Gemcitabine, Vinorelbine, and Cisplatin in the Treatment of Advanced Nonsmall Cell Lung Cancer

Abstract

Objectives: Currently, cisplatin-based doublet combinations are accepted to be the first-line chemotherapy for advanced nonsmall cell lung cancer (NSCLC). Although triplet chemotherapeutics have been shown to be more effective and active than doublets, their toxicity was higher as expected. Therefore, we conducted this phase 11 trial using the combination of gemcitabine-cisplatin-vinorelbine with lower than usual but acceptable doses of gemcitabine and cisplatin to obtain higher response rate than doublet but less toxicity than triplet combinations. Methods: In this trial, stage IIIB and IV chemotherapy naive NSCLC patients with measurable disease and performance status of 0 to 2 were included. Gemcitabine and vinorelbine at the doses of 900 mg/m(2) and 25 mg/m(2), respectively were administered on days I and 8, and cisplatin at a dose of 50 mg/m(2) on day 1, every 21 days. Results: Three of the 39 patients included in the trial were complete responders (7.7%). The overall response rate was 56.4%, median time to the progression was 6 months, median overall survival time was 12 months, and 1-year survival rate was 49.6%. Grade 11 to III neutropenia and thrombocytopenia occurred in 24% and 30% of the patients, respectively. Febrile neutropenia was observed in 13.5% of the patients and only these patients received G-CSF. Platelet and erythrocyte transfusions were required in 12 (32.4%) patients. No toxic or early death was observed. Conclusions: This combination of gemcitabine-cisplatin-vinorelbine with lower doses of cisplatin and gemcitabine was effective and active in advanced NSCLC. The overall response rate, I-year survival and median survival time were nearly similar to previous trials in which higher doses of these 3 drugs were used. The toxicities were more acceptable and manageable than the regimes with higher doses; therefore, we may suggest a treatment option for advanced stage NSCLC.