Aspects concerning the study of the quantitative carcinogenic effects of chemotherapeutic agents in man

It is well-known that second primary tumours occur at elevated levels in patients undergoing cancer treatment with cytotoxic drugs. While this is clearly an undesirable outcome, it represents one of the few situations where the relationship between dose and effect of a carcinogen can be studied in humans. Current epidemiological methods for studying this relationship are described, as well as some of the issues involved in the quantification of risk from human data. Finally, the possibility of measuring biochemical markers and other parameters of DNA damage in patients undergoing treatment with antineoplastic agents is discussed.