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

To evaluate the efficacy and toxicity of the combination of gemcitabine and docetaxel in pretreated patients with small-cell lung cancer (SCLC).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/m2 on days 1 and 8 and docetaxel 75 mg/m2 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.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.The combination of gemcitabine and docetaxel was inactive as salvage treatment in this poor prognosis group of patients with SCLC.