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Mammography and Beyond:
Developing Technologies for the Early Detection of Breast Cancer

Committee on Technologies for the Early Detection of Breast Cancer

Sharyl J. Nass, I. Craig Henderson, and Joyce C. Lashof, Editors

National Cancer Policy Board

INSTITUTE OF MEDICINE
and
Division of Earth and Life Studies

NATIONAL RESEARCH COUNCIL

NATIONAL ACADEMY PRESS
Washington, DC



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Page i Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer Committee on Technologies for the Early Detection of Breast Cancer Sharyl J. Nass, I. Craig Henderson, and Joyce C. Lashof, Editors National Cancer Policy Board INSTITUTE OF MEDICINE and Division of Earth and Life Studies NATIONAL RESEARCH COUNCIL NATIONAL ACADEMY PRESS Washington, DC

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Page ii NATONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Institute of Medicine and the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the Breast Cancer Research Foundation, the Carl J. Herzog Foundation, Mr. John K. Castle, the Jewish Healthcare Foundation (Pittsburgh, PA), the Josiah Macy, Jr., Foundation, the Kansas Health Foundation, and the New York Community Trust. The views presented in this report are those of the Committee on Technologies for Early Detection of Breast Cancer and are not necessarily those of the sponsors. Library of Congress Cataloging-in-Publication Data Mammography and beyond : developing technologies for the early detection of breast cancer / Committee on the Early Detection of Breast Cancer ; Sharyl J. Nass, I. Craig Henderson, and Joyce C. Lashof, editors ; National Cancer Policy Board, Institute of Medicine and Commission on Life Sciences, National Research Council. p. ; cm. Includes bibliographical references and index. ISBN 0-309-07283-2 1. Breast—Cancer—Diagnosis. 2. Breast—Imaging. 3. Medical screening. I. Nass, Sharyl J. II. Henderson, I. Craig. III. Lashof, Joyce C. IV. Institute of Medicine (U.S.). Committee on the Early Detection of Breast Cancer. V. National Cancer Policy Board (U.S.). [DNLM: 1. Breast Neoplasms—diagnosis. 2. Mammography. 3. Mass Screening. WP 870 M2649 2001] RC280.B8 M29 2001 616.99′449075—dc21 2001030885 Additional copies of this report are available from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. The full text of this report is available on line at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2001 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. COVER: Rosalie Ann Cassell, Waiting for the Biopsy, 1998. 18″ x 22″. Watercolor and ink. http:/www.breastcancerfund.org/gallery_6.html. Art. Rage. Us. The Art and Outrage of Breast Cancer.

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Page iii THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Page v COMMITTEE ON TECHNOLOGIES FOR THE EARLY DETECTION OF BREAST CANCER JOYCE C. LASHOF, M.D., FACP, CHAIR, Professor Emerita, School of Public Health, University of California at Berkeley, Berkeley, CA I. CRAIG HENDERSON, M.D., VICE CHAIR, Adjunct Professor of Medicine, University of California at San Francisco, San Francisco, CA D. CRAIG ALLRED, M.D., Professor of Pathology, Baylor College of Medicine, Houston, TX WADE M. AUBRY, M.D., Vice President, The Lewin Group, Associate Clinical Professor of Medicine, University of California at San Francisco, San Francisco, CA JANET K. BAUM, M.D., FACR, Associate Professor of Radiology, Harvard Medical School, Director, Breast Imaging, Beth Israel Deaconess Medical Center, Boston, MA SUZANNE W. FLETCHER, M.D., M.Sc., Professor of Ambulatory Care and Prevention, Harvard School of Medicine, Harvard Pilgrim Health Care, Professor of Epidemiology, Harvard School of Public Health, Boston, MA MARTHE R. GOLD, M.D., M.P.H., Chair, Department of Community Health and Social Medicine, City University of New York Medical School, New York, NY LEON GORDIS, M.D., D.P.H., Professor of Epidemiology, Johns Hopkins School of Public Health & Hygiene, Baltimore, MD DANIEL F. HAYES, M.D., Clinical Director, Breast Cancer Program, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC CAROLINA HINESTROSA, M.A., Cofounder and Executive Director, Nueva Vida, Silver Spring, MD JEAN J. LATIMER, Ph.D., Investigator, Magee-Womens Research Institute, Assistant Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA RICHARD R. NELSON, Ph.D., George Blumenthal Professor, School of International and Public Affairs, Columbia University, New York, NY KENNETH OFFIT, M.D., M.P.H., Chief, Clinical Genetics Service, Department of Human Genetics, Memorial Sloan-Kettering Cancer Center, New York, NY FAINA SHTERN, M.D., Director, Office of Research Affairs, Department of Radiology, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, MA

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Page vi MICHAEL W. VANNIER, M.D., Professor and Head, Department of Radiology, University of Iowa College of Medicine, Iowa City, Iowa DEREK VAN AMERONGEN, M.D., M.S., FACOG, Chief Medical Officer, Humana/ Choice Care, Cincinnati, OH Liaison for the National Cancer Policy Board ROBERT DAY, M.D., M.P.H., Ph.D., Emeritus President and Director, Fred Hutchinson Cancer Research Center, Seattle, WA Consultants LARRY NORTON, M.D., Chief, Solid Tumors, Memorial Sloan-Kettering, New York, NY BARRON LERNER, M.D., Ph.D, Assistant Professor of Medicine and Public Health (in the Center for the Study of Society and Medicine), Columbia University, New York, NY Staff SHARYL J. NASS, Ph.D., Study Director ROBERT COOK-DEEGAN, M.D., Director, National Cancer Policy Board (through August 2000) ROGER HERDMAN, M.D., Director, National Cancer Policy Board (from September 2000) CARMIE CHAN, Research Assistant (through August 2000) MARYJOY BALLANTYNE, Research Assistant (from August 2000) BIANCA TAYLOR, Project Assistant JOHN KUCEWICZ, Intern KEVIN COLLINS, Intern ELLEN JOHNSON, Administrative Assistant (through June 2000) NICCI DOWD, Administrative Assistant (from August 2000) GARY WALKER, Financial Associate (through September 2000) JENNIFER CANGCO, Financial Associate (from September 2000) Commissioned Writers (for lay summaries of the report, workshop proceedings, and current practice in breast cancer diagnosis) MARGIE PATLAK (see http://www4.nationalacademies.org/IOM/IOMHome.nsf/Pages/Breast+Cancer+Detection) LAURA NEWMAN, M.A. (see http://www.nap.edu/catalog/9893.html» and http://www.nap.edu/catalog/10011.html)

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Page vii THE NATIONAL CANCER POLICY BOARD ARNOLD J. LEVINE, Ph.D. CHAIR, President, The Rockefeller University, New York, NY JOSEPH V. SIMONE, M.D. VICE-CHAIR, Medical Director, Huntsman Cancer Institute, Salt Lake City, UT ELLEN STOVALL, VICE-CHAIR, Executive Director, National Coalition for Cancer Survivorship, Silver Spring, MD DIANA PETITTI, M.D., VICE-CHAIR, Director, Research & Evaluation, Kaiser Permanente of Southern California, Pasadena, CA TIM BYERS, M.D., M.P.H., Professor of Epidemiology, University of Colorado, Denver, CO VIVIAN WAI-MEI CHEN, Ph.D., Chief & Professor of Epidemiology, Louisiana State University, New Orleans, LA SUSAN J. CURRY, Ph.D., Director, Center for Health Studies, Group Health of Puget Sound, Seattle, WA NORMAN DANIELS, Ph.D., Professor of Philosophy, Tufts University, Newton, MA KATHLEEN M. FOLEY, M.D., Chief of Pain Service, Memorial Sloan-Kettering Cancer Center, New York, NY THOMAS KELLY, M.D., Ph.D., Chairman of Department of Molecular Biology & Genetics, Johns Hopkins University, Baltimore, MD MARK MCCLELLAN, Assistant Professor of Economics, Stanford University, Stanford, CA WILLIAM MCGUIRE, M.D., Chairman and CEO, United Health Group, Minnetonka, MN JOHN MENDELSOHN, M.D., President, University of Texas, Houston, TX MONICA MORROW, M.D., Professor of Surgery, Northwestern University, Chicago, IL NANCY MUELLER, Sc.D, Professor of Epidemiology, Harvard School of Public Health, Boston, MA PILAR N. OSSORIO, Ph.D., J.D., Assistant Professor, University of Wisconsin Law School, Madison, WI CECIL B. PICKETT, Ph.D., Executive Vice President, Discovery Research, Kenilworth, NJ JOHN SEFFRIN, Ph.D., CEO, American Cancer Society, Atlanta, GA SANDRA M. UNDERWOOD, RN, PH.D FAAN, ACS Oncology Nursing Professor, University of Wisconsin, Milwaukee, WI FRANCES VISCO, President, National Breast Cancer Coalition, Washington, DC SUSAN WIENER, Ph.D., President, The Children's Cause, Silver Spring, MD

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Page viii National Cancer Policy Board Staff ROGER HERDMAN, Director (from September 2000) ROBERT COOK-DEEGAN, Director (through August 2000) MARIA HEWITT, Senior Program Officer HELLEN GELBAND, Senior Program Officer SHARYL NASS, Program Officer MARYJOY BALLANTYNE, Research Assistant BIANCA TAYLOR, Project Assistant NICCI DOWD, Administrative Assistant

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Page ix Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Thomas F. Budinger, M.D., Ph.D., Head, Center for Functional Imaging, E.O. Lawrence Berkeley National Laboratory Webster K. Cavanee, Ph.D., Director, Laboratory of Tumor Biology, Ludwig Institute for Cancer Research, University of California-San Diego Joann G. Elmore, Ph.D., Assistant Professor, Department of Medicine, University of Washington Samuel Hellman, M.D., A.N. Pritzker Distinguished Service Professor, Center for Advanced Medicine, The University of Chicago Barbara J. McNeil, M.D., Ph.D., Professor and Head, Department of Health Care Policy, Harvard Medical School Susan Scherr, Director, Survivorship Programs, National Coalition for Cancer Survivorship, Silver Spring, MD

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Page x Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Barbara Hulka, M.D., M.P.H., Kenan Professor, Department of Epidemiology, University of North Carolina at Chapel Hill, appointed by the Institute of Medicine, and Mary Jane Osborn, Ph.D., Department of Microbiology, University of Connecticut Health Center, appointed by the NRC's Report Review Committee, who were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Page xi Preface Breast cancer remains a leading cause of cancer death among women in the United States. More than 180,000 new cases of invasive breast cancer are diagnosed each year, and more than 40,000 women die of the disease. Recent years, however, have seen improvements in survival attributed to better treatment and earlier diagnosis. Research efforts have been directed toward better treatment, preventive strategies, and early detection. Although mammography has been the mainstay of early detection, its limitations are well recognized and the search for more effective technologies for early detection has been receiving increased attention. As part of this increased attention, the Institute of Medicine (IOM) convened a committee to examine the current state of the art in early breast cancer detection, to identify promising new technologies, and to examine the many steps in medical technology development and the policies that influence their adoption and use. The IOM committee consisted of a 16-member interdisciplinary group with a wide range of views and expertise in breast cancer, medical imaging, cancer biology, epidemiology, economics, and technology assessment. The committee examined the peer-reviewed literature, met four times, held two workshops that dealt with new technologies as well as policies related to their adoption and dissemination, and consulted with experts in the field. Early detection is widely believed to save lives by facilitating intervention early in the course of the disease, at a stage when cancer treatment is most likely to be effective. This concept, however, belies a number of complexities, not the least of which is the need to understand the

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Page xii basic biology of breast cancer. The committee recognized the need for research on the natural history of breast cancer to more clearly define the significance of early lesions, the need for the development of biomarkers, and the importance of assessing the effectiveness of new technologies in decreasing morbidity and mortality. This report describes many novel technologies that are being developed for the purpose of early breast cancer detection, as well as recent technological advances in detection modalities already in use. Because the many technologies that the committee examined were at different stages of development and thus the evidence of their accuracy and effectiveness varied, the committee found it difficult to predict which of the many new technologies were likely to play a role in the future of early breast cancer detection. The committee also identified a number of barriers to both the development and the dissemination of new technologies and made recommendations for actions that can be taken to overcome them. Many new technologies are on the horizon and intriguing research in basic biology is under way, but much remains to be done. We are hopeful that this report will contribute in some small way to the efforts to improve our ability to detect breast cancer at an early stage. The committee was impressed with the dedication and commitment of the researchers in both the public and the private sectors and with the governmental personnel working to save the lives of women, and we are hopeful that their efforts will prove fruitful. Joyce C. Lashof Chair

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Page xiii Acknowledgments The committee wishes to thank all of the people who contributed to this report. First and foremost we wish to acknowledge the outstanding work of the study director, Sharyl Nass. Sharyl was responsible for the extensive literature search, for selecting an outstanding group of speakers for the two workshops, as well as preparing the initial drafts and revisions of the entire report. Her ability to identify the key issues as well as the key players was instrumental in carrying out the work of the committee. She was responsive to the committee members throughout, and we all found it a pleasure to work with her. We also thank Carmie Chan and MaryJoy Ballantyne who provided invaluable research assistance. We were further assisted by two interns, John Kucewicz and Kevin Collins, who made substantial contributions to the completion of Chapters 2 and 6, respectively. We also appreciate the efforts of Bianca Taylor, who took primary responsibility for organizing the logistics of all the committee meetings and workshops and who was very helpful in keeping the study on schedule. The senior staff of the National Cancer Policy Board (Roger Herdman, Robert Cook-Deegan, Maria Hewitt, and Hellen Gelband) all provided valuable feedback on drafts of the report. We also wish to thank all of the workshop speakers and participants, as well as a host of others who contributed to the study by speaking at meetings or by providing data and other written materials. The names and affiliations of all the speakers and other contributors are listed in Appendix A. All of the committee members gave generously of their time and were

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Page xiv important collaborators throughout the deliberations and preparation of the report. Several members made primary contributions in drafting the report, and are noted for their efforts as follows: Chapter 1, Daniel Hayes; Chapter 2, Janet Baum and Michael Vannier; Chapter 3, Craig Allred, Jean Latimer, and Kenneth Offitt; Chapter 5, Suzanne Fletcher, Marthe Gold, Derek Van Amerongen, and Wade Aubry. In addition, Carolina Hinestrosa provided valuable and insightful comments that were incorporated into all the chapters of the report. We also thank Craig Henderson, vice-chair of the committee, for his thoughtful advice and insight throughout. Finally, we owe a debt of gratitude to the seven independent foundations and individuals who provided the funds needed to undertake this study. This report could not have been produced were it not for the generosity of the Breast Cancer Research Foundation, the Carl J. Herzog Foundation, Mr. John K. Castle, the Jewish Healthcare Foundation, the Josiah Macy, Jr., Foundation, the Kansas Health Foundation, and the New York Community Trust.

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Page xv Acronyms ABBI advanced breast biopsy instrumentation ABR American Board on Radiology ACRIN American College of Radiology Imaging Network ACS American Cancer Society AHRQ Agency for Healthcare Research and Quality ART Advanced Research and Technology AT ataxia telangiectasia ATP Advanced Technology Program BBE Biofield Breast Examination BCBSA Blue Cross/Blue Shield Association BC-PRG Breast Cancer Progress Review Group BCRP Breast Cancer Research Program BCSC Breast Cancer Surveillance Consortium BIRADS Breast Imaging Reporting and Data System BISTIC Biomedical Information Science and Technology Implementation Consortium BRCA breast cancer-associated tumor suppressor gene BSE breast self-examination CAD computer-aided detection or diagnosis CBE clinical breast examination CDC Centers for Disease Control and Prevention cDNA complementary deoxyribonucleic acid CEA carcinoembryonic antigen CGAP Cancer Genome Anatomy Project

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Page xvi CIA Central Intelligence Agency CLIA Clinical Laboratory Improvement Amendments CNB core-needle biopsy CPTA Center for Practice and Technology Assessment DOD U.S. Department of Defense EITS electrical impedance tomography system EPC evidence-based practice centers ESS elastic scattering spectroscopy FDA Food and Drug Administration FDAMA Food and Drug Administration Modernization Act FFDM Full-field digital mammography FISH fluorescent in situ hybridization FNA fine-needle aspiration FNAB fine-needle aspiration biopsy FSM film-screen mammography GAO General Accounting Office HCFA Health Care Financing Administration HEI Hall effect imaging HGRI National Human Genome Research Institute HIP Health Insurance Plan of Greater New York HMEC human mammary epithelial cells HRSA Health Resources and Services Administration IBC invasive breast cancer IDE investigational device exemption IGF1 insulin-like growth factor type 1 IMDS Imaging Diagnostic System, Inc. IOM Institute of Medicine IRB institutional review board LCIS lobular carcinoma in situ LOH loss of heterozygosity MCAC Medicare Coverage Advisory Committee MIBI technetium-99m sestamibi MMG magnetomammography MQSA Mammography Quality Standards Act of 1976 MRI magnetic resonance imaging

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Page xvii mRNA messenger ribonucleic acid MRS magnetic resonance spectroscopy NAF nipple aspiration fluid NCHCT National Center for Health Care Technology NCI National Cancer Institute NEMA National Electrical Manufacturers' Association NIH National Institutes of Health NIST National Institute of Standards and Technology NMD National Mammography Database OBBB Office of Bioengineering, Bioimaging, and Bioinformatics OTA Office of Technology Assessment OWH Office on Women's Health PCR polymerase chain reaction PET positron emission tomography PMA premarketing approval PPV positive predictive value PSA Prostate specific antigen PTEN tumor suppressor gene QALY quality-adjusted life year RCP riboflavin carrier protein RNA ribonucleic acid RO1 a type of grant from the National Institutes of Health RT reverse transcription RVU relative value unit SACGT Secretary's Advisory Committee on Genetic Testing SBI Society of Breast Imaging SBIR Small Business Innovative Research SNP single nucleotide polymorphism SPECT Single-photon emission computed tomography SQUID superconducting quantum interference device STTR Small Business Technology Transfer Research TACT tuned aperture computed tomography TCT thermoacoustic computed tomography TEC Technology Evaluation Center USAMRMC U.S. Army Medical Research and Materiel Command USPSTF U.S. Preventive Services Task Force

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Page xix Contents Executive Summary 1 1     Introduction 15 2     Breast Imaging and Related Technologies 55 3     Technologies in Development: Genetics and Tumor Markers 105 4     Development and Regulation of New Technologies 133 5     Evaluation and Cost Coverage of New Technologies 167 6     Dissemination: Increasing the Use and Availability of New Technologies 199 7     Findings and Recommendations 221 Glossary 237 References 249 Appendix: Workshop speakers and other contributors 269 Index 273

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Page xxi Mammography and Beyond:

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