Oral doxifluridine in advanced hepatocellular carcinoma: A phase II study

Hepatocellular carcinoma (HCC) remains one of the most common neoplasms in the world, Doxifluridine is an oral fluoropyrimidine derivative activated t o 5-fluorouracil by uridine phosphorylase which is more expressed in malign ant cells. Therefore, we conducted a phase II study to evaluate the activit y of oral doxifluridine in patients with advanced hepatocellular carcinoma. Twenty-five advanced hepatocellular carcinoma patients entered the study; doxifluridine was given orally at the initial daily total dose of 2,250 mg for 4 consecutive days every week. All patients are evaluable for toxicity: these included mainly grade 1-2 (WHO) diarrhea, stomatitis, nausea and vom iting; 4 patients (16%) experienced grade 3-4 diarrhea, Twenty-four patient s are evaluable for response and 1 complete and 3 partial responses have be en observed (response rat 17%, 95% confidence interval: 5-37). Oral doxiflu ridine at the dose and schedule we used, although having only modest activi ty in advanced HCC, may represent an alternative to other frequently used c hemotherapeutic agents, because of its favorable toxicity profile and its s imple route of administration, Copyright (C) 2000 S. Karger AG. Basel.