Regorafenib Combined with Immune Checkpoint Inhibitors Versus Regorafenib Monotherapy As a Late-line Treatment for Metastatic Colorectal Cancer: a Single-center, Retrospective Cohort Study

Overview

Journal J Gastrointest Oncol

Date 2024 Sep 16

PMID 39279938

Authors

Can Chen

Xi Luo

Wenhua Tang

Haofei Geng

Julia Martinez-Perez

Timothy Price

Lili Kang

Honglian Lu

Yanling Zhang

Affiliations

Soon will be listed here.

Abstract

Background: Few data are available on metastatic colorectal cancer (mCRC) treated with late-line regorafenib monotherapy or combined with other therapies. This study thus aimed to examine regorafenib combined with immune checkpoint inhibitors (ICIs) compared with regorafenib monotherapy in patients with advanced CRC.

Methods: This single-center retrospective cohort study included patients with advanced CRC who experienced recurrence and progression after standard first- and second-line treatments treatment from November 2018 to December 2021. The patients received regorafenib plus ICIs or regorafenib monotherapy. Treatment response was evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST). Overall survival (OS) and progression-free survival (PFS) were analyzed via multivariate analysis.

Results: The combined group and the monotherapy group included 30 and 43 patients, respectively. The median OS (13.7 . 10.1 months; P=0.10) and PFS (4 . 3.6 months; P=0.32) were not significantly different between the two groups. In males, the median OS was significantly longer in the combined group compared with the monotherapy group (not reached . 8.03 months; P=0.02), but the median PFS showed no significant difference (7.23 . 3.90 months; P=0.16). There was no significant difference in OS (P=0.71) or PFS (P=0.89) in females. Eastern Cooperative Oncology Group performance status (ECOG PS) 1 [. 0; hazard ratio (HR) =3.13, 95% confidence interval (CI): 1.61-6.10; P<0.001] was independently associated with PFS. ECOG PS 1 (. 0; HR =3.63, 95% CI: 1.54-8.56; P=0.003) and combined therapy (. monotherapy; HR =0.47, 95% CI: 0.22-0.99; P=0.048) were associated with OS.

Conclusions: Regorafenib combined with ICIs led to numerically longer PFS and significantly prolonged OS in patients with mCRC compared to regorafenib monotherapy, especially in male patients.

Citing Articles

Regorafenib with or without chemotherapy/immunotherapy in second-line treatment of metastatic colorectal cancer during the COVID-19 pandemic: a single-center retrospective analysis.

Xiao Y, Liu Z, Mannavola F, Cao B J Gastrointest Oncol. 2025; 15(6):2496-2506.

PMID: 39816017 PMC: 11732335. DOI: 10.21037/jgo-2024-891.

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