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Phase II Trial of Cisplatin, Interferon -2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer¹

Department of Gastrointestinal Medical Oncology and Digestive Diseases [Y. Z. P., M. M. H., A. I. F., S. L., I. I. S., I. R.], Division of Pharmacy [R. D. L.], Departments of Diagnostic Radiology [K. A. W.], Clinical Cancer Prevention [A. M. H.], and Surgical Oncology [L. E., J. N. V., S. A. C.], The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030

The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN -2b, doxorubicin, Adriamycin, and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting chemotherapy doses were as follows: cisplatin, 80 mg/m² i.v. over 2 h; doxorubicin, 40 mg/m² i.v. over 2 h; and 5-fluorouracil, 500 mg/m² by continuous infusion daily for 3 days. IFN -2b (5 x 10⁶ units/m²) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was 21.1% [95% confidence interval (CI), 10–37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates were 9.5% (95% CI, 1–32%) and 35.3% (95% CI, 14–62%), respectively. Overall median survival time was 14 months (95% CI, 9.5–18.5), 18.1 months (95% CI, 12.1–24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9–17.1) for the gallbladder carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia (41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore, this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma, particularly among patients who were refractory to higher priority investigational agents.

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