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  • NIH Consensus Development Conference on Adjuvant Therapy for Breast Cancer

    November 1–3, 2000 William H. Natcher Conference Center

    National Institutes of Health Bethesda, Maryland

    Sponsored by:

    ¤ National Cancer Institute ¤ Office of Medical Applications of Research ¤

    Cosponsored by:

    ¤ National Institute of Nursing Research ¤ Office of Research on Women’s Health ¤

  • Contents

    Introduction......................................................................................................................................1

    Agenda .............................................................................................................................................3

    Panel Members.................................................................................................................................9

    Speakers .........................................................................................................................................11

    Planning Committee.......................................................................................................................15

    Abstracts.........................................................................................................................................17

    I. Overview

    Overview of Conference William C. Wood, M.D., FACS...................................................................................................19

    II. Factors Used To Select Adjuvant Therapy

    Factors Used To Select Adjuvant Therapy—Overview Gary M. Clark, Ph.D....................................................................................................................21

    Traditional and Newer Pathological Factors Stuart J. Schnitt, M.D. .................................................................................................................23

    Prognostic and Predictive Role of Proliferation Indices Maria Grazia Daidone, Ph.D.......................................................................................................25

    Racial/Ethnic Background and Benefits of Adjuvant Therapy for Breast Cancer James J. Dignam, Ph.D. ...............................................................................................................29

    Patient-Specific Factors—Young Patients Aron Goldhirsch, M.D. ................................................................................................................33

    Factors Used To Select Adjuvant Therapy: An Overview of Age and Race Hyman B. Muss, M.D...................................................................................................................39

    iii

  • III. Adjuvant Hormone Therapy

    Duration of Adjuvant Hormonal Treatment Christina Davies, MBChB, M.Sc. ...............................................................................................43

    Duration of Adjuvant Tamoxifen Therapy John L. Bryant, Ph.D. ..................................................................................................................47

    Recent NSABP Adjuvant Studies in Primary (Stage One) Breast Cancer Bernard Fisher, M.D....................................................................................................................53

    Who Should Not Get Tamoxifen? C. Kent Osborne, M.D. ................................................................................................................57

    Hormonal Ablation Nancy E. Davidson, M.D..............................................................................................................63

    IV. Adjuvant Chemotherapy

    Overview: Progress in Systemic Chemotherapy of Primary Breast Cancer Gabriel N. Hortobagyi, M.D., FACP ..........................................................................................67

    Is Her-2/neu a Predictor of Anthracycline Utility in Adjuvant Therapy? A Qualified Yes. Peter M. Ravdin, M.D., Ph.D. .....................................................................................................71

    Is HER-2/neu a Predictor of Anthracycline Utility? No. George W. Sledge, Jr., M.D.........................................................................................................75

    Adjuvant Chemotherapy: Taxanes—the “Pro” Position I. Craig Henderson, M.D. ............................................................................................................79

    Evaluating the Use of Paclitaxel Following Doxorubicin/Cyclophosphamide in Patients With Breast Cancer and Positive Axillary Nodes Eleftherios P. Mamounas, M.D. ..................................................................................................83

    Taxanes in the Adjuvant Setting: Why Not Yet? Martine J. Piccart, M.D., Ph.D. ..................................................................................................85

    Preoperative Chemotherapy: NSABP Protocols B-18 and B-27 Norman Wolmark, M.D. .............................................................................................................89

    Who Should Not Receive Chemotherapy?—International Databases Jonas C. Bergh, M.D., Ph.D. .......................................................................................................95

    Who Should Not Receive Chemotherapy?—U.S. Databases and Trials Monica Morrow, M.D. .................................................................................................................97

    iv

  • A Prospective, Randomized Comparison of Two Doses of Combination Alkyating Agents (AA) as Consolidation After CAF in High-Risk Primary Breast Cancer Involving Ten or More Axillary Lymph Nodes (LN): Preliminary Results of CALGB 9082/SWOG 9114/NCIC MA-13 William P. Peters, M.D., Ph.D...................................................................................................101

    Overview of the Six Randomized Adjuvant Trials of High-Dose Chemotherapy

    in Breast Cancer Karen H. Antman, M.D.. ...........................................................................................................103

    V. Adjuvant Postmastectomy Radiotherapy

    Overview: Postmastectomy Radiotherapy Jack Cuzick, Ph.D. .....................................................................................................................107

    Adjuvant Postmastectomy Radiotherapy: Review of Treatment Guidelines and Techniques Lori Pierce, M.D.........................................................................................................................113

    VI. Influences of Treatment-Related Side Effects and Quality-of-Life Issues on Individual Decision-Making About Adjuvant Therapy

    Side Effects, Quality-of-Life Issues, and Tradeoffs in Adjuvant Therapy for Breast Cancer: The Patient Perspective Amy S. Langer, M.B.A. .............................................................................................................117

    Impact of Tamoxifen Adjuvant Therapy on Symptoms, Functioning, and Quality of Life Patricia A. Ganz, M.D. ..............................................................................................................119

    Side Effects of Chemotherapy and Combined Chemohormonal Therapy Eric P. Winer, M.D. ...................................................................................................................123

    Decision-Making Process—Communicating Risks/Benefits: Is There an

    Ideal Technique? Mark Norman Levine, M.D. .....................................................................................................129

    Assessing Individual Benefit

    Alan Coates, M.D., FRACP.......................................................................................................131

    v

  • Introduction

    The National Institutes of Health (NIH) will sponsor a Consensus Development Conference on Adjuvant Therapy for Breast Cancer on November 1–3, 2000.

    Each year, more than 180,000 women in the United States are diagnosed with breast cancer, the most common type of cancer among women in this country. If current breast cancer rates stay constant, a female born today has a 1 in 8 chance of developing breast cancer sometime during her life.

    Through continuing research into new treatment methods, women with breast cancer now have more treatment options and hope for survival than ever before. Studies have shown that adjuvant therapy—treatment to kill cancer cells that may have begun to spread, or metastasize, from the breast tumor—given in addition to surgery or other primary therapies increases a woman's chance of long-term survival.

    Two types of systemic adjuvant therapy are used for breast cancer, either alone or in combination: adjuvant chemotherapy involves a combination of anticancer drugs; adjuvant hormone therapy deprives cancer cells of the female hormone estrogen, which some breast cancer cells need to grow. In addition to these systemic therapies, radiation therapy is sometimes used as a local adjuvant treatment to help destroy breast cancer cells that have spread to nearby parts of the body.

    The rapid pace of discovery in this area continues to broaden the knowledge base from which informed treatment decisions can be made. The purpose of this conference is to clarify, for clinicians, patients, and the general public, various issue