Efficacy of Stereotactic Body Radiotherapy in Patients With Hepatocellular Carcinoma Not Suitable for Transarterial Chemoembolization (HERACLES: HEpatocellular Carcinoma Stereotactic RAdiotherapy CLinical Efficacy Study).

Thomas B Brunner,Eleni Gkika,Christian Goetz,Gabriele Ihorst,Nils Henrik Nicolay,Lukas Sturm,Dominik Bettinger,Hannes P Neeff,Ivana Koundurdjieva,Fabian Bamberg,Lars Maruschke,Robert Thimme,Simon Kirste,Anca-Ligia Grosu,Nico Bartl,Michael Schultheiss

doi:10.3389/fonc.2021.653141

Abstract

The aim of this prospective observational trial was to evaluate the efficacy, toxicity and quality of life after stereotactic body radiation therapy (SBRT) in patients with hepatocellular carcinoma (HCC) and to assess the results of this treatment in comparison to trans-arterial chemoembolization (TACE). Patients with HCC, treated with TACE or SBRT, over a period of 12 months, enrolled in the study. The primary endpoint was feasibility; secondary endpoints were toxicity, quality of life (QOL), local progression (LP) and overall survival (OS). Between 06/2016 and 06/2017, 19 patients received TACE and 20 SBRT, 2 of whom were excluded due to progression. The median follow-up was 31 months. The QOL remained stable before and after treatment and was comparable in both treatment groups. Five patients developed grade ≥ 3 toxicities in the TACE group and 3 in the SBRT group. The cumulative incidence of LP after 1-, 2- and 3-years was 6, 6, 6% in the SBRT group and 28, 39, and 65% in the TACE group (p = 0.02). The 1- and 2- years OS rates were 84% and 47% in the TACE group and 44% and 39% in the SBRT group (p = 0.20). In conclusion, SBRT is a well-tolerated local treatment with a high local control rates and can be safely delivered, while preserving the QOL of HCC patients.

Highlights

The incidence and mortality of hepatocellular carcinoma (HCC) is rising worldwide due to the rise of viral hepatitis and nonalcoholic steatohepatitis (NASH) [1]
Patient Characteristics Between 06/2016 and 06/2017, patients received trans-arterial chemoembolization (TACE) and patients were planned for stereotactic body radiation therapy (SBRT); SBRT was halted in two patients due to progression (Figure 1), resulting in 18 evaluable patients
In patients with Barcelona Clinic Liver Cancer (BCLC) stage B TACE appears to be the treatment with the best quality of evidence leading to an improvement of the overall survival (OS), in advanced HCC, which poses a more heterogeneous group, the selection of treatment type depends on many factors such as the performance status of the patient, the underlying cirrhosis, the presence of metastases or the extent of macrovascular extension [9]

Summary

Introduction

The incidence and mortality of hepatocellular carcinoma (HCC) is rising worldwide due to the rise of viral hepatitis and nonalcoholic steatohepatitis (NASH) [1]. In about 15–20% of the patients who would benefit from local therapy, none of those treatments can be offered, due to the respective limitations and contraindications, such as decompensated cirrhosis, tumor extension, severely reduced portal flow, renal insufficiency [3]. For these patients, SBRT could be offered as an alternative local ablative therapy with high rates of local control [4], while maintaining a good quality of life [5, 6]. The aim of this study was to assess the feasibility of SBRT in everyday clinical practice, in patients with HCC, prior to a randomized trial

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Conclusion