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Ars Pharmaceutica (Internet)
On-line version ISSN 2340-9894
Abstract
GONZALEZ-FURELOS, Tania; FRAGA-BUENO, Eva; RODRIGUEZ-LEGAZPI, Iria and RODRIGUEZ-PENIN, Isaura. Safety and tolerability of cabozantinib in renal cancer and hepatocarcinoma. Ars Pharm [online]. 2023, vol.64, n.1, pp.19-27. Epub Mar 13, 2023. ISSN 2340-9894. https://dx.doi.org/10.30827/ars.v64i1.26725.
Introduction:
Cabozantinib is a drug indicated for the treatment of renal cancer and hepatocarcinoma with proven efficacy in clinical trials. However, when we analyze its safety profile, the pivotal trials themselves show a high percentage of adverse effects, making it necessary in many cases to reduce the dose or interrupt treatment due to toxicity. Therefore, our study aims to analyze the tolerability and safety of cabozantinib in our population.
Method:
Observational, retrospective and single-center study. Different variables related to the safety and tolerability of the drug were evaluated. To assess toxicity, the National Cancer Institute criteria (CTCAE version 5.0) were used. Tolerance was assessed based on the presence of adverse effects during treatment with cabozantinib. A descriptive and inferential statistical analysis of the data was performed.
Results:
A total of 17 patients were included (mean age: 63.5 years old). All of them presented adverse effects. The main toxicities presented of any grade were asthenia, diarrhea, skin toxicity, hypomagnesemia, hypertransaminemia, and palmoplantar syndrome. 41.2% were grade 3 toxicity, the main adverse reactions being hypertransaminemia and hypomagnesemia. Hospital admission due to drug toxicity was required by 23.5%. Dose reduction to 40 mg due to toxicity was required by 94.1% of patients.
Conclusions:
Cabozantinib has an unfavorable safety profile with a high percentage of adverse effects that require dose reduction or treatment interruption.
Keywords : Cabozantinib; Carcinoma, Renal Cell; Drug-Related Side Effects and Adverse Reactions; Carcinoma, Hepatocellular.