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ASCO GI 2023: Phase III Study Combines SBRT and Sorafenib in Hepatocellular Carcinoma

By: Vanessa A. Carter, BS
Posted: Monday, January 23, 2023

Laura A. Dawson, MD, FRCPC, of Princess Margaret Cancer Centre, Toronto, and colleagues evaluated whether the addition of stereotactic body radiation therapy (SBRT) to sorafenib treatment might improve survival outcomes in patients with hepatocellular carcinoma. The results of this trial, presented during the 2023 American Society of Clinical Oncology (ASCO) GI Cancers Symposium (Abstract 489), suggest that SBRT improved both progression-free and overall survival compared with sorafenib alone and did not increase the frequency of adverse events.

The investigators focused on 177 patients with newly diagnosed or recurrent hepatocellular carcinoma who were deemed unsuitable for surgery or ablation. Participants were randomly assigned to receive sorafenib alone (n = 92) or following SBRT (n = 85).

The median patient age was 66 years, and 40% of patients had a single hepatocellular carcinoma. With a median follow-up of 13.2 and 33.7 months for all and living patients, respectively, 22% of individuals received SBRT after discontinuing sorafenib. There were 153 overall survival events, and the median overall survival was improved from 12.3 months with sorafenib alone to 15.8 months when combined with SBRT; median progression-free survival improved from 5.5 to 9.2 months (P = .0001).

Adverse events included eight cases of grade 3 or higher bleeding, affecting five patients and three patients in the sorafenib and SBRT-plus-sorafenib arms, respectively. Although prevalent, treatment-related adverse events of grade 3 or higher did not statistically differ between groups (42% vs. 47%). Adverse events of grade 5 included hepatic failure, lung infection, and death (n = 1 each). Of note, 35% of patients given SBRT plus sorafenib reported having an improved quality of life compared with 10% given sorafenib alone.

Disclosure: For full disclosures of the study authors, visit

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