Accreditation/Credit Designation

Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians’ Education Resource®, LLC, designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Pfizer, Inc.

Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer


Release Date: December 31, 2018
Expiration Date: December 31, 2019
Media: Internet - based

Activity Overview

We are pleased to present this CME-certified activity, a PER® Live Tumor Board titled Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer – Enduring CME Activity. This activity is an enduring version of the live Tumor Board originally presented by PER® at www.gotoper.com on December 12, 2018, at 3:00 PM EST.

This program will update oncology healthcare professionals who participate in the multidisciplinary treatment of patients with estrogen receptor–positive (ER+) metastatic breast cancer (MBC) by providing expert guidance, interpretation, and insight on the importance and impact of CDK4/6 inhibitor therapy. Unfortunately, current understanding of how to utilize CDK4/6 inhibitors is generally limited to registrational studies.

Retroactive observational studies on real-world populations will aid clinicians in understanding how concepts such as dose adjustments and adverse event management are performed in patient populations that were not a part of the original clinical trials that drug approvals were based on. This activity will incorporate recent real-world data to ensure that clinicians maintain state-of-the-art treatment practices.

Benefits of Participating

  • Apply novel management strategies to your practice to improve patient outcomes
  • Participate in an exciting case-based format about current challenges and controversies in the treatment of ER+ breast cancer
  • Incorporate evolving treatment paradigms in the setting of ER+ breast cancer
  • Update your clinical decision-making based upon individual patient/tumor characteristics

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Pfizer, Inc.

Instructions for This Activity and Receiving Credit

  • You will need to log in to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review audio files/content until you finish the presentation.
  • At the end of the activity, educational content/audio files will be available for your reference.
  • In order to receive a CME certificate, you must complete the activity.
  • Complete the Posttest and pass with a score of 70% or higher, complete the Evaluation, and then click on “Request for Credit.” You may immediately download a CME certificate upon completion of these steps.


Target Audience

This educational activity is directed toward medical, surgical, and radiation oncologists involved in the treatment of patients with breast cancer. Fellows, nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of breast cancer are also invited to participate.

Learning Objectives

Upon successful completion of this activity, you should be better prepared to:

  • Evaluate results from studies of CDK4/6 inhibitor therapies for the treatment of metastatic breast cancer (MBC), including evidence generated from randomized clinical trials and real-world data analyses
  • Integrate evidence from clinically relevant randomized trials and real-world data analyses of CDK4/6 inhibitor therapies for MBC into existing and emerging management strategies
  • Incorporate key insights and strategies derived from real-world evidence into the mitigation and management of predictable treatment-related toxicities in the management of MBC

Faculty, Staff, and Planners' Disclosures

Chair

Hope S. Rugo
Hope S. Rugo, MD, FASCO
Professor of Medicine
Director, Breast Oncology and Clinical Trials Education
University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Disclosures: Grant/Research Support: Research support for clinical trials through the University of California from Pfizer, Merck, Novartis, Lilly, Genentech, OBI, Plexxikon, Odonate, Daiichi Sankyo, Eisai, MacroGenics; Consultant (Honorarium): Celltrion

Faculty

Angela DeMichele
Angela DeMichele, MD, MSCE
Alan and Jill Miller Endowed Chair in Breast Cancer Excellence
Professor of Medicine and Epidemiology
Co-Leader, Breast Cancer Research Program
Abramson Cancer Center Senior Scholar
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine
Philadelphia, PA

Disclosures: Grant/Research Support: Genentech, Pfizer, Novartis, Menarini; Consultant: Pfizer

Komal Jhaveri
Komal Jhaveri, MD, FACP
Attending, Breast Medicine Service and Early Drug Development Service, Department of Medicine
Memorial Sloan Kettering Cancer Center
New York, NY

Disclosures: Grant/Research Support: Pfizer, Genentech, Novartis, Novita Pharmaceuticals, Debiopharm, Menarini; Consultant: Novartis, Pfizer, AstraZeneca, BMS, Taiho Oncology, Jounce Therapeutics, Spectrum Pharmaceuticals, ADC Therapeutics

Joseph A. Sparano
Joseph A. Sparano, MD
Professor of Medicine & Women's Health
Albert Einstein College of Medicine
Montefiore Medical Center
Bronx, NY

Disclosures: Grant/Research Support: Deciphera, Prescient; Consultant: Roche/Genentech, Eli Lilly, AstraZeneca, Celldex, Juno, Pfizer; Stock/Shareholder: MetaStat

The staff of PER® have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse Recap

1 of 3
Insights From Joseph A. Sparano, MD, Professor of Medicine & Women's Health, Albert Einstein College of Medicine, Bronx, NY—PER Pulse™ Recap:
Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer

In this continuing medical education–certified activity, Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer expert faculty join program chair Hope S. Rugo, MD, FASCO, professor of medicine and director of Breast Oncology and Clinical Trials Education at the University of Southern California, San Francisco, Helen Diller Family Comprehensive Cancer Center, to discuss the treatment and management of estrogen receptor–positive (ER+) metastatic breast cancer (MBC). The panel focuses on first-line treatment planning for hormone receptor–positive (HR+)/HER-negative (HER-) MBC, further discusses how to integrate evidence from clinically relevant randomized trials and real-world data analyses of CDK4/6 inhibitor therapies palbociclib, ribociclib, and abemaciclib in clinical practice, and provides real-world evidence for managing neutropenia and other adverse events associated with MBC treatment using CDK4/6 inhibitors.

This first of 3 PER Pulse™ Recaps summarizing the online program focuses on a historical overview of the treatment of HR+ MBC and a patient case scenario representing the first-line treatment planning for HR+/HER- MBC.

Below are some highlights from the activity featuring Dr. Sparano:

  • The presentation of a patient case in the metastatic setting and the discussion of treatment options by the panel.1-4
  • A discussion of the need for participation in clinical trials evaluating novel MBC management strategies: the MAINTAIN clinical trial (NCT02632045)
  • A discussion of the toxicity profiles of available treatments and how they influence the choices of treatment.
  • A discussion of combination therapies with CDK4/6 inhibitors and immunotherapeutic agents, as well as other targeted approaches such as PI3K inhibitors.

“There are some clinical scenarios that might favor using one CDK4/6 inhibitor versus another. One would be the patient with CNS [central nervous system] disease, given the fact that abemaciclib does seem to penetrate better than the other two.”

— Joseph A. Sparano, MD

References

  1. Di Leo A, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for patients with HR+/HER2- advanced breast cancer. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract 236O_PR. oncologypro.esmo.org/Meeting-Resources/ESMO-2017-Congress/MONARCH-3-Abemaciclib-as-initial-therapy-for-patients-with-HR-HER2-advanced-breast-cancer.
  2. Hortobagyi GN, Stemmer SM, Burris HA, et al. First-line ribociclib + letrozole for postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer (ABC). Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA1_PR. oncologypro.esmo.org/Meeting-Resources/ESMO-2016/First-line-ribociclib-letrozole-for-postmenopausal-women-with-hormone-receptor-positive-HR-HER2-negative-HER2-advanced-breast-cancer-ABC.
  3. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer [erratum in N Engl J Med. 2018;379(26):2582. doi: 10.1056/NEJMx180043]. N Engl J Med. 2016;375(18):1738-1748.
  4. Finn RS, Martin M, Rugo HS, et al. PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2– advanced breast cancer (ABC). J Clin Oncol. 2016;34(suppl; abstr 507). ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.507.

2 of 3
Insights From Komal Jhaveri, MD, FACP, Breast Medicine Service and Early Drug Development Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY—PER Pulse™ Recap:
Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer

As a follow-up to the continuing medical education–certified activity, Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer, this second of 3 PER Pulse™ Recaps summarizing the online program focuses on patients with hormone receptor–positive (HR+)/HER-negative metastatic breast cancer (MBC) previously treated with endocrine therapy. Below are some highlights from the activity featuring Dr. Jhaveri:

  • Dr. Jhaveri presents a patient case and discusses the treatment options for HR+/HER-negative MBC previously treated with endocrine therapy with the panel of experts.
  • The panel discusses the use of CDK4/6 therapy in the first line versus the second line.
  • The faculty discuss clinical trial versus real world experience of using CDK4/6 therapy.
  • The panel presents strategies to manage neutropenia in patients considering dose reducing.

“The data support that even with dose reductions of palbociclib, the efficacy is maintained”

— Komal Jhaveri, MD, FACP


3 of 3
Insights From Angela DeMichele, MD, MSCE, Alan and Jill Miller Endowed Chair in Breast Cancer Excellence, University of Pennsylvania School of Medicine Philadelphia, PA —PER Pulse™ Recap:
Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer

As a follow-up to the continuing medical education–certified activity, Live Tumor Board: Real-World Evidence to Inform Treatment and Management of ER+ Metastatic Breast Cancer, this third of 3 PER Pulse™ Recaps summarizing the online program focuses on real-world evidence for managing neutropenia and other adverse events (AEs).

Below are some highlights from the activity featuring Dr. DeMichele:

  • Dr. DeMichele describes managing neutropenia and other AEs in one of her patients receiving CDK4/6 inhibitor therapy.
  • The panel discusses options for managing and avoiding AEs.
  • The faculty discuss maintaining therapy dose and schedule versus quality of life and how is quality of life impacted by treatment-associated toxicity and how should it be managed.
  • The faculty present data and provide strategies to dose reduce CDK4/6 inhibitors without compromising the efficacy of treatment.1

“The really important point here is that the neutropenia that we see with CDK4/6 inhibitors is different from the neutropenia we see with chemotherapy.”

— Angela DeMichele, MD, MSCE

References

  1. 1. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379(20):1926-1936. doi: 10.1056/NEJMoa1810527.

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