For For patients with advanced hepatocellular carcinoma (HCC), especially those with macrovascular invasion, stereotactic radiation therapy (SBRT) appears to offer a survival benefit when combined with systemic therapy. This is the result of a Phase 3 clinical trial presented at the American Society for Radiation Oncology Annual Meeting.
For inoperable HCC or in cases that cannot be treated with thermal ablation or regional therapy, the current standard of care is systemic therapy.When the study was conducted, the recommended therapy was sorafenib, a tyrosine kinase inhibitor. However, since the publication of the IMbrave-150 study in 2021, atezolizumab plus bevacizumab is increasingly preferred by some oncologists.
In 2008, the SHARP study found that sorafenib improves median survival but provides fewer benefits in patients with macrovascular invasion. Various studies have looked at whether radiation could improve the survival of this group of patients, but the results have not been encouraging. Direct comparisons between sorafenib and radiotherapy in the study periods; SARAH and SIRveNIB found no significant differences in outcome.
To determine the efficacy of the combined SBRT and sorafenib, researchers randomly assigned 177 patients with locally advanced HCC to either 400 mg sorafenib every 12 hours or SBRT with 27.5-50 Gy in 5 fractions, followed by 200 mg sorafenib every 12 hours for 4 weeks and then 400 mg sorafenib every 12 hours.The average age of patients was 66 years, 85% of patients were male, and 74% had macrovascular invasion. The study enrolled patients with locally advanced tumors up to a total diameter of 20 cm or up to a conglomerate tumor of 20 cm, as well as patients with metastases of 3 cm in size or less.
After a median follow-up of 13.2 months, the median OS was 15.8 months in the combination group vs. 12.3 months in the sorafenib group (HR 0.77; 1-sided p=0.055). After a multivariable analysis, combined treatment was associated with better OS (HR 0.72; p=0.042).
«This overall survival rate is higher than expected and impressive even in today’s era of immunotherapy trials,» said Dr. Laura Dawson, who presented the study’s findings at a press conference at the meeting. Dr. Dawson is Professor of Radiation Oncology at the University of Toronto and Radiation Oncologist at Princess Margaret Hospital in Toronto.
Median PFS was 9.2 months in the combination group vs.5.5 months in the pure sorafenib group (HR 0.55; p=0.0001). At 24 months, 17% of the combination group and 7% of the sorafenib group were without progression. The median time to progression was 18.5 months in the combination group and 9.5 months in the sorafenib group (HR 0.69; p=0.034). The frequency of adverse events was similar in both groups. The study enrolled patients with any degree of vascular invasion, in contrast to many previous studies that excluded patients with main portal vein involvement.
«I think this is really one of the most important studies that has come out in recent years in terms of practice-changing results. We have seen that in patients with high-risk HCC, especially in patients with portal vein or macrovascular invasion, there has been a significant improvement in overall survival, and this is a very difficult group of patients. The addition of SBRT in this group improved both progression-free survival and overall survival, so I think we’re really at a point where we can call this standard of care for patients,» said Karyn A.Goodman, MD, Professor and Vice Chair of Clinical Research and Radiation Oncology at the Icahn School of Medicine at Mount Sinai, New York.
One limitation of the study is that patient recruitment was terminated prematurely due to a change in the standard of care.
This article was originally published on MDedge.com.
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Source — https://www.univadis.de/viewarticle/stereotaktische-strahlentherapie-zeigt-nutzen-bei-fortgeschrittenem-leberkrebs