Study on efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with regorafenib and PD-1 antibody versus continued TACE combined with regorafenib in patients with hepatocellular carcinoma after failed second-line treatment with regorafenib

Abstract

Background: At present, there is no standard for the posterior treatment of hepatocellular carcinoma (HCC). This study isTo evaluate and compare the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with regorafenib and anti-PD-1 antibody with continued TACE combined with regorafenib in patients with HCC after the failure of second-line treatment with regorafenib. Methods:We enrolled patients with advanced HCC who were treated with sorafenib and sequential regorafenib. All patients were treated with TACE and found to have tumor progression in 2021. After tumor progression, patients were treated with TACE combined with regorafenib and PD-1 antibody or with continued TACE combined with regorafenib according to the wishes of the patient. Efficacy was evaluated after 1 month of treatment. The objective response rate (ORR), disease-control rate (DCR), and safety were evaluated according to adverse reactions of patients.Results: Nine patients were treated with TACE combined with regorafenib and PD-1 antibody, and the 9 patients continued to receive TACE combined with regorafenib. There was no significant difference in baseline data between the 2 groups. In the PD-1 group five patients achieved a partial response (PR), three achieved stable disease (SD), and one patient had progressive disease (PD) after 1 month of treatment.The ORR was 55.6% and the DCR was 88.9%. In the continued TACE-regorafenib group, four patients achieved PR, one achieved SD, and four patients achieved PD after 1 month of treatment, while the ORR was 44.4% and the DCR was 55.6%. There was a significant difference in the DCR between the two groups (P=0.012), while adverse events were similar in both.Conclusions: TACE combined with regorafenib and PD-1 antibody had a higher DCR and was more effective than continued TACE combined with regorafenib in patients with HCC who failed second-line treatment with regorafenib. However, PD-1 antibody therapy might increase the risk of death by causing an uncontrollable immune response. Given the risk of an immune response, patients may choose to continue TACE combined with regorafenib, given the similar ORR of the two treatments.

Efficacy and safety analysis of selective hepatic vein occlusion combined with arterial chemoembolization versus conventional transarterial chemoembolization in the treatment of hepatocellular carcinoma

“…In early to mid-stage HCC, the superior prognosis of combining TACE with ablation over either modality alone has been well-documented ( 14 - 16 ). A single treatment replicating the effects of combination therapy would not only alleviate patient discomfort but also lessen the financial burden, aligning with the principles of refined TACE ( 17 , 18 ).…”

A multi-center retrospective study on the efficacy and safety of regorafenib vs. regorafenib combined with PD-1 inhibitors as a second-line therapy in patients with advanced hepatocellular carcinoma

“…Up to now, regorafenib monotherapy has been recommended by many guidelines as a second-line treatment; as far as systemic therapy is concerned, patients with HCC who have progressed in first-line treatment are currently the first choice for sequential treatment with regorafenib. However, its actual effect cannot meet clinical expectations ( 11 ) as it can only improve OS inferiority compared to other treatment options ( 12 ). In real-world clinical practice, regorafenib combined with PD-1 is increasingly being used in the second-line treatment of advanced HCC, but it remains uncertain if it is more effective and provides improved outcomes compared with regorafenib alone.…”