Efficacy of regorafenib following first-line immune checkpoint inhibitor failure in patients with advanced hepatocellular carcinoma: A multicenter study.
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引用次数: 0
Abstract
Background: Hepatocellular carcinoma (HCC) remains a significant global health challenge. While first-line treatments with immune checkpoint inhibitors (ICIs) have improved patient outcomes, the selection of effective second-line therapies remains unclear. This study evaluated the efficacy and safety of regorafenib as a second-line option in advanced HCC patients post-progression on ICI-based therapies.
Methods: Advanced HCC patients from eight hospitals in China who received regorafenib after progression on first-line ICI therapies, alone or combined with ICIs were enrolled. Clinical data were collected, and propensity score matching (PSM) was used to ensure comparability between treatment groups. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events. The study was registered at www.chictr.org.cn (ChiCTR2400091318).
Results: A total of 149 patients were included: 113 in the combination therapy group (Rego-ICI group) and 36 in the regorafenib monotherapy group (Rego group). After PSM, the Rego-ICI group showed significantly improved and OS [19.0 vs. 11.0 months, hazard ratio (HR) = 0.426, 95% confidence interval (CI): 0.235-0.772, P = 0.005] and PFS (4.0 vs. 3.0 months, HR = 0.539, 95% CI: 0.337-0.863, P = 0.010) compared to the Rego group. Differences in ORR and DCR were not statistically significant (ORR: 19.4% vs. 9.7%, P = 0.226; DCR: 64.2% vs. 48.4%, P = 0.139), but the Rego-ICI group showed better disease control. Regorafenib plus ICI improved both OS and PFS with no new safety signals.
Conclusions: The combination of ICIs and regorafenib significantly enhances OS in advanced HCC patients post-progression on first-line ICI treatments. These findings support the potential of regorafenib plus ICIs as an effective second-line therapy.
期刊介绍：
Hepatobiliary & Pancreatic Diseases International (HBPD INT) (ISSN 1499-3872 / CN 33-1391/R) a bimonthly journal published by First Affiliated Hospital, Zhejiang University School of Medicine, China. It publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatobiliary and pancreatic diseases. Papers cover the medical, surgical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas under the headings Liver, Biliary, Pancreas, Transplantation, Research, Special Reports, Editorials, Review Articles, Brief Communications, Clinical Summary, Clinical Images and Case Reports. It also deals with the basic sciences and experimental work. The journal is abstracted and indexed in SCI-E, IM/MEDLINE, EMBASE/EM, CA, Scopus, ScienceDirect, etc.
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