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Article first published online: 6 JAN 2005
Copyright © 2005 American Cancer Society
Volume 103, Issue 4, pages 756–762, 15 February 2005
How to Cite
Ikeda, M., Okusaka, T., Ueno, H., Takezako, Y. and Morizane, C. (2005), A phase II trial of continuous infusion of 5-fluorouracil, mitoxantrone, and cisplatin for metastatic hepatocellular carcinoma. Cancer, 103: 756–762. doi: 10.1002/cncr.20841
Presented at the 35th meeting of the American Society of Clinical Oncology (Atlanta, GA, May 15-18, 1999); 40th meeting of the American Society of Clinical Oncology (New Orleans, LA, June 5-8, 2004); and the 2004 Gastrointestinal cancer symposium (San Francisco, CA, January 22-24, 2004)
The current study was planned originally by Dr. Shuichi Okada, who died of cancer in 2002 at the age of 45 years old. The authors appreciate his dedicated work. His contributions will be sadly missed.
- Issue published online: 3 FEB 2005
- Article first published online: 6 JAN 2005
- Manuscript Accepted: 22 OCT 2004
- Manuscript Revised: 13 OCT 2004
- Manuscript Received: 2 AUG 2004
- Ministry of Health and Welfare, Japan
- hepatocellular carcinoma;
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).
Fifty-one patients with metastatic HCC who had not undergone previous systemic chemotherapy were enrolled. The therapy consisted of intravenous administration of 80 mg/m2 cisplatin and 6 mg/m2 mitoxantrone on Day 1 and continuous intravenous infusion of 450 mg/m2 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.
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.
FMP therapy had significant antitumor activity with acceptable toxicity in patients with metastatic HCC. Cancer 2005. © 2005 American Cancer Society.