Capecitabine and oxaliplatin as first and second line treatment for locally advanced and metastatic pancreatic ductal adenocarcinoma.

BACKGROUND: There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). We conducted a phase II study evaluating the efficacy and safety of capecitabine/oxaliplatin (CAPOX) in patients with locally advanced and metastatic PDAC treated in the first and second lines. METHODS: Forty subjects with advanced PDAC and ECOG performance status ≥2 were enrolled. Treatment consisted of capecitabine 2,000 mg/m2 orally in two divided doses daily for 14 days and oxaliplatin 130 mg/m2 intravenously day 1 every 21 days. The primary endpoint was response rate (RR); secondary endpoints included safety analysis, progression free survival (PFS) and overall survival (OS). RESULTS: The overall RR was 12.5% (N=3); the disease control rate was 67% (N=16). Due to the protocol definition for eligibility of response evaluation, only 60% (N=24) were evaluable for the primary endpoint. Median progression free survival (mPFS) was 3.8 months (95% CI: 1.3, 6.2); median OS (mOS) was 7.4 months (95% CI: 4.8, 12.2). The most common grade 3/4 toxicities included: fatigue (19%), nausea (17%), and diarrhea (14%). CONCLUSIONS: CAPOX is an active regimen in patients with advanced PDAC and is associated with acceptable toxicity. Careful consideration should be given to response endpoints and outcome measures when studying this characteristically ill population.