Effectiveness and Toxicity Profile of Reduced Dose Sorafenib for the Treatment of Hepatocellular Carcinoma: A Retrospective, Single Institutional Experience.

Background The treatment with sorafenib in hepatocellular carcinoma (HCC) is affected by toxicity and discontinuation rates. There is limited data on whether ensuring compliance by reducing the dose of sorafenib can influence outcomes. Methods In this retrospective study, we used hospital records to retrieve data on patients treated with low-dose sorafenib (400 mg /day) from July 2017 to June 2022 at the Malabar Cancer Centre, Thalassery. Results During the study period, 80 patients received low-dose sorafenib for HCC. Sixty-eight (85%) patients were males with median age being 62 years, ranging from 17 to 79 years. More than three-fourths (76.2%) of the patients had Barcelona stage C and nearly one-third (31.2%) had Child-Pugh B status. Alcohol consumption and obesity were seen in 36 (45%) and 24 (30%) patients respectively. Clinical benefit rate (at least stable disease) at three months was seen for 45 (56.25%) patients. The median follow-up was six months. The median progression-free survival (PFS) and overall survival (OS) were 3.68 (CI 2.89-4.46) and 5.26 (CI 3.26-7.27) months respectively. Nine patients (11.25%) had grade 3 toxicity, and six (7.5%) patients stopped sorafenib due to toxicity despite dose reduction. Conclusion In comparison to other published landmark studies, our study demonstrates that reduced dose sorafenib in advanced hepatocellular carcinoma has a similar response rate and progression-free survival with lesser toxicity. In the real world, a reduced dose of sorafenib is nevertheless effective when tolerance and cost are concerns. Additionally, since a third of the study cohort has Child-Pugh B, a reduced dose of sorafenib may be a choice for these patients.