Biweekly Administration of Cisplatin/Gemcitabine in Advanced Nonsmall Cell Lung Cancer

Abstract

In an attempt to increase the dose intensity of cisplatin and gemcitabine given to patients with stage IIIB or IV nonsmall cell lung cancer without increasing toxicity, we have studied a biweekly administration schedule. We analyze the safety and efficacy of this treatment. In this study, cycles of 50 mg/m2 cisplatin with 2500 mg/m2 gemcitabine were given on days 1 and 15 every 28 days. The median age of the 49 patients was 62 years and 23 were in stage IIIB patients (46.9%), whereas 26 (53.1%) were in stage IV. Overall response rate was 38.8%, 52.2% for stage IIIB and 26.9% for stage IV. Median survival was 48 weeks and 1-year survival was 44%, with 66.7% of stage IIIB patients and 13.3% of stage IV patients surviving for 1 year. In the study, 178 cycles were administered, a mean of 4 cycles per patient. The intensity of the 359 administrations reached 91.16% of the planned dosage, although 49 were delayed for 1 week while subjects recovered from the toxicity. There was 1 toxic death and 2 patients experienced vascular toxicity with distal arterial ischemic severe changes in their lower extremities. There were 7 episodes of grade 2 neutropenia, 2 of grade 3, and one of grade 4; however, no cases of febrile neutropenia were seen. The predominant nonhematologic toxic effects were asthenia and nausea/vomiting. The schedule of cisplatin and gemcitabine analyzed is active with a good therapeutic index.