A randomized phase II study of carboplatin/gemcitabine (CG) versus vinorelbine/gemcitabine (VG) in patients with advanced non-small cell lung cancer (NSCLC); mature results of West Japan Thoracic Oncology Group (WJTOG) 0104

7124 Background: Non-platinum regimen may improve efficacy with less toxicity than platinum-based combination. Newer platinum regimen, CG has shown activity in advanced NSCLC and a better toxicity profile than cisplatin/gemcitabine. A randomized phase II study was performed between 06/01 and 10/02 to compare the efficacy and safety of non-platinum regimen (VG) with newer platinum regimen (CG). Method: 128 chemotherapy-naive patients with stage IIIB/IV were enrolled in the study and randomized to vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 both given on d1, 8, q3w or carboplatin at AUC 5 on d1 and gemcitabine 1000 mg/m2 on d1, 8, q3w. All patients had measurable disease, ECOG PS 0–1, and adequate organ function. The primary endpoint was 1-year survival and secondary were response rate, toxicity profile, and overall survival. Results: The median treatment cycles were 3 and 4 in CG and VG, respectively. The Median survival time and 1-year survival rate were 494 days and 64.4% for CG arm (42 patients cens...