%0 Journal Article
%T Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis.
%A Wang F
%A He MM
%A Yao YC
%A Zhao X
%A Wang ZQ
%A Jin Y
%A Luo HY
%A Li JB
%A Wang FH
%A Qiu MZ
%A Lv ZD
%A Wang DS
%A Li YH
%A Zhang DS
%A Xu RH
%J Cell Rep Med
%V 2
%N 9
%D Sep 2021 21
%M 34622226
%F 16.988
%R 10.1016/j.xcrm.2021.100383
%X 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).