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Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis
This is a phase Ib/II study of regorafenib plus toripalimab for colorectal cancer. The objective response rate (ORR) is 15.2% and the disease control rate is 36.4% in evaluable patients with recommended phase II dose (80 mg regorafenib plus toripalimab). The median progression-free survival (PFS) an...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484502/ https://www.ncbi.nlm.nih.gov/pubmed/34622226 http://dx.doi.org/10.1016/j.xcrm.2021.100383 |
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author | Wang, Feng He, Ming-Ming Yao, Yi-Chen Zhao, Xia Wang, Zhi-Qiang Jin, Ying Luo, Hui-Yan Li, Ji-Bin Wang, Feng-Hua Qiu, Miao-Zhen Lv, Zhi-Da Wang, De-Shen Li, Yu-Hong Zhang, Dong-Sheng Xu, Rui-Hua |
author_facet | Wang, Feng He, Ming-Ming Yao, Yi-Chen Zhao, Xia Wang, Zhi-Qiang Jin, Ying Luo, Hui-Yan Li, Ji-Bin Wang, Feng-Hua Qiu, Miao-Zhen Lv, Zhi-Da Wang, De-Shen Li, Yu-Hong Zhang, Dong-Sheng Xu, Rui-Hua |
author_sort | Wang, Feng |
collection | PubMed |
description | This is a phase Ib/II study of regorafenib plus toripalimab for colorectal cancer. The objective response rate (ORR) is 15.2% and the disease control rate is 36.4% in evaluable patients with recommended phase II dose (80 mg regorafenib plus toripalimab). The median progression-free survival (PFS) and the median overall survival are 2.1 months and 15.5 months, respectively. Patients with liver metastases have lower ORR than those without (8.7% versus 30.0%). All patients (3/3) with lung-only metastasis respond, whereas no patients (0/4) with liver-only metastasis respond. 94.9% and 38.5% of patients have grade 1 and grade 3 treatment-related adverse events, respectively. Gut microbiome analysis of the baseline fecal samples shows significantly increased relative abundance and positive detection rate of Fusobacterium in non-responders than responders. Patients with high-abundance Fusobacterium have shorter PFS than those with low abundance (median PFS = 2.0 versus 5.2 months; p = 0.002). |
format | Online Article Text |
id | pubmed-8484502 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-84845022021-10-06 Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis Wang, Feng He, Ming-Ming Yao, Yi-Chen Zhao, Xia Wang, Zhi-Qiang Jin, Ying Luo, Hui-Yan Li, Ji-Bin Wang, Feng-Hua Qiu, Miao-Zhen Lv, Zhi-Da Wang, De-Shen Li, Yu-Hong Zhang, Dong-Sheng Xu, Rui-Hua Cell Rep Med Article This is a phase Ib/II study of regorafenib plus toripalimab for colorectal cancer. The objective response rate (ORR) is 15.2% and the disease control rate is 36.4% in evaluable patients with recommended phase II dose (80 mg regorafenib plus toripalimab). The median progression-free survival (PFS) and the median overall survival are 2.1 months and 15.5 months, respectively. Patients with liver metastases have lower ORR than those without (8.7% versus 30.0%). All patients (3/3) with lung-only metastasis respond, whereas no patients (0/4) with liver-only metastasis respond. 94.9% and 38.5% of patients have grade 1 and grade 3 treatment-related adverse events, respectively. Gut microbiome analysis of the baseline fecal samples shows significantly increased relative abundance and positive detection rate of Fusobacterium in non-responders than responders. Patients with high-abundance Fusobacterium have shorter PFS than those with low abundance (median PFS = 2.0 versus 5.2 months; p = 0.002). Elsevier 2021-08-27 /pmc/articles/PMC8484502/ /pubmed/34622226 http://dx.doi.org/10.1016/j.xcrm.2021.100383 Text en © 2021 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Wang, Feng He, Ming-Ming Yao, Yi-Chen Zhao, Xia Wang, Zhi-Qiang Jin, Ying Luo, Hui-Yan Li, Ji-Bin Wang, Feng-Hua Qiu, Miao-Zhen Lv, Zhi-Da Wang, De-Shen Li, Yu-Hong Zhang, Dong-Sheng Xu, Rui-Hua Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title | Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title_full | Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title_fullStr | Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title_full_unstemmed | Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title_short | Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis |
title_sort | regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase ib/ii clinical trial and gut microbiome analysis |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484502/ https://www.ncbi.nlm.nih.gov/pubmed/34622226 http://dx.doi.org/10.1016/j.xcrm.2021.100383 |
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