Oxaliplatin as first-line treatment in inoperable biliary tract carcinoma - A multicenter phase II study

Background: A multicenter phase II study was conducted in order to evaluate the efficacy and safety of oxaliplatin as first- line treatment of patients with locally advanced or metastatic carcinoma of the biliary tract. Patients and Methods: Twenty-nine chemo- nave patients with locally advanced or metastatic biliary tract carcinoma received oxaliplatin 130 mg/m(2) i. v. every 21 days. Patients were treated until tumor progression or unacceptable toxicity. Results: An objective response ( 3 complete responses, 3 partial responses) was achieved in 6 patients ( 20.6%, 95% CI 5.95 - 35.4). Disease control ( complete response, partial response and stable disease) was observed in 14 patients ( 48.2%). The median time to tumor progression was 3 months ( range 0.7 - 39) and the median overall survival was 7 months ( range 1 - 39). The 1year survival rate was 32%. Toxicity was mild. Conclusion: Oxaliplatin is an active agent against biliary tract carcinoma and therefore should be further investigated in combination with other cytotoxic drugs. Copyright (c) 2006 S. Karger AG, Basel.