Phase II study of combination chemotherapy with gemcitabine and irinotecan in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens

OBJECTIVE: The aim of this study was to evaluate the efficacy and toxicity of gemcitabine combined with irinotecan in patients with previously treated non-small-cell lung cancer (NSCLC). METHODS: Patients who failed to respond to platinum-containing first-line chemotherapy were enrolled and treated with gemcitabine 1000 mg/m(2) and irinotecan 150 mg/m(2) on days 1 and 15. Cycles were repeated every 4 weeks. RESULTS: Twenty-seven of 30 registered patients were evaluated. There were previous combination treatments of platinum and taxane regimens in 21 out of 27 patients, with 17 patients treated with carboplatin and paclitaxel and 4 patients treated with cisplatin or carboplatin and docetaxel. A total of 87 cycles was administered and the median number of cycles administered per patient was 3.5 cycles. Objective responses were observed in 5 out of 27 patients (18.5%). No severe hematologic and non-hematologic toxicities were observed (grade 3 leukopenia in 3 patients; grade 3 anemia in 3 patients; grade 3 thrombocytopenia in 2 patients; grade 3 diarrhea in 1 patient). The median survival time was 7.7 months and 1-year survival rate was 34.8%. CONCLUSION: Bi-weekly gemcitabine and irinotecan was well tolerated and had an acceptable response rate and a reasonable median survival time for patients with NSCLC who had previously been treated with platinum-based chemotherapy.