Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer

Purpose To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer (SCLC). Patients and methods SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible. Patients were required to have a performance status of 0–2 and adequate organ function. Treatment consisted of gemcitabine (1,000 mg/m²) and irinotecan (150 mg/m²) on days 1 and 15 of a 28 day cycle. Results Thirty-one patients were enrolled and 30 patients received protocol treatment (10 had refractory disease and 20 had sensitive disease). The median age was 64 years, and the median performance status was one. An objective response was obtained in 36.7% (95% CI: 17.3.1–56.0%) of the patients. The median overall survival time was 14.4 months, and the 1 year survival rate was 51%. The chief grade 3/4 toxicities included neutropenia (42%), thrombocytopenia (3%), diarrhea (9%), and liver dysfunction (3%). The only grade 4 toxicities were one case of grade 4 neutropenia (3.3%) and one case of grade 4 thrombocytopenia (3.3%). Conclusion Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC.