Premedication and incidence of infusion-related reactions in patients with metastatic colorectal cancer treated with cetuximab plus irinotecan-based chemotherapy.

Abstract

3561 Background: The randomized phase III CRYSTAL study (n=1,202) and the large phase II MABEL study (n=1,147) confirmed the benefit of adding cetuximab respectively to infusional 5-fluorouracil, folinic acid, and irinotecan (FOLFIRI) or irinotecan alone in the first- or subsequent-line treatment of patients (pts) with metastatic colorectal cancer (mCRC). Methods: A post hoc analysis of the pooled population of pts receiving cetuximab was performed to investigate the effect of adding corticosteroid to antihistamine prophylactic premedication on the incidence of infusion-related reactions (IRRs) occurring following the first cetuximab infusion. Results: The incidence of grade 3/4 IRRs based on a broad selection of medical conditions (preferred Medical Dictionary for Regulatory Activities terms) was 1.0% in pts who received antihistamine plus corticosteroid as prophylactic premedication compared with 2.7% in those who received antihistamine alone. A comparable trend was seen for any grade IRRs (8.3% vs. 21....