Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial

Abstract

PurposeChemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6months in patients
with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy
with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.

MethodsWe carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in
patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine
1,000mg/m2 (day 1 and 8) and oxaliplatin 100mg/m2 (day 1), every 3weeks.

ResultsFifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response
rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated
population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients.
Median progression-free survival was 4.8months (3.1–6.5, 95% CI) and median overall survival was 8.3months (5.8–10.8, 95%
CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).

ConclusionsThe GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.