VIDEO: CDK4/6, ET, LHRH combo improves PFS in premenopausal breast cancer

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– For premenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer, the addition of the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) to endocrine therapy and goserelin was associated with a near doubling in progression-free survival (PFS), improvement in pain scores and a longer time to deterioration of quality of life scores.

Previous clinical trials have shown the advantage of adding a CDK4/6 inhibitor to standard aromatase inhibitor therapy in postmenopausal women, but the randomized phase 3 MONALEESA-7 trial is the first phase 3 study of an agent in this class in premenopausal women with breast cancer, and is the first randomized trial in this population in nearly 2 decades, notes Debu Tripathy, MD, from the University of Texas MD Anderson Cancer Center in Houston.

The median PFS for women treated with ribociclib plus endocrine therapy with either an aromatase inhibitor or tamoxifen plus the lutenizing hormone-releasing hormone agonist goserelin was 23.8 months, compared with 13 months for women treated with the same combination except for a ribociclib placebo.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Tripathy discusses the therapeutic benefits and quality of life improvements associated with adding ribociclib to endocrine therapy and ovarian suppression in this population.

The MONALEESA 7 trial was supported by Novartis. Dr. Tripathy disclosed steering committee consulting fees and institutional funding from the company.

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– For premenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer, the addition of the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) to endocrine therapy and goserelin was associated with a near doubling in progression-free survival (PFS), improvement in pain scores and a longer time to deterioration of quality of life scores.

Previous clinical trials have shown the advantage of adding a CDK4/6 inhibitor to standard aromatase inhibitor therapy in postmenopausal women, but the randomized phase 3 MONALEESA-7 trial is the first phase 3 study of an agent in this class in premenopausal women with breast cancer, and is the first randomized trial in this population in nearly 2 decades, notes Debu Tripathy, MD, from the University of Texas MD Anderson Cancer Center in Houston.

The median PFS for women treated with ribociclib plus endocrine therapy with either an aromatase inhibitor or tamoxifen plus the lutenizing hormone-releasing hormone agonist goserelin was 23.8 months, compared with 13 months for women treated with the same combination except for a ribociclib placebo.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Tripathy discusses the therapeutic benefits and quality of life improvements associated with adding ribociclib to endocrine therapy and ovarian suppression in this population.

The MONALEESA 7 trial was supported by Novartis. Dr. Tripathy disclosed steering committee consulting fees and institutional funding from the company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– For premenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer, the addition of the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) to endocrine therapy and goserelin was associated with a near doubling in progression-free survival (PFS), improvement in pain scores and a longer time to deterioration of quality of life scores.

Previous clinical trials have shown the advantage of adding a CDK4/6 inhibitor to standard aromatase inhibitor therapy in postmenopausal women, but the randomized phase 3 MONALEESA-7 trial is the first phase 3 study of an agent in this class in premenopausal women with breast cancer, and is the first randomized trial in this population in nearly 2 decades, notes Debu Tripathy, MD, from the University of Texas MD Anderson Cancer Center in Houston.

The median PFS for women treated with ribociclib plus endocrine therapy with either an aromatase inhibitor or tamoxifen plus the lutenizing hormone-releasing hormone agonist goserelin was 23.8 months, compared with 13 months for women treated with the same combination except for a ribociclib placebo.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Tripathy discusses the therapeutic benefits and quality of life improvements associated with adding ribociclib to endocrine therapy and ovarian suppression in this population.

The MONALEESA 7 trial was supported by Novartis. Dr. Tripathy disclosed steering committee consulting fees and institutional funding from the company.

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VIDEO: 5 years of additional AI no better than 2 in HR+ breast cancer

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– Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.

In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.

The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.

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– Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.

In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.

The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.

In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.

In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.

The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.

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VIDEO: Dr. Matteo Lambertini answers questions on temporary ovarian suppression

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– A meta-analysis of five trials among 873 premenopausal women with early breast cancer finds that temporarily suppressing ovarian function with a gonadotropin-releasing hormone analog during chemotherapy helps preserve fertility, reducing risk of premature ovarian insufficiency by 62% and nearly doubling the posttreatment pregnancy rate. In an interview at the San Antonio Breast Cancer Symposium, lead investigator Matteo Lambertini, MD, of the Institut Jules Bordet in Brussels, Belgium, discussed subgroup findings, the risk-benefit profile, and appropriate patient selection, as well as avenues for future research in this area.

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– A meta-analysis of five trials among 873 premenopausal women with early breast cancer finds that temporarily suppressing ovarian function with a gonadotropin-releasing hormone analog during chemotherapy helps preserve fertility, reducing risk of premature ovarian insufficiency by 62% and nearly doubling the posttreatment pregnancy rate. In an interview at the San Antonio Breast Cancer Symposium, lead investigator Matteo Lambertini, MD, of the Institut Jules Bordet in Brussels, Belgium, discussed subgroup findings, the risk-benefit profile, and appropriate patient selection, as well as avenues for future research in this area.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– A meta-analysis of five trials among 873 premenopausal women with early breast cancer finds that temporarily suppressing ovarian function with a gonadotropin-releasing hormone analog during chemotherapy helps preserve fertility, reducing risk of premature ovarian insufficiency by 62% and nearly doubling the posttreatment pregnancy rate. In an interview at the San Antonio Breast Cancer Symposium, lead investigator Matteo Lambertini, MD, of the Institut Jules Bordet in Brussels, Belgium, discussed subgroup findings, the risk-benefit profile, and appropriate patient selection, as well as avenues for future research in this area.

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VIDEO: Good responses with antibody-drug conjugate in third-line metastatic TNBC therapy

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– Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.

Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.

In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.

The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.

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– Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.

Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.

In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.

The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 

 

– Fully one-third of patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) had a response to therapy with a novel antibody-drug conjugate called sacituzumab govitecan. The conjugate consists of the active metabolites of the topoisomerase I inhibitor irinotecan linked to a humanized monoclonal antibody target Trop-2, a cell-surface glycoprotein expressed in triple-negative breast cancers and most other epithelial malignancies.

Aditya Bardia, MD, from Massachusetts General Hospital in Boston, previously reported results of a phase 1/2 basket trial that resulted in sacituzumab govitecan receiving a breakthrough designation from the Food and Drug Administration.

In this video interview, he discusses the conjugate’s activity in the third-line or greater setting for patients with metastatic TNBC, with an overall response rate of 34%, including some complete responses according to independent reviewers, and describes planned clinical trials pitting the agent against standard-of-care single-drug therapies.

The trial was supported by Immunomedics. Dr. Bardia reported institutional funding from the company, but no other conflicts of interest.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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VIDEO: Dr. Sherene Loi discusses PANACEA trial and implications for pembrolizumab use

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– The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.

 

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– The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

 

 

 

 

– The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

 

 

 

 

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VIDEO: Meta-analysis lead author Dr. Richard Gray on dose intensity benefit

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– Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.

 

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– Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

 

 

 

 

– Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.

 

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MACRA Monday: Osteoarthritis assessment

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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:


 

Measure #109: Osteoarthritis Function and Pain Assessment

This measure is aimed at capturing the percentage of visits that included an assessment of function and pain for patients with a diagnosis of osteoarthritis (OA) who are aged 21 years or older.

What you need to do: Perform an assessment of symptoms and functional status for patients with OA and document it in the medical record. Validated scales and questionnaires may be used but are not required.

Eligible cases include patients aged 21 years and older with a diagnosis of OA and a patient encounter during the performance period. Applicable codes include (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1006F indicates that OA symptoms and functional status were assessed. Add the 8P modifier to CPT II 1006F if the assessment was not performed and the reason is not otherwise specified.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:


 

Measure #109: Osteoarthritis Function and Pain Assessment

This measure is aimed at capturing the percentage of visits that included an assessment of function and pain for patients with a diagnosis of osteoarthritis (OA) who are aged 21 years or older.

What you need to do: Perform an assessment of symptoms and functional status for patients with OA and document it in the medical record. Validated scales and questionnaires may be used but are not required.

Eligible cases include patients aged 21 years and older with a diagnosis of OA and a patient encounter during the performance period. Applicable codes include (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1006F indicates that OA symptoms and functional status were assessed. Add the 8P modifier to CPT II 1006F if the assessment was not performed and the reason is not otherwise specified.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:


 

Measure #109: Osteoarthritis Function and Pain Assessment

This measure is aimed at capturing the percentage of visits that included an assessment of function and pain for patients with a diagnosis of osteoarthritis (OA) who are aged 21 years or older.

What you need to do: Perform an assessment of symptoms and functional status for patients with OA and document it in the medical record. Validated scales and questionnaires may be used but are not required.

Eligible cases include patients aged 21 years and older with a diagnosis of OA and a patient encounter during the performance period. Applicable codes include (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1006F indicates that OA symptoms and functional status were assessed. Add the 8P modifier to CPT II 1006F if the assessment was not performed and the reason is not otherwise specified.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

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What is the optimal opioid prescription length after women’s health surgical procedures?

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WHAT DOES THIS MEAN FOR PRACTICE?

  • 7-day opioid prescriptions should be sufficient after common gyn procedures
  • Monitor patients closely
  • Transfer patients as soon as possible to non-opioid pain medication
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Dietary restrictions with MAOIs

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How to address these 3 opioid adverse effects

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