文摘
Treatment results of NSCLC in advanced stages are still unsatisfactory. Paclitaxel (Taxol) and Carboplatin have revealed significant activity and acceptable toxicity when used as single agents. In this phase-I/II-study we have evaluated the maximal tolerated dose (MTD), efficacy and toxicity of this combination in untreated pts. with NSCLC (stage III/IV). To reduce myelotoxicity, G-CSF was applied after chemotherapy. From 30 patients (pts.) enrolled, 102 courses were evaluated for toxicity and 23 pts. were evaluated for response. The average age was 58 years, range 28-75. Paclitaxel was administered intravenously over 3 hours followed by Carboplatin at a doses of 300 mg/m2; the cycles were repeated every 21 days. Pts. received between two and six courses of Paclitaxel at 150 (5 pts.), 175 (7 pts.), 200 (12 pts.) and 225 mg/m2 (6 pts.). All pts. received G-CSF s.c., starting on day 6 until recovery of neutrophils. (8.7 % ) valuable pts. reached a complete remission, 7 (30.4 % ) pts. achieved a partial response, 4 (17.3 % ) pts. had no change and 10 (43.4 % ) pts. progressed. Toxicity was generally mild with WHO grade III/IV neutropenia in 4 courses (4 % ), grade III thrombopenia in 1 cycle (1 % ) and grade III anemia in 1 cycles (1 % ), respectively. Neurotoxicity (WHO grade III) was developed by 1 pt. (175 mg/m2). The MTD for Taxol in this combination was evaluated with 200 mg/m2. This regimen is effective in treatment of advanced NSCLC. The MTD for Carboplatin will now be calculated according to the “AUC”.