“COMPARISON OF EFFICACY OF LOW DOSE AND HIGH DOSE SORAFENIB IN PATIENTS OF HEPATOCELLULAR CARCINOMA”
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Keywords
Hepatocellular carcinoma; Sorafenib; Low-dose therapy; High-dose therapy; Drug efficacy; Adverse effects; Progression-free survival; Targeted therapy; Cost-effectiveness; multiple centers including Bahawal Victoria Hospital Bahawalpur, Sheikh Zayad Teaching Hospital and Omer diagnostic and specialist hospital Islamabad.
Abstract
Background: Hepatocellular carcinoma (HCC) is one of the most common causes of cancer-related deaths all over the world, and there are few treatment options in the case of advanced disease. Sorafenib is a multikinase inhibitor, which is the standard systemic therapy for unresectable HCC. However, the best dose that is acceptable and at the same time effective is still in debate, particularly in countries with limited resources, such as Pakistan.
Objective: To compare the efficacy and safety of low-dose and high-dose sorafenib in patients with hepatocellular carcinoma in JPMC, Karachi.
Methods: The proposed comparative study was conducted at multiple centers including Bahawal Victoria Hospital Bahawalpur, Sheikh Zayad Teaching Hospital and Omer diagnostic and specialist hospital Islamabad. Total 80 patients with confirmed HCC during the period between March 2024 to February, 2025. Group A was low-dose sorafenib (200mg twice a day), and Group B was high-dose sorafenib (400mg twice a day). The tumor response was evaluated using the assistance of the RECIST 1.1 criteria, and the adverse events were assessed using the CTCAE v5.0 criteria.
Results: The overall response rate of the low-dose group was 45% and the high-dose group was 57.5% (p = 0.21). The progression-free survival was a little higher in the high-dose group (7.4 months vs. 6.8 months), but the difference was not significant. Nevertheless, poisoning related to treatment, including hand-foot skin reaction and diarrhea, was much more common with the high-dose group (p < 0.05).
Conclusion: The low-dose sorafenib showed a similar effect to the high-dose regimen but with significantly fewer side effects. It is a safer, cost-effective, and better-tolerated therapy for patients with hepatocellular carcinoma in Pakistan.
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Dr Omer Hassaan Aftab Ahmad
Consultant Gastroenterologist, Omer Diagnostics and Specialist Clinics G8 Markaz, Islamabad
Dr Sher Alam
Consultant and Assistant Professor Gastroenterology, Shaikh Zayed University Teaching Hospital
Dr Shan Alam
Senior Gastroenterologist, DHQ Hospital Gilgit
Dr Abid Ali Rana
Assistant Professor Gastroenterology, Bahawal Victoria Hospital Bahawalpur
Dr Muhammad Waseem Sharif
Medical Officer, Bahawal Victoria Hospital Bahawalpur
Dr Tanveer Ahmed
Senior Registrar Gastroenterology, Bahawal Victoria Hospital Bahawalpur