Uracil-tegafur as an adjuvant for hepatocellular carcinoma: a randomized trial.

Abstract

Frequent recurrence of hepatocellular carcinoma (HCC) after surgery remains a major clinical problem. This randomized controlled trial evaluated whether postoperative adjuvant therapy with oral uracil-tegafur (UFT) prevents recurrence of HCC. A total of 160 patients who underwent curative hepatic resection for HCC were randomly assigned to receive either 300 mg/day of UFT for 1 year after surgery (n = 79, UFT group) or surgery alone (n = 80, control group). The primary endpoint was recurrence-free survival, and the secondary endpoint was overall survival. Other study variables included liver function and type of recurrence. During a median follow-up of 4.8 years (range: 0.5-7.9), recurrence-free survival curves in the groups were similar (P = .87). Overall survival was slightly but not significantly worse in the UFT group than in the control group (P = .08). The rates of recurrence-free and overall survival at 5 years were 29% and 58%, respectively, in the UFT group, as compared with 29% and 73%, respectively, in the control group. The hazard ratio for recurrence in the UFT group, relative to the control, was 1.01 (95% confidence interval: 0.84-1.22, P = .87). The proportion of patients with advanced recurrence (i.e., multiple, extrahepatic, or associated with vascular invasion) was significantly higher in the UFT group (74%, 43 of 58 patients with recurrence) than in the control group (53%, 30 of 57) (P = .02). In conclusion, our results offer no evidence to support potential benefits of adjuvant chemotherapy with UFT after surgery in patients with HCC and suggest that such treatment may even worsen overall survival.

• Authors: Kiyoshi Hasegawa, Tadatoshi Takayama, Masayoshi Ijichi, Yutaka Matsuyama, Hiroshi Imamura, Keiji Sano, Yasuhiko Sugawara, Norihiro Kokudo, Masatoshi Makuuchi
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 44 Issue 4 Pg. 891-5 (Oct 2006) ISSN: 0270-9139 [Print] United States
• PMID: 17006925 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Tegafur
• Uracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Hepatocellular (drug therapy, surgery)
• Chemotherapy, Adjuvant
• Disease-Free Survival
• Female
• Follow-Up Studies
• Humans
• Liver Neoplasms (drug therapy, surgery)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (prevention & control)
• Survival Rate
• Tegafur (administration & dosage)
• Uracil (therapeutic use)