Phase I/II Study of 3-Week Cycle Cisplatin–Gemcitabine in Advanced Non-small Cell Lung Cancer

Background: The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer. Methods: 80 mg/m2 of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m2 and was escalated in 250 mg/m2 increments. Results: Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin. Nine of 24 patients (37.5%) achieved a partial response. Conclusion: This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin to be the recommended dose.