Background: Biliary tract cancers are uncommon tumors with a poor prognosis. Since most patients present with invasive and inoperable disease at diagnosis, treatment consists of palliative chemotherapy, with poor response rates and a median survival of less than 6 months. Oxaliplatin and gemcitabine have shown interesting activity as single agents in this patient group. Objective: A single-institution phase II study was performed to evaluate the efficacy and safety of combination therapy with oxaliplatin and gemcitabine in locally advanced and metastatic biliary tract carcinomas. Patients and Methods: Combination chemotherapy consisted of gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 100 mg/m2 on day 2 every 2 weeks. Treatment was administered until disease progression, unacceptable toxicity or patient refusal. Thirty-five consecutive patients with advanced biliary tract carcinoma, aged 18–80 years, with Eastern Cooperative Oncology Group performance status ≤2 were entered into our study from November 2003. Results: Thirty- four patients were evaluable for response and toxicity. According to RECIST criteria, 2 patients had a complete response and 12 had a partial response, with an overall response rate of 41%. Overall survival in our patients was 10 months (range 2–30). According to WHO criteria, 3 patients (9%) suffered from grade 3 neutropenia and 7 patients (21%) from grade 3 thrombocytopenia. Only 3 patients (9%) had grade 3 neuropathy. Conclusions: The GEMOX combination seems to be active with a favorable safety profile in first-line chemotherapy of advanced biliary tract cancers.

Keywords:
Biliary tract cancers, Chemotherapy, Gemcitabine, Oxaliplatin
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2008
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