Phase III open-label comparison of gemcitabine/oxaliplatin versus paclitaxel/carboplatin as first line therapy for advanced non-small cell lung cancer (NSCLC)

8024 Background: Platinum-based doublets are the standard of care for advanced and metastatic NSCLC. Gemcitabine/cisplatin is one of the most active regimens; however many patients cannot tolerate the non-hematological side effects of this combination. This study was designed to compare the efficacy and tolerability of Gemcitabine + Oxaliplatin (GEMOX) to that of Paclitaxel/Carboplatin (PCb) in chemotherapy-naive Stage IIIB/IV NSCLC patients. Methods: Newly diagnosed patients greater than 18 years of age with histologically proven NSCLC and ECOG PS ≤ 1 were randomly assigned 1:1 and stratified by stage (IIIB vs IV) in a 1:4 proportion to receive either PCb (P 225 mg/m2 day 1 followed by Cb AUC = 6) or GEMOX (GEM 1000mg/m2 days1 and 8 and OX 130 mg/m2 on day 1 after GEM) for a maximum of 6 cycles. The primary endpoint was time-to-progression (TTP), with tumor response rate, overall survival (OS), and quality of life (QoL) as secondary endpoints. Results: A total of 383 patients were randomized; 371 patient...