Adjuvant therapy with capecitabine postpones recurrence of hepatocellular carcinoma after curative resection: a randomized controlled trial.

BACKGROUND: Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective in preventing or delaying recurrence. The aim of this prospective randomized study was to evaluate the effectiveness of capecitabine as a postoperative adjuvant regimen in inhibiting the recurrence of HCC. MATERIALS AND METHODS: Between August 2003 and January 2005, 60 HCC patients who underwent curative resection were randomized into a capecitabine (n = 30) or a control (n = 30) group. The capecitabine group received 4-6 episodes of capecitabine treatment plus routine supportive care. Each episode consisted of 2 weeks of capecitabine followed by 1-week rest. The control group received routine supportive care only. The follow-up was 4-65 months (median: 47.5 months). RESULTS: Cancer recurred in 16 patients (53.3%) in the capecitabine group and in 23 patients (76.7%) in the control group. The median time to recurrence (TTR) was 40.0 months (95% confidence interval [95% CI], 31.0-49.2 months) and 20.0 months (95% CI, 12.8-27.2 months) in the capecitabine and control groups, respectively (P = 0.046). The 5-year overall survival rate was 62.5% and 39.8% in the capecitabine group and control group, respectively (P = .216). Adverse reactions to capecitabine were generally mild and included nausea, vomiting, diarrhea, and decreased white blood cell and/or platelet counts. CONCLUSION: Postoperative adjuvant therapy with capecitabine is well tolerated, postpones the recurrence of HCC, and reduces the risk of tumor recurrence. In addition, it is likely to improve postoperative survival.