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Adjuvant Therapy With Capecitabine Postpones Recurrence of Hepatocellular Carcinoma After Curative Resection: A Randomized Controlled Trial

Annals of Surgical Oncology volume 17, pages 3137–3144 (2010)Cite this article

Abstract

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.

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Acknowledgment

This work was supported by The State Key Project on Infection Diseases of China (Grant No. 2008ZX10002-025) and Foundation of Science and Technology Committee of Shanghai Municipal Government (Grant No. 09411960200).

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Affiliations

  1. The First Department of Comprehensive Treatment, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China

    Yong Xia MD, Yinghe Qiu MD, Jun Li MD, Lehua Shi MD, Kui Wang MD, Tao Xi MD, Feng Shen MD, Zhenlin Yan MD & Mengchao Wu MD

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Correspondence to Zhenlin Yan MD.

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Xia, Y., Qiu, Y., Li, J. et al. Adjuvant Therapy With Capecitabine Postpones Recurrence of Hepatocellular Carcinoma After Curative Resection: A Randomized Controlled Trial. Ann Surg Oncol 17, 3137–3144 (2010). https://doi.org/10.1245/s10434-010-1148-3

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Keywords

  • Overall Survival
  • Capecitabine
  • Hepatocyte Growth Factor
  • pTNM Stage
  • Hepatocyte Growth Factor Level