title: Three-weekly oxaliplatin combined with gemcitabine and capecitabine in the first-line treatment of patients with advanced biliary tract cancer.
abstract: The primary objective of this study was to determine the activity and safety of 3-weekly oxaliplatin combined with gemcitabine and oral capecitabine in the first-line treatment of advanced biliary tract cancer. Treatment consisted of intravenous oxaliplatin 100 mg/m every 3 weeks combined with intravenous gemcitabine 1000 mg/m on days 1 and 8 and oral capecitabine 1500 mg/m 14 days on 21 in two divided doses. Treatment was administered until progressive disease, unacceptable toxicity, or patient refusal. Thirty-seven patients were enrolled: eight patients had Eastern Cooperative Oncology Group 2 performance status at presentation. The overall response rate was 35.1% [95% confidence interval (CI): 20.2-52.5%] and the disease control rate was 72.9%. The median progression-free survival was 9.4 months (95% CI: 4.1-12.2 months) and the median overall survival was 13.8 months (95% CI: 7.7-17.1 months). There were no grade 4 toxicities. Grade 3 neutropenia occurred in 13.5% of patients and grade 3 thrombocytopenia in 10.8%. The present study suggests that 3-weekly oxaliplatin combined with gemcitabine and oral capecitabine is an active and well-tolerated chemotherapy regimen in the first-line treatment of metastatic biliary tract cancer.
authors: aMedical Oncology Unit bPharmacology Unit, Department of Medicine, Surgery and Neuroscience cUnit of General and Minimally Invasive Surgery dUnit of Surgical Oncology, Department of Surgery and Neurosciences, University of Siena, Siena eMedical Oncology Unit, Policlinico Umberto I Hospital, University of Rome, Rome, Italy.
authors: Roberto
authors: R
authors: Petrioli
authors: Giandomenico
authors: G
authors: Roviello
authors: Anna I
authors: AI
authors: Fiaschi
authors: Letizia
authors: L
authors: Laera
authors: Franco
authors: F
authors: Roviello
authors: Daniele
authors: D
authors: Marrelli
authors: Edoardo
authors: E
authors: Francini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017734:Bile Ducts, Extrahepatic / Q000473:pathology; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005706:Gallbladder Neoplasms / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine