Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer

摘要: The aim of this study was to test the efficacy a chemotherapy combination cisplatin, IFN alpha-2b, doxorubicin, Adriamycin, and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer biliary tree. Forty-one patients (19 gallbladder carcinoma 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting doses follows: 80 mg/m(2) i.v. over 2 h; 40 5-fluorouracil, 500 by continuous infusion daily 3 days. alpha-2b (5 x 10(6) units/m(2)) administered s.c. before cisplatin thereafter total four doses. overall response rate 21.1% [95% confidence interval (CI), 10-37]. For cholangiocarcinoma patients, rates 9.5% (95% CI, 1-32%) 35.3% 14-62%), respectively. Overall median survival time 14 months 9.5-18.5), 18.1 12.1-24.1) 11.5 5.9-17.1) patients. This difference not statistically significant. most common grade III IV toxicities neutropenia (41%), thrombocytopenia (20%), nausea vomiting (34%), fatigue (20%). In conclusion, PIAF seemed more active against than but associated significant toxicity. Therefore, regimen cannot be recommended cholangiocarcinoma, it may have role in carcinoma, particularly among who refractory higher priority investigational agents.