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Evidence Report/Technology Assessment Number 197 Alcohol Consumption and Cancer Risk: Understanding Possible Causal Mechanisms for Breast and Colorectal Cancers 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 290-2007-10063-I Prepared by: ECRI Institute Evidence-based Practice Center, Plymouth Meeting, PA Investigators Olu Oyesanmi, M.D., M.P.H David Snyder, Ph.D Nancy Sullivan, B.A James Reston, Ph.D., M.P.H Jonathan Treadwell, Ph.D Karen M Schoelles, M.D., S.M., F.A.C.P AHRQ Publication No 11-E003 November 2010 This report is based on research conducted by the ECRI Institute Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No 290-2007-10063-I) The findings and conclusions in this document are those of the author(s), who are responsible for its content, and not necessarily represent the views of AHRQ 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 clinicians, employers, policymakers, and others make informed decisions about the provision of health care services This report is intended as a reference and not as a substitute for clinical judgment This report may be used, in whole or in part, as the basis for the 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 Suggested Citation This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders Oyesanmi O, Snyder D, Sullivan N, Reston J, Treadwell J, Schoelles KM Alcohol Consumption and Cancer Risk: Understanding Possible Causal Mechanisms for Breast and Colorectal Cancers Evidence Report/Technology Assessment No 197 (prepared by ECRI Institute Evidence-based Practice Center under Contract No 290-2007-10063-I) AHRQ Publication No 11-E003 Rockville, MD: Agency for Healthcare Resarch and Quality November 2010 No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States The Centers for Disease Control and Prevention (CDC) requested and funded this report The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation The reports undergo peer review prior to their release AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality We welcome comments on this evidence report 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 E-mail to epc@ahrq.gov Carolyn M Clancy, M.D Director Agency for Healthcare Research and Quality Jean Slutsky, P.A., M.S.P.H Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Thomas R Frieden, M.D., M.P.H Director Centers for Disease Control and Prevention Stephanie Chang, M.D., M.P.H Director and Task Order Officer EPC Program Center for Outcomes and Evidence Agency for Healthcare Research and Quality Mary White Sc.D., M.P.H Branch Chief, Epidemiology and Applied Research Branch Division of Cancer Prevention and Control Centers for Disease Control and Prevention iii Acknowledgments The Evidence-based Practice Center would like to thank Eileen Erinoff, MSLIS, and Helen Dunn for providing literature retrieval and documentation management support; Lydia Dharia and Kitty Donahue for their assistance with the final preparations of the report; Mary White, Sc.D., M.P.H., of the Centers for Disease Control and Prevention; and Stephanie Chang, M.D., M.P.H., of the Agency for Healthcare Research and Quality, for advice as our Task Order Officer Technical Expert Panel Philip Brooks, Ph.D Molecular Neurobiologist, Laboratory of Neurogenetics National Institute of Alcohol Abuse and Alcoholism Bethesda, MD Joanne Dorgan, M.P.H., Ph.D Member, Division of Population Studies Fox Chase Cancer Center Philadelphia, PA Joel Mason, M.D Scientist I and Director, Vitamins and Carcinogenesis Laboratory Jean Mayer USDA Human Nutrition Research Center on Aging Tufts University Boston, MA Mikko Salaspuro, M.D., Ph.D Professor, Research Unit of Substance Abuse Medicine University of Helsinki Helsinki, Finland Helmut Seitz, M.D., Ph.D Director, Department of Medicine Salem Medical Center and Laboratory of Alcohol Research Heidelberg, Germany AHRQ Contacts Stephanie Chang, M.D., M.P.H Director and Task Order Officer Evidence-based Practice Center Program Agency for Healthcare Research and Quality Rockville, MD Karen Lohmann Siegel, P.T., M.A CAPT, U.S Public Health Service Associate Director Evidence-based Practice Center Program Agency for Healthcare Research and Quality Rockville, MD iv Structured Abstract Objectives: The purpose of this report is to systematically examine the possible causal mechanism(s) that may explain the association between alcohol (ethanol) consumption and the risk of developing breast and colorectal cancers Data Sources: We searched 11 external databases, including PubMed and EMBASE, for studies on possible mechanisms These searches used Medical Subject Headings and free text words to identify relevant evidence Review Methods: Two reviewers independently screened search results, selected studies to be included, and reviewed each trial for inclusion We manually examined the bibliographies of included studies, scanned the content of new issues of selected journals, and reviewed relevant gray literature for potential additional articles Results: Breast Cancer Five human and 15 animal studies identified in our searches point to a connection between alcohol intake and changes in important metabolic pathways that when altered may increase the risk of developing breast cancer Alterations in blood hormone levels, especially elevated estrogen-related hormones, have been reported in humans Several cell line studies suggest that the estrogen receptor pathways may be altered by ethanol Increased estrogen levels may increase the risk of breast cancer through increases in cell proliferation and alterations in estrogen receptors Human studies have also suggested a connection with prolactin and with biomarkers of oxidative stress Of 15 animal studies, six reported increased mammary tumorigenesis (four administered a co-carcinogen and two did not) Other animal studies reported conversion of ethanol to acetaldehyde in mammary tissue as having a significant effect on the progression of tumor development Fifteen cell line studies suggested the following mechanisms: increased hormonal receptor levels increased cell proliferation a direct stimulatory effect DNA adduct formation increase cyclic adenosine monophosphate (cAMP) change in potassium channels modulation of gene expression Colorectal Cancer One human tissue study, 19 animal studies (of which 12 administered a cocarcinogen and seven did not), and 10 cell line studies indicate that ethanol and acetaldehyde may alter metabolic pathways and cell structures that increase the risk of developing colon cancer Exposure of human colonic biopsies to acetaldehyde suggests that acetaldehyde disrupts epithelial tight junctions v Among 19 animal studies the mechanisms considered included: mucosal damage after ethanol consumption increased degradation of folate stimulation of rectal carcinogenesis increased cell proliferation increased effect of carcinogens Ten cell line studies suggested: folate uptake modulation tumor necrosis factor modulation inflammation and cell death DNA adduct formation cell differentiation modulation of gene expression One study used a combination of animal and cell line and suggested intestinal cell proliferation and disruption of cellular signals as possible mechanisms Conclusions: Based on our systematic review of the literature, many potential mechanisms by which alcohol may influence the development of breast or colorectal cancers have been explored but the exact connection or connections remain unclear The evidence points in several directions but the importance of any one mechanism is not apparent at this time vi Contents Executive Summary Evidence Report Chapter Introduction Scope Ethanol Metabolism Alcohol and Cancer 10 Breast Cancer 14 Colorectal Cancer 14 Chapter Methods 15 Technical Expert Panel 15 Peer Review and Public Commentary 15 Key Questions 15 Analytical Framework 16 Identification of Clinical Studies 17 Electronic Database Searches 17 Study Selection 18 Criteria for Inclusion/Exclusion of Studies in the Review 18 Literature Review Procedures 18 Data Abstraction and Data Management 19 Disposition of the Documents Identified by Literature Searches 19 Assessing the Evidence for Each Key Question 21 Assessment of Internal and External Validity 21 Data Synthesis 22 Assessment of Internal Validity of Breast and Colorectal Studies 22 Assessment of External Validity of Breast and Colorectal Studies 23 Chapter Results 25 Evidence Base Describing Possible Mechanisms Connecting Alcohol Consumption and Breast Cancer Risk 25 Human Studies 25 Animal Studies 26 Cell Line Studies 27 Evidence Base for Describing Possible Mechanisms Connecting Alcohol Consumption and Colorectal Cancer Risk 28 Human Studies 28 Animal Studies 28 Cell Line Studies 29 Combination Study (Animal, Cell Line) 30 Systematic Reviews and Narrative Reviews of Epidemiology Studies 30 Reported Mechanisms in the Epidemiology Literature 41 Ongoing Clinical Trials 43 vii Chapter Discussion 45 Breast Cancer 45 Alcohol-related Changes in Circulating Hormones 46 Cell Proliferation and Tumor Progression 46 Polymorphism in Ethanol Metabolism 46 DNA Adduct Formation 46 Other Potential Mechanisms 47 Colorectal Cancer 49 Excluded Studies 53 Future Research Goals 53 Conclusions 53 Limitations 56 References and Included Studies 59 List of Acronyms/Abbreviations 81 Figures Figure Figure Figure Figure Three stages of carcinogenesis 12 Analytical framework for breast cancer 16 Analytical framework for colorectal cancer 17 Disposition of the documents identified by literature searches 20 Tables Table Table Table Table Table Table Table Table Table Table 10 Table 11 Table 12 Table 13 Table 14 Table 15 Table 16 Table 17 Systematic reviews/meta-analyses for breast cancer epidemiology studies 31-35 Systematic reviews/meta-analyses for colorectal cancer epidemiology studies 36-40 Breast cancer epidemiology studies 41 Colorectal cancer epidemiology studies 41 Hypothesis-generating breast cancer studies 42 Hypothesis-generating colorectal cancer studies 43 Overall results from human breast cancer studies 48 Overall results from animal breast cancer studies 49 Overall results from human colorectal cancer study 51 Overall results from animal colorectal cancer studies 52 Reported mechanisms in human breast cancer studies 54 Reported mechanisms in animal breast cancer studies 54 Reported mechanisms in cell line breast cancer studies 55 Reported mechanisms in human colorectal cancer study 56 Reported mechanisms in animal colorectal cancer studies 56 Reported mechanisms in cell line colorectal cancer studies 56 Reported mechanisms in combination (animal, cell lines) colorectal cancer study 56 viii Appendixes Appendix A: Exact Search Strings Appendix B: Sample Data Abstraction Forms Appendix C: Evidence tables Appendix D: List of Excluded Studies Appendix E: Peer Reviewers Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/downloads/pub/evidence/pdf/alccan/alccan.pdf ix Study Mechanism Examined Seitz et al 123 1985 Generation of acetaldehyde Amount and Duration of Ethanol and/or Experimental Acetaldehyde Model Exposure Use of Carcinogen Results Rats DMH There was a 2.8 fold increase in rectal tumors on the ethanol fed rats compared to controls (p