A phase II study of continuous concurrent thoracic radiotherapy in combination with mitomycin, vindesine and cisplatin in unresectable stage III non-small cell lung cancer.

The split-course concurrent thoracic radiation therapy (TRT) and full-dose chemotherapy for unresectable stage III non-small cell lung cancer (NSCLC) has produced promising results by comparison with the sequential approach. Instead of split-course radiation, we conducted a phase II study to investigate the feasibility of continuous concurrent TRT and chemotherapy. Twenty-two patients with unresectable NSCLC were enrolled onto a phase II study of continuous concurrent radiotherapy and chemotherapy. Treatment consisted of two courses of cisplatin (80 mg/m(2) on days 1 and 29), vindesine (3 mg/m(2) on days 1, 8, 29 and 36), and mitomycin (8 mg/m(2) on days 1 and 29). TRT began on day 2 at a dose of 60 Gy (2 Gy per fraction and 5 fractions per week for a total of 30 fractions). Of 22 patients assessable for response, none achieved a CR and 17 (77.3%) achieved a PR with an overall response rate of 77.3% (95% confidence interval, 54.6-92.2%). Grade 3 or 4 leukopenia was observed in 5/13 (81.8%) patients. Six patients (27.3%) experienced > or = grade 3 thrombocytopenia. Non-hematological toxicity was relatively mild. The overall median survival time was 19.0 months and the 1- and 2-year survival rates were 84.8 and 34.5%, respectively. It was possible to administer two courses of chemotherapy in 18 patients (81.8%) as planned. Nineteen (86.4%) of the 22 patients received the planned 60 Gy radiation. It seems to be difficult to administer the planned treatment without any interruption for the majority of patients. However, in the selected patients who completed the 60 Gy TRT, nearly half of the patients completed TRT without interruption. This combination regimen is considered to be feasible on condition that the stopping rule of the treatment is followed. We recommend administering radiotherapy continuously as far as possible.

A feasibility study of paclitaxel 225 mg/m(2) and carboplatin AUC = 6 in untreated advanced non-small cell lung cancer patients in Japan.

BACKGROUND: The combination of paclitaxel (225 mg/m(2), 3 h infusion) and carboplatin [area under the curve (AUC) 6 mg/ml x min] is used widely for non-small cell lung cancer in the USA and is one of the standard regimens in the Southwest Oncology Group. In Japan, however, the upper limit of the approved dose for single-use paclitaxel is 210 mg/m(2) and the optimum dose of this agent in combination with carboplatin has not yet been established. This study was designated to determine whether the paclitaxel dose of 225 mg/m(2 ) plus carboplatin (AUC = 6) is tolerable for Japanese patients with untreated advanced non-small cell lung cancer. METHODS: Ten patients were enrolled between October 1999 and June 2000 and all of these patients were evaluable for toxicity. Chemotherapy consisted of carboplatin (AUC = 6 mg/ml x min) and 225 mg/m(2 )of paclitaxel on day 1 every 3 weeks. RESULTS: Neutropenia was the major toxicity and grade 4 neutropenia was observed in seven of the 10 patients (70%), but febrile neutropenia was not observed. Grade 4 anemia as a dose-limiting toxicity was observed in two patients. This was due to gastric ulcer bleeding in both patients. Only one patient experienced grade 3 peripheral neuropathy. No grade 3 or more myalgia or arthralgia was reported. Overall, 44 courses of chemotherapy were administered in 10 patients. Partial responses were observed in six of the 10 patients (60%). Median survival time was 7.7 months. CONCLUSION: Paclitaxel at 225 mg/m(2) in a 3 h infusion and carboplatin AUC = 6 appears to be tolerable in Japanese patients with untreated advanced non-small cell lung cancer.