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. 21.0%, respectively). In pts with a known or suspected or without predisposition to allergic reactions, a lower incidence of grade 3/4 and any grade IRRs occurred in each case for pts receiving antihistamine plus corticosteroid compared with antihistamine alone. Conclusions: These retrospective results indicate that the incidence of cetuximab-related grade 3/4 IRRs was reduced to 1.0% by a combined prophylaxis consisting of an antihistamine and a corticosteroid. N IRR incidence, N (%) Grade 3/4 Grade 4 Any grade Pooled population 1,747 Prophylactic pretreatment Antihistamine alone 596 125 (21.0) 16 (2.7) 7 (1.2) Antihistamine plus corticosteroid 1,061 88 (8.3) 11 (1.0) 2 (0.2) Other 90 Patients without predisposition to allergies 1,507 Prophylactic pretreatment Antihistamine alone 531 106 (20.0) 13 (2.4) 6 (1.1) Antihistamine plus corticosteroid 899 70 (7.8) 8 (0.9) 2 (0.2) Other 77 Patients with known or suspected* predisposition to allergies 240 Prophylactic pretreatment Antihistamine alone 65 19 (29.2) 3 (4.6) 1 (1.5) Antihistamine plus corticosteroid 162 18 (11.1) 3 (1.9) 0 Other 13 * For example, asthma, dermatitis (if not clearly of allergic origin). Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Merck KGaA, Merck Serono Amgen, AstraZeneca, Celgene, Fresenius Biotech, Merck Serono, Roche Amgen, Bristol-Myers Squibb, Merck Serono, Pfizer, Roche, sanofi-aventis Merck Serono