[Definitive results of a phase I study of a chemotherapy regimen using cisplatin and paclitaxel for non-small cell bronchial cancer].

A phase I trial has been performed in patients with advanced non-small lung cancer without prior chemotherapy in order to determine the optimal administration schedule of a combination of high dose cisplatin and paclitaxel (Taxol). Those drugs have been evaluated at respective dosages of 100-120 mg/m2 and of 135-170-200 mg/m2, the later being given over a 3-hour infusion. Seventeen patients have been treated in 4 different steps, without occurrence of an acute limiting toxicity, neither hematological, neither of another type. No major acute hypersensitivity reaction has been observed but three cases of potential cardiac toxicity including one death were documented. The regime appeared to be active with an objective response rate of 47% (8/17) but a severe polyneuropathy occurred lately, avoiding further treatment administration in the majority of responders (5/7). In conclusion, the combination can only be recommended for short treatment.