First-line oxaliplatin-based chemotherapy and nivolumab for metastatic microsatellite-stable colorectal cancer-the randomised METIMMOX trial

We evaluated first-line treatment of metastatic microsatellite-stable colorectal cancer with short-course oxaliplatin-based chemotherapy alternating with immune checkpoint blockade. Patients were randomly assigned to chemotherapy (the FLOX regimen; control group) or alternating two cycles each of FL...

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Published in:British journal of cancer 2024-04, Vol.130 (12), p.1921-1928
Main Authors: Ree, Anne Hansen, Šaltytė Benth, Jūratė, Hamre, Hanne M, Kersten, Christian, Hofsli, Eva, Guren, Marianne G, Sorbye, Halfdan, Johansen, Christin, Negård, Anne, Bjørnetrø, Tonje, Nilsen, Hilde L, Berg, Jens P, Flatmark, Kjersti, Meltzer, Sebastian
Format: Article
Language:eng ; nor
Subjects:
C-reactive protein
Cancer
Chemotherapy
Colorectal cancer
Colorectal carcinoma
Immune checkpoint inhibitors
Immunotherapy
Metastases
Metastasis
Monoclonal antibodies
Oxaliplatin
Regression analysis
Targeted cancer therapy
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Summary:We evaluated first-line treatment of metastatic microsatellite-stable colorectal cancer with short-course oxaliplatin-based chemotherapy alternating with immune checkpoint blockade. Patients were randomly assigned to chemotherapy (the FLOX regimen; control group) or alternating two cycles each of FLOX and nivolumab (experimental group). Radiographic response assessment was done every eight weeks with progression-free survival (PFS) as the primary endpoint. Cox proportional-hazards regression models estimated associations between PFS and relevant variables. A post hoc analysis explored C-reactive protein as signal of responsiveness to immune checkpoint blockade. Eighty patients were randomised and 38 in each group received treatment. PFS was comparable-control group: median 9.2 months (95% confidence interval (CI), 6.3-12.7); experimental group: median 9.2 months (95% CI, 4.5-15.0). The adjusted Cox model revealed that experimental-group subjects aged ≥60 had significantly lowered progression risk (p = 0.021) with hazard ratio 0.17 (95% CI, 0.04-0.76). Experimental-group patients with C-reactive protein
ISSN:0007-0920
1532-1827
1532-1827
DOI:10.1038/s41416-024-02696-6