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 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.
Papakostas
P
P
Oncology Unit, Hippokratio General Hospital of, Athens, Greece.
Kouroussis
C
C
Androulakis
N
N
Samelis
G
G
Aravantinos
G
G
Kalbakis
K
K
Sarra
E
E
Souglakos
J
J
Kakolyris
S
S
Georgoulias
V
V
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
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel