Regorafenib with or without a programmed cell death protein 1 antibody as third‐line treatment for microsatellite stable metastatic colorectal cancer. (13th November 2022)

• Record Type: Journal Article
• Authors: He, Wen‐Zhuo; Wang, Lei; Yin, Chen‐Xi; Yi, Jia‐Hong; Jin, Ya‐Nan; Jiang, Chang; Guo, Gui‐Fang; Xia, Liang‐Ping
• Is Part Of: Cancer medicine. Volume 12:Number 6(2023)
• Page Start: 6488
• Page End: 6498
• Publication Date: 2022-11-13
• Subjects: colorectal cancer -- microsatellite stable -- programmed cell death protein 1 -- regorafenib; 616.994005
• DOI: 10.1002/cam4.5417
• Languages: English
• ISSNs: 2045-7634

Abstract

Abstract: Background: Although the use of regorafenib plus nivolumab demonstrates promising outcomes in patients with refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC), this effect has not been substantiated in other studies. Moreover, a comparison between the outcomes of regorafenib and programmed cell death protein 1 (PD‐1) antibody combination therapy and regorafenib monotherapy remains unexplored. In this study, we aimed to assess whether regorafenib and PD‐1 antibody combination therapy is superior to regorafenib monotherapy as a third‐line treatment for MSS mCRC. Methods: Patients with MSS mCRC who received regorafenib and PD‐1 antibody or regorafenib monotherapy as third‐line treatment were eligible for inclusion. Results: In total, 179 patients were enrolled, of which 84 were administered regorafenib combined with a PD‐1 antibody and 95 were administered regorafenib monotherapy. Patients administered regorafenib combined with a PD‐1 antibody had similar progression‐free survival (PFS) as those on regorafenib monotherapy (median PFS was 2.4 months and 1.9 months, respectively, p = 0.086). The administration of regorafenib combined with a PD‐1 antibody resulted in significantly longer PFS than that seen with regorafenib monotherapy in both male (5.2 months vs. 2.4 months, p = 0.001) and female (3.9 months vs. 1.8 months, p = 0.037) patients without liver metastasis. Female patients with liver metastasis who were administered regorafenib combined with a PD‐1 antibody had shorter PFS than those administered regorafenib monotherapy (1.8 months vs. 2.0 months, p = 0.030). Conclusion: Liver metastasis and sex are predictors of survival benefit following the addition of a PD‐1 antibody to regorafenib in patients with MSS mCRC. Abstract : Our study suggested that an age less than 60 years, in males, without liver metastasis was associated with benefit from treatment with the regorafenib and PD‐1 antibody combination as third‐line treatment for microsatellite stable metastatic colorectal cancer.