Korean J Med.  2013 Oct;85(4):385-395.

Data Analysis for Anti-Neoplastic Chemotherapy-Related Adverse Events Reported to the Korean Pharmacovigilance Regional Network

• Lee JY
• Jung JW
• Kang HR
• Lee SH
• Kim HS
• Cho SH

Abstract

BACKGROUND/AIMS
To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA).
METHODS
Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products.
RESULTS
In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs.
CONCLUSIONS
The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.

Keyword

Anti-neoplastic agents; Adverse drug reaction reporting system; Drug toxicity; Neoplasm

MeSH Terms

Antineoplastic Agents
Drug Toxicity
Expert Testimony
Humans
Male
Pharmacovigilance
Platinum Compounds
Product Labeling
Protein Kinase Inhibitors
Pyrimidines
Skin
Statistics as Topic
Taxoids
United States Food and Drug Administration
Antineoplastic Agents
Platinum Compounds
Protein Kinase Inhibitors
Pyrimidines
Taxoids