Neoadjuvant mFOLFOXIRI with or without cadonilimab versus mFOLFOX6 in locally advanced colorectal cancer: A randomized phase 2 trial (OPTICAL-2) - PubMed
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- Neoadjuvant mFOLFOXIRI plus cadonilimab significantly improved pathological complete response (pCR) rates compared to mFOLFOX6 in locally advanced colorectal cancer.
- The pCR rate for mFOLFOXIRI plus cadonilimab was 26.8% versus 9.8% for mFOLFOX6, with a significant odds ratio of 3.4.
- mFOLFOXIRI alone did not show a significant improvement in pCR over mFOLFOX6, indicating the importance of adding cadonilimab.
- Major pathological response (MPR) rates were highest in the mFOLFOXIRI plus cadonilimab group at 68.3%, significantly higher than mFOLFOX6's 43.9%.
- Downstaging to ypStage 0-I was significantly higher with mFOLFOXIRI plus cadonilimab (66%) compared to other groups, supporting its efficacy.
- Grade ≥3 adverse events were manageable, with liver enzyme elevation and neutropenia being the most common, indicating a tolerable safety profile.
- The study supports further investigation of neoadjuvant mFOLFOXIRI plus cadonilimab for proficient mismatch repair/microsatellite-stable locally advanced colorectal cancer.