Add Stereotactic body radiation therapy (SBRT) seems to provide a survival benefit to patients with advanced hepatocellular carcinoma (HCC), especially those with macrovascular invasion. This is the result of a clinical trial of phase 3 presented at the annual meeting of the American Society for Radiation Oncology.
The current standard of care for unresectable HCC or cases that cannot be treated with thermal ablation or regional therapy is systemic therapy.When the study was conducted, the recommended therapy was sorafenib, a tyrosine kinase inhibitor. However, after the publication in 2021 of the study IMbrave 150 atezolizumab plus bevacizumab are now increasingly preferred by some oncologists.
In 2008, study SHARP indicated that sorafenib improved median survival but offered fewer benefits to patients with macrovascular invasion. Several studies have tried to clarify whether radiotherapy could improve the survival of this patient population, but the results have not been encouraging. Direct comparisons between sorafenib and radiotherapy in the SARAH and SIRveNIB showed no significant differences in outcomes.
To determine the efficacy of the SBRT and sorafenib combination, researchers randomly assigned 177 patients with locally advanced HCC to receive 400 mg sorafenib every 12 hours or SBRT at a dose of 27.5–50 Gy in 5 fractions, followed by 200 mg sorafenib every 12 hours for 4 weeks, then 400 mg sorafenib every 12 hours thereafter.The median age of patients was 66 years, 85% of patients were male, and 74% of patients had macrovascular invasion. The study included patients with locally advanced tumours with a sum of diameters up to 20 cm or a conglomerate tumour up to 20 cm, as well as patients with metastases of 3 cm or smaller.
After a median follow-up of 13.2 months, median overall survival (OS) was 15.8 months in the combination group compared with 12.3 months in the sorafenib group (HR=0.77; One-sided P=0.055). According to the multivariable analysis, the combination treatment was associated with better OS (HR=0.72; P=0.042).
«Observed overall survival is better than expected and remarkable even in the current era of immunotherapy trials,» says Dr. Laura Dawson, who presented the results of the study at the congress during a press conference.Dr. Dawson is Professor of Radio-Oncology at the University of Toronto and a radiation oncologist at Princess Margaret Hospital in Toronto.
Median progression-free survival (PFS) was 9.2 months in the combination group compared with 5.5 months in the sorafenib alone group (HR=0.55; P=0.0001). After 24 months, 17% of the combination group and 7% of the sorafenib alone group had not progressed. Median time to progression was 18.5 months in the combination group and 9.5–_-months in the sorafenib alone group (HR=0.69; P=0.034). The frequency of adverse events was similar in both groups. The study included patients with any level of vascular invasion, in contrast to many previous trials, which excluded patients with main portal vein involvement.
«I think this is really one of the most important studies published in many years in terms of clinical practice-changing outcomes.We observed that for patients with HCC at very high risk, especially patients presenting with vascular invasion of the portal vein or macrovascular invasion, there was a significant improvement in overall survival; And this is a very difficult patient population. In this group, the addition of SBRT improved both progression-free survival and overall survival, so I think we’ve really come to a point where we can define this [regimen] as a standard of care for patients,» said Dr. Karyn A. Goodman, Professor and Vice President of Clinical Research and Radio-Oncology at the Icahn School of Medicine at Mount Sinai. New York.
A limitation of the study is the early termination of enrollment due to a change in the standard of care.
The article was originally published on MDedge.com.
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Source — https://www.univadis.it/viewarticle/la-radioterapia-stereotassica-corporea-evidenzia-benefici-nel-tumore-epatico-in-stadio-avanzato