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CER 93: Local Hepatic Therapies for Metastases to the Liver from Unresectable Colorectal Cancer

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CER 93: Local Hepatic Therapies for Metastases to the Liver from Unresectable Colorectal Cancer Comparative Effectiveness Review Number 93 Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer Comparative Effectiveness Review Number 93 Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10058-I Prepared by: Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center Chicago, IL Investigators: Suzanne Belinson, M.P.H., Ph.D. Ryan Chopra, M.P.H. Yoojung Yang, M.S., Pharm.D. Veena Shankaran, M.D. Naomi Aronson, Ph.D. AHRQ Publication No. 13-EHC014-EF December 2012 This report is based on research conducted by the Blue Cross Blue Shield Association Technology Evaluation Center (BCBSA TEC) Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA 290 2007 10058-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation: Belinson S, Chopra R, Yang Y, Shankaran V, Aronson N. Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer. Comparative Effectiveness Review No. 93. (Prepared by Blue Cross and Blue Cross Blue Shield Association Technology Evaluation Center under Contract No. 290-2007-10058-I.) AHRQ Publication No. 13-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input from are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. We welcome comments on this systematic review. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Supriya Janakiraman, M.D., M.P.H. Director Task Order Officer Evidence-based Practice Program Center for Outcomes and Evidence Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Claudia Bonnell, R.N., M.L.S.; Jennifer Brock, M.P.H.; Stacey C. Chapman Tobin, Ph.D., E.L.S.; Lisa Garofalo, B.A.; Jenna Khan, M.P.H., David Samson, M.S.; Lisa Sarsany, M.A.; Kathleen Ziegler, Pharm.D. Key Informants James Andrews, M.D. Suzanne Lindley, M.S.W. Professor of Radiology Patient Advocate Mayo Clinic YES! Beat Liver Tumors Rochester, MN Canton, TX Al Benson, M.D. Mark Sands, M.D. Professor of Medicine Vice Chair, Clinical Ops, Quality/Section Northwestern University Head, Interventional Radiology Chicago, IL Cleveland Clinic Cleveland, OH Virginia Calega, M.D., M.B.A. Vice President of Medical Management/Policy Highmark, Inc. Camp Hill, PA iv Technical Expert Panel James Andrews, M.D. Nancy Kemeny, M.D. Professor of Radiology Medical Oncology Mayo Clinic Memorial Sloan-Kettering Cancer Center Rochester, MN New York, NY Afsaneh Barzi, M.D., Ph.D. David C. Madoff, M.D. Assistant Professor of Clinical New York Presbyterian Hospital/Weil Medicine/Hematology and Oncology Cornell Medical Center University of Southern California Hospital New York, NY Los Angeles, CA Mark Sands, M.D. Al Benson, M.D. Vice Chair, Clinical Ops, Quality/Section Professor of Medicine Head, Interventional Radiology Northwestern University Cleveland Clinic Chicago, IL Cleveland, OH Virginia Calega, M.D., M.B.A. Vice President of Medical Management/Policy Highmark, Inc. Camp Hill, PA Peer Reviewers Stephen Alberts, M.D. Todd Crocenzi, M.D. Professor of Oncology Medical Oncologist Mayo Clinic Providence Portland Medical Center Rochester, MN Portland, OR Cathy Eng, M.D. Michael Soulen, M.D. Associate Professor, Department of Professor of Radiology Gastrointestinal Medical Oncology The Hospital of the University of University of Texas Pennsylvania MD Anderson Cancer Center Philadelphia, PA Houston, TX v Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer Structured Abstract Objectives. To characterize the comparative effectiveness and harms of various local hepatic therapies for metastases to the liver from unresectable colorectal cancer (CRC) in two distinct populations: patients with liver-dominant metastases (i.e., majority of disease located in the liver) who are not eligible for continued systemic chemotherapy because their disease is refractory (i.e., they have experienced disease progression while on therapy), and patients who are candidates for local liver therapies as an adjunct to systemic chemotherapy. Local hepatic therapies include ablation, embolization, and radiotherapy approaches. Data sources. We searched MEDLINE® and Embase® from January 2000 to June 2012. We also searched for gray literature in databases with regulatory information, clinical trial registries, abstracts and conference papers, grants and federally funded research, and information from manufacturers. Review methods. We sought studies reporting two outcomes—overall survival and quality of life—and various adverse events related to the different interventions for the two populations of interest. Data were dually abstracted by a team of reviewers. A third reviewer resolved conflicts when necessary. We assessed the quality of individual studies and graded the strength of the body of evidence according to prespecified methods. Results. We identified 937 articles through the literature search and excluded 913 at various stages of screening; 24 articles were included in our review. We also included one hand-searched article from Annals of Oncology, two published articles from scientific information packets, and three articles identified from conference abstracts; the total number of articles was 30. Twenty- three articles addressed Key Questions (KQ) 1 (effectiveness) and 2 (harms) for patients ineligible for systemic chemotherapy, and seven addressed KQ3 (effectiveness) and KQ4 (harms) for patients who are candidates for systemic chemotherapy. One randomized controlled trial (RCT) was included but this was
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