A randomized phase II trial of gemcitabine plus carboplatin: biweekly versus standard schedules in patients with advanced non-small cell lung cancer.

Objective: Gemcitabine combined with carboplatin (GC) is a widely used regimen for advanced non-small cell lung cancer (NSCLC), but clinical outcome is still hampered by its toxicity. We conducted a randomized phase II study of GC and compared biweekly versus standard schedules in patients with advanced NSCLC with respect to toxicity and outcome.

Methods: Forty patients with stage IIIB or IV NSCLC were randomized to receive either a biweekly regimen of GC [gemcitabine (1,000 mg/m(2) on days 1 and 14) and carboplatin (area under the concentration-time curve, AUC = 3 on days 1 and 14)] every 28 days or a standard regimen of GC [gemcitabine (1,000 mg/m(2) on days 1 and 8) and carboplatin (AUC = 5 on day 1)] every 21 days. These cycles were repeated until disease progression.

Results: Response rates were 55% for the biweekly regimen and 40% for the standard regimen. Median overall and progression-free survival times were 19.7 and 6.2 months, respectively, for the biweekly regimen, and 11.8 and 2.8 months, respectively, for the standard GC regimen. Hematologic toxicity was prominent. However, the incidence of grade 1 or 2 thrombocytopenia was significantly lower in the biweekly than in the standard GC regimen (p < 0.05). Nonhematologic toxicity was mild.

Conclusion: A biweekly GC regimen was better tolerated than a standard GC regimen in patients with advanced NSCLC.