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

✍ Scribed by Pedro M. Sanz-Altamira; Karen Ferrante; Roger L. Jenkins; W. David Lewis; Mark S. Huberman; Keith E. Stuart

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 65 KB
• Volume: 82
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19980615)82:12<2321::aid-cncr4>3.0.co;2-v

✦ Synopsis

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.