Abstract
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-naïve 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 patients received treatment and have full safety data available (184 patients received GEMOX; 187 patients received PCb). Of the 371 patients with safety data, 204 (55.0%) were male, 193 (52.0%) < 65 years old, 340 (91.6 %) were Caucasian and 6 (1.6%) Hispanic, 193 (52.0 %) had an ECOG score = 0, 302 (81.4%) had Stage IV disease at diagnosis and 33 (8.9%) had brain metastases. Mean ± SD number of cycles completed was 4.1 ± 1.8 (range 1–6). There were 26 deaths (7.0%) within 30 days of completing treatment. At the end of the follow-up period (684 days from start of study treatment) 38 pts (10.2%) were still alive. Neutropenia (32.9%) and thrombocytopenia (17.3%) were the most common Grade 4 toxicities. Conclusions: Additional safety and full efficacy data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis sanofi-aventis
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
