Efficacy and safety of radiotherapy plus anti-PD1 versus transcatheter arterial chemoembolization plus sorafenib for advanced hepatocellular carcinoma: a real-world study

Abstract

Background The combination of transcatheter arterial chemoembolization (TACE) plus sorafenib prolonged progression-free survival (PFS) and overall survival (OS) than sorafenib or TACE monotherapy for patients with hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of radiotherapy (RT) plus monoclonal antibody against programmed cell death 1 (anti-PD1) versus TACE plus sorafenib for patients with advanced HCC. Methods Patients with advanced HCC who treated with RT plus anti-PD1 and TACE plus sorafenib were enrolled. Objective response rate (ORR), PFS, disease control rate (DCR) and OS were calculated to assess the antitumor response and the treatment-related adverse events to the safety. Results Between January 2018 to March 2021, 37 patients underwent RT plus anti-PD1 and 41 patients underwent TACE plus sorafenib. The baseline characteristics between the two groups were comparable. The ORR and DCR were significantly higher in the RT + PD1 group than the TACE plus sorafenib group according to RECIST 1.1 (54.05% vs. 12.20%, P < 0.001; 70.27% vs. 46.37%, P = 0.041; respectively) and according to mRECIST (56.76% vs. 31.71%, P = 0.039; 70.27% vs. 46.37%, P = 0.041; respectively). RT plus anti-PD1 provided significantly better PFS (HR, 0.51; 95% CI 0.30–0.86; P = 0.017) than TACE plus sorafenib. Moreover, patients with RT plus anti-PD1 had significantly higher 3-, 6-, and 9-month OS rates than those with TACE plus sorafenib(97.3% vs. 92.30%, P < 0.001; 91.89% vs. 68.60%, P < 0.001; 75.5% vs. 60.60%, P < 0.001; respectively). The median OS was more favorable 17.4 months for the RT + PD1 group and 11.9 months for the TACE plus sorafenib group. No treatment-related death was observed. Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT + PD1 group than the TACE plus sorafenib group (29.7% vs. 75.6%, P < 0.001), and all TRAEs were manageable. Conclusions In this real-world study, RT plus anti-PD1 showed significantly promising efficacy and manageable safety than TACE plus sorafenib in patients with advanced HCC. Toxicities were manageable, with no unexpected safety signals. The study provides evidence on a new therapeutic method in the treatment of advanced HCC.

A Novel Nomogram to Predict Prognosis of Advanced Hepatocellular Carcinoma Treated with Intensity-Modulated Radiotherapy Plus Anti-PD1

“…Meanwhile, RT plus anti-PD1 was associated with a significantly better OS than TACE plus sorafenib among patients with BCLC stage C (11.8 vs 9.7 months, P = 0.031). 13 Similarly, the feasible efficacy evaluation results showed that the ORR of IMRT combined with anti-PD1 was 56.99%, the PR rate was 51.61%, and the CR rate was 5.38%, with an encouraging OS of 14.3 months in the present study. IMRT combined with anti-PD1 seems to have considerable clinical efficacy in the treatment of advanced HCC.…”

“…The safety of IMRT plus anti -PD1 therapy in this population was consistent with that of RT +PD1 in previously reported studies. 13,14 However, in IMbrave150 study, grade 3 or 4 AEs occurred in 56.5% of patients treated with atezolizumab plus bevacizumab. 6 In summary, no short-term fatal AEs were observed following IMRT and anti-PD1 combination treatment.…”

“…Its efficacy and safety have been previously described. 13 The OS was defined as the time from enrollment to death from any cause. Tumor responses were evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).…”

“… 11 , 12 Therefore, the combination of RT and anti‑PD1 may be a useful strategy to enhance the anti-tumor immune response. Recent studies have found this combination to show significantly promising efficacy and manageable safety 13 , 14 providing a novel effective therapeutic strategy for HCC.…”

Efficacy of radiotherapy in combined treatment of hepatocellular carcinoma patients with portal vein tumor thrombus: a real-world study

“…Recent studies have indicated that RT can enhance antitumor immunity when combined with immune checkpoint inhibitors [ 12 ]. RT plus anti-PD1 showed significantly promising efficacy in patients with advanced HCC [ 13 ]. RT alone or combined with other therapies has the potential for tumor downstaging, creating surgical opportunities for more advanced patients [ 14 – 16 ].…”