Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study

Abstract

Background: Since gemcitabine–oxaliplatin (GEMOX) has been used in pancreatic adenocarcinoma, we studied its activity and tolerability in advanced biliary tract adenocarcinoma (ABTA). Patients and methods: Consecutive adult patients with confirmed ABTA were recruited from four centers. Those in group A had performance status (PS) 0–2, bilirubin 2 and/or bilirubin >2.5× normal and/or prior chemotherapy. All received gemcitabine 1000 mg/m² as a 10 mg/m²/min infusion on day 1, followed by oxaliplatin 100 mg/m² as a 2-h infusion on day 2, every 2 weeks. Results: Tumor sites were gallbladder (19), extrahepatic bile ducts (5), ampulla of vater (3) and intrahepatic bile ducts (29). Results for group A (n=33) were: objective response 36% [95% confidence interval (CI) 18.7% to 52.3%], stable disease 26%, progressive disease 39%, median progression-free survival (PFS) 5.7 months and overall survival (OS) 15.4 months. Results for group B (n=23) were: objective response 22% (95% CI 6.5% to 37.4%), stable disease 30%, progressive disease 48%, PFS 3.9 months and OS 7.6 months. National Cancer Institute Common Toxicity Criteria grade 3–4 toxicities were neutropenia 14% of patients, thrombocytopenia 9%, nausea/vomiting 5% and peripheral neuropathy 7%. Conclusion: The GEMOX combination is active and well tolerated in ABTA.