Paclitaxel/Carboplatin/Gemcitabine Versus Gemcitabine/Vinorelbine in Advanced Non–Small-Cell Lung Cancer: A Phase II/III Study of the Minnie Pearl Cancer Research Network

PURPOSE This prospective randomized study compared overall survival (OS) in patients with previously untreated advanced non–small-cell lung cancer (NSCLC) when treated with the platinum agent–based triple drug combination of paclitaxel/carboplatin/gemcitabine (PCG) versus the nonplatinum agent–based doublet drug combination of gemcitabine/vinorelbine. PATIENTS AND METHODS Advanced (stages IIIB, IV, and recurrent) chemotherapynaive patients with NSCLC and performance status 0-2 were randomly assigned to the PCG arm (paclitaxel 200 mg/m 2 on day 1, carboplatin area under the concentration-time curve of 5 on day 1, and gemcitabine 1000 mg/ m 2 on days 1 and 8, every 21 days) or to the gemcitabine/vinorelbine arm (gemcitabine 1000 mg/m 2 on days 1, 8, and 15 and vinorelbine 25 mg/m 2 on days 1, 8, and 15, every 28 days). RESULTS A total of 337 patients were randomly assigned to the 2 arms. The median time to progression was 6 months for PCG and 3.9 months for gemcitabine/vinorelbine with 1- and 2-year progression-free survival rates of 13% and 2% versus 14% and 4% ( P = .324 log rank). Median OS for PCG was 10.3 months versus 10.7 months for gemcitabine/vinorelbine with 1-, 2-, and 3-year OS rates of 38%, 12%, and 2% versus 45%, 12%, and 6%, respectively ( P = 0.269 log rank). Grade 3/4 thrombocytopenia, nausea/vomiting, myalgia/arthralgia, and neuropathy were significantly greater in the PCG arm. CONCLUSION There was no difference in OS or progression-free survival when comparing PCG and gemcitabine/vinorelbine, and gemcitabine/vinorelbine was significantly less toxic. Gemcitabine/vinorelbine is a reasonable nonplatinum agent–based doublet therapy for patients with advanced NSCLC.