Safety profile of dual blockade treatment with trastuzumab and pertuzumab in patients with her2+metastatic breast cancer: real-world study
DOI:
https://doi.org/10.11606/issn.2176-7262.rmrp.2024.217197Keywords:
Breast neoplasm, Biosimilar pharmaceuticals, Tastuzumab, Adverse eventAbstract
Aims: This study analyzed the safety profile related to dual blockade with or without chemotherapy or hormone therapy in the treatment of HER2+ metastatic breast cancer. Adding potential variables associated with the risk of severe adverse events and possible implications of using biosimilars were analyzed, in a Brazilian referral hospital between October 2020 and April 2022. Methods: This is a real-world study conducted with 64 female participants divided into three groups: Dual Blockade, Dual Blockade + Chemotherapy, and Dual Blockade + Hormone Therapy. The analysis considered total treatment cycles and adverse events, which were classified by severity across groups. The association of social and clinical variables with adverse events was checked. The cycle-adjusted adverse events rate was calculated. Associations were estimated using Fisher’s Exact test. The risk probability for variables predicting severe adverse events was calculated using the Odds Ratio, with a 95% Confidence Interval. Results: Diarrhea was the main adverse event identified. Overall, 33.9% of patients had some severe adverse events. The Dual Blockade + Hormone Therapy group showed the highest frequency of adverse events. White skin color and undergoing radiotherapy concomitant were associated with the risk of severe adverse events. Cycle-adjusted adverse events rates showed no significant difference between dual blockade with biosimilar and dual blockade with original trastuzumab. Conclusion: The safety profile identified was similar in the different groups analyzed and between dual blockade with biosimilar or original trastuzumab.
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Copyright (c) 2024 Kariny Gomes Pereira, Mario Jorge Sobreira-da-Silva, Patrícia Ribeiro Portella de Araújo, Ludmila Andrade Alves Ferreira, Maely Peçanha Favero Retto
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