PMID- 38130300 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231223 IS - 2219-6803 (Electronic) IS - 2218-676X (Print) IS - 2218-676X (Linking) VI - 12 IP - 11 DP - 2023 Nov 30 TI - Fruquintinib in combination with sintilimab or TAS-102 as third-line or above treatment in patients with metastatic colorectal cancer: a real-world study. PG - 3034-3044 LID - 10.21037/tcr-23-867 [doi] AB - BACKGROUND: For metastatic colorectal cancer (mCRC), the efficacy of third-line or above treatments is not ideal. Combining targeted vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) biological agents with chemotherapy or anti-programmed death receptor 1 (PD-1) treatment can bring longer survival benefits to patients with mCRC compared with the application of a single drug. In this study, fruquintinib was used as the research drug, and the main purpose was to compare the efficacy and safety of fruquintinib in combination with sintilimab (FS) or trifluridine and tipiracil (TAS-102) (FT) in the third-line or above treatment in mCRC patients. METHODS: Based on real-world clinical practice, mCRC patients who progressed after second-line or higher-line chemotherapy regimens and received FS or FT as third-line or above treatment from December 2020 to November 2022 were analyzed. Progression-free survival (PFS) was the primary endpoint. Safety, disease control rate (DCR) and objective response rate (ORR) were secondary end points. RESULTS: In the FS group, 47 patients received FS, and in the FT group, 45 patients received FT. The DCR values in the FS and FT groups were 80.9% (38/47) and 55.6% (25/45), respectively (P<0.05). The median PFS (mPFS) in the FS group was 6.0 months, and the mPFS in the FT group was 3.5 months (P<0.05). Most adverse events (AEs) were grade 1-2 in severity. CONCLUSIONS: As a third-line or above regimen in mCRC patients, compared to FT, treatment with FS provides a higher DCR and longer mPFS and is better tolerated. The combination of fruquintinib and sintilimab may become a new treatment option for mCRC patients. CI - 2023 Translational Cancer Research. All rights reserved. FAU - Li, Luchun AU - Li L AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Wang, Ting AU - Wang T AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Wu, Zhijuan AU - Wu Z AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Li, Yan AU - Li Y AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Ma, Huiwen AU - Ma H AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Wang, Lulu AU - Wang L AD - Department of Radiotherapy, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Lei, Shuangyi AU - Lei S AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. FAU - Chen, Wen AU - Chen W AD - Department of Oncology, Chongqing University, Cancer Hospital, Chongqing, China. LA - eng PT - Journal Article DEP - 20231030 PL - China TA - Transl Cancer Res JT - Translational cancer research JID - 101585958 PMC - PMC10731331 OTO - NOTNLM OT - Metastatic colorectal cancer (mCRC) OT - fruquintinib OT - progression-free survival (PFS) OT - sintilimab OT - trifluridine and tipiracil (TAS-102) COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tcr.amegroups.com/article/view/10.21037/tcr-23-867/coif). All authors report receiving funding from the Chongqing Natural Science Foundation (No. cstc2018jcyjAX0814), Chongqing Science and Health Joint Project (No. 2022MSXM131) and 2021 Chongqing Young and Middle-aged Medical High-end Talent Project. The authors have no other conflicts of interest to declare. EDAT- 2023/12/22 06:42 MHDA- 2023/12/22 06:43 PMCR- 2023/11/30 CRDT- 2023/12/22 03:45 PHST- 2023/05/28 00:00 [received] PHST- 2023/09/28 00:00 [accepted] PHST- 2023/12/22 06:43 [medline] PHST- 2023/12/22 06:42 [pubmed] PHST- 2023/12/22 03:45 [entrez] PHST- 2023/11/30 00:00 [pmc-release] AID - tcr-12-11-3034 [pii] AID - 10.21037/tcr-23-867 [doi] PST - ppublish SO - Transl Cancer Res. 2023 Nov 30;12(11):3034-3044. doi: 10.21037/tcr-23-867. Epub 2023 Oct 30.