PMID- 36226061 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221014 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 12 DP - 2022 TI - Microsatellite stable metastatic colorectal cancer without liver metastasis may be preferred population for regorafenib or fruquintinib plus sintilimab as third-line or above therapy:A real-world study. PG - 917353 LID - 10.3389/fonc.2022.917353 [doi] LID - 917353 AB - OBJECTIVES: The antitumor activity of nivolumab plus regorafenib in colorectal cancer from a phase Ib REGONIVO study is encouraging. The present study was conducted to evaluate the efficacy and safety of regorafenib or fruquintinib plus sintilimab as third-line or above therapy in patients with microsatellite stable (MSS) metastatic colorectal cancer. METHODS: Patients with MSS metastatic colorectal cancer who have failed from prior treatment and received regorafenib or fruquintinib plus sintilimab as third-line or above therapy from January 2019 to December 2020 were prospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. RESULTS: 42 patients received regorafenib plus sintilimab(RS), and the other 30 patients received fruquintinib plus sintilimab(FS). In the general population, the ORR and DCR were 13.9% and 70.8%, and the median PFS and OS was 4.2(95% CI=2.9-5.5) and 10.5 (95% CI=8.6-12.4) months, respectively. There were no statistically significant differences between RS and FS group in PFS (3.5(2.2-4.8) vs. 5.5(3.5-7.5) months, P=0.434) and OS (11.0(7.0-15.0) vs. 10.5(3.8-17.2) months, P=0.486). Subgroup analysis suggested that patients without liver metastasis responded well to this combination regimen (ORR: 21.4% vs. 9.1%) and obtained better OS (26(8.8-43.2) vs. 10.0(7.4-12.6) months, P=0.016). The incidence of Grade 3-4 adverse events (AEs) was 15.3% and the toxicities were generally tolerable and manageable. CONCLUSIONS: Regorafenib or fruquintinib plus sintilimab as third-line or above therapy provide a feasible treatment regimen for MSS metastatic colorectal cancer with tolerated toxicity. Patients without liver metastasis may be the preferred population for this combination regimen. CI - Copyright (c) 2022 Nie, Lv, Chen, Xu, Wang, Liu, Wang, Zhao, He and Chen. FAU - Nie, Caiyun AU - Nie C AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Lv, Huifang AU - Lv H AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Chen, Beibei AU - Chen B AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Xu, Weifeng AU - Xu W AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Wang, Jianzheng AU - Wang J AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Liu, Yingjun AU - Liu Y AD - Department of General Surgery, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. FAU - Wang, Saiqi AU - Wang S AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Zhao, Jing AU - Zhao J AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - He, Yunduan AU - He Y AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. FAU - Chen, Xiaobing AU - Chen X AD - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. AD - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, China. AD - Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. AD - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, China. LA - eng PT - Journal Article DEP - 20220926 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC9549285 OTO - NOTNLM OT - colorectal cancer OT - immunotherapy OT - liver metastasis OT - microsatellite stable OT - targeted therapy COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/10/14 06:00 MHDA- 2022/10/14 06:01 PMCR- 2022/01/01 CRDT- 2022/10/13 02:46 PHST- 2022/04/29 00:00 [received] PHST- 2022/09/12 00:00 [accepted] PHST- 2022/10/13 02:46 [entrez] PHST- 2022/10/14 06:00 [pubmed] PHST- 2022/10/14 06:01 [medline] PHST- 2022/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2022.917353 [doi] PST - epublish SO - Front Oncol. 2022 Sep 26;12:917353. doi: 10.3389/fonc.2022.917353. eCollection 2022.