Seguran2

Nota

O perfil de segurança descrito na bula de sacituzumabe govitecana é derivado de dados agrupados dos estudos ASCENT (IMMU-132-05) e TROPICS-02 (IMMU-132-09), multicêntricos, abertos e randomizados, que envolveram 529 pacientes e 543 pacientes, respectivamente. Os pacientes receberam 10 mg/kg de peso corporal de sacituzumabe govitecana para o tratamento de CMTNm e CMm HR+/HER2- e, portanto, podem haver diferenças em comparação com as taxas relacionadas às reações adversas apresentadas neste material.

Abreviações

RA - Reção adversa;

EA - Evento adverso;

Referências

• Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021;384(16):1529-1541;
• Rugo HS, Bardia A, Marmé F, et al. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022;40(29):3365-3376;
• Tolaney S, Bardia, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPICS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (mBC). Abstract #1003 apresentado na ASCO 2023. Disponível em: https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.1003. Acesso em 25/08/2023;
• Loriot Y, et al. Presented at the Virtual 2020 ESMO Congress;
• Rugo HS, et al. Primary Results From TROPICS-02: A Randomized Phase 3 Study of Sacituzumab Govitecan Vs Treatment of Physician's Choice in Patients With Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer. Abstract LBA1001 apresentado na ASCO 2022. Disponível em: https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.17_suppl.LBA1001. Acesso em 25/08/2023;
• Schettini F, Venturini S, Giuliano M, et al. Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer. Cancer Treat Rev. 2022; 111:102468;
• Aditya Bardia et al., Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. JCO 42, 1738-1744(2024);
• Hope S Rugo et al., Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPICS-02): a randomised, open-label, multicentre, phase 3 trial. V 402, ISSUE 10411, P1423-1433, October 21, 2023;
• Trodelvy (sacituzumabe govitecana). Bula do medicamento. Disponível em: https://consultas.anvisa.gov.br/#/bulario/q/?nomeProduto-Trodelvy. Acesso em 01/12/2024;

Aprovado em Dezembro de 2024 - BR-TRO-0486.