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

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

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 Insti￾tute of Medicine and the Governing Board of the National Research Council,

whose members are drawn from the councils of the National Academy of Sci￾ences, 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 Founda￾tion, 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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the Academy has a mandate that requires it to advise the federal government on

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A. Wulf is president of the National Academy of Engineering.

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Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice

chairman, respectively, of the National Research Council.

National Academy of Sciences

National Academy of Engineering

Institute of Medicine

National Research Council

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

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)

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

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

viii

ix

Reviewers

This report has been reviewed in draft form by individuals chosen for

their diverse perspectives and technical expertise, in accordance with pro￾cedures 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 integ￾rity of the deliberative process. We wish to thank the following individu￾als 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

x REVIEWERS

Although the reviewers listed above have provided many construc￾tive comments and suggestions, they were not asked to endorse the con￾clusions 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 in￾dependent examination of this report was carried out in accordance with

institutional procedures and that all review comments were carefully con￾sidered. Responsibility for the final content of this report rests entirely

with the authoring committee and the institution.

Preface

xi

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 de￾tection, its limitations are well recognized and the search for more effec￾tive technologies for early detection has been receiving increased atten￾tion. 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 poli￾cies 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, epidemiol￾ogy, 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 inter￾vention early in the course of the disease, at a stage when cancer treat￾ment is most likely to be effective. This concept, however, belies a num￾ber of complexities, not the least of which is the need to understand the

xii PREFACE

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 com￾mittee 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 devel￾opment and the dissemination of new technologies and made recommen￾dations for actions that can be taken to overcome them. Many new tech￾nologies 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

Acknowledgments

xiii

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 revi￾sions 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 commit￾tee. 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

xiv ACKNOWLEDGMENTS

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 incor￾porated 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 founda￾tions 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.