Cetuximab 주입관련반응의 발생 빈도 및 관련 인자 분석

Abstract

Monoclonal antibody treatments can result in severe infusion reactions. Among these, cetuximab, mouse-human chimeric monoclonal antibody reported 15~20% infusion reactions (severe infusion reactions 3~5%). However, there are no actual reported incidences in Korea, and little information regarding the prevention, management or outcomes of infusion reactions. This study represents one of the first attempts to describe the clinical consequences regarding the incidence rates of infusion reactions, effect of premedication and test dose. A retrospective chart review was conducted in Asan Medical Center. Eligible patients were treated with cetuximab as either single agents or in combination with additional chemotherapy. Case searches were conducted by electronic medical records from June 2006 to October 2010. Source documents were evaluated for infusion reactions based on the Common Terminology Criteria for Adverse Events version3.0 (CTCAE v3.0). A total of 336 patients (215 men and 121 women) with the mean age of 56 years (27-76 years) were enrolled in this study. 11 patients were identified with infusion reactions. Mild and moderate infusion reactions are 9 (≤grade2, 3.3%) and severe infusion reactions are 2 (grade4, 0.6%). In premedication, 7 of 285 patients (2.5%) who received antihistamine were identified with a infusion reaction, while 4 of 51 patients (15.2%) who received antihistamine and corticosteroid (p=0.63). 4 of 84 patients (4.8%) treated with monotherapy and 7 of 252 patients (2.8%) treated with combination therapy suffered from infusion reaction (p=0.712). Patients with the administration of test dose (n = 49) experienced infusion reactions were 5 people. Further, 3 of these 5 patients (60%) were identified with infusion reactions at the main dose, not test dose. In addition, 6 patients of the past 2 mg/ml formulation with the unfiltered group (n = 288) (2.1%) and 5 patients of the present 5 mg/ml of the formulation was filtered (n = 48) (10%) were identified with a infusion reactions (p=0.915). It was difficult to find significant factors relating to the infusion reactions because incidences of cetuximab infusion reactions were lower than the previously reported. However, we found that antihistamine with corticosteroids as a premedication tended to reduce infusion reactions and the test dose is not valid.