Abstract
Immunotherapy has achieved modest clinical activity in HCC patients. Propensity score matching analysis was conducted to compare the efficacy and safety of combined stereotactic SBRT-IO versus TACE in patients with locally advanced HCC in a tertiary center of Hong Kong. Patients with locally advanced HCC who were medically inoperable for, refractory to, or refused to curative surgical interventions were eligible. The primary outcome was PFS; the secondary outcomes were OS, ORR as per mRECIST version 1.1, and TRAEs. Matching pair analysis was performed to compare the clinical outcomes. A total of 226 patients were eligible. Approximately 16 patients in the SBRT-IO group were matched with 48 patients treated with TACE. The median tumor size was 10 cm (range: 2.9–19.6 cm) and 20.3% of the patients had portal vein invasion. The 12- and 24-month PFS were significantly better in the SBRT-IO group (93.3% vs 16.7% and 77.8% vs 2.1%, respectively, p <0.001); the 12- and 24-month OS were also better in the SBRT-IO arm (93.8% vs 31.3% and 80.4% vs 8.3%, respectively, p <0.001). The ORR was 87.5% (CR: 50%, PR: 37.5%) in SBRT-IO arm compared to 16.7% (CR: 2.4%, PR: 14.3%) in those receiving TACE alone (p <0.001). There were fewer ≥grade 3 TRAE (60.4% vs 18.8%, p = 0.004) and treatment discontinuations (25% vs 12.5%, p = 0.295) due to adverse events in the SBRT-IO arm. SBRT-IO had significant superior survival and less treatment toxicity than TACE in patients with locally advanced HCC. Our results provide rationale for studying this combination therapy in prospective randomized trials.
Highlights
Recent advances in cancer immunotherapy have profoundly influenced the care of patients with hepatocellular carcinoma (HCC)
Programmed cell death protein 1/programmed deathligand 1 (PD-1/Programmed death-ligand 1 (PD-L1)) targeted therapies have been increasingly used as first-line and second-line treatments of patients with advanced HCC [1,2,3]
A total of 226 patients with HCC were eligible and enrolled in the present study, namely, 210 patients who initially received Transarterial chemoembolization (TACE) and the remaining 16 who were treated with stereotactic body radiotherapy and immunotherapy (SBRT-IO)
Summary
Recent advances in cancer immunotherapy have profoundly influenced the care of patients with hepatocellular carcinoma (HCC). Programmed cell death protein 1/programmed deathligand 1 (PD-1/PD-L1) targeted therapies have been increasingly used as first-line and second-line treatments of patients with advanced HCC [1,2,3]. Because the primary resistance of HCC may underlie these low response rates, strategies to overcome these primary or secondary resistances to immune checkpoint inhibitors (ICI) using combination therapies such as combined stereotactic body radiotherapy and immunotherapy (SBRT-IO) are under investigation. RT can prime the immune system by enhancing antigen presentation, promoting the infiltration of cytotoxic T-cells, and reprogramming the tumor microenvironment against the immune evasion of cancer, while ICI can reverse the RT-mediated exhaustion pathway [7]. Evidence on the combination of ICI and SBRT in HCC patients is lacking
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