A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): Update of the Alpha Oncology trial (A1-99002L).

LBA7025 Background: Two-drug regimens are the 'standard of care' for treatment of advanced NSCLC. The role of non-platinum containing doublets continues to evolve. Gemcitabine and paclitaxel, a non-platinum-containing doublet needs to be prospectively compared to standard doublets. We are conducting a multicenter, randomized trial designed to compare the efficacy of gemcitabine-containing platinum and non-platinum doublet regimens with the most commonly used regimen of P+C to identify the combination associated with the best therapeutic index. We are now able to provide an update to the preliminary analysis of this ongoing trial previously reported.,Between July 2000 and Nov 2004, 929 chemonaive patients (pts) with advanced stage (IIIB/IV) NSCLC, and ECOG PS < 2 were randomized to: (GC) G 1,000 mg/m IV on days 1, 8 plus C AUC 5.5, day 1 vs. (GP) G 1,000 mg/m IV on days 1,8 plus paclitaxel 200 mg/m, day 1 vs. the control arm (PC) paclitaxel 225 mg/m plus carboplatin AUC 6.0, day 1. All three regimens were administered as 21-d cycles. The primary end point is overall survival (OS). Secondary endpoints are TTP, RR, and QoL analysis using FACT-L questionnaire.,At the time of this updated analysis, 681/929 pts have sufficient (> 6 mos) follow-up for response evaluation. (CR + PR = 39.5%; 95% CI 36% - 43%). Toxicity data are available for 812 pts. Pts characteristics include: (M/F 564/361), median age 64.1 years (range 32.7-91.0), ECOG PS (0-344/1-585), stage (IIIB-102/IV-827). The table summarizes response and toxicity data.,All three regimens demonstrate similar activity as defined by objective tumor response. GC resulted in a higher incidence of uncomplicated grade 3/4 myelosuppression but was associated with less alopecia and neuro-sensory toxicity. TTP, OS and QoL data are being analyzed. [Figure: see text] [Table: see text].