Gemcitabine/docetaxel (GD) versus gemcitabine/cisplatin (GC) in stage III/IV non-small cell lung cancer (NSCLC): Preliminary results

Abstract

17116 Background: This study was designed to compare the response rates and toxicities of the standard GC regimen versus GD, a non-platin regimen, in locally advanced and metastatic NSCLC. Methods: In both arms, gemcitabine 1250 mg/m2 was administered on days 1 and 8. In the GD arm, docetaxel 75 mg/m2 was given on day 8. In the GC arm, cisplatin 70 mg/m2 was given on day 1. Both regimens were repeated every 3 weeks. Results: From September 2004 to September 2005, 47 patients were enrolled In the GD arm (N = 25), the median age was 54.6 years (range, 45–70), and 22 (88.0%) were male. The majority of patients had either squamous cell (52.0%) or adenocarcinoma (44.0%), and stage IIIB disease (64.0%). In the GC arm (N = 22), the median age was 60.9 years (range, 42–74), and 20 (90.9%) were male. Most patients also had either squamous cell (50.0%) or adenocarcinoma (31.8%), and stage IIIB disease (59.1%). The difference in age between arms was significant (p = 0.046), but the differences in the remaining baseline characteristics and demographics were not significant. Toxicity and response results are in the table below. Conclusions: Overall response rate was numerically higher in the GC arm than the GD arm, but the difference was not significant because of the small sample size in each arm. The toxicity profile was significantly better in the GC arm for fatigue and nausea/vomiting. We think that GC regimen will remain the standard in treatment for advanced and metastatic NSCLC; however, we will confirm these findings in a randomized phase II study. [Table: see text] No significant financial relationships to disclose.