Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study
PurposeApatinib is an approved third-line treatment for metastatic gastric cancer in China and demonstrates good safety, tolerability, and efficacy in other advanced solid tumors. The aim of this prospective, single-arm, multicenter, phase 2 study was to assess the efficacy and safety of low-dose ap...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2021-09-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2021.728854/full |
| _version_ | 1819147898189774848 |
|---|---|
| author | Ning Li Wenying Deng Guifang Zhang Yali Du Yanwei Guo Yijie Ma Chen Wei Liangyu Bie Chi Zhang Tao Song Suxia Luo Baijun Fang |
| author_facet | Ning Li Wenying Deng Guifang Zhang Yali Du Yanwei Guo Yijie Ma Chen Wei Liangyu Bie Chi Zhang Tao Song Suxia Luo Baijun Fang |
| author_sort | Ning Li |
| collection | DOAJ |
| description | PurposeApatinib is an approved third-line treatment for metastatic gastric cancer in China and demonstrates good safety, tolerability, and efficacy in other advanced solid tumors. The aim of this prospective, single-arm, multicenter, phase 2 study was to assess the efficacy and safety of low-dose apatinib combined with S-1 in the treatment of refractory mCRC.Patients and MethodsPatients with refractory mCRC were enrolled and administered apatinib combined with S-1 until disease progression, patient decision to withdraw, or unacceptable toxic effects. The primary endpoint was investigator-evaluated progression-free survival (PFS) and the secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR).ResultsFrom December 2017 to December 2018, 30 patients were enrolled and 29 patients were eligible for the evaluation of efficacy and safety. The median PFS (mPFS) and OS (mOS) were 7.9 and 12.9 months, respectively. Exploratory analysis revealed that patients administered S-1 ≥ 70 days achieved longer mPFS and mOS. Four patients achieved a partial response, 22 achieved stable disease, and three had progressive disease, attributing to an ORR of 13.79% and a DCR of 89.66%. Ten grade 3 adverse events were reported and the frequency of each grade 3 adverse event was less than 5%. No grade 4 side events were observed.ConclusionsThese results indicated that apatinib combined with S-1 showed promising efficacy and manageable toxicity in patients with progressive mCRC after at least 2 prior lines of therapy, making it a promising therapeutic option for mCRC treatment.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT03397199, identifier NCT03397199. |
| first_indexed | 2024-12-22T13:37:08Z |
| format | Article |
| id | doaj.art-2392548c283241d0b7421cb2c7b8869f |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-12-22T13:37:08Z |
| publishDate | 2021-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-2392548c283241d0b7421cb2c7b8869f2022-12-21T18:24:01ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2021-09-011110.3389/fonc.2021.728854728854Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective StudyNing Li0Wenying Deng1Guifang Zhang2Yali Du3Yanwei Guo4Yijie Ma5Chen Wei6Liangyu Bie7Chi Zhang8Tao Song9Suxia Luo10Baijun Fang11Department of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Xinxiang Central Hospital, Xixiang, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Imaging, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Hematology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, ChinaPurposeApatinib is an approved third-line treatment for metastatic gastric cancer in China and demonstrates good safety, tolerability, and efficacy in other advanced solid tumors. The aim of this prospective, single-arm, multicenter, phase 2 study was to assess the efficacy and safety of low-dose apatinib combined with S-1 in the treatment of refractory mCRC.Patients and MethodsPatients with refractory mCRC were enrolled and administered apatinib combined with S-1 until disease progression, patient decision to withdraw, or unacceptable toxic effects. The primary endpoint was investigator-evaluated progression-free survival (PFS) and the secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR).ResultsFrom December 2017 to December 2018, 30 patients were enrolled and 29 patients were eligible for the evaluation of efficacy and safety. The median PFS (mPFS) and OS (mOS) were 7.9 and 12.9 months, respectively. Exploratory analysis revealed that patients administered S-1 ≥ 70 days achieved longer mPFS and mOS. Four patients achieved a partial response, 22 achieved stable disease, and three had progressive disease, attributing to an ORR of 13.79% and a DCR of 89.66%. Ten grade 3 adverse events were reported and the frequency of each grade 3 adverse event was less than 5%. No grade 4 side events were observed.ConclusionsThese results indicated that apatinib combined with S-1 showed promising efficacy and manageable toxicity in patients with progressive mCRC after at least 2 prior lines of therapy, making it a promising therapeutic option for mCRC treatment.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT03397199, identifier NCT03397199.https://www.frontiersin.org/articles/10.3389/fonc.2021.728854/fullapatinibS-1colorectal cancermetastaticefficacy |
| spellingShingle | Ning Li Wenying Deng Guifang Zhang Yali Du Yanwei Guo Yijie Ma Chen Wei Liangyu Bie Chi Zhang Tao Song Suxia Luo Baijun Fang Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study Frontiers in Oncology apatinib S-1 colorectal cancer metastatic efficacy |
| title | Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study |
| title_full | Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study |
| title_fullStr | Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study |
| title_full_unstemmed | Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study |
| title_short | Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study |
| title_sort | low dose apatinib combined with s 1 in refractory metastatic colorectal cancer a phase 2 multicenter single arm prospective study |
| topic | apatinib S-1 colorectal cancer metastatic efficacy |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2021.728854/full |
| work_keys_str_mv | AT ningli lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT wenyingdeng lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT guifangzhang lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT yalidu lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT yanweiguo lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT yijiema lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT chenwei lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT liangyubie lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT chizhang lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT taosong lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT suxialuo lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy AT baijunfang lowdoseapatinibcombinedwiths1inrefractorymetastaticcolorectalcanceraphase2multicentersinglearmprospectivestudy |