Clinical Outcomes of 2nd- and 3rd-Line Regorafenib for Advanced Hepatocellular Carcinoma

Abstract

<b><i>Introduction:</i></b> This study compared clinical outcomes of 2nd- and 3rd-line regorafenib in patients with unresectable hepatocellular carcinoma. <b><i>Methods:</i></b> In this retrospective cohort study, 48 patients were treated with regorafenib for unresectable hepatocellular carcinoma. Thirty-five and 13 patients were initiated on 2nd- and 3rd-line therapy, respectively. We assessed the responses to and safety of the therapy. <b><i>Results:</i></b> There were no statistically significant differences in clinical characteristics at the start of 2nd- or 3rd-line regorafenib therapy. The overall response rate of 2nd- and 3rd-line regorafenib was 20 and 8%, respectively. The disease control rate was 57 and 54%, respectively. Median overall survival (mOS) from the start of 2nd-line regorafenib was 17.5 months. mOS from the start of 3rd-line regorafenib was not obtained. Median progression-free survival of 2nd- and 3rd-line regorafenib was 4.9 and 2.3 months, respectively. mOS from 1st-line therapy with tyrosine kinase inhibitor plus sorafenib-regorafenib-lenvatinib was 29.5 months; that with lenvatinib-sorafenib-regorafenib was not obtained. Patients on 3rd-line therapy tended to have better Child-Pugh scores and tumor factors at the start of 1st-line therapy than other patients. <b><i>Conclusion:</i></b> Patients on 2nd- and 3rd-line regorafenib showed favorable responses. Good Child-Pugh scores and tumor factors may be associated with a better response rate and OS.

Impact of post‐progression survival in second‐line treatment with molecular target agents for unresectable hepatocellular carcinoma

“…A search of the PubMed database identified 24 cohorts in 23 studies encompassing 2074 patients treated with REG (Figure 1 and Table ) 11,14–35 . Similarly, six cohorts from six studies comprising 621 patients treated with RAM 12,36–40 were identified, as well as seven cohorts from six studies involving 1240 patients treated with CAB 13,23,33,41–43 (Figure 1 and Tables and , respectively).…”

Regorafenib plus programmed death‑1 inhibitors vs. regorafenib monotherapy in second‑line treatment for advanced hepatocellular carcinoma: A systematic review and meta‑analysis

“…A pivotal randomized, double-blind, placebo-controlled phase 3 trial ( 7 ) substantiated the significant enhancement of overall survival (OS) in patients with progressive HCC after sorafenib treatment. Consequently, it was approved as a pioneering second-line targeted therapy, with subsequent clinical trials corroborating its efficacy in patients with late-stage HCC ( 8 ).…”