Patterns of Toxicity and Treatment Discontinuation in Egyptian Hepatocellular Carcinoma (HCC) Patients Receiving Sorafenib Monotherapy

Abstract

Introduction: Sorafenib, a multikinase inhibitor, is the only approved systemic therapy for advanced hepatocellular carcinoma; however a number of side effects remains challenging in management; thus we have explored our database to determine patterns of toxicity and treatment discontinuation in our patients. Methods: HCC patients treated at Ain Shams University Hospitals, Clinical Oncology Department (Cairo, Egypt) in the period between2010-2012 were reviewed. Eligible patients were those who had complete information on date of diagnosis, histopathological or radiological confirmation of the diagnosis and received sorafenib for advanced HCC not eligible for or progressed after surgery or locoregional therapy. We investigated the toxicity and treatment discontinuation patterns in our HCC patients. Results: 41 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 6.1 months (95% CI 3.2-8.7); the median OS for the whole group is 7.05 months (95% CI 5.58-8.43). The median duration of treatment was 4 months (range, 1 to 18). Adverse events that were reported for patients receiving sorafenib were predominantly grade 1 or 2 in severity and gastrointestinal or dermatologic in nature. HFSR of all grades occurs in 61% and grade 3/4 in 38%. Liver dysfunction of all grades occurs in 11% and grade 3/4 in 7%. Rash/desquamation of all grades occurs in 7% and grade 3/4 in 3%. Diarrhea of all grades occurs in 30% and grade 3/4 in 0%. Fatigue of all grades occurs in 26% and grade 3/4 in 3%. The most common reasons for discontinuation in our patients were progression (33 patients), intolerable toxicity (7 patients; of which 5 patients due to HFSR) and death (one patient). Conclusion: According to our data, the use of sorafenib in advanced HCC should be under the supervision of appropriately qualified and trained physicians due to the very peculiar side effect profile. Educational programs for patients and their caregivers are highly recommended.