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A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity
Annals of Oncology, 03/27/08

Tol J et al. – For first-line treatment of advanced colorectal cancer (ACC), cetuximab addition to capecitabine, oxaliplatin and bevacizumab is safe and feasible with no observed excessive or unexpected toxicity in the cetuximab treatment arm

Methods

Study to evaluate the effect of adding cetuximab to capecitabine, oxaliplatin and bevacizumab in first-line treatment of ACC (CAIRO2 study)
Randomization of 755 pts to treatment with capecitabine, oxaliplatin and bevacizumab with or without cetuximab
Primary end point: progression-free survival
Toxicity results for first 400 pts reported

Results

Incidence of overall grade 3–4 toxicity was significantly higher in arm B (81%) vs arm A (72%)
Toxicity difference is fully attributed to cetuximab-related skin toxicity
Addition of cetuximab did not increase gastrointestinal toxicity or treatment-related mortality

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