Appropriate Use of
Advanced Technologies for
RADIATION THERAPY
and
SURGERY IN ONCOLOGY
Workshop Summary
Sharyl J. Nass and Margie Patlak, Rapporteurs
National Cancer Policy Forum
Board on Health Care Services
Institute of Medicine
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This project was supported by Contract No. HHSN261200900003C and Contract No. HHSN263201200074I (Task Order No. HHSN26300052) between the National Academy of Sciences and the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, EMD Serono, Helsinn Healthcare SA, LIVESTRONG Foundation, National Comprehensive Cancer Network, Novartis Oncology, the Oncology Nursing Society, and Pfizer Inc.
International Standard Book Number-13: 978-0-309-38129-1
International Standard Book Number-10: 0-309-38129-0
Digital Object Identifier: 10.17226/21859
Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.
Copyright 2016 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Appropriate use of advanced technologies for radiation therapy and surgery in oncology: Workshop summary. Washington, DC: The National Academies Press. doi: 10.17226/21859.
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WORKSHOP PLANNING COMMITTEE1
YA-CHEN TINA SHIH (Co-Chair), Professor of Health Economics, Chief, Section of Cancer Economics and Policy, Department of Health Services Research, University of Texas MD Anderson Cancer Center
RALPH R. WEICHSELBAUM (Co-Chair), Daniel K. Ludwig Professor, Chair, Department of Radiation & Cellular Oncology, Director, Ludwig Center for Metastasis Research, University of Chicago
MONICA M. BERTAGNOLLI, Professor of Surgery, Harvard University Medical School, Associate Surgeon, Dana-Farber Cancer Institute, Group Chair, Cancer and Leukemia Group, Brigham and Women’s Hospital
OTIS W. BRAWLEY, Chief Medical Officer, American Cancer Society
ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network
PATRICIA A. GANZ, Distinguished University Professor, University of California, Los Angeles (UCLA), Fielding School of Public Health, David Geffen School of Medicine at UCLA, Jonsson Comprehensive Cancer Center
CAROL A. HAHN, Associate Professor of Radiation Oncology, Duke University Medical Center, Medical Director of Radiation Oncology, Duke Raleigh Hospital, Department of Radiation Oncology, Duke University Medical Center
LORI HOFFMAN-HÕGG, Veterans Health Administration National Oncology Clinical Advisor, Department of Veterans Affairs, Cancer Program Director, Albany Stratton Veterans Affairs Medical Center
JAMES HU, Ronald Lynch Professor of Urologic Oncology, Director, LeFrak Center for Robotic Surgery, Weill Cornell Medical College
THEODORE LAWRENCE, Isadore Lampe Professor and Chair, Department of Radiation Oncology, University of Michigan Medical School
STEVEN PIANTADOSI, Phase One Foundation Endowed Chair and Director, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center
__________________
1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
Project Staff
SHARYL J. NASS, Director, National Cancer Policy Forum
PATRICK ROSS, Research Assistant
HANNAH DURING, Senior Program Assistant
NATIONAL CANCER POLICY FORUM1
MICHAEL CALIGIURI (Chair), Chief Executive Officer, James Cancer Hospital and Solove Research Institute; Director, Ohio State University Comprehensive Cancer Center
PATRICIA A. GANZ (Vice Chair), Distinguished Professor, University of California, Los Angeles (UCLA), Fielding School of Public Health, David Geffen School of Medicine at UCLA, Jonsson Comprehensive Cancer Center
AMY P. ABERNETHY, Chief Medical Officer and Senior Vice President for Oncology, Flatiron Health; Professor, Division of Medical Oncology, Duke University School of Medicine; Director, Center for Learning Health Care, Duke Clinical Research Institute
LUCILE ADAMS-CAMPBELL, Professor of Oncology, Associate Director for Minority Health and Health Disparities Research, Georgetown University Lombardi Cancer Center
KENNETH ANDERSON, Kraft Family Professor of Medicine, American Cancer Society Clinical Research Director, Jerome Lipper Multiple Myeloma Center, Harvard Medical School, Dana-Farber Cancer Institute
LOYCE PACE BASS, Health Policy Director, LIVESTRONG Foundation
MONICA M. BERTAGNOLLI, Professor of Surgery, Harvard University Medical School, Associate Surgeon, Dana-Farber Cancer Institute, Group Chair, Cancer and Leukemia Group, Brigham and Women’s Hospital
OTIS BRAWLEY, Chief Medical Officer, American Cancer Society
CARLTON BROWN, Director of Professional Services, Oregon Nurses Association, and Past President, Oncology Nursing Society
SERGIO CANTOREGGI, Chief Scientific Officer and Global Head of Research and Development, Helsinn Group
ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network
GREGORY CURT, Executive Director, External Scientific and Clinical Relations, U.S. Medical Affairs, AstraZeneca
__________________
1 Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
WILLIAM S. DALTON, Chief Executive Officer, M2Gen Personalized Medicine Institute, Moffitt Cancer Center; Chair, American Association for Cancer Research Science Policy & Legislative Affairs Committee
GWEN DARIEN, Executive Vice President, Programs and Services, Cancer Policy Institute, Cancer Support Community
WENDY DEMARK-WAHNEFRIED, Associate Director for Cancer Prevention and Control, University of Alabama at Birmingham Comprehensive Cancer Center
JAMES DOROSHOW, Deputy Director, National Cancer Institute
LORI HOFFMAN-HÕGG, Veterans Health Administration National Oncology Clinical Advisor, Department of Veterans Affairs, Cancer Program Director, Albany Stratton Veterans Affairs Medical Center
SAMIR N. KHLEIF, Director, Georgia Health Sciences University Cancer Center, Georgia Regents University Cancer Center
RONALD M. KLINE, Medical Officer, Patient Care Models Group, Center for Medicare and Medicaid Innovation, Centers for Medicare & Medicaid Services
LEE M. KRUG, Disease Area Head, Immuno-Oncology, Bristol-Myers Squibb
RICHARD A. LARSON, Hematology/Oncology Director, University of Chicago
MICHELLE M. LE BEAU, Arthur and Marian Edelstein Professor of Medicine, Director, Comprehensive Cancer Center, University of Chicago
GRETA MASSETTI, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention
DANIEL R. MASYS, Affiliate Professor, Biomedical Informatics, University of Washington
MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on Cancer
RICHARD PAZDUR, Director, Office of Oncology and Hematology Products, Food and Drug Administration
STEVEN PIANTADOSI, Phase One Foundation Endowed Chair and Director, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center
JENNIFER A. PIETENPOL, Director, Vanderbilt-Ingraham Cancer Center, Benjamin F. Byrd, Jr., Professor of Oncology, Professor of Biochemistry, Vanderbilt University
MACE L. ROTHENBERG, Chief Medical Officer and Senior Vice President, Clinical Development and Medical Affairs, Pfizer Oncology, Pfizer Inc.
AUGUST SALVADO, Senior Vice President, US Oncology Clinical Development & Medical Affairs, Novartis Oncology
ANDREW SCHIERMEIER, Senior Vice President, Head of Global Oncology, Merck Serono
RICHARD SCHILSKY, Chief Medical Officer, American Society of Clinical Oncology
DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School
YA-CHEN TINA SHIH, Professor of Health Economics, Chief, Section of Cancer Economics and Policy, Department of Health Services Research, University of Texas MD Anderson Cancer Center
ELLEN V. SIGAL, Chair and Founder, Friends of Cancer Research
RALPH WEICHSELBAUM, Daniel K. Ludwig Professor and Chair, Department of Radiation Oncology, Director, Ludwig Center for Metastasis Research, The University of Chicago Medical Center
GEORGE J. WEINER, Director, Holden Comprehensive Cancer Center, University of Iowa, President, Association of American Cancer Institutes
WENDY WOODWARD, Associate Professor and the Section Chief of Clinical Breast Radiation, Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
National Cancer Policy Forum Staff
SHARYL J. NASS, Forum Director and Director, Board on Health Care Services
ERIN BALOGH, Senior Program Officer
PATRICK ROSS, Research Assistant
HANNAH DURING, Senior Program Assistant (until August 2015)
CYNDI TRANG, Senior Program Assistant (from August 2015)
PATRICK BURKE, Financial Associate
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Reviewers
This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary 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 process. We wish to thank the following individuals for their review of this workshop summary:
Stanley W. Ashley, Harvard Medical School
Justin Bekelman, University of Pennsylvania
Jim Hayman, University of Michigan
Ian M. Thompson, University of Texas Health Science Center at San Antonio
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this report was overseen by Judith R. Lave, University of Pittsburgh. She was 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 rapporteurs and the institution.
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Acknowledgments
Support from the many annual sponsors of the Institute of Medicine’s National Cancer Policy Forum is crucial to the work of the forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Non-federal sponsors include the American Association for Cancer Research, American Cancer Society, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, EMD Serono, Helsinn Healthcare SA, LIVESTRONG Foundation, National Comprehensive Cancer Network, Novartis Oncology, the Oncology Nursing Society, and Pfizer Inc.
The forum wishes to express its gratitude to the expert speakers whose presentations helped examine the appropriate use of advanced technologies for radiation therapy and surgery in oncology. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.
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Contents
Technology Advances in Radiation Therapy for Cancer
Technology Advances in Surgery for Cancer
EVALUATION OF COMPARATIVE EFFECTIVENESS
RAPID WIDESPREAD ADOPTION OF NEW TECHNOLOGIES
Potential Misuse of New Technologies
The Difficulties of De-Adoption
Potential Incentives for Rapid Adoption and Overuse of New Technologies
Lack of Integrated and Accessible Data
Long Time Frames and Large Number of Patients Needed
Evolving Technology and Expertise
Observational Studies Versus Randomized Controlled Trials
TRAINING AND MONITORING CLINICAL PERFORMANCE
Training and Credentialing of Surgeons
Monitoring of Surgical Performance
Boxes, Figures, and Tables
BOXES
1 Suggestions Made by Individual Workshop Participants
2 Development and Regulation: Drugs Versus Devices
4 Evolution of Prostate Cancer Treatment
6 Medicare Reimbursement Decisions
7 California Technology Assessment Forum
8 Physician–Payer Collaboration to Optimize Use of New Technologies
FIGURES
2 Surgical options in gynecology
3 Whole-body radiation dose: Marked reduction in integral dose
4 Proton beam therapy centers in operation in the United States
5 Current usage of robot-assisted prostatectomies
6 Radiation therapy options for prostate cancer treatment in 2015
3D | three-dimensional |
ACGME | Accreditation Council for Graduate Medical Education |
ACO | accountable care organization |
ADT | androgen deprivation therapy |
AHRQ | Agency for Healthcare Research and Quality |
APBI | accelerated partial-breast irradiation |
APTC | Advanced Procedures and Technology Committee |
AS | active surveillance |
ASCO | American Society of Clinical Oncology |
ASTRO | American Society for Radiation Oncology |
CED | coverage with evidence development |
CMS | Centers for Medicare & Medicaid Services |
CON | Certificate of Need |
CT | computed tomography |
CTAF | California Technology Assessment Forum |
FDA | Food and Drug Administration |
Gy(RBE) | grays (relative biological effectiveness) |
IMRT | intensity-modulated radiotherapy |
IOM | Institute of Medicine |
IRCC | International Robotic Cystectomy Consortium |
MDEpiNet | Medical Device Epidemiology Network Initiative |
MOC | Maintenance of Certification |
MRI | magnetic resonance imaging |
NCCN | National Comprehensive Cancer Network |
NCI | National Cancer Institute |
NCPF | National Cancer Policy Forum |
NIH | National Institutes of Health |
NROR | National Radiation Oncology Registry |
ORP | open radical prostatectomy |
PBRT | proton beam radiation therapy |
PCORnet | National Patient-Centered Clinical Research Network of the Patient-Centered Outcomes Research Institute (PCORI) |
PSA | prostate-specific antigen |
QALY | quality-adjusted life year |
QUANTEC | Quantitative Analysis of Normal Tissue Effects in the Clinic |
Rad Px | radical prostatectomy |
RARP | robot-assisted radical prostatectomy |
RCT | randomized controlled trial |
ROI | Radiation Oncology Institute |
SBRT | stereotactic body radiation therapy |
SEER | Surveillance, Epidemiology, and End Results Program |
UCLA | University of California, Los Angeles |