A multicenter phase II study of the combination of gemcitabine and docetaxel in previously treated patients with small cell lung cancer

Purpose: To evaluate the efficacy and toxicity of the combination of gemcitabine and docetaxel in pretreated patients with small-cell lung cancer (SCLC). Patients and methods: Twenty-two pretreated patients (median age 61 years, PS: 0-1 in 77% and 2 in 23%) with limited or extensive stage disease were treated with gemcitabine 1000 mg/m(2) on days 1 and 8 and docetaxel 75 mg/m(2) on day 8, every 21 days. Fifteen (68%) of the 22 patients had received two prior regimens and fourteen (64%) were refractory to front-line chemotherapy. Results: All patients were evaluable for efficacy analysis. No complete or partial responses were observed. Disease stabilization was obtained in one (5%) patient. The median survival was 14 weeks and the six-month survival rate was 28%. WHO grade 2 and 3 toxicities were infrequent and easily manageable. Conclusion: The combination of gemcitabine and docetaxel was inactive as salvage treatment in this poor prognosis group of patients with SCLC. (C) 2003 Elsevier Ireland Ltd. All rights reserved.