A Prospective Observational Study for Assessment of Chemotherapy-Induced Adverse Drug Reactions in Cancer Patients

Research Article

Abstract

A prospective observational study was carried out to evaluate the patterns, severity, and management of chemotherapy-induced adverse drug reactions (ADRs) in cancer patients. The study included 135 patients receiving chemotherapy at a tertiary care hospital over six months. ADRs were assessed using Naranjo's causality assessment scale, Hartwig's severity scale, and Schumock and Thornton preventability criteria. The mean age of patients was 49.31 ± 12.69 years, with females (63%) experiencing more ADRs than males (37%). Breast cancer was the most prevalent malignancy (34.8%), followed by ovarian and cervical cancers in females, while lung cancer predominated in males. The most frequent ADRs were alopecia, nausea and vomiting, loss of appetite, peripheral neuropathy, and skin/nail pigmentation changes. Gastrointestinal and dermatological reactions were the most commonly affected organ systems. Naranjo's algorithm revealed 76% probable, 20% possible, and 4% definite causality relationships. According to Hartwig's scale, 58.03% ADRs were mild and 41.6% moderate in severity. The Schumock and Thornton criteria classified 62% of reactions as definitely preventable. Statistical analysis showed no significant association between ADR severity and patient age (p=0.73) or gender (p=0.45). Notably, myelosuppression persisted despite dose adjustments, and emesis remained poorly controlled despite prophylactic antiemetic therapy. The study shows the need for enhanced pharmacovigilance and personalized approaches to minimize chemotherapy-induced ADRs.