A phase II trial of 5‐fluorouracil, leucovorin, and carboplatin in patients with unresectable biliary tree carcinoma

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Abstract
BACKGROUND Unresectable adenocarcinoma of the biliary tree are associated with a very poor prognosis. 5‐fluorouracil (5‐FU) combination regimens have produced objective response rates in approximately 10‐20% of patients. Leucovorin increases the selective cytotoxicity of 5‐FU. There also are encouraging reports of carboplatin in combination with 5‐FU in other gastrointestinal tract malignancies. METHODS Fourteen consecutive eligible patients were treated with a combination of carboplatin, 300 mg/m2, intravenously (i.v.) on Day 1 only and 5‐FU, 400 mg/m2, i.v. with leucovorin, 25 mg/m2, i.v. on Days 1‐4. All patients were required to have a histologically confirmed diagnosis and measurable disease. Patients were evaluated for response, survival, and toxicity. RESULTS A total of 48 cycles of therapy were delivered. The median survival was 5 months. One patient achieved complete remission and two others partial remission, for a total response rate of 21.4%. Four additional patients had stable disease for a median duration of 4 months. The therapy was well tolerated, with moderate myelosuppression as the main dose‐limiting toxicity. CONCLUSIONS The current combination regimen of leucovorin‐modulated 5‐FU with carboplatin is well tolerated with appropriate supportive care, produces significant objective responses in 21% of patients with biliary tree carcinoma, and should be considered for the treatment of this disease. Cancer 1998;82:2321‐2325. © 1998 American Cancer Society.

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