Efficacy of Stereotactic Ablative Radiotherapy in Patients with Oligometastatic Hepatocellular Carcinoma: A Phase II Study

Abstract

Background & Aims

Stereotactic ablative radiotherapy (SABR) has demonstrated curative potential with survival benefits in patients with oligometastatic disease (OMD). However, limited evidence exists regarding its use in oligometastatic hepatocellular carcinoma (HCC). We aimed to prospectively investigate the efficacy and safety of SABR in patients with oligometastatic HCC.

Methods

We enrolled patients with controlled primary HCC and one to five metastatic lesions amenable to SABR. The primary endpoint was treatment efficacy defined as overall survival (OS) and progression-free survival (PFS). The secondary endpoints included time to local progression, objective response rate, disease control rate, toxicities, and quality of life (QOL), assessed using the EORTC QLQ-C30 before, and 0, 1, and 3 months after SABR.

Results

Overall, 40 consecutive patients received SABR on 62 lesions between 2021 and 2022. The most common locations for OMD were the lungs (48.4%), lymph nodes (22.6%), and bone (17.7%). After a median follow-up of 15.5 months, the 2-year OS was 80%. Median PFS was 5.3 months, with 1- and 2-year rates of 21.2% and 0%, respectively. A shorter time to OMD from the controlled primary independently correlated with PFS (p=0.039, hazard ratio 2.127) alongside age, Child–Pugh class, and α-fetoprotein (p=0.002, 0.004, 0.019). The 2-year time to local progression, objective response rate, and disease control rate were 91.1%, 75.8%, and 98.4%, respectively. Overall, 10% of the patients experienced acute toxicity, and 7.5% experienced late toxicity, with no grade 3+ toxicity. All QOL scores remained stable, whereas the patients without systemic treatments had improved insomnia and social functioning scores.

Conclusions

SABR is an effective and feasible option for oligometastatic HCC, excellently controls local tumors, and improves survival without adversely affecting QOL.

Clinical Trial Number

NCT05173610