A Retrospective Observational Study on the Clinical Safety of Capecitabine in Cancer and Its Implications

Fatima Nashra; E. Evangileen B; Harish Y; Mounika N

doi:10.37022/jcscr.v5i2.933

Nashra Fatima Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
B.E. Evangileen Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
Y. Harish Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
N. Mounika Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.

DOI https://doi.org/10.37022/jcscr.v5i2.933

Abstract

Cancer chemotherapy is frequently associated with adverse drug reactions that may compromise treatment adherence and clinical outcomes. Capecitabine, an oral fluoropyrimidine widely used in the management of breast, colorectal, gastric, pancreatic, and other solid malignancies, has demonstrated favourable efficacy but is commonly associated with treatment-related toxicities. The present retrospective observational study was conducted to evaluate the clinical safety of capecitabine and its implications in routine oncology practice. The study was carried out over a period of six months at a tertiary care hospital and included 60 patients receiving capecitabine-based chemotherapy. Demographic characteristics, cancer type, capecitabine brands, adverse drug reactions, and treatment-related safety outcomes were assessed from medical records and electronic databases. Female patients constituted 68.3% of the study population, and the highest proportion of patients belonged to the 61–70-year age group. Breast cancer was the most common indication for capecitabine therapy (41 patients). Hand-foot syndrome was the most frequently reported adverse drug reaction (37 patients), followed by nausea and vomiting, mouth ulcers, alopecia, and neuritis. Female patients experienced a slightly higher incidence of hand-foot syndrome than males. The findings indicate that capecitabine is generally safe when appropriately monitored; however, early recognition and management of adverse drug reactions are essential to minimize toxicity, improve treatment adherence, and optimise therapeutic outcomes in cancer patients.

Keywords: Capecitabine, Cancer, Clinical safety, Hand-foot syndrome, Adverse drug reactions, Retrospective observational study, Chemotherapy

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