Is It A Human Carcinogen?

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Presentation transcript:

Is It A Human Carcinogen? Samuel M. Cohen, M.D., Ph.D. Professor and Chair, Pathology and Microbiology Havlik-Wall Professor of Oncology University of Nebraska Medical Center 983135 Nebraska Medical Center Omaha, NE 68198-3135 Debate at March, 2005 SOT Meeting

2 Year Bioassay – Gold Standard In past 40 years we have identified precursor changes of carcinogenesis.

Present Paradigm: 4 and 13 week assays 2 year bioassay tumors evaluate dose, metabolism, kinetics, MOA New Approach: 4 and 13 week assays, DNA reactivity, estrogenicity, immunosuppression precursor changes detailed evaluation of dose, metabolism, kinetics, MOA evaluate relevance to humans.

MOA – Key Events A B C D Cancer Focus on precursor key events! Detailed analysis – dose, metabolism, kinetics, MOA. Is it relevant to humans?

Bladder Hyperplasia SEM Changes BrdU LI - urothelium Urinary Bladder DNA Reactivity Yes No Bladder Hyperplasia Bladder Hyperplasia SEM Changes BrdU LI - urothelium Yes No Likely Bladder Carcinogen Not Likely a Bladder Carcinogen Possible Bladder Carcinogen Not a Bladder Carcinogen Evaluate Fresh Void Urine Urinary Solids Urinary Composition? Reactive Chemical and/or metabolite

Is It A Human Carcinogen?