Gemcitabine, docetaxel, and capecitabine (GTX) as a first-line regimen in metastatic pancreatic adenocarcinomas (mPAC): A single institution experience.

Abstract

385 Background: After decades of minimal to no therapeutic options, Gemcitabine emerged as the only safe & effective frontline regimen for mPAC. A 3-drug combination regimen, GTX, first optimized by Fine et al in 2009 showed improved progression free (PFS) & median overall survival (mOS) based on a multicentric prospective phase II study. It didn’t receive much wider acceptance likely due to lack of phase III data and emergence of newer regimens such as Gemcitabine plus nab-Paclitaxel (GA) and FOLFIRINOX (FFX). We reviewed our institutions experience with GTX and other regimens in mPAC patients. Methods: We performed a retrospective review of clinical outcomes in patients diagnosed with mPAC between January 2005 and December 2015 and treated at our institution. Attempts were made to include all eligible patients to reduce any selection bias. Results: Fifty patients with mPAC were analyzed for mOS and toxicities with different regimens. 50% patients received GTX while remaining received – FFX (22%), Gemcitabine (14%), GA (4%), FOLFOX (4%) & other (6%) regimens. The mOS for all the patients was 7.67 months (95% CI 5.98-10.81). The mOS was significantly improved in patients who received GTX as first line regimen compared to patients who received non-GTX regimens (9.45 vs 6.08 months; P-0.0157). GTX also showed non-statistically significant improvement in mOS compared to FFX (9.45 vs 6.08 months; P-0.1436). Compared with FFX, GTX was associated with fewer severe GI (40 vs 45.5%; p – 1.00) and hematologic (20 vs 36.4%; p – 0.40) toxicities. Conclusions: GTX significantly improved mOS and had fewer severe toxicities compared to non-GTX regimens. Limitations include the retrospective and non-randomized nature of the study and the small sample size. However, GTX may be considered an alternative first line regimen in mPAC patients who are unable to tolerate aggressive regimens such as FFX and in whom the need to balance quality of life with efficacy is particularly important.