3-week-scheduled combination chemotherapy of gemcitabine and cisplatin in patients with advanced NSCLC.

Background : The combination chemotherapy of gemcitabine and cisplatin has been proven effective in the treatment of advanced non-small cell lung cancer (NSCLC). However, the optimal schedule for administration of the two drugs has not yet been determined. We therefore started a phase II trial to evaluate efficacy, toxicity and dose intensity (DI) as three-week scheduled chemotherapy of gemcitabine and cisplatin. Methods : Between October 2000 and March 2003, a total of 56 patients with stage IIIB and IV NSCLC were enrolled in this study. Treatment schedule consisted of gemcitabine 1200 mg/ i.v. on days 1 and 8, and cisplatin 80 mg/ i.v. on day 1 of each chemotherapy cycle followed by two weeks of rest. Results : Forty-eight patients were evaluable in response and adverse effects in this study. The median DI was 529 mg//week for gemcitabine (66%) and 22 mg//week for cisplatin (83%). Partial response was observed in 23 patients. The overall response rate was 47.8% (95% confidence interval [CI], range from 33.6% to 61.9%). Anemia and thrombocytopenia were the main hematologic adverse effects, with 8.3% and 8.3% of patients experiencing grade III to IV toxicity, respectively. The median survival time was 11.78 months (95% CI, range from 8.59 to 14.97months). No significant differences in response rate were observed according to sex, age, histology and DI of gemcitabine and cisplatin. Conclusion : The 3-week-scheduled combination chemotherapy of gemcitabine and cisplatin has feasibility to treat advanced stage IIIB and IV NSCLC with modest adverse effects. The regimen deserves further evaluaton in a phase III prospective randomized trial.