Pattern of Chemotherapy-Related Adverse Effects Among Adult Patients With Cancer Treated at Gondar University Referral Hospital, Ethiopia: A Cross-Sectional Study

Abstract

Abstract 32 Purpose Adverse drug reactions (ADRs) are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the current study was to assess the pattern of ADRs that occur in patients with cancer who were treated with chemotherapy in a tertiary care teaching hospital in Ethiopia. Methods A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted in patients with cancer who underwent chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. Reported ADRs were assessed for causality using the WHO causality assessment scale and Naranjo’s algorithm. Severities of the reported reactions were also assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). Pearson’s χ2 test was used to examine the association between two categorical variables. Results A total of 815 ADRs were identified from 203 patients who were included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%), infections (16.7%), neutropenia (14.7%), fever and/or chills (11.3%), and anemia (9.3%). Platinum compounds (31.4%) were the most common group of drugs that caused ADRs. Of reported ADRs, 65.8% were grades 3 to 4 (severe level), 29.9% were grades 1 to 2 (mild level), and 4.3% were grade 5 (toxic level). Significant association was found between age, number of chemotherapeutic agents, and dose of chemotherapy with the occurrence of grades 3 to 5 toxicity. Conclusion The high incidence of chemotherapy-related ADRs among patients with cancer is of concern. Establishing an effective ADR monitoring and reporting system—oncopharmacovigilance—and creating awareness among health care professionals of the importance of ADR reporting may help prevent the problem. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from the authors.