Spectrum of Adverse Effects Associated with Immunotherapy and Biologicals in Patients with Malignancy

A BSTRACT Background: This study aimed to determine the toxicity profile of cancer drugs in the Indian population and to evaluate their usage patterns among Indian patients. Materials and Methods: A prospective and observational study was conducted in the department of medicine from April 2023 to March 2024. Patients aged ≥18 years with cancer receiving immunotherapy or biological therapy were enrolled, excluding pregnant/postpartum women and those with central nervous system-related causes of weakness. A total of 152 patients were included based on the sample size estimation. Demographic, clinical, laboratory, and imaging evaluations were performed. Adverse events (AEs) were graded using the Common Terminology Criteria for Adverse Events v5.0. Statistical analysis was performed using Fisher’s exact test, with P < 0.05 considered statistically significant. Results: The mean age was 45.76 ± 12.6 years; 117 (76.97%) were males. Breast cancer (16.45%) was the most frequent diagnosis. Drugs administered included atezolizumab (20.39%), pembrolizumab (17.11%), and nivolumab (14.47%). Most AEs were mild to moderate. Cardiac events (atrial fibrillation/flutter) were mainly Grade III–IV, occurring more often with bevacizumab ( P < 0.0001). Endocrine AEs (hypothyroidism and hypopituitarism) were frequent with atezolizumab, nivolumab, ipilimumab, and avelumab (100% each, P < 0.0001). Respiratory toxicities (acute respiratory distress syndrome and allergic rhinitis) were severe with pembrolizumab, atezolizumab, and ipilimumab (>80%, P < 0.0001). Gastrointestinal AEs occurred in nearly all patients on bevacizumab, ipilimumab, and avelumab ( P = 0.004). Conclusion: Immunotherapies and biologicals produced diverse AEs, predominantly Grade I–II, but clinically significant respiratory and neurological toxicities occasionally progressed to Grade IV–V. Vigilant monitoring and individualized management are essential.