P-0087 - Patterns of efficacy, toxicity and treatment discontinuation in Egyptian hepatocellular carcinoma (HCC) patients receiving capecitabine monotherapy

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter Omar Abdel-Rahman
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors M. Abdel Wahab
  • Ain Shams University, Cairo/EG

Abstract

Introduction

The burden of hepatocellular carcinoma (HCC) has been increasing in Egypt in the past 10 years. Sorafenib which is the only approved systemic agent for advanced HCC is not affordable economically for the vast majority of HCC patients in Egypt; a preliminary study suggested that capecitabine may be effective in advanced HCC thus we explored the use of capecitabine monotherapy for HCC in this phase 2 study.

Methods

HCC patients treated at Ain Shams University Hospitals, Clinical Oncology Department (Cairo, Egypt) in the period between2010-2012 were reviewed. The study population consisted of patients with advanced-stage hepatocellular carcinoma, as confirmed by pathological analysis or by typical radiological criteria. Patients were classified as having advanced disease if they were not eligible for or had disease progression after surgical or locoregional therapies. We investigated the efficacy, toxicity and treatment discontinuation patterns in our cohort of advanced HCC patients receiving capecitabine monotherapy.

Results

21 patients were included in the analysis fulfilling the inclusion criteria. At a median follow up period of 13 months, the median PFS for the whole group was 3.9 months (95% CI 3.6-4.3); the median OS for the whole group is 5.07 months (95% CI 4.65-5.48).only 3% of our patients achieved partial response, 53% achieved stable disease while the rest of our patients had progressive disease. The median duration of treatment was 4 months (range, 1 to 8). Adverse events that were reported for patients receiving capecitabine were predominantly grade 1 or 2 in severity and gastrointestinal or hepatotoxic in nature. HFSR of all grades occurs in 46% and grade ¾ in 3%. Liver dysfunction of all grades occurs in 34% and grade ¾ in 11%. Thrombocytopenia of all grades occurs in 38% and grade ¾ in 7%. Diarrhea of all grades occurs in 30% and grade ¾ in 4%. Fatigue of all grades occurs in 11% and grade ¾ in 0%. The most common reasons for discontinuation in our patients were progression (17 patients), intolerable toxicity (4 patients; of which 3 patients due to hepatic toxicity).

Conclusion

According to our preliminary data, capecitabine monotherapy for advanced HCC has a high risk side effect profile with minimal efficacy; we do not recommend its routine use outside the setting of a clinical trial.