title: First-line chemotherapy with docetaxel for unresectable or metastatic carcinoma of the biliary tract. A multicentre phase II study.
abstract: The purpose was to evaluate the efficacy and safety profile of docetaxel as first-line chemotherapy for patients with locally advanced or metastatic biliary tract carcinoma. 25 chemotherapy-naïve patients with unresectable or metastatic biliary tract carcinoma were entered into this phase II trial. Docetaxel was given at the dose of 100 mg/m2 as a 1-h infusion on day 1, after appropriate premedication with dexamethasone; treatment was repeated every 21 days. Patients were assessed for response every three chemotherapy cycles. 24 patients were evaluable for response and 25 for toxicity. A total of 98 cycles were administered with a median of three cycles/patient. Two complete (CR=8%) and three partial (PR=12%) responses were observed (overall response rate: 20%; 95% confidence interval (C.I.) 4-36%); in addition, 6 (24%) patients had stable disease and 14 (58%) progressive disease. With a median follow-up of 8 months, the median duration of response was 4 months, the median time to tumour progression (TTP) was 6 months and the overall median survival was 8 months. The 1-year survival rate was 26%. Grade 3 and 4 granulocytopenia occurred in 36 and 20% of the patients, respectively, and febrile neutropenia was observed in 16% of them; there were no treatment-related deaths. Grade 2-3 fatigue was reported in 24% of patients. These results indicate that docetaxel is an active drug against adenocarcinomas of the biliary tract.
authors.affiliation: Oncology Unit, Hippokratio General Hospital of, Athens, Greece.
authors.forename: P
authors.initials: P
authors.lastname: Papakostas
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: G
authors.initials: G
authors.lastname: Samelis
authors.forename: G
authors.initials: G
authors.lastname: Aravantinos
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: E
authors.initials: E
authors.lastname: Sarra
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D010349:Patient Compliance; D015996:Survival Rate; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel