Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
Background/Aim: Kidney tumors account for 2-3% of all tumors. Renal cell carcinoma is the tenth most common malignancy. Sunitinib ise used as the first treatment line in patients with a good and intermediate prognosis. The main goal of this study is to analyze the risk factors, frequency and adverse drug reactions (ADRs) of sunitinib in patients with metastatic renal cell carcinoma. Methods: The retropective study included 170 patients treated in Clinic for Oncology of the Clinical Center of Montenegro, Urology Clinic of the Clinical Center of Serbia and Clinic for Oncology of the Clinical Center Nis. As a data source, we used patient medical histories and/or electronic patient records. ADRs were characterized by using Rawlins and Thompson classification. Each ADRs severity was assessed in accordance with the WHO criteria. Causality was assessed using the Naranjo probability scale. Results: Adverse drug reactions of sunitinib occurred in 152 patients (89,4%). ADRs were 89% type A and 11% type C. Disorders of the blood and lymphatic system, gastrointestinal disorders and disorders of the skin and subcutaneous tissue were the most common manifestations of ADRs of sunitinib. Causality assesment was most commonly classified as certain (60%). Serious ADRs occurred in 4.5% of patients. Most patients recovered without consequences. The most common manifestations of ADRs were: leukopenia, hypothyroidism, thrombocytopenia, diarrhea, stomatitis, asthenia and hypertension. All ADRs were expected. The number of concomitant medications and the duration of therapy were shown to be the most significant risk factors for adverse reactions to sunitinib. Conclusion: Our study shows that the incidence of ADRs of sunitinib in patients with kidney cancer is high. The ADRs were mostly moderate and mild in intensity and occurred as a consequence of the pharmacological action of the drug. It is necessary to conduct continuous education of medical oncologists in the field of the safe use of drugs monitoring, as well as patients on sunitinib therapy, in order to improve their awareness of the ADRs of sunitinib and the risk factors that lead to them, with the aim of reducing their frequency.