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KMID : 0869620140310050973
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Journal of Korean Society of Hospital Pharmacists
2014 Volume.31 No. 5 p.973 ~ p.982
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Analysis of Anti-neoplastic Agent-Related Adverse Events in a Single Hospital
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Song Ji-Ye
Song Su-Jeong
Suh Sung-Yun
Kim Hyang-Suk
Lee Hye-Sook
Lee Ju-Yeun
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Abstract
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Background : Anti-neoplastic agents act by killing cells that divide rapidly, one of the main properties of most cancer cells. Chemotherapy can also harms cells that divide rapidly under 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 antineoplastic agents. However there is a paucity of such research in Korea. We analyzed the status
of anti-neoplastic agent-related adverse events reported in a single hospital in Korea.
Methods : Adverse drug reaction data was collected prospectively from the Seoul National University 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 a total of 8102 cases. We retrospectively analyzed patient information, cause drug, regimen, clinical symptoms, serious adverse events, and un-reported adverse events. We evaluated by Common Terminology Criteria for Adverse Events(CTCAE), the severity based on the report by WHO Adverse Reactions Terminology(WHO-ART).
Results : Patients with adverse events(AEs) had a median age of 57.7 years, between 51-60 years 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 compared to the total AEs was sunitinib. The most common clinical manifestation of AEs was skin and appendage disorders (32.6%), and hypersensitivity (10.4%) was the most common clinical symptom, followed by nausea (6.9%), and pruritus (5.3%). A total of 265 cases were reported as serious 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 ratings and the chemotherapy protocol, is needed.
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KEYWORD
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Anti-neoplastic agent, WHO-ART, CTCAE, ADR(Adverse Drug Reaction)
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