Phase II study of topotecan with cisplatin in Japanese patients with small cell lung cancer.

BACKGROUND: We conducted a phase II study of topotecan (Tp) with cisplatin (CDDP) in previously untreated Japanese patients with extensive-disease small cell lung cancer (ED-SCLC). PATIENTS AND METHODS: In stage 1, a total of 30 patients were allocated to Tp 0.65 mg/m(2) with CDDP 60 mg/m(2) day 1 or Tp 1.00 mg/m(2) with CDDP day 5 following prophylactic granulocyte colony stimulating factor (G-CSF) from day 6. In stage 2, the selective combination in 29 patients was evaluated for response rate, toxicity and overall survival. RESULTS: In stage 1, Tp 1.00 mg/m(2) with CDDP day 5 was selected this schedule had a better hematological profile. In stage 2, the response rate was 83%, and grade 3/4 adverse events were hematological-toxicities. The median survival time was 17.5 months and the 1 year survival rate was 79%. CONCLUSION: Combination of Tp and CDDP on day 5 with G-CSF support is safe and effective for previously untreated ED-SCLC Japanese patients.

Phase III randomized trial of docetaxel plus cisplatin versus vindesine plus cisplatin in patients with stage IV non-small-cell lung cancer: the Japanese Taxotere Lung Cancer Study Group.

PURPOSE: Few randomized trials have demonstrated survival benefit of combination chemotherapy involving new agents plus cisplatin compared with classic combination chemotherapy in advanced non-small-cell lung cancer (NSCLC). The primary aim of this study was to test whether docetaxel plus cisplatin (DC) improves survival compared with vindesine plus cisplatin (VdsC) in patients with previously untreated stage IV NSCLC. PATIENTS AND METHODS: Eligible, stage IV, chemotherapy-naive patients (n = 311) were randomly assigned to receive docetaxel 60 mg/m(2) intravenously on day 1 plus cisplatin 80 mg/m(2) intravenously on day 1 of a 3- or 4-week cycle, or vindesine 3 mg/m(2) intravenously on days 1, 8, and 15 plus cisplatin 80 mg/m(2) intravenously on day 1 of a 4-week cycle. Cross-over administration of docetaxel and vindesine was prohibited for both treatment groups. RESULTS: Overall, 302 patients were eligible for evaluation. The DC arm demonstrated significant improvements compared with the VdsC arm in overall response rates (37% v 21%, respectively; P <.01) and median survival times (11.3 v 9.6 months, respectively; P =.014). Two-year survival rates were 24% for the DC arm compared with 12% for the VdsC arm. The physical domain of the Quality of Life for Cancer Patients Treated with Anticancer Drugs measure was significantly better in the DC arm than in the VdsC arm (P =.020). Toxicity was predominantly hematologic and was more severe in the VdsC arm. CONCLUSION: As first-line treatment for stage IV NSCLC, DC resulted in greater clinical benefit in terms of response rate (with marked improvements in overall and 2-year survival rates) and quality of life than did treatment with VdsC.