title: Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer.
abstract: This phase II study was conducted to determine the efficacy and toxicity of a gemcitabine (GEM) and oxaliplatin (OX) chemotherapy protocol in patients with unresectable biliary tract cancer (BTC). Patients were treated with GEM 1000 mg m-2 (30 min infusion) on days 1, 8, 15, and OX 100 mg m-2 (2 h infusion) on days 1 and 15 (gemcitabine and oxaliplatin (GEMOX-3 protocol), repeated every 28 days. The data were collected according to the Simon 2-stage design for a single centre phase II study (alpha=0.05; beta=0.2). Primary end point was response rate; secondary end points were time-to-progression (TTP), median survival, and safety profile. Thirty-one patients were enrolled in the study between July 2002 and April 2005. Therapeutic responses were as follows: partial response in eight patients (26%, 95% confidence interval (CI) 14-44), stable disease in 14 patients (45%, 95%CI 29-62), resulting in a disease control rate of 71%. Nine patients (29%, 95%CI 16-47) had progressive disease. Median TTP was 6.5 months. Median overall survival was 11 months. Common Toxicity Criteria (CTC) Grade 3-4 toxicities were transient thrombocytopenia (23%), peripheral sensory neuropathy (19%), leucopenia (16%), and anaemia (10%). In conclusion the GEMOX-3 protocol is active and well tolerated in patients with advanced BTC. It can be applied in an outpatient setting with three visits per month only.
authors.affiliation: Department of Gastroenterology and Hepatology, Freiburg University Hospital, Hugstetterstr. 55, Freiburg D-79106, Germany. harder@medizin.ukl.uni-freiburg.de
authors.forename: J
authors.initials: J
authors.lastname: Harder
authors.forename: B
authors.initials: B
authors.lastname: Riecken
authors.forename: O
authors.initials: O
authors.lastname: Kummer
authors.forename: C
authors.initials: C
authors.lastname: Lohrmann
authors.forename: F
authors.initials: F
authors.lastname: Otto
authors.forename: H
authors.initials: H
authors.lastname: Usadel
authors.forename: M
authors.initials: M
authors.lastname: Geissler
authors.forename: O
authors.initials: O
authors.lastname: Opitz
authors.forename: H
authors.initials: H
authors.lastname: Henss
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D018718:Home Infusion Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine