Increased survival using platinum analog combined with gemcitabine as compared to gemcitabine single agent in advanced pancreatic cancer (APC): Pooled analysis of two randomised trials, the GERCOR/GISCAD Intergroup Study and a German Multicenter Study
4003 Background: Two randomized trials (GERCOR/GISCAD: gemcitabine [GEM] plus oxaliplatin versus Gem; German multicenter trial: Gem plus cisplatin versus Gem) indicated superior efficacy in terms of response rate and progression-free survival (PFS) for combined therapy. While a trend for prolonged overall survival (OS) was reported in these underpowered studies, they failed to demonstrate a significant advantage. Methods: We report a pooled analysis of both studies. Standard methods for meta-analysis based on individual patient (pt) data were used. Results: Among 503 evaluable pts, 252 received the combination therapy (GP), while 251 pts were treated with Gem single agent (G). In the GP vs G groups, an ECOG performance status = 0 was observed in 40% vs 35%, distant metastasis in 72% vs 73%, and pathological tumor grading of 3 in 34% vs 38%, respectively. A high degree of homogeneity was noted among the study groups with regard to survival data. For PFS, the pooled univariate analysis indicated a hazard ratio (HR) of 1.34 (95% CI, 1.11–1.63, p=.0030; median PFS 5.5 m vs 3.5 m) in favour of the GP-combination. The benefit of the GP-combination was greatest in the subgroup of pts with PS 0 (HR=1.56; 95% CI, 1.11–2.20, p=.013). OS was significantly superior in the GP pts (HR=1.23; 95% CI, 1.02–1.49, p=.031; median OS 8.3 m vs 6.7m). Again, pts with a PS=0 may have a greater benefit from treatment intensification (HR=1.38; 95% CI, 0.99–1.93, p=.063). Conclusions: This pooled data analysis indicates that combination of gemcitabine with a platinum analog such as oxaliplatin or cisplatin significantly improves PFS and OS as compared to single-agent gemcitabine in APC. [Table: see text]