Onkologie
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There is clear evidence that the epidemiologic importance of malignant diseases will continue to rise in the future. This creates the ethical obligation to further intensify the search for improved systemic treatment options. This review is focussed on principles and practices of phase I trials. ⋯ Although for formal reasons antitumor activity cannot be an endpoint in phase I studies the careful observation and documentation of potential anticancer efficacy is of utmost importance in these early clinical trials. Signals of antitumor activity may serve as important guidance for subsequent clinical development plans. Inclusion criteria, dose escalation schemes, and the importance of the concept of the maximum tolerable dose (MTD) are addressed together with ethical principles of exposure to novel chemical agents.