First-line chemotherapy with docetaxel for unresectable or metastatic carcinoma of the biliary tract. A multicentre phase II study

The purpose was to evaluate the efficacy and safety profile of docetaxel as first-line chemotherapy for patients with locally advanced or metastatic b iliary tract carcinoma. 25 chemotherapy-naive patients with unresectable or metastatic biliary tract carcinoma were entered into this phase II trial. Docetaxel was given at the dose of 100 mg/m(2) 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 tot al of 98 cycles were administered with a median of three cycles/patient. Tw o complete (CR=8%) and three partial (PR=12%) responses were observed (over all 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 mont hs, the median time to tumour progression (TTP) was 6 months and the overal l median survival was 8 months. The 1-year survival rate was 26%. Grade 3 a nd 4 granulocytopenia occurred in 36 and 20% of the patients, respectively, and febrile neutropenia was observed in 16% of them; there were no treatme nt-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. (C) 2001 Elsevier Science Ltd. All rights reserved.