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)

摘要: 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 benefit for combining VEGF EGFR targeting agents The CAIRO2 study was designed to investigate effect of adding cetuximab capecitabine oxaliplatin (CapOx) bevacizumab Methods: Previously untreated pts were randomized between 1000 mg/m² orally b.i.d. day 1–14, 130 i.v. 1, 7.5 mg/kg 1 (arm A) or same schedule plus 400 week cycle 250 weekly thereafter B). All cycles given q 3 weeks. primary endpoint progression-free survival (PFS). Response assessed (RECIST). detect an increase median PFS months from 11 14 (21% reduction hazard ratio progression, HR=0.79) Results: A total...