Gemcitabine alone versus gemcitabine plus cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic adenocarcinoma: A retrospective analysis of multicenter study.

Abstract

e14534 Background: The majority of patients with pancreatic cancer is advanced disease The aim of this retrospective multicenter study is to evaluated the efficiency of gemcitabine alone versus gemcitabine plus cisplatin in patients with locally advanced and/or metastatic pancreatic adenocarcinoma. Methods: A total of 372 patients, from referral center were evaluated retrospectively. All patients received gemcitabine (Gem) or gemcitabine plus cisplatin (GemCis) as first-line treatment between September 2005 to January 2011. Primary end of this study were to evaluate the toxicity, clinical response rate, progression-free survival (PFS) and overall survival (OS) between the arms. Results: Gemcitabine arm 130 (M: 86, F: 44), the combination arm 242 (M: 171, F: 71) were patients. Gemcitabine arm patients older than the combination arm (median 63 vs 57.5, p=0.001). In patients with the combination arm had a higher dose reduction (25% vs 9%, p=0.001) and dose delay (34% vs 17.2%, p=0.001). Among patients with the combination and gemcitabine alone arm gender, diabetes mellitus, performance status, cholestasis, grade, stage did not have a statistically difference (p>0.05). Clinical response rate to the combination arm was higher than the gemcitabine alone arm (69.1% vs 50.9, p=0.001). Progression-free survival (PFS) were more favorable in the GemCis arm than Gem arm, but the difference did not attain statistical significance (7.8 vs 5.0, p=0.07). Overall survival (OS) was not significantly superior in the GemCis arm (9.4 vs 8.0, p>0.05). Grade III-IV neutropenia (21% vs 8.3% p=0.006), and diarrhea (7.7% vs 2%, p=0.05), was higher in the combination arm. Other toxicities profile was similar in both groups (p>0.05). Conclusions: PFS was more favorable in the GemCis arm than Gem alone, but the difference did not attain statistical significance. Overall survival (OS) was not significantly superior in the GemCis arm.