Drug Utilization Study and Safety Pattern of Biologicals in a Tertiary Care Hospital at Eastern India

Background Biological agents have revolutionized cancer treatment by offering targeted therapeutic effects with improved selectivity over conventional chemotherapy. However, real-world data on their utilization and safety in Indian tertiary care settings remain limited. This study aimed to evaluate the drug utilization pattern and safety profile of biologics in cancer patients. Methods A prospective, observational study was conducted over 18 months (July 2022-December 2023) at a tertiary care oncology center in eastern India. A total of 373 prescriptions were analyzed, of which 100 included biological agents and were evaluated in detail. Patients aged 15-70 years with confirmed malignancy were included. Data on demographics, cancer characteristics, drug utilization, and adverse events (AEs) were collected. The primary outcome was the percentage utilization of biologics, while secondary outcomes included comparison of AE incidence between biologics and conventional therapy, and severity assessment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Biologics were prescribed in 26.8% of total prescriptions. The majority of patients were aged 46-70 years, with a slight female predominance. Breast, lung, and colorectal cancers were the most common malignancies, with most patients presenting at Stage III. Bevacizumab (30/373, 8.04%) was the most frequently used biologic, followed by trastuzumab (27/373, 7.24%) and rituximab (16/373, 4.29%). AE analysis showed that gastrointestinal toxicities such as nausea and vomiting were significantly higher with conventional therapy (61/373, 22.34% vs. 12/100, 12.00%, p=0.03), and neuropathy was also more common (45/273, 16.48% vs. 7/100, 7.00%, p=0.02). In contrast, biologics were associated with significantly higher hematological toxicities, including anemia, neutropenia, thrombocytopenia, and lymphocytopenia (p<0.001), as well as pneumonitis (15/100, 15.00% vs. 11/273, 4.03%, p=0.0008). Most AEs were mild to moderate, with no fatal events reported. Conclusion Biologics represent an important component of cancer therapy with an acceptable safety profile. While they reduce gastrointestinal and neurological toxicities, they are associated with higher hematological AEs and pneumonitis, emphasizing the need for careful monitoring.