Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study

• Published in: British journal of cancer Vol. 99; no. 6; pp. 862 - 867
• Main Authors: André, T, Reyes-Vidal, J M, Fartoux, L, Ross, P, Leslie, M, Rosmorduc, O, Clemens, M R, Louvet, C, Perez, N, Mehmud, F, Scheithauer, W
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 16.09.2008; Nature Publishing Group
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biliary Tract Neoplasms - drug therapy; Biliary Tract Neoplasms - mortality; Biliary Tract Neoplasms - pathology; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Clinical Study; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease-Free Survival; Drug Resistance; Epidemiology; Female; Humans; International Agencies; Male; Medical sciences; Middle Aged; Molecular Medicine; Neoplasm Staging; Oncology; Organoplatinum Compounds - therapeutic use; Survival Rate; Time Factors; Treatment Outcome; Tumors; GEMOX; oxaliplatin; gemcitabine; biliary tract carcinoma; Antineoplastic agent; Biliary tract; Carcinoma; Gemcitabine; Digestive system; Malignant tumor; Alkylating agent; Cancerology; Oxaliplatin; Treatment; Antimetabolic; Phase II trial; Pyrimidine derivatives; Advanced stage; Fluorine Organic compounds; Pyrimidine nucleoside; Cancer; Platinum II Complexes
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6604628

Advanced biliary tract carcinomas (BTCs) are often diagnosed at an advanced/metastatic stage and have a poor prognosis. The combination of gemcitabine and oxaliplatin (GEMOX) has shown promising activity in this setting. This international 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 BTC received gemcitabine 1000 mg m −2 (day 1) and oxaliplatin 100 mg m −2 (day 2), every 2 weeks. Seventy patients were enroled; 72.9% had metastatic disease. Sixty-seven patients were treated. There were 10 confirmed partial responses (14.9%; 95% confidence interval (CI), 7.4–25.7%) in the treated population (RECIST). Twenty-four patients (35.8 %) had stable disease. The objective response rate was 20.5% in patients with non-gallbladder cancers (9/44 patients) and 4.3% in patients with gallbladder cancers (1/23). Median overall survival for the intent-to-treat population was 8.8 months (95% CI, 6.9–11.1%) and progression-free survival was 3.4 months (95% CI, 2.5–4.6%). Grade 3/4 toxicities included thrombocytopenia (14.9% of patients), alanine aminotransferase elevation (13.4%), anaemia (10.4%), neutropenia (11.9%) and pain (11.9%). In this study, GEMOX demonstrated activity in non-gallbladder carcinoma, but poor activity in gallbladder carcinoma. GEMOX is well tolerated in advanced BTCs.