Development of new anti-cancer drugs.

In the first award lecture of the European Society of Medical Oncology (ESMO) the topic of new drug development and the role of the European Organization for Research and Treatment of Cancer (EORTC) was highlighted. New aspects in each of the drug development steps are discussed: acquisition, screening, formulation, toxicology and phase I studies. In the search for new compounds to treat human solid tumors it is proposed to use human tumors as xenografts in primary screening. Phenomena related to doxorubicin resistance are presented together with a new approach to circumvent this in the clinic. The value of biochemical modulation is discussed, exemplified by the combination of 5-fluorouracil and uridine. The complexity of the biological response modifiers and the importance of evaluating them adequately in the clinic is stressed. The EORTC has recently decided on requirements for the minimum toxicology for phase I trials of a new cytostatic drug in order to ensure safe and rapid evaluation of new anti-cancer compounds. The therapeutic intents of phase I studies are questionable and therefore the main goals of these studies to be reached quickly; possibly supported by a pharmacokinetic rational.