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A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic NSCLC
Annals of Oncology, 10/19/09

Treat JA et al. – Paclitaxel–carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen. Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. The treatment arms had distinct toxicity profiles.

Methods

1135 chemonaive patients with stage IIIB or IV NSCLC
Randomly allocated to receive gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under concentration–time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m2 on days 1 and 8 plus paclitaxel 200 mg/m2 on day 1 (GP), or paclitaxel 225 mg/m2 plus carboplatin AUC 6.0 on day 1 (PC)
Stratification based on disease stage, baseline weight loss, and presence or absence of brain metastases
Cycles repeated every 21 days for up to 6 cycles or disease progression

Results

Median survival (months) with GC 7.9 compared with 8.5 for GP and 8.7 for PC
Response rates (RRs) as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%
The GC arm associated with greaterincidence of grade 3 or 4 hematologic events but lower rate of neurotoxicity and alopecia when compared with GP and PC

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