CE Information and Faculty Disclosures

• TARGET AUDIENCE
  This activity is intended for medical oncologists and other healthcare providers involved in the treatment of ER-positive metastatic breast cancer (mBC).
  
  OVERVIEW OF ACTIVITY
  Among the widely acknowledged BC phenotypes, ER-positive disease, which represents approximately 63% of all cases, is perhaps the most nuanced with regard to therapeutic decision-making in the advanced disease setting. Specifically, unlike other phenotypes for which systemic therapy almost always includes chemotherapy, for patients with hormonally driven tumors, the availability of effective endocrine therapy may initially abrogate and significantly delay the need for cytotoxic intervention. Although this and various other factors have historically defined the management of ER-positive mBC, several groundbreaking advances have added greater complexity to this prevalent clinical situation. Specifically, improved understanding of the mechanisms by which breast tumors develop resistance to endocrine therapy has led to the appreciation that several other biologic pathways may be implicated in this process and has in turn fostered a spate of clinical research designed to evaluate novel therapies with inhibitory activity against these potential targets. Significantly, the results of these efforts have now been actualized in the clinic as over the past several years the FDA has granted approval to several unique treatments that, when combined with hormonal therapy, have been shown to enhance efficacy over endocrine intervention alone. Importantly, although the availability of these therapies undoubtedly provides immense benefit to patients, the many related issues (eg, sequencing, side effects) have increased the demands placed on clinicians and created additional areas of uncertainty.
  To bridge this gap between research and patient care, this video presentation by Dr Sara M Tolaney uses a review of recent relevant publications and presentations, ongoing clinical trials and clinical investigator treatment preferences to assist medical oncologists and other healthcare providers involved in the treatment of ER-positive mBC with the formulation of up-to-date clinical management strategies.
  
  LEARNING OBJECTIVES

  • Individualize the selection and sequence of systemic therapy for patients with newly diagnosed mBC, considering clinical presentation (eg, age, menopausal status, comorbidities, symptomatology) and prior treatment course (eg, de novo metastatic disease, type and duration of adjuvant therapy).
  • Describe known and proposed mechanisms of resistance to hormonal therapy, and identify available therapies and investigational efforts attempting to leverage this knowledge.
  • Recognize the FDA approvals of palbociclib, ribociclib and abemaciclib for ER-positive mBC, and discern how these agents can be optimally employed in nonresearch patient care.
  • Educate patients regarding the unique side effects associated with approved CDK4/6 inhibitors, and develop preventive and emergent strategies to reduce or ameliorate these toxicities.
  • Identify clinical situations in which endocrine therapy alone or in combination with HER2-directed therapy should be considered in the management of ER-positive, HER2-positive mBC.

  ACCREDITATION STATEMENT
  Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
  
  CREDIT DESIGNATION STATEMENT
  CME credit is no longer available for this issue
  
  AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
  CME credit is no longer available for this issue
  
  HOW TO USE THIS CME ACTIVITY
  This CME activity consists of a video component.
  CME credit is no longer available for this issue
  
  CONTENT VALIDATION AND DISCLOSURES
  Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.
  
  FACULTY — The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:
  
  Presenting Faculty Member
  
  Sara M Tolaney, MD, MPH
  Dana-Farber Cancer Institute
  Associate Director of Clinical Research
  Susan F Smith Center for Women’s Cancers
  Senior Physician
  Assistant Professor in Medicine
  Harvard Medical School
  Boston, Massachusetts
  
  Advisory Committee and Consulting Agreements: AstraZeneca Pharmaceuticals LP, Merck, NanoString Technologies, Nektar, Puma Biotechnology Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Exelixis Inc, Genentech, Lilly, Merck, Nektar, Novartis, Pfizer Inc.
  
  Project Steering Committee Members
  
  Adam M Brufsky, MD, PhD
  Professor of Medicine
  Associate Director for Translational Investigation
  University of Pittsburgh Cancer Institute
  Co-Director, Comprehensive Breast Cancer Center
  Associate Division Chief
  Department of Medicine, Division of Hematology/Oncology
  University of Pittsburgh
  Pittsburgh, Pennsylvania
  
  Consulting Agreements: Amgen Inc, AstraZeneca Pharmaceuticals LP, Celgene Corporation, Eisai Inc, Genentech, Lilly, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Spectrum Pharmaceuticals Inc.
  
  Matthew P Goetz, MD
  Professor of Oncology and Pharmacology
  Mayo Clinic
  Rochester, Minnesota
  
  Advisory Committee: ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company; Paid Research: Lilly, Pfizer Inc.
  
  Sara A Hurvitz, MD
  Associate Professor of Medicine
  Director, Breast Oncology Program, Division of Hematology/Oncology
  University of California, Los Angeles
  Medical Director, Jonsson Comprehensive Cancer Center Clinical Research Unit
  Los Angeles, California
  Co-Director, Santa Monica-UCLA Outpatient Oncology Practices
  Santa Monica, California
  
  Paid Research: Ambryx Inc, Amgen Inc, BioMarin, Boehringer Ingelheim Pharmaceuticals Inc, Cascadian Therapeutics, Daiichi Sankyo Inc, Dignitana AB, Genentech, GlaxoSmithKline, Lilly, MacroGenics Inc, Medivation Inc, a Pfizer Company, Merrimack Pharmaceuticals Inc, Novartis, OBI Pharma Inc, Pfizer Inc, Pieris Pharmaceuticals Inc, Puma Biotechnology Inc, Roche Laboratories Inc, Seattle Genetics; Paid Travel: Lilly, Novartis, OBI Pharma Inc.
  
  Ian E Krop, MD, PhD
  Director of Clinical Research
  Breast Oncology Center
  Dana-Farber Cancer Institute
  Chief, Breast Oncology Center
  Susan F Smith Center for Women’s Cancers
  Associate Professor of Medicine, Harvard Medical School
  Boston, Massachusetts
  
  Advisory Committee and Contracted Research: Genentech, Roche Laboratories Inc; Consulting Agreement: Daiichi Sankyo Inc; Spouse Employment/Salary, Ownership Interest and Leadership Role: AMAG Pharmaceuticals.
  
  Joyce O’Shaughnessy, MD
  Chair, Breast Cancer Research Program
  Baylor Charles A Sammons Cancer Center
  Celebrating Women Chair in Breast Cancer Research
  Texas Oncology
  US Oncology
  Dallas, Texas
  
  Advisory Committee: AstraZeneca Pharmaceuticals LP, Celgene Corporation, Daiichi Sankyo Inc, Eisai Inc, Lilly, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Sanofi Genzyme; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Celgene Corporation, Daiichi Sankyo Inc, Eisai Inc, Genomic Health Inc, Lilly, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Sanofi Genzyme; Contracted Research: Takeda Oncology.
  
  Hope S Rugo, MD
  Professor of Medicine
  Director, Breast Oncology and Clinical Trials Education
  University of California, San Francisco
  Helen Diller Family Comprehensive Cancer Center
  San Francisco, California
  
  Contracted Research: Eisai Inc, Genentech, Lilly, MacroGenics Inc, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Plexxikon Inc, Roche Laboratories Inc; Paid Travel: Lilly, Mylan NV, Puma Biotechnology Inc.
  
  Denise A Yardley, MD
  Senior Investigator, Breast Cancer Research
  Sarah Cannon Research Institute
  Tennessee Oncology PLLC
  Nashville, Tennessee
  
  Advisory Committee, Contracted Research and Speakers Bureau: Genentech, Novartis.
  
  EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Inc, Astellas Pharma Global Development Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech, Genomic Health Inc, Gilead Sciences Inc, Guardant Health, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite Pharma Inc, Lexicon Pharmaceuticals Inc, Lilly, Medivation Inc, a Pfizer Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro Inc, Teva Oncology and Tokai Pharmaceuticals Inc.
  
  RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.
  
  This educational activity contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.
  
  This activity is supported by an educational grant from Lilly.
  
  Hardware/Software Requirements:
  A high-speed Internet connection
  A monitor set to 1280 x 1024 pixels or more
  Internet Explorer 11 or later, Firefox 56 or later, Chrome 61 or later, Safari 11 or later, Opera 48 or later
  Adobe Flash Player 27 plug-in or later
  Adobe Acrobat Reader
  (Optional) Sound card and speakers for audio
  
  Release date: September 2018
  Expiration date: September 2019