparable weight loss with a 35% lower amount of loop diuretic dose, a difference that fell just short of significance (P = .06).

However, treatment with dapagliflozin also significantly boosted 24-hour natriuresis and 24-hour diuresis, and it significantly shortened the time to stopping treatment with IV diuretics and to hospital discharge, Dr. Cox reported. Dapagliflozin initiation and ongoing treatment was also safe and well tolerated compared with usual care.

The fact that the primary endpoint fell short of significance was “largely related” to the study’s relatively small size, Dr. Wiviott suggested. He noted that the DAPA ACT HF-TIMI 68 study, which is a much larger and potentially more definitive study of the safety and efficacy of dapagliflozin in comparison with usual care for patients with acute heart failure, is in progress. The study includes about 2,400 patients.

The primary outcome is the combined rate of cardiovascular death or worsening heart failure during the 2 months following randomization. Results are expected in 2024.

DICTATE-AHF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Cox has received research funding from AstraZeneca and has been a consultant to Roche and Translational Catalyst. Dr. Wiviott has received research funding from AstraZeneca and from Merck and has been a consultant to Icon Clinical and Novo Nordisk.
 

A version of this article appeared on Medscape.com.

With the advent of artificial intelligence (AI), the era of double reading of mammograms is likely coming to a close, according to Liane Philpotts, MD, a radiology and biomedical imaging professor at Yale University in New Haven, Conn.

The reason is because AI is proving to be as good as humans in interpreting mammograms, at least in the research setting.

In one of the latest reports, published online in Radiology, British investigators found that the performance of a commercially available AI system (INSIGHT MMG version 1.1.7.1 – Lunit) was essentially equivalent to over 500 specialized readers. The results are in line with other recent AI studies.

Double reading – having mammograms read by two clinicians to increase cancer detection rates – is common in the United Kingdom and elsewhere in Europe.

The British team compared the performance of 552 readers with Lunit’s AI program on the Personal Performance in Mammographic Screening exam, a quality assurance test which mammogram readers in the United Kingdom are required to take twice a year. Readers assign a malignancy score to 60 challenging cases, a mix of normal breasts and breasts with benign and cancerous lesions. The study included two test sessions for a total of 120 breast screenings.

Fifty-seven percent of the readers in the study were board-certified radiologists, 37% were radiographers, and 6% were breast clinicians. Each read at least 5,000 mammograms a year.

There was no difference in overall performance between the AI program and the human readers (AUC 0.93 vs. 0.88, P = .15).

Commenting in an editorial published with the investigation, Dr. Philpotts said the results “suggest that AI could confidently act as a second reader to decrease workloads.”

As for the United States, where double reading is generally not done, she pointed out that “many U.S. radiologists interpreting mammograms are nonspecialized and do not read high volumes of mammograms. Thus, the AI system evaluated in the study “could be used as a supplemental tool to aid the performance of readers in the United States or in other countries where screening programs use a single reading.”

There was also no difference in sensitivity between AI and human readers (84% vs. 90%, P = .34), but the AI algorithm had a higher specificity (89% vs. 76%, P = .003).

Using AI recall scores that matched the average human reader performance (90% sensitivity, 76% specificity), there was no difference with AI in regard to sensitivity (91%, P = .73) or specificity (77%, P = .85), but the investigators noted the power of the analysis was limited.

Overall, “diagnostic performance of AI was comparable with that of the average human reader.” It seems “increasingly likely that AI will eventually play a part in the interpretation of screening mammograms,” said investigators led by Yan Chen, PhD, of the Nottingham Breast Institute in England.

“That the AI system was able to match the performance of the average reader in this specialized group of mammogram readers indicates the robustness of this AI algorithm,” Dr. Philpotts said.

However, there are some caveats.

For one, the system was designed for 2D mammography, the current standard of care in the United Kingdom, while digital breast tomosynthesis (DBT) is replacing 2D mammography in the United States.

In the United States, “AI algorithms specific to DBT are necessary and will need to be reliable and reproducible to be embraced by radiologists,” Dr. Philpotts said.

Also in the United Kingdom, screening is performed at 3-year intervals in women aged 50-70 years old, which means that the study population was enriched for older women with less-dense breasts. Screening generally starts earlier in the United States and includes premenopausal women with denser breasts.

A recent study from Korea, where many women have dense breasts, found that 2D mammography and supplementary ultrasound outperformed AI for cancer detection.

“This underscores the challenges of finding cancers in dense breasts, which plague both radiologists and AI alike, and provides evidence that breast density is an important factor to consider when evaluating AI performance,” Dr. Philpotts said.

The work was funded by Lunit, the maker of the AI program used in the study. The investigators and Dr. Philpotts had no disclosures.

With the advent of artificial intelligence (AI), the era of double reading of mammograms is likely coming to a close, according to Liane Philpotts, MD, a radiology and biomedical imaging professor at Yale University in New Haven, Conn.

The reason is because AI is proving to be as good as humans in interpreting mammograms, at least in the research setting.

In one of the latest reports, published online in Radiology, British investigators found that the performance of a commercially available AI system (INSIGHT MMG version 1.1.7.1 – Lunit) was essentially equivalent to over 500 specialized readers. The results are in line with other recent AI studies.

Double reading – having mammograms read by two clinicians to increase cancer detection rates – is common in the United Kingdom and elsewhere in Europe.

The British team compared the performance of 552 readers with Lunit’s AI program on the Personal Performance in Mammographic Screening exam, a quality assurance test which mammogram readers in the United Kingdom are required to take twice a year. Readers assign a malignancy score to 60 challenging cases, a mix of normal breasts and breasts with benign and cancerous lesions. The study included two test sessions for a total of 120 breast screenings.

Fifty-seven percent of the readers in the study were board-certified radiologists, 37% were radiographers, and 6% were breast clinicians. Each read at least 5,000 mammograms a year.

There was no difference in overall performance between the AI program and the human readers (AUC 0.93 vs. 0.88, P = .15).

Commenting in an editorial published with the investigation, Dr. Philpotts said the results “suggest that AI could confidently act as a second reader to decrease workloads.”

As for the United States, where double reading is generally not done, she pointed out that “many U.S. radiologists interpreting mammograms are nonspecialized and do not read high volumes of mammograms. Thus, the AI system evaluated in the study “could be used as a supplemental tool to aid the performance of readers in the United States or in other countries where screening programs use a single reading.”

There was also no difference in sensitivity between AI and human readers (84% vs. 90%, P = .34), but the AI algorithm had a higher specificity (89% vs. 76%, P = .003).

Using AI recall scores that matched the average human reader performance (90% sensitivity, 76% specificity), there was no difference with AI in regard to sensitivity (91%, P = .73) or specificity (77%, P = .85), but the investigators noted the power of the analysis was limited.

Overall, “diagnostic performance of AI was comparable with that of the average human reader.” It seems “increasingly likely that AI will eventually play a part in the interpretation of screening mammograms,” said investigators led by Yan Chen, PhD, of the Nottingham Breast Institute in England.

“That the AI system was able to match the performance of the average reader in this specialized group of mammogram readers indicates the robustness of this AI algorithm,” Dr. Philpotts said.

However, there are some caveats.

For one, the system was designed for 2D mammography, the current standard of care in the United Kingdom, while digital breast tomosynthesis (DBT) is replacing 2D mammography in the United States.

In the United States, “AI algorithms specific to DBT are necessary and will need to be reliable and reproducible to be embraced by radiologists,” Dr. Philpotts said.

Also in the United Kingdom, screening is performed at 3-year intervals in women aged 50-70 years old, which means that the study population was enriched for older women with less-dense breasts. Screening generally starts earlier in the United States and includes premenopausal women with denser breasts.

A recent study from Korea, where many women have dense breasts, found that 2D mammography and supplementary ultrasound outperformed AI for cancer detection.

“This underscores the challenges of finding cancers in dense breasts, which plague both radiologists and AI alike, and provides evidence that breast density is an important factor to consider when evaluating AI performance,” Dr. Philpotts said.

The work was funded by Lunit, the maker of the AI program used in the study. The investigators and Dr. Philpotts had no disclosures.

With the advent of artificial intelligence (AI), the era of double reading of mammograms is likely coming to a close, according to Liane Philpotts, MD, a radiology and biomedical imaging professor at Yale University in New Haven, Conn.

The reason is because AI is proving to be as good as humans in interpreting mammograms, at least in the research setting.

In one of the latest reports, published online in Radiology, British investigators found that the performance of a commercially available AI system (INSIGHT MMG version 1.1.7.1 – Lunit) was essentially equivalent to over 500 specialized readers. The results are in line with other recent AI studies.

Double reading – having mammograms read by two clinicians to increase cancer detection rates – is common in the United Kingdom and elsewhere in Europe.

The British team compared the performance of 552 readers with Lunit’s AI program on the Personal Performance in Mammographic Screening exam, a quality assurance test which mammogram readers in the United Kingdom are required to take twice a year. Readers assign a malignancy score to 60 challenging cases, a mix of normal breasts and breasts with benign and cancerous lesions. The study included two test sessions for a total of 120 breast screenings.

Fifty-seven percent of the readers in the study were board-certified radiologists, 37% were radiographers, and 6% were breast clinicians. Each read at least 5,000 mammograms a year.

There was no difference in overall performance between the AI program and the human readers (AUC 0.93 vs. 0.88, P = .15).

Commenting in an editorial published with the investigation, Dr. Philpotts said the results “suggest that AI could confidently act as a second reader to decrease workloads.”

As for the United States, where double reading is generally not done, she pointed out that “many U.S. radiologists interpreting mammograms are nonspecialized and do not read high volumes of mammograms. Thus, the AI system evaluated in the study “could be used as a supplemental tool to aid the performance of readers in the United States or in other countries where screening programs use a single reading.”

There was also no difference in sensitivity between AI and human readers (84% vs. 90%, P = .34), but the AI algorithm had a higher specificity (89% vs. 76%, P = .003).

Using AI recall scores that matched the average human reader performance (90% sensitivity, 76% specificity), there was no difference with AI in regard to sensitivity (91%, P = .73) or specificity (77%, P = .85), but the investigators noted the power of the analysis was limited.

Overall, “diagnostic performance of AI was comparable with that of the average human reader.” It seems “increasingly likely that AI will eventually play a part in the interpretation of screening mammograms,” said investigators led by Yan Chen, PhD, of the Nottingham Breast Institute in England.

“That the AI system was able to match the performance of the average reader in this specialized group of mammogram readers indicates the robustness of this AI algorithm,” Dr. Philpotts said.

However, there are some caveats.

For one, the system was designed for 2D mammography, the current standard of care in the United Kingdom, while digital breast tomosynthesis (DBT) is replacing 2D mammography in the United States.

In the United States, “AI algorithms specific to DBT are necessary and will need to be reliable and reproducible to be embraced by radiologists,” Dr. Philpotts said.

Also in the United Kingdom, screening is performed at 3-year intervals in women aged 50-70 years old, which means that the study population was enriched for older women with less-dense breasts. Screening generally starts earlier in the United States and includes premenopausal women with denser breasts.

A recent study from Korea, where many women have dense breasts, found that 2D mammography and supplementary ultrasound outperformed AI for cancer detection.

“This underscores the challenges of finding cancers in dense breasts, which plague both radiologists and AI alike, and provides evidence that breast density is an important factor to consider when evaluating AI performance,” Dr. Philpotts said.

The work was funded by Lunit, the maker of the AI program used in the study. The investigators and Dr. Philpotts had no disclosures.