Addition of sunitinib to cetuximab and irinotecan in patients with heavily pre-treated advanced colorectal cancer

Results of continuous sunitinib, in combination with cetuximab and irinotecan every other week ( SIC) for compassionate use in heavily pre-treated patients with mCRC are presented. Patients and methods. Patients with mCRC resistant to oxaliplatin, irinotecan, 5-FU and cetuximab received SIC at two Danish oncologic departments. The regimen consisted of sunitinib given as a continuous-dosing in combination with cetuximab and irinotecan every other week (CetIri). The first six patients started with a daily oral dose of sunitinib of 12.5 mg. Subsequent patients started at a daily dose of 25 mg with the possibility to escalate to 37.5 mg. Results. Twenty-nine patients received SIC. No patient had an objective response, but 13 patients had subjective relief and 42% had stable disease. The median time to progression was 3.2 months and median overall survival was 7.4 months. Fatigue and leukopenia were the most frequently reported severe adverse event (18% grade 3 and 18% grade 3/4, respectively). Discussion. Sunitinib continuous-dosing with 25 mg/day can safely be combined with CetIri administered every other week