Premium
A phase II trial of continuous infusion of 5‐fluorouracil, mitoxantrone, and cisplatin for metastatic hepatocellular carcinoma
Author(s) -
Ikeda Masafumi,
Okusaka Takuji,
Ueno Hideki,
Takezako Yoriko,
Morizane Chigusa
Publication year - 2005
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.20841
Subject(s) - medicine , leukocytopenia , mitoxantrone , neutropenia , gastroenterology , chemotherapy , fluorouracil , toxicity , hepatocellular carcinoma , phases of clinical research , cisplatin , surgery
BACKGROUND The aim of the current study was to evaluate the antitumor activity and toxicity of continuous infusion of 5‐fluorouracil, mitoxantrone, and cisplatin (FMP therapy) in chemotherapy‐naive patients with metastatic hepatocellular carcinoma (HCC). METHODS Fifty‐one patients with metastatic HCC who had not undergone previous systemic chemotherapy were enrolled. The therapy consisted of intravenous administration of 80 mg/m 2 cisplatin and 6 mg/m 2 mitoxantrone on Day 1 and continuous intravenous infusion of 450 mg/m 2 5‐fluorouracil per day on Days 1–5. The treatment was repeated every 4 weeks for a maximum of 6 courses with dose adjustments based on the observed toxic effects if there was no evidence of tumor progression or unacceptable toxicity. RESULTS Of the 51 enrolled patients, 14 (27%) achieved a partial response (95% confidence interval, 16–42%) with a median duration of 7.6 months (range, 2.3–18.4 months). Twenty‐seven patients (53%) showed no change and 9 (18%) had progressive disease. The median survival time, 1‐year survival rate, and median progression‐free survival time for all patients were 11.6 months, 44.3%, and 4.0 months, respectively. The main Grade 3 and 4 toxicities were leukocytopenia (67%), neutropenia (71%), thrombocytopenia (27%), and elevated levels of aspartate aminotransferase (37%) and alanine aminotransferase (41%). These symptoms were generally brief and reversible, with the exception of one treatment‐related death due to acute hepatic failure. CONCLUSIONS FMP therapy had significant antitumor activity with acceptable toxicity in patients with metastatic HCC. Cancer 2005. © 2005 American Cancer Society.