Efficacy and Safety of Sorafenib Versus Supportive Care in Egyptian Advanced Hepatocellular Carcinoma Patients

El Baghdady, Noha; Elwakeel, Lamia; Ellithy, Mahmoud; Hussein, Nawal; Shahin, Sara; El Naggar, Abdel Rahman

doi:10.21608/aps.2020.45180.1043

Efficacy and Safety of Sorafenib Versus Supportive Care in Egyptian Advanced Hepatocellular Carcinoma Patients

Document Type : Original Article

Authors

¹ Department of Clinical Pharmacy , New Giza School of Pharmacy, Giza, Egypt.

² Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, POX 11566, Cairo, Egypt

³ Department of Oncology, Faculty of Medicine Ain Shams University, Egypt

⁴ Medical Oncology Department, Electricity Hospital, Cairo, Egypt.

⁵ Clinical Pharmacology Department, Faculty of Medicine, Cairo University, Egypt

10.21608/aps.2020.45180.1043

Abstract

Objectives: Sorafenib is the standard first-line treatment for HCC. No sufficient data exists regarding its efficacy in the Egyptian population being a costly medication that is not endorsed by insurance and hence is not used in most institutions. This study aimed to evaluate the overall survival [OS], progression-free survival [PFS] and quality of life [QOL] of Egyptian HCC patients receiving sorafenib versus supportive care.
Design: A Prospective cohort observational study.
Setting: Electricity Hospital, Medical Oncology Department-Ain Shams University, and Nasser Institute for Research and Treatment, Egypt
Subjects: Fifty-five patients with HCC were eligible for enrolment in the trial. Eligible HCC patients were stratified into one of two groups based on institutions’ protocols for HCC treatment. Group (1) received supportive care [n= 20] and Group (2) received sorafenib [n=35]; the patients follow up were continued for one year after diagnosis.
Main outcome measures: Patients’ survival, PFS, and QOL.
Results: The one-year survival rates were 0.0% and 75.5% [p= 0.008] for group (1) versus group (2), respectively. The median PFS was 5 months and 12 months for group (1) versus group (2), respectively [p= 0.008]. The QOL of the sorafenib group was better than the supportive care group [p = 0.047]. The most common side effects with sorafenib were diarrhoea [42.8%] and hand-foot syndrome [34.2%]. In the sorafenib group, 48.57 % of the patients were requiring dose reduction.
Conclusion: Sorafenib was an effective first-line therapy in Egyptian HCC patients with a superior QOL, OS and PFS than those receiving supportive care.

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