Gemcitabine combined with Oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma

Background: Gemcitabine (GEM) and Oxaliplatin (OX) are single active drugs in biliary system adenocarcinomas. The combination GEM-OX showed supradditive effect in human cancer cell lines. We evaluated the safety and efficacy of this combination in patients with advanced or metastatic biliary system adenocarcinomas. Patients and Methods: sixteen advanced or metastatic biliary tract adenocarcinoma chemonaive patients were treated with gemcitabine 1000 mg/m2 as a 10 mg/m2/min infusion followed by oxaliplatin 85 mg/m2 as a 3-hour infusion on day 1, every two weeks.Prophylactic antiemetic treatment with ondansetron and desametasone was administered to all patients. Granulocyte colony stimulating factor was allowed for patients developing grade 3–4 neutropenia. Eligibility criteria were: histocytologically proven biliary system adenocarcinoma, mesaurable disease, age <75 years, ECOG PS 0–2, adequate hematological, liver and renal functions, and informed written consent. Response evaluation was planned every four cycles. Results: Median age 63 years (range 43–75); ECOG PS O=8, 1=6, 2=2; Male/Female 9/7; 10 locally advanced, 6 metastatic. Patients received a median of 5 cycles of treatment (range 1–12). Fourteen patients were evaluable for response, two too early. No patient achieved a complete response and 5 (35.7%) a partial response; 4 (28.5%) patients had stable disease. PR were obtained only in patients with locally advanced disease.The median time to tumor progression was 6 months (range 1–12) and median overall survival was 14 months (range 1–19). National Cancer Institute Common Toxicity criteria grade 3–4 toxicity were neutropenia in 5 pts (no febrile neutropenia) and thrombocytopenia in 3 pts. Grade 1–2 (according Carousel scale) sensitive neuropathy was registered in 8 pts, no grade 3. Alopecia, nausea and vomiting, diarrhea and mucositis were not significant. Cycle delays were reported in four patients and no dose reduction was required. Conclusion: Our study confirms Gemcitabine Oxaliplatin combination is an active and well-tolerated regimen as first line treatment of biliary system adenocarcinomas.