Drug Utilisation Pattern and Adverse Drug Reactions in Stage II Breast Cancer Patients in a Tertiary Care Centre of Odisha- An Observational Study

Abstract

Introduction: Breast cancer is the most common cancer occurring in women with an estimated prevalence of 28.94% in Cuttack, Odisha, India. Adverse Drug Reactions (ADRs) associated with the use of anticancer drugs is a worldwide problem which needs further attention. Aim: To know about treatment regimens, premedications used for toxicity amelioration or any associated ADRs occurring during treatment of stage II breast cancer patients. Materials and Methods: This was a prospective observational study carried out in the Department of Pharmacology in collaboration with Acharya Harihar Regional Cancer Center (AHRCC), SCB Medical College and Hospital, Odisha, India. A total of 181 female breast cancer patients of stage II were finally analysed about their treatment protocol pattern including premedication, chemotherapy regimen, associated ADRs and their treatment. Different outcomes measured were Absolute Neutrophil Count (ANC), febrile neutropenia, anaemia, thrombocytopenia. ADRs were analysed by using World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) Scale and Hartwig-Siegel Scale. All analysis was performed using Statistical Package For the Social Sciences (SPSS) version 18.0. Results: Most common chemotherapy combination regimen used was cyclophosphamide + doxorubicin + paclitaxel + trastuzumab in 30.9% of patients, out of which 28.7% showed ADRs. Ondansetron and aprepitant were commonly used as premedication in 96% of patients. Most commonly reported ADR was Chemotherapy Induced Nausea and Vomiting (CINV) in 43.6% patients and Chemotherapy Induced Neutropenia (CIN) (34.8%). Fifty percent ADRs were mild and 3.3% ADRs were severe in nature. A 64% ADRs were possible and 23% ADRs were probable according to WHO-UMC causality assessment scale. Grade 4 Neutropenia was present in 1.3% patients. Mild haematological problems were treated by blood transfusion while severe cases by additional growth factor support like Granulocyte Colony Stimulating Factor (G-CSF). In this study, mean age of presentation was found to be 44.6 years. Conclusion: Despite use of drugs for toxicity amelioration, some grade four life threatening ADRs were observed. Mostly ADRs were missed and under-reported. Regular monitoring, increased care and patient compliance was needed to detect new ADRs and to reduce the morbidity as well as burden on the patients.

Keywords

• causality assessment
• chemotherapy
• neutropenia