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
ObjectivesThe 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 micros...
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.917353/full |
| _version_ | 1811204272519380992 |
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| author | Caiyun Nie Caiyun Nie Caiyun Nie Caiyun Nie Huifang Lv Huifang Lv Huifang Lv Huifang Lv Beibei Chen Beibei Chen Beibei Chen Beibei Chen Weifeng Xu Weifeng Xu Weifeng Xu Weifeng Xu Jianzheng Wang Jianzheng Wang Jianzheng Wang Jianzheng Wang Yingjun Liu Saiqi Wang Saiqi Wang Saiqi Wang Saiqi Wang Jing Zhao Jing Zhao Jing Zhao Jing Zhao Yunduan He Yunduan He Yunduan He Yunduan He Xiaobing Chen Xiaobing Chen Xiaobing Chen Xiaobing Chen |
| author_facet | Caiyun Nie Caiyun Nie Caiyun Nie Caiyun Nie Huifang Lv Huifang Lv Huifang Lv Huifang Lv Beibei Chen Beibei Chen Beibei Chen Beibei Chen Weifeng Xu Weifeng Xu Weifeng Xu Weifeng Xu Jianzheng Wang Jianzheng Wang Jianzheng Wang Jianzheng Wang Yingjun Liu Saiqi Wang Saiqi Wang Saiqi Wang Saiqi Wang Jing Zhao Jing Zhao Jing Zhao Jing Zhao Yunduan He Yunduan He Yunduan He Yunduan He Xiaobing Chen Xiaobing Chen Xiaobing Chen Xiaobing Chen |
| author_sort | Caiyun Nie |
| collection | DOAJ |
| description | ObjectivesThe 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.MethodsPatients 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.Results42 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.ConclusionsRegorafenib 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. |
| first_indexed | 2024-04-12T03:09:50Z |
| format | Article |
| id | doaj.art-be1252b4efe5496c88e802949ce315b9 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-12T03:09:50Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-be1252b4efe5496c88e802949ce315b92022-12-22T03:50:24ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-09-011210.3389/fonc.2022.917353917353Microsatellite 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 studyCaiyun Nie0Caiyun Nie1Caiyun Nie2Caiyun Nie3Huifang Lv4Huifang Lv5Huifang Lv6Huifang Lv7Beibei Chen8Beibei Chen9Beibei Chen10Beibei Chen11Weifeng Xu12Weifeng Xu13Weifeng Xu14Weifeng Xu15Jianzheng Wang16Jianzheng Wang17Jianzheng Wang18Jianzheng Wang19Yingjun Liu20Saiqi Wang21Saiqi Wang22Saiqi Wang23Saiqi Wang24Jing Zhao25Jing Zhao26Jing Zhao27Jing Zhao28Yunduan He29Yunduan He30Yunduan He31Yunduan He32Xiaobing Chen33Xiaobing Chen34Xiaobing Chen35Xiaobing Chen36Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of General Surgery, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaState Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, ChinaHenan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaZhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, ChinaObjectivesThe 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.MethodsPatients 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.Results42 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.ConclusionsRegorafenib 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.https://www.frontiersin.org/articles/10.3389/fonc.2022.917353/fullmicrosatellite stableimmunotherapytargeted therapyliver metastasiscolorectal cancer |
| spellingShingle | Caiyun Nie Caiyun Nie Caiyun Nie Caiyun Nie Huifang Lv Huifang Lv Huifang Lv Huifang Lv Beibei Chen Beibei Chen Beibei Chen Beibei Chen Weifeng Xu Weifeng Xu Weifeng Xu Weifeng Xu Jianzheng Wang Jianzheng Wang Jianzheng Wang Jianzheng Wang Yingjun Liu Saiqi Wang Saiqi Wang Saiqi Wang Saiqi Wang Jing Zhao Jing Zhao Jing Zhao Jing Zhao Yunduan He Yunduan He Yunduan He Yunduan He Xiaobing Chen Xiaobing Chen Xiaobing Chen Xiaobing Chen 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 Frontiers in Oncology microsatellite stable immunotherapy targeted therapy liver metastasis colorectal cancer |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | microsatellite stable immunotherapy targeted therapy liver metastasis colorectal cancer |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.917353/full |
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