Phase II Study of an Alternate Carboplatin and Gemcitabine Dosing Schedule in Advanced Non–Small-Cell Lung Cancer

Abstract

We conducted a phase II single-institution trial in a homogenous patient population with advanced non–smallcell lung cancer to determine whether changing the carboplatin schedule in the carboplatin/gemcitabine doublet would enhance tolerability and/or results. Thirty patients with stage IIIB (with malignant effusion) or stage IV disease received gemcitabine 1100 mg/m2, days 1 and 8 plus carboplatin at an area under the curve of 5 on day 8. Cycles were repeated every 28 days, up to 6 cycles. A response rate of 10% was demonstrated (none complete), but an additional 45% of patients had stable disease. The median time to progression was 5.8 months and the median survival was 8.3 months. A 1-year survival rate of 27% and a 2-year survival rate of 16% were seen. The main nonhematologic toxicity was non-neutropenic infection. Thrombocytopenia occurred in 8 patients (27%; 7 grade 3, 1 grade 4). Carboplatin/gemcitabine with a day 8 administration of carboplatin is well tolerated with a similar survival to established platinum-based doublets.