Regorafenib plus toripalimab in patients with metastatic colorectal cancer: a phase Ib/II clinical trial and gut microbiome analysis.
prospective_cohort · Level II
Where this comes from
- Record sourced from PubMed, PMID 34622226.
- Also identified by DOI 10.1016/j.xcrm.2021.100383 and PMC identifier 8484502.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
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 <i>Fusobacterium</i> in non-responders than responders. Patients with high-abundance <i>Fusobacterium</i> have shorter PFS than those with low abundance (median PFS = 2.0 versus 5.2 months; p = 0.002).
Medical subject headings
- Antibodies, Monoclonal, Humanized
- Colorectal Neoplasms
- Gastrointestinal Microbiome
- Phenylurea Compounds
- Pyridines