Subscribe to Podcasts or download MP3s of this program at MeetTheProfessors.com CME Certified from the publishers of A case-based discussion on the management
of breast cancer in the adjuvant and
metastatic settings Meet The Professors E D I T O R Neil Love, MD F A C U L T Y G Thomas Budd, MD
Charles E Geyer Jr, MD
Julie R Gralow, MD
John Mackey, MD 2008 VOL 6, ISSUE 1 Meet The Professors: A case-based discussion on the management of breast cancer in the adjuvant and metastatic settings S T A T E M E N T O F N E E D / T A R G E T A U D I E N C E Breast cancer is one of the most rapidly evolving fields in medical oncology. Published results from ongoing clinical trials lead to the continuous emergence of new therapeutic agents and changes in the indications for existing treatments. To offer optimal patient care including the option of clinical trial participation practicing medical oncologists, hematologists and hematology-oncology fellows must be well informed of these advances. Meet The Professors utilizes relevant case-based discussions between community oncologists and clinical investigators to help practicing clinicians incorporate this information into their management strategies for patients with breast cancer. L E A R N I N G O B J E C T I V E S Evaluate the clinical implications of emerging clinical trial data in breast cancer treat- ment, and incorporate these data into management strategies in the adjuvant, neoadjuvant,
metastatic and preventive settings. Counsel patients who are postmenopausal with ER-positive breast cancer about the risks and benefits of adjuvant aromatase inhibitors and of switching to or sequencing aromatase
inhibitors after tamoxifen. Talk with patients who are premenopausal about the risks and benefits of adjuvant ovarian suppression alone or with other endocrine interventions. Implement an algorithm for HER2 testing and treatment of patients with HER2-positive breast cancer in the adjuvant, neoadjuvant and metastatic settings. Appraise the emerging data on various adjuvant chemotherapy approaches, including modified doses and schedules and the use of taxanes, and explain the absolute risks and
benefits of adjuvant chemotherapy regimens to patients. Describe the computerized risk models and genetic markers to determine prognostic infor- mation on the quantitative risk of breast cancer relapse, and when applicable, utilize these
to guide therapy decisions. Assess the emerging data for novel biologic and molecular-targeted therapies with clinical activity in breast cancer, and determine how these should be incorporated into the treat-
ment algorithm for appropriate patients with metastatic disease, including patients with
triple-negative tumors. A C C R E D I T A T I O N S T A T E M E N T Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. C R E D I T D E S I G N A T I O N S T A T E M E N T Research To Practice designates this educational activity for a maximum of 3.25 AMA PRA Category 1 Credit(s) . Physicians should only claim credit commensurate with the extent of their participation in the activity. H O W T O U S E T H I S C M E A C T I V I T Y This CME activity contains both audio and print components. To receive credit, the participant should listen to the CDs, review the CME information and complete the Educational Assessment and Credit Form located in the back of this book or on our website, MeetTheProfessors.com . This program is supported by educational grants from Abraxis BioScience, AstraZeneca Pharmaceuticals LP, Genentech BioOncology and Genomic Health Inc. Guide to Audio Program Compact Disc 1: Tracks 1-6 case from Dr Bobrow; Tracks 7-11 case from Dr Vacirca; Tracks 12-17 case from Dr Schwartz; Compact Disc 2: Tracks 1-7 case from Dr Astrow; Tracks 8-10 case from Dr Marcom; Tracks 11-13 case from Dr Hoffman; Tracks 14-16 case from Dr Moss; Compact Disc 3: Tracks 1-5 case from Dr Allison; Tracks 6-7 case from Dr Seigel; Tracks 8-11 case from Dr Lunin; Tracks 12-13 case from Dr Levy 3 Medical Oncologist Community Panel C O N T E N T V A L I D A T I O N A N D D I S C L O S U R E S Research To Practice is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess potential conflicts of interest with faculty, planners and managers of CME activities. Real or apparent 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 Research To Practice scientific staff and an external, independent reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.
FACULTY Dr Geyer No real or apparent conflicts of interest to disclose. The following faculty (and their spouses/partners) reported real or apparent conflicts of interest, which have been resolved through a conflict of interest resolution process: Dr Budd Advisory Committee: Amgen Inc, AstraZeneca Pharmaceuticals LP, Novartis Pharmaceuticals Corporation, Pfizer Inc, Wyeth. Dr Gralow Consulting Agreements: Amgen Inc, Genentech BioOncology, Genomic Health Inc, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Roche Laboratories Inc, Sanofi-Aventis. Dr Mackey Honoraria: Amgen Inc, AstraZeneca Pharmaceuticals LP, Roche Laboratories Inc, Sanofi-Aventis.
COMMUNITY PANEL Drs Allison, Astrow, Bobrow, Hoffman, Levy, Lunin and Schwartz No real or apparent conflicts of interest to disclose. Dr Marcom Preceptorship: Novartis Pharmaceuticals Corporation, Sanofi-Aventis. Dr Moss Advisory Committee: Celgene Corporation, Millennium Pharmaceuticals Inc, Pharmion Corporation; Paid Research: Abraxis BioScience, Amgen Inc, Archimedes Development Limited, Eisai Inc, Genentech BioOncology, Novartis Pharmaceuticals Corporation, Ortho Biotech Products LP, Pharmatech Inc, Sanofi-Aventis, Taiho Pharmaceutical Co Ltd. Dr Seigel Stock Ownership: AstraZeneca Pharmaceuticals LP, Celgene Corporation, Genentech BioOncology, Millennium Pharmaceuticals Inc. Dr Vacirca Speakers Bureau: Abraxis BioScience, OSI Pharmaceuticals Inc, Sanofi-Aventis.
RESEARCH TO PRACTICE STAFF AND EXTERNAL REVIEWERS The scientific staff and reviewers for Research To Practice have no real or apparent conflicts of interest to disclose.
This educational activity contains 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 grantors. Mary Ann K Allison, MD Comprehensive Cancer Centers of Nevada Siena Campus Henderson, Nevada
Alan B Astrow, MD Director, Division of Medical Oncology/Hematology Maimonides Cancer Center Brooklyn, New York
Samuel N Bobrow, MD Associate Clinical Professor of Medicine, Yale University Attending Physician at Yale-New Haven Hospital Attending Physician at the Hospital of St Raphael New Haven, Connecticut Kenneth R Hoffman, MD, MPH Teaneck, New Jersey
Isaac Levy, MD Memorial Hospital West Pembroke Pines, Florida
Scott D Lunin, MD Florida Cancer Specialists Port Charlotte, Florida
Paul K Marcom, MD Duke University Medical Center Durham, North Carolina
Robert A Moss, MD President Medical Oncology Association of Southern California Private Practice Fountain Valley, California Michael A Schwartz, MD Attending Mount Sinai Medical Center Miami Beach, Florida
Leonard J Seigel, MD Bienes Cancer Center Ft Lauderdale, Florida
Jeffrey L Vacirca, MD Assistant Professor of Medicine at University Hospital, Stony Brook North Shore Hematology/ Oncology Associates East Setauket, New York M E E T T H E P R O F E S S O R S D O W N L O A D A B L E A U D I O A N D P O D C A S T S MP3 audio files are available for download on our website www.MeetTheProfessors.com/ download-audio Case Studies 4 Case 1 from the practice of Samuel N Bobrow, MD: A 63-year-old woman was treated six years previously with local therapy alone for a 0.9-cm, node-negative, ER-negative, PR-negative, HER2-positive invasive ductal carcinoma (IDC). In February 2007, she was treated with bilateral mastectomies and docetaxel/cyclophosphamide (TC) followed by trastuzumab for a second 0.9-cm, ipsilateral, node-negative, ER-negative, PR-negative, HER2-positive IDC (presented to Drs Geyer and Mackey). Case 2 from the practice of Jeffrey L Vacirca, MD: An 80-year-old woman with a history of diabetes, hypertension and CHF was diagnosed with multifocal (4-cm, 2.8-cm and 2.5-cm), ER-positive, PR-positive, HER2-positive, poorly differentiated lobular carcinoma with signet ring features and 13/14 positive axillary lymph nodes, for which she underwent mastectomy and axillary node dissection. She received TCH with growth factor support followed by an aromatase inhibitor (presented to Drs Budd and Gralow). Case 3 from the practice of Michael A Schwartz, MD: A 36-year-old woman with a 2-cm, Grade III, ER-positive, PR-positive, HER2-negative, node-negative IDC had an Oncotype DX recurrence score of 27 and was treated with chemotherapy followed by radiation therapy and hormonal therapy (presented to Drs Budd and Gralow). Case 4 from the practice of Alan B Astrow, MD: A 56-year-old woman was treated with dose- dense AC paclitaxel for a 3.7-cm, triple-negative, node-negative left breast tumor. One year later, she developed right upper quadrant pain and multiple liver metastases (presented to Drs Geyer and Mackey). Case 5 from the practice of Paul K Marcom, MD: A 48-year-old premenopausal woman presented with a 5-cm, triple-negative breast tumor, and CT/PET revealed diffuse bone and nodal metastatic disease. LVEF was 20 percent. She was diagnosed with cardiomyopathy, for which she received an ACE inhibitor, beta-blocker and furosemide. Her tumor was treated with carboplatin, nab paclitaxel and bevacizumab (presented to Drs Budd and Gralow). Case 6 from the practice of Kenneth R Hoffman, MD, MPH: A 76-year-old man underwent a simple mastectomy in 1999 for breast cancer of unknown stage. Follow-up in 2007 revealed a 3 x 5 x 4.2-cm left supraclavicular lymph node mass, and biopsy was consistent with a triple- negative adenocarcinoma of the breast (presented to Drs Budd and Gralow). Case 7 from the practice of Robert A Moss, MD: A 54-year-old woman whose metastatic breast cancer progressed through a number of hormonal, chemotherapy and biologic treatments developed pulmonary metastases with lymphangitic spread, rapidly increasing dyspnea and bone pain, for which she received nab paclitaxel/bevacizumab and experienced dramatic symptom relief. Trastuzumab was added to her treatment, and after one year she had slowly progressive disease and was switched to lapatinib/capecitabine (presented to Drs Budd and Gralow). Case 8 from the practice of Mary Ann K Allison, MD: An 84-year-old woman with medically controlled, asymptomatic CAD and myeloproliferative syndrome was diagnosed with a 10-cm, strongly ER-positive, weakly PR-positive, HER2-negative infiltrating lobular carcinoma. After six months of neoadjuvant therapy with an aromatase inhibitor, she underwent a lumpectomy (positive margins and two positive nodes) followed by a mastectomy and radiation therapy. She is now receiving an aromatase inhibitor and a bisphosphonate without complications (presented to Drs Geyer and Mackey). Case 9 from the practice of Leonard J Seigel, MD: A 40-year-old woman diagnosed with a 1-cm, poorly differentiated, Grade III, ER-positive, PR-positive, HER2-positive IDC discontinued tamoxifen after two years and currently intends to undergo fertility treatment (presented to Drs Budd and Gralow). Case 10 from the practice of Scott D Lunin, MD: A 39-year-old woman was diagnosed with a 2-cm, moderately differentiated, ER-positive, PR-positive, HER2-negative IDC and a 3-cm lung mass that was confirmed on biopsy to be metastatic breast cancer (presented to Drs Budd and Gralow). Case 11 from the practice of Isaac Levy, MD: A 78-year-old woman was diagnosed with a 10-cm, triple-negative invasive breast carcinoma of myoepithelial origin with adenocystic features and several enhancing bony lesions in the pelvis and L5 vertebral body, with bone biopsy histologically identical to the primary tumor. She was treated with dose-dense AC paclitaxel and zoledronic acid (presented to Drs Geyer and Mackey). 5 Research To Practice is committed to providing valuable continuing education for oncology clinicians, and your input is critical to helping us achieve this important goal. Please take the time to assess the activity you just completed, with the assurance that your answers and suggestions are strictly confidential. PA R T O N E Please tell us about your experience with this educational activity Was the activity evidence based, fair, balanced and free from commercial bias? 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Please respond to the following LEARNER statements by circling the appropriate selection: 4 = Yes 3 = Will consider 2 = No 1 = Already doing N/M = Learning objective not met N/A = Not applicable As a result of this activity, I will: Evaluate the clinical implications of emerging clinical trial data in breast cancer treatment, and incorporate these data into management strategies in the adjuvant, neoadjuvant, metastatic and preventive settings. . . . . . . . . . . . . . . . . . . . . . . . .4 3 2 1 N/M N/A Counsel patients who are postmenopausal with ER-positive breast cancer about the risks and benefits of adjuvant aromatase inhibitors and of switching to or sequencing aromatase inhibitors after tamoxifen. . . . . . . . . . . . . . . . . . . . . . . . .4 3 2 1 N/M N/A Talk with patients who are premenopausal about the risks and benefits of adjuvant ovarian suppression alone or with other endocrine interventions.. . . . . .4 3 2 1 N/M N/A Implement an algorithm for HER2 testing and treatment of patients with HER2- positive breast cancer in the adjuvant, neoadjuvant and metastatic settings. . . . .4 3 2 1 N/M N/A Appraise the emerging data on various adjuvant chemotherapy approaches, including modified doses and schedules and the use of taxanes, and explain the absolute risks and benefits of adjuvant chemotherapy regimens to patients. . . . .4 3 2 1 N/M N/A Describe the computerized risk models and genetic markers to determine prognostic information on the quantitative risk of breast cancer relapse, and when applicable, utilize these to guide therapy decisions.. . . . . . . . . . . . . . .4 3 2 1 N/M N/A Assess the emerging data for novel biologic and molecular-targeted therapies with clinical activity in breast cancer, and determine how these should be incorporated into the treatment algorithm for appropriate patients with metastatic disease, including patients with triple-negative tumors. . . . . . . .4 3 2 1 N/M N/A BEFORE completion of this activity, how would you characterize your level of knowledge on the following topics? 4 = Expert 3 = Above average 2 = Competent 1 = Insufficient Treatment of patients with triple-negative tumors . . . . . . . . . . . . . . 4 3 2 1 Role of Oncotype DX in clinical decision-making . . . . . . . . . . . . . . . . . . . 4 3 2 1 Approach to patients with HER2-positive disease progressing on trastuzumab . . . . . . . . . . 4 3 2 1 Selection of endocrine therapy for postmenopausal patients with ER-positive disease . . . . . . . . . . . . . 4 3 2 1 AFTER completion of this activity, how would you characterize your level of knowledge on the following topics? 4 = Expert 3 = Above average 2 = Competent 1 = Insufficient Treatment of patients with triple-negative tumors . . . . . . . . . . . . . . 4 3 2 1 Role of Oncotype DX in clinical decision-making . . . . . . . . . . . . . . . . . . . 4 3 2 1 Approach to patients with HER2-positive disease progressing on trastuzumab . . . . . . . . . . 4 3 2 1 Selection of endocrine therapy for postmenopausal patients with ER-positive disease . . . . . . . . . . . . . 4 3 2 1 Educational Assessment and Credit Form:
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8 Editor Neil Love, MD Managing Editor Kathryn Ault Ziel, PhD Scientific Director Richard Kaderman, PhD Senior Director, Medical Affairs Aviva Asnis-Alibozek, PA-C, MPAS Writers Lilliam Sklaver Poltorack, PharmD Douglas Paley Continuing Education Administrator for Nursing Sally Bogert, RNC, WHCNP Content Validation Margaret Peng Erin Wall Director, Creative and Copy Editing Aura Herrmann Creative Manager Fernando Rendina Graphic Designers Jessica Benitez Jason Cunnius Tamara Dabney Claudia Munoz Senior Production Editor Alexis Oneca Traffic Manager Tere Sosa Copy Editors Dave Amber Margo Harris David Hill Rosemary Hulce Kirsten Miller Pat Morrissey/Havlin Carol Peschke Susan Petrone Production Manager Tracy Potter Audio Production Frank Cesarano Web Master John Ribeiro Faculty Relations Manager Melissa Vives CME Director/CPD Director Isabelle Tate Contact Information Neil Love, MD Research To Practice One Biscayne Tower 2 South Biscayne Boulevard, Suite 3600 Miami, FL 33131 Fax: (305) 377-9998 Email: DrNeilLove@ResearchToPractice.com For CME/CNE Information Email: CE@ResearchToPractice.com Meet The Professors Copyright