Stereotactic body radiation therapy (SBRT) administered prior to Nexavar (sorafenib) was associated with a clinically important but not statistically significant improvement in overall survival (OS) compared with Nexavar alone in patients with locally advanced hepatocellular carcinoma (HCC), according to study findings published in JAMA Oncology.
In the NRG/RTOG1112 trial, after a median follow-up of 13.2 months for all patients and 33.7 months for surviving patients, the median OS was 12.3 months with Nexavar alone versus 15.8 months following treatment with SRBT and Nexavar. After adjusting for stratification factors, the OS continued to show improvement with SBRT and Nexavar. In addition, the median progression-free survival (PFS) rate was improved from 5.5 months with Nexavar alone to 9.2 months with the combination.
Furthermore, improved quality-of-life was seen in two out of 20 patients in the Nexavar alone group and six out of 17 patients in the combo group, at six months.
Of note, 74% of patients had macrovascular invasion, which is a particularly tough presentation of liver cancer. Dr. Laura Dawson, the lead study author, emphasized the importance of considering radiotherapy for patients with this condition.
Regarding safety, grade 3 (severe) treatment-related adverse events (TRAEs, side effects) were experienced by 37 out of 88 patients treated with Nexavar alone, and 39 out of 83 patients treated with SBRT and Nexavar. Dawson discussed the difficulty in determining the direct cause of such side effects, noting that the majority of symptoms are due to the advanced cancer itself.
There were two treatment-related deaths in the Nexavar group (causes unspecified and liver failure) and one in the SBRT and Nexavar group (lung infection).
The primary end goal of this trial was OS, with secondary end goals including PFS, safety, and quality-of-life. Dawson also mentioned the uncertainty of how radiation fits for patients receiving immunotherapy, the current standard of care for many, and the need for further trials to explore the benefits, risks, and best sequencing of these therapies.
