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

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.

SBRT vs. Y90

“…The 2021 HERACLES study was a prospective, 2-arm, nonrandomized study analyzing the role of SBRT and TACE in patients with HCC. 12 Patients received either TACE or SBRT according to the decision reached by the institution's tumor board. SBRT was indicated for patients who were not candidates for TACE or systemic treatment.…”

“…Other studies of patients treated with SBRT have shown similar cohort characteristics, specifically that SBRT cohorts have greater disease burden with high rates of previous treatment. The 2021 HERACLES study was a prospective, 2-arm, nonrandomized study analyzing the role of SBRT and TACE in patients with HCC 12 . Patients received either TACE or SBRT according to the decision reached by the institution’s tumor board.…”

Dosimetric Comparison of Intraoperative Radiotherapy and SRS for Liver Metastases

“…The utility of radiotherapy as stereotactic body radiotherapy (SBRT) has caused a resurge of the specialty in this scenario. Recent clinical data are progressively clarifying the differences between SBRT with other strategies, namely, trans-arterial chemoembolization (TACE), showing at least comparable outcomes in terms of toxicity and control outcomes ( 12 ). The rationale for selecting IORT and SRS as treatment schemes lies on the capacity of reproducing a surgical cavity from a tangible target structure.…”

S3-Leitlinie „Diagnostik und Therapie des Hepatozellulären Karzinoms“ – Langversion 4.0

“…In einer prospektiven nicht-randomisierten Beobachtungsstudie („HERACLES“), wurde die TACE mit der SBRT verglichen. Dabei lag die kumulative Inzidenz einer lokalen Progression nach 1, 2- und 3 Jahren bei 6 %, 6 % und 6 % nach der SBRT und bei 28 %, 39 % und 65 % nach TACE (p = 0.02) Die Lebensqualität war nach der SBRT nicht eingeschränkt und das Risiko für drittgradige Nebenwirkungen gering 332 . Bei der Durchführung der SBRT sollten Qualitätskriterien wie z.…”