Xu YJ, Zhang P, Hu JL, Liang H, Zhu YY, Cui Y, Niu P, Xu M, Liu MY. Regorafenib combined with programmed cell death-1 inhibitor against refractory colorectal cancer and the platelet-to-lymphocyte ratio’s prediction on effectiveness. World J Gastrointest Oncol 2022; 14(4): 920-934 [PMID: 35582108 DOI: 10.4251/wjgo.v14.i4.920]
Corresponding Author of This Article
Ming-Yue Liu, Doctor, MD, PhD, Chief Doctor, Department of Oncology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, No. 7 Weiwu Road, Zhengzhou 450003, Henan Province, China. 1816160187@e.gzhu.edu.cn
Research Domain of This Article
Oncology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastrointest Oncol. Apr 15, 2022; 14(4): 920-934 Published online Apr 15, 2022. doi: 10.4251/wjgo.v14.i4.920
Regorafenib combined with programmed cell death-1 inhibitor against refractory colorectal cancer and the platelet-to-lymphocyte ratio’s prediction on effectiveness
Yu-Jie Xu, Peng Zhang, Jin-Long Hu, Hong Liang, Yan-Yan Zhu, Yao Cui, Po Niu, Min Xu, Ming-Yue Liu
Yu-Jie Xu, Jin-Long Hu, Yan-Yan Zhu, Yao Cui, Po Niu, Ming-Yue Liu, Department of Oncology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou 450003, Henan Province, China
Peng Zhang, Hong Liang, Department of Gastrointestinal Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou 450003, Henan Province, China
Min Xu, Department of Hepatology, The Third People's Hospital of Zhengzhou, Zhengzhou 450003, Henan Province, China
Author contributions: Liu MY and Xu YJ designed the research; Xu YJ, Zhang P, and Hu JL performed the research; Liang H, Zhu YY, and Cui Y contributed new reagents/analytic tools; Xu YJ, Zhang P, Niu P, and Xu M analyzed the data; Liu MY, Xu YJ, and Zhang P wrote the paper.
Supported bythe Henan Provincial Department of Science and Technology, No. 212102310047.
Institutional review board statement: This study was approved by the ethics committee of People’s Hospital of Zhengzhou University (Henan Province, China) and performed in accordance with the Declaration of Helsinki.
Informed consent statement: The requirement for informed consent was waived by the committee because of the retrospective nature of the study.
Conflict-of-interest statement: The authors declare no conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Received: October 9, 2021 Peer-review started: October 9, 2021 First decision: December 12, 2021 Revised: January 4, 2022 Accepted: March 25, 2022 Article in press: March 25, 2022 Published online: April 15, 2022 Processing time: 187 Days and 19.3 Hours
ARTICLE HIGHLIGHTS
Research background
The effectiveness of the combination therapy using regorafenib and programmed cell death-1 (PD-1) inhibitors in treating metastatic colorectal cancer (mCRC) in the REGONIVO trial in Japan and a retrospective study in the United States are inconsistent.
Research motivation
As the effectiveness of the combination therapy remains controversial, we evaluated the situation and data of the combination therapy including the efficacy and safety in our medical centre in order to provide more clinical evidence for this treatment.
Research objectives
The objectives of this study were to investigate the tumor response, progression-free survival, overall survival, and treatment-related adverse events of the treatment and explore a potential indicators predicting response and prognosis.
Research methods
We identified patients with microsatellite stable (MSS) mCRC treated with regorafenib combined with PD-1 inhibitor at Henan Provincial People’s Hospital between December 2018 and December 2020. Collected data included age, sex, Eastern Cooperative Oncology Group (ECOG) performance status (PS), site of the primary tumor, site of the metastases, MSI/MMR, gene status, lines of treatment, and previous treatments. The blood routine examination and CEA results before treatment and after three and five cycles of combination therapy were longitudinally analyzed.
Research results
We included 30 patients with MSS mCRC treated with regorafenib combined with PD-1 inhibitor. The disease control rate was 60.0%. The median follow-up time was 12.0 mo, and median PFS was 3.4 mo [95% confidence interval (CI): 2.2-4.6 mo]. The median PFS in the low-PLR group was 4.2 mo (95%CI: 3.5-4.9 mo), compared with 2.8 mo (95%CI: 1.4-4.2 mo) in the high-PLR group (P = 0.005). Four (13.3%) patients experienced grade 3 TRAE.
Research conclusions
We find that some patients can benefit from the combination therapy even after multi-line therapy and adverse events are generally tolerable. The PLR might be a potential indicator to predict patient response to this combination therapy.
Research perspectives
This study provides experiences and could help to design a prospective trial for patients with MSS mCRC those who failure to standard therapy.
