Chemotherapy-Related Adverse Drug Reaction (ADR) Profile in Geriatric Cancer Patients: A Prospective Study From Western India

Background Chemotherapy adverse drug reactions (ADRs) among geriatric cancer patients (≥65 years) are a major cause of morbidity. Real-world data for the Western Indian population are lacking. In the absence of data and guidelines, geriatric patients either suffer treatment-related toxicities or remain undertreated. The present study aimed to study the clinical profile, geriatric assessment (GA), chemotherapy-related ADRs, and survival outcomes. Methods This prospective, observational study enrolled patients aged ≥65 years who were starting curative-intent chemotherapy. Baseline clinical and GA was performed. Treatment details, including planned chemotherapy regimens and modifications in chemotherapy dosing, schedule, or protocol selection based on initial assessments, were recorded. Chemotherapy-related ADRs were assessed using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Grade 3-5 adverse events were defined as severe. In total, 150 patients were accrued. Patients were followed up for one year post-chemotherapy. Results Out of 150 patients, 72 patients (48%) completed all planned cycles. Forty-nine patients (32.66%) reported severe-grade ADRs (CTCAE grades 3, 4, and 5). A total of nine (6%) deaths were reported during chemotherapy (i.e., CTCAE grade 5). The baseline GA parameters were not associated with CTCAE grade (p value > 0.05, nonsignificant). The estimated Kaplan-Meier survival at the end of four years of follow-up suggests worse outcomes in patients who experienced severe-grade ADRs and were unable to complete all the planned chemotherapy cycles. Conclusions A significant proportion of geriatric cancer patients experience severe-grade chemotherapy ADRs. Completing planned chemotherapy cycles in patients being treated with curative intent is an important determinant of survival. Patients who experience severe-grade toxicities have adverse survival outcomes, emphasizing the need for personalized toxicity management.