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 (RCC) is the tenth most common malignancy. Sunitinib is used as the first treatment line in patients with a good and intermediate prognosis. The aim of this study was to analyze the risk factors, frequency, and advers...

Full description

Saved in:
Bibliographic Details
Main Authors: Mugoša Snežana, Džamić Zoran, Sahman-Zaimović Majda, Lukovac-Janjić Nevenka
Format: Article
Language:English
Published: Ministry of Defence of the Republic of Serbia, University of Defence, Belgrade 2021-01-01
Series:Vojnosanitetski Pregled
Subjects:
Online Access:http://www.doiserbia.nb.rs/img/doi/0042-8450/2021/0042-84502000145M.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850214490337968128
author Mugoša Snežana
Džamić Zoran
Sahman-Zaimović Majda
Lukovac-Janjić Nevenka
author_facet Mugoša Snežana
Džamić Zoran
Sahman-Zaimović Majda
Lukovac-Janjić Nevenka
author_sort Mugoša Snežana
collection DOAJ
description Background/Aim. Kidney tumors account for 2–3% of all tumors. Renal cell carcinoma (RCC) is the tenth most common malignancy. Sunitinib is used as the first treatment line in patients with a good and intermediate prognosis. The aim of this study was to analyze the risk factors, frequency, and adverse drug reactions (ADRs) of sunitinib in patients with metastatic RCC. Methods. The retrospective study included 170 patients treated at the 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 Niš. 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 World Health Organization criteria. Causality was assessed using the Naranjo probability scale. Results. ADRs of sunitinib occurred in 152 (89.4%) patients. 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 assessment 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 proved to be the most significant risk factors for ADR 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 monitoring safe drug use, as well as patients on sunitinib therapy, in order to improve their awareness of the sunitinib ADRs and the risk factors that lead to them, with the aim of reducing their frequency.
format Article
id doaj-art-80e441ad4dd14cd282bbe0283f8ca5ca
institution OA Journals
issn 0042-8450
2406-0720
language English
publishDate 2021-01-01
publisher Ministry of Defence of the Republic of Serbia, University of Defence, Belgrade
record_format Article
series Vojnosanitetski Pregled
spelling doaj-art-80e441ad4dd14cd282bbe0283f8ca5ca2025-08-20T02:08:53ZengMinistry of Defence of the Republic of Serbia, University of Defence, BelgradeVojnosanitetski Pregled0042-84502406-07202021-01-0178445646110.2298/VSP201109145M0042-84502000145MAdverse drug reactions associated with sunitinib therapy: Characteristics and risk factorsMugoša Snežana0Džamić Zoran1Sahman-Zaimović Majda2Lukovac-Janjić Nevenka3University of Montenegro, Faculty of Medicine, Podgorica, Montenegro + Institute for Medicines and Medical Devices, Podgorica, MontenegroUniversity of Belgrade, Faculty of Medicine, Clinic for Urology, Belgrade, SerbiaUniversity of Montenegro, Faculty of Medicine, Podgorica, Montenegro + Institute for Medicines and Medical Devices, Podgorica, MontenegroUniversity of Montenegro, Institute for Oncology and Radiotherapy, Podgorica, MontenegroBackground/Aim. Kidney tumors account for 2–3% of all tumors. Renal cell carcinoma (RCC) is the tenth most common malignancy. Sunitinib is used as the first treatment line in patients with a good and intermediate prognosis. The aim of this study was to analyze the risk factors, frequency, and adverse drug reactions (ADRs) of sunitinib in patients with metastatic RCC. Methods. The retrospective study included 170 patients treated at the 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 Niš. 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 World Health Organization criteria. Causality was assessed using the Naranjo probability scale. Results. ADRs of sunitinib occurred in 152 (89.4%) patients. 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 assessment 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 proved to be the most significant risk factors for ADR 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 monitoring safe drug use, as well as patients on sunitinib therapy, in order to improve their awareness of the sunitinib ADRs and the risk factors that lead to them, with the aim of reducing their frequency.http://www.doiserbia.nb.rs/img/doi/0042-8450/2021/0042-84502000145M.pdfdrug-related side effects and adverse reactionskidney neoplasmssunitinib
spellingShingle Mugoša Snežana
Džamić Zoran
Sahman-Zaimović Majda
Lukovac-Janjić Nevenka
Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
Vojnosanitetski Pregled
drug-related side effects and adverse reactions
kidney neoplasms
sunitinib
title Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
title_full Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
title_fullStr Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
title_full_unstemmed Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
title_short Adverse drug reactions associated with sunitinib therapy: Characteristics and risk factors
title_sort adverse drug reactions associated with sunitinib therapy characteristics and risk factors
topic drug-related side effects and adverse reactions
kidney neoplasms
sunitinib
url http://www.doiserbia.nb.rs/img/doi/0042-8450/2021/0042-84502000145M.pdf
work_keys_str_mv AT mugosasnezana adversedrugreactionsassociatedwithsunitinibtherapycharacteristicsandriskfactors
AT dzamiczoran adversedrugreactionsassociatedwithsunitinibtherapycharacteristicsandriskfactors
AT sahmanzaimovicmajda adversedrugreactionsassociatedwithsunitinibtherapycharacteristicsandriskfactors
AT lukovacjanjicnevenka adversedrugreactionsassociatedwithsunitinibtherapycharacteristicsandriskfactors