Randomized phase III study of capecitabine, oxaliplatin, and bevacizumab with or without cetuximab in advanced colorectal cancer (ACC), the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG)

LBA4011 Background: Cetuximab, a chimaeric monoclonal antibody against the epidermal growth factor receptor (EGFR) has shown efficacy in patients (pts) with ACC. Preclinical and early clinical studies suggest a benefit for combining VEGF and EGFR targeting agents in ACC. The CAIRO2 study was designed to investigate the effect of adding cetuximab to capecitabine and oxaliplatin (CapOx) and bevacizumab in ACC. Methods: Previously untreated pts were randomized between capecitabine 1000 mg/m² orally b.i.d. day 1–14, oxaliplatin 130 mg/m² i.v. day 1, and bevacizumab 7.5 mg/kg i.v. day 1 (arm A) or the same schedule plus cetuximab 400 mg/m² i.v. in week 1, cycle 1, and 250 mg/m² i.v. weekly thereafter (arm B). All cycles were given q 3 weeks. The primary endpoint was progression-free survival (PFS). Response was assessed q 3 cycles (RECIST). The study was designed to detect an increase in the median PFS of 3 months from 11 to 14 months (21% reduction in the hazard ratio of progression, HR=0.79) Results: A total...