Objective. To confirm the safety and effectiveness of combination therapy with carboplatin plus taxol in Japanese patients with non-small cell lung cancer (NSCLC). Methods. For inoperable patients with stage III NSCLC, concurrent chemoradiotherapy with carboplatin plus taxol was done. Forty-five mg/m2 of taxol plus AUC = 2 dose of carboplatin were given weekly and radiotherapy was done concurrently at a dose of 1.8-2.0 Gy/day (total dose of 60-65 Gy). When CR or PR was obtained, weekly chemotherapy was added upto 16 weeks. On the other hand, previous phase I trial have shown that the recommended doses in biweekly administration of carboplatin and taxol were AUC = 3 (carboplatin) and 140 mg/m2 (Taxol), respectively. Based on the result, we have conducted a phase II trial. Result. For chemoradiotherapy, 72 patients were registered and 68 patients were eligible. In 61 evaluable patients, CR was obtained in 4 patients, PR was in 40 patients, and the response rate was 72%. In interium analysis, estimated median survival time was 14 months and one-year survival rate was 56%. There were 3 cases with treatment related death; interstitial pneumonia, pneumocystis carinii pneumonia which occurred after the recovery from bone marrow suppression, and mediastinitis due to radiation necrosis. For protocol in advanced NSCLC, registration of all 80 patients has finished. So far, interium analysis has finished in 23/80 patients; ≥grade 3 leukopenia was seen in 21% patients, ≥grade3 neutropenia in 46%, fever in 3%, allergy in 3%, and fatigue in 3%, respectively. Eight of 21 patients evaluated was judged to be PR, and response ratio was 38%. Conclusion. Although they are interium analysis, the combination of carboplatin and taxol appeared safe and effective in Japanese patients.
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