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Application of Biomarkers in Cancer Epidemiology Edited by P. Toniolo, P. Boffetta, D.E.G. Shuker, N. Rothman, В. Hulka and N. Pearce 'ARC Scientific Publications No.142 International Agency for Research on Cancer, Lyon, 1997 Foreword Although biological markers have been used in epidemiology for decades, it is oniy in recent years, that advances in cellular and molecular biology have greatly expanded their potential. Biomarkers have possibilities in measuring whole-body or organ-specific exposures, as indicators of biological change or of early disease, and in assessing indi- vidual susceptibility to exposure, These developments foster the incorporation of a more biological thinking into studies of cancer epidemiology aid open up new perspectives for elucidating the mechanisms of pathogenesis in vivo at the cellular and molecular level. Although the promise that biological markers hold in expanding the boundaries of epi- demiological research is enormous, the criteria for their effective use in human observa- tional research are as yet poorly understood, as are their limitations. Biomarkers have many useful future applications in cancer prevention and public health; particularly in the monitoring of exposure to hazardous substances, in identifying individuals at increased risk of disease, and in risk assessment at the population level. This volume aims to provide a set of state-of-the-art reviews of methodological issues iп the use of biological markers in cancer epidemiology. In addition, it provides a brief expert statement of our present understanding of these issues under three broad headings: study design and analysis; development of biomarkers; and application of bio- markers. The support of the United Kingdom Department of the Environment and the collabora- tion of the New York University are gratefully acknowledged. We thank Fred Garber for kindly designing the artwork for the cover of the book. P. Kleihues Director, IAFIC International Agency For Research On Cancer The International Agency for Research on Cancer ('ARC) was established in 1965 by the World Health Assembly, as an independently financed organization within the framework of the World Health Organization. The headquarters of the Agency are in Lyon, France. The Agency conducts a programme of research concentrating particularly on the epi- demiology of cancer and the study of potential carcinogens in the human environment. Its field studies are supplemented by biological and chemical research carried out in the Agency's laboratories in Lyon and, through collaborative research agreements, in national research institutions in many countries. The Agency also conducts a programme for the education and training of personnel for cancer research. The publications of the Agency contribute to the dissemination of authoritative infor- mation on different aspects of cancer research. А complete list is printed at the back of this book. Information about 'ARC publications, and how to order them, is also available via the Internet at: http:llwww.iarc.frl Workshop on the Application of Biomarkers to Cancer Epidemiology, Lyon, 20-23 February 1996 List of participants R.J. Albertini S. Gaгte F, Perera E.Taioli Genetics Laboratory, Program in Environmental Division of Environmental Department of Environmental University of Vermont, 32 Carcinogenesis, NY University Sciences, Columbia University Medicine, NYU School of North Prospect St, Burlington, Medical Center, MSB Room Sсhool of Public Health Medicine, 341 East 25th VT 05401-0508, USA 209, 550 First Avenue Room 8109, 60 Haven Avenue Street, 2nd Floor, New York, NY 10010, USA New York, NY-10032, USA New York, NY 10010, USA B.K. Armstrong Cancer Control Information D. Gompertz J.D. Potter P Toniolo Centre, NSW Cancer Council MRC Institute for Environment Head, Cancer Prevention Head, Unit of Cancer P.O. Box 572, Kings Cross, and Health, University of Research Program Epidemiology, New York NSW 2011, Australia Leicester, 94 Regent Street Fred Hutchinson Cancer University School of Medicine, Leicester LEI 91N, UK Research Center 341 East 25th St, New York, Н. Bartsch 1124 Columbia Street NY 10010-2598, USA German Cancer Research K. Hemminki Seattle, WA 98104, USA Centre, Center for Nutrition and E. White 1m Neuenheimer Feld 280 Toxicology, Karolinka Institute, N. Rothman Cancer Prevention Research 69120 Heidelberg, Germany НdlSovagen 7, 14157 Environmental Epidemiology Program, Fred Hutchinson Huddinge, Sweden Branch, National Cancer Cancer Research Center С.W. Boone Institute, EPN 418, 6130 1124 Columbia Street, МP-702 Chemoprevention Branch B. Hulka Executive Boulevard, Bethesda, Seattle, WA 98104, USA Division of Cancer Prevention Department of Epidemiology MD 20892-7364, USA and Control, National Cancer School of Public Health T.F. Zhang Institute, Bldg 31, Am 10А52 University of North Carolina R. Saracci Department of Epidemiology 31 Center Drive, Bethesda, СВ NO. 7400 McGavran» lstituto Fisiologia Clinica CNR and Biostatistics, Memorial MD 20892-2580, USA Greenberg Hall, Chapel Hill, Epidemiology Section Sloan Kettering Cancer Center NC 27599.7400, USA Via Trieste, 41 1275 York Avenue, B ox 44 F.X. Bosch 56106 Pisa, Italy New York, NY 10021, USA Servei d'Epidemiologia D.J. Hunier Hospital Duran i Reynals Channing Laboratory, Harvard A. Schatzkin Autovia de CastelldeteIs, Km 2.7 School of Public Health Division of Cancer Prevention Observers 08907 Hospitalet de Llobregat 677 Huntington Avenue Studies Branch, National H. Auirup Barcelona, Spain Boston, MA 02115, USA Cancer Institute, 6130 Department of Environmental Executive Boulevard, and Occupational Medicine N. Caporaso M.T. Landi Bethesda, MD 20852, USA Aarhus University, Genetic Epidemiology Branch Genetic Epidemiology Branch Universitetsparken bygriing 180, National Cancer Institute, National Cancer Institute P.A. 5сhulte 8000 Aarhus C., Denmark EPN 439, 6130 Executive Executive Plaza North, Am Screening and Notification Boulevard, Bethesda, 439, 6130 Executive Section T. Ballard MD 20892-7377, USA Boulevard, Msc 7372, National Institute for Venetian Tumour Registry Bethesda, Occupational Safety and Via Giustiniaiii, 2, D. Coggon MD 20892-7372, USA Health 35100 Padua, Italy MRC Environmental 4678 Columbia Parkway, Epidemiology Unit A.J. McMichael Room 42, Cincinnati, University it Southampton Department of Epidemiology OH 45226-1998, USA Southampton General Hospital London School of Hygiene and 'ARC participants Southampton 5016 6YD, UK Tropical Medicine, Keppel D. 5huker R Boffetla Street, London WC1 E lIT, UK Toxicology Unit M.Freisen R Farmer University of Leicester P. Hainaut MRC Toxicology Unit. N. Pearce Hodgkin Building, Lancaster J. Hall R. Montesano University of Leicester, Wellington Asthma Research Road, Р.O. Box 138 Hodgkin Building, Lancaster Group, Department of Leicester LEI 91N, UK N.Munoz P. Pisani Road, Р.O. Box 138, Medicine, Wellington School of Leicester LE1 9HN, UK Medicine, P.O. Box 7343 E. Riboli Wellington South, New Zealand C. Wild Contents Application of biomarkers to cancer epidemiology 1 Workshop report Transitional studies 19 P.A. Schulte and F.P. Perera Logistics and design issues ïn the use of biological samples in 31 observational epidemiology J.D. Potter Methodological issues in the use of biological markers in cancer 39 epidemiology: cohort studies D.J. Hunter General issues of study design and analysis in the use of biomarkers in 47 cancer epidemiology N. Pearce and P Boffetta Saurces of variation in biomarkers 59 R Vineis Effects of biomarker measurement error on epidemiological studies 73 Е. White Markers of internal dose: chemical agents 95 D. Coggon and M.D. Friesen Biochemical markers of dietary intake 103 R. Kaaks, Е. Riboli and R. Sinha Biomarkers for biological agents 127 N. Mилог and EX. Bosch Carcinogen-DNA and carcinogen-protein adducts in molecular 143 epidemiology С.P. Wild and P Pisani Somatïc cell mutations in cancer epidemiology 159 R.J. Albertini and R.B. Hayes Cytogenetic end-points as biological dosimeters and predictors 185 of risk in epidemiological studies J.D. Tucker, D.A. Eastmorid and L.G. Littlefield Methodological issues in the use of tumour markers in cancer epidemiology 201 Z-F, Zhang, C. Cordon-Cardo, N. Rothman, A.N. Freedman and J.A. Taylor Quality control of biomarker measurement in epidemiology 215 D. Gompertz vi sample collection' processing and storage 223 M.T. Landi and N. Caporaso issues involving biomarkers in the study of the genetics of human cancer 237 N. Caporaso and A. Goldstein Gene-environment interactions iп the application of biomarkers of cancer 251 susceptibility in epidemiology S. Garte, C. Zocchetti and E. Taioli Using and interpreting surrogate end-points иn cancer research 265 A. Schatzk;n, L.S. Freedman, J Dorgan, L. МсShапе, M.H. Sсhiffтаn and S.M. Dawsey Biomarker end-points in cancer chemoprevention trials 273 C. W. Boone and G.J. Kelloff The use of biological markers as predictive early-outcome measures 281 in epidemiological research A.J. Mclichael and A.J. Hall The use of biomarkers to study pathogenesis and mechanisms of cancer; 291 oesphagus and skin cancer as models R. Montesano, R Hainaut and J. Hall Comparing measurements of biomarkers with other measurements of 303 exposure R. Sаraссi Ethical and social issues in the use of biomarkers in epidemiological studies 313 P.A. Schulte, D. Hunter and N. Rothman vii Application of Biomarkers in Cancer Epidemiology (IARC Scientгfic Pubications No. 142) Errata • List of participants attending the Workshop on the Application
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