Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4515
© 2007 American Society of Clinical Oncology

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Abstract

Gemcitabine-based combinations (gem+x) vs gemcitabine (gem) alone in the treatment of advanced pancreatic cancer: a meta- analysis of sixteen randomized trials

University of Munich - Klinikum Grosshadern, Munich, Germany; WiSP Research Institute, Langenfeld, Germany; Ospedali Riuniti, Bergamo, Italy; Service d’Oncologie, Médecine Interne, Paris, France

4515

Background: Sixteen randomised trials have compared Gem-based combination chemotherapy to Gem alone in advanced and metastatic pancreatic cancer. This analysis was performed to better define the role of combination chemotherapy in pancreatic cancer. Methods: The meta-analysis included 16 studies comparing Gem vs. Gem+X. Fifteen trials were evaluable for survival, the primary end-point of the investigation. Overall, 4465 patients (pts) were included, 2222 pts in the Gem+X arm, and 2243 pts in the Gem arm). The analysis was predominantly based on published summary data. Results: Three groups were formed: combinations with platinum analogs, fluoropyrimidines, or other cytotoxic agents. Five trials evaluated platinum-based combinations (3 cisplatin, 2 oxaliplatin). The combined analysis indicated a hazard ratio (HR) of 0.85 (95% CI: 0.76–0.96) demonstrating a significant (p=0.010) superiority of the combination. Further 6 trials investigated the combination of Gem with fluoropyrimidines (3 5-FU, 3 capecitabine). Again, a significant superiority of the combination therapy was observed with a HR of 0.90 (95% CI: 0.81–0.99; p=0.030). Among the fluoropyrimidine combinations greatest homogeneity of results was observed in trials combining gemcitabine with capecitabine. In four randomised trials no improvement of survival was observed when Gem was combined with other cytotoxic agents such as pemetrexed, exatecan or irinotecan (HR=0.99; 95% CI: 0.88–1.10; p=0.80). When all 15 evaluable trials are taken together, an overall hazard ratio of HR=0.91 (95% CI: 0.85–0.97; p=0.004) was achieved. Five trials including 1682 pts provided adequate information on baseline performance status (PS). Combination chemotherapy had a marked benefit on survival in pts with a good PS (HR=0.76; 95%CI: 0.67 - 0.87; p<0.0001), while it was not more effective than Gem alone in pts with an initially poor PS (HR=1.08; 95% CI: 0.90 - 1.29). Conclusions: A meta-analysis of fifteen randomised trials indicated a significant survival benefit for Gem+X as compared to Gem alone when Gem was combined with either a platinum analog or capecitabine. This benefit was greatest in pts with a good PS, while no benefit was evident in poor PS pts.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting