Single-agent gemcitabine in patients with resistant small-cell lung cancer

Objective: This study was conducted to assess the activity and toxicity of gemcitabine in patients with resistant small-cell lung cancer (SCLC). Patients and methods: Forty-one patients with limited- or extensive-stage S CLC, who were previously treated with at least one chemotherapeutic regimen and progressed during or within three months of finishing the last regimen , were treated with 1000 mg/m(2) gemcitabine on days 1, 8, and 15 of a four -week cycle. Results: Thirty-eight patients were evaluable for response. Five partial an d no complete responses were seen, for an overall response rate of 13% (95% confidence interval (CI): 6%-27%). Time to progression varied from 4 to 20 weeks, with a median of 8 weeks. Median survival was 17 weeks (range 4-84 weeks). Hematological toxicity mainly consisted of NCI-CTC grade 3 thromboc ytopenia (29% of patients) and, to a lesser extent, grade 3 leukopenia (18% of patients). Non-hematological toxicity was mild, with nausea being the m ost commonly reported event. Conclusions: Gemcitabine has modest activity in patients with resistant SCL C. There is some non-cross resistance to most agents against SCLC.