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 in non-responders than responders. Patients with high-abundance have shorter PFS than those with low abundance (median PFS = 2.0 versus 5.2 months; p = 0.002).
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484502 | PMC |
http://dx.doi.org/10.1016/j.xcrm.2021.100383 | DOI Listing |
Front Oncol
October 2023
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
World J Clin Cases
April 2022
Department of Dermatology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China.
Cell Rep Med
September 2021
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
J Oncol
September 2021
Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.
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