770 - Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter Manal Abdelwahab
Authors M. Abdelwahab1, M. Shaker2, S. Abdelwahab1, M. Elbassiouny1, M. Ellithy1, O. Abdelrhman1
  • 1Clinical Oncology, Ain Shams University, 113331 - Cairo/EG
  • 2Tropical Medicine, Ain Shams University, Cairo/EG

Abstract

Background

The only approved systemic therapy for patients with advanced hepatocellular carcinoma (HCC) till now is sorafenib. a preliminary study suggested that capecitabine, an oral fluoropyrimidine may be effective in advanced HCC. We have tested this hypothesis in this phase 2 study.

Methods

In this single centre, phase 2, open label trial, we randomly assigned 52 patients with advanced HCC who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or capecitabine 1000 mg/m2 twice daily (day 1-day 14). Primary outcomes were progression free survival. Secondary outcomes included the overall survival and safety.

Results

Median overall survival was 7.05 months in the sorafenib group and 5.07 months in the placebo group (hazard ratio in the capecitabine group, 2.36; 95% confidence interval, 1.174-4.74; P < 0.016). The median progression free survival was 6 months in the sorafenib group and 4 months in the capecitabine group (P < 0.005). Three patients in the sorafenib group (11.5%) and 1 patient in the capecitabine group (3%) had a partial response; one patient (3%) had a complete response in the sorafenib group. hand–foot skin reaction was more frequent in the sorafenib group, hyperbilirubinemia was more common in the capecitabine group and diarrhea was equivalent between both groups.

Conclusions

In patients with advanced HCC, capecitabine monotherapy is inferior to sorafenib in terms of median progression free survival and overall survival and it should not be used alone for the treatment of advanced HCC but rather combination therapy of capecitabine plus sorafenib should be considered for further randomized clinical trials.

Disclosure

All authors have declared no conflicts of interest.