단일 의료기관에서의 항암제 유해사례 보고 분석

Abstract

Background : Anti-neoplastic agents act by killing cells that divide rapidly, one of themain properties of most cancer cells. Chemotherapy can also harms cells that divide rapidlyunder normal circumstances, leading to various side effects such as anemia, leukopenia, alopecia,and mucositis. This pattern of side effects depends on the type and dosage regimen of the antineoplasticagents. However there is a paucity of such research in Korea. We analyzed the statusof anti-neoplastic agent-related adverse events reported in a single hospital in Korea. Methods : Adverse drug reaction data was collected prospectively from the Seoul NationalUniversity Hospital Pharmacovigilance Center, from February 2010 to June 2012. One-thousand, one-hundred and seventy-six anti-neoplastic agent-related cases (14.5%) were analyzed from atotal of 8102 cases. We retrospectively analyzed patient information, cause drug, regimen, clinicalsymptoms, serious adverse events, and un-reported adverse events. We evaluated by CommonTerminology Criteria for Adverse Events(CTCAE), the severity based on the report by WHOAdverse Reactions Terminology(WHO-ART). Results : Patients with adverse events(AEs) had a median age of 57.7 years, between 51-60years of age was most common. The most common causative anti-neoplastic agent was oxaliplatin(24.2%), followed by irinotecan (12.2%), docetaxel (6.9%) and the highest proportion comparedto the total AEs was sunitinib. The most common clinical manifestation of AEs was skinand appendage disorders (32.6%), and hypersensitivity (10.4%) was the most common clinicalsymptom, followed by nausea (6.9%), and pruritus (5.3%). A total of 265 cases were reported asserious AEs. Conclusions : Unreported AEs may be expressed, hence more active AE reporting is required. Anti neoplastic agents-specific adverse events reporting system, based on. the toxicity ratingsand the chemotherapy protocol, is needed.