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Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study.
Suzuki, Daniele Assad; Morelle, Alessandra Menezes; de Brito, Mayana Lopes; Paes, Flavia Rocha; Mattar, André; Leal, Jorge H Santos; Simon, Sérgio D; Lima, Ellias Magalhães Abreu; Werutsky, Gustavo; Piotto, Gustavo H Munhoz; Bines, José; Damiani, Lucas Petri; Macedo, Ariane; Campos, Lígia; Buehler, Anna Maria.
Afiliación
  • Suzuki DA; Hospital Sírio Libanês, Brasília, Brazil.
  • Morelle AM; Associação Hospitalar Moinhos de Vento, Porto Alegre, Brazil.
  • de Brito ML; Ensino e Terapia de Inovação-Clínica AMO, Salvador, Brazil.
  • Paes FR; Oncoclínicas do Brasil Serviços Médicos S.A., Belo Horizonte, Brazil.
  • Mattar A; Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA, São Paulo, Brazil.
  • Leal JHS; IPD-CAM Instituto de Pesquisa e Desenvolvimento Carlos Aristides Maltez, Salvador, Brazil.
  • Simon SD; Centro Paulista de Oncologia S.A, São Paulo, Brazil.
  • Lima EMA; Centro Integrado de Estudos e Pesquisa Clínica em Oncologia da Oncomed LTDA, Belo Horizonte, Brazil.
  • Werutsky G; União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS, Porto Alegre, Brazil.
  • Piotto GHM; Instituto de Educação, Pesquisa e Gestão em Saúde, São Paulo, Brazil.
  • Bines J; Oncologia Rede D'OR S.A., Rio de Janeiro, Brazil.
  • Damiani LP; Research Institute at Hospital do Coração, São Paulo, Brazil.
  • Macedo A; Brazilian Clinical Research Institute, Alameda Campinas, São Paulo, Brazil.
  • Campos L; Local Medical Affairs-Oncology, Novartis Biociências S.A., São Paulo, Brazil.
  • Buehler AM; Local Medical Affairs-Oncology, Novartis Biociências S.A., São Paulo, Brazil.
JCO Glob Oncol ; 10: e2300484, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38603658
ABSTRACT

PURPOSE:

Cyclin inhibitors plus endocrine therapy represent the reference standard for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (ABC). Efficacy results on hard end points such as overall survival come from well-designed randomized clinical trials (RCTs). However, a limitation of RCTs is the low external results validity, and their extrapolation to a broader population may not be appropriate. Real-world studies can overcome these limitations, also increasing the reliability of RCTs. MATERIALS AND

METHODS:

The BrasiLEEira was an observational, longitudinal, retrospective, multicenter study to evaluate the effectiveness and safety of ribociclib plus nonsteroidal aromatase inhibitors in Brazilian women age 18 years or older with HR+/HER2- ABC. The study was approved by the institutional review boards of all 11 hospitals. Data were collected anonymously from medical records using an electronic case report form designed by an independent academic research organization, which conducted the study considering all recommendations of international guidelines. The primary end point was 1-year progression-free survival (PFS) rate. Secondary end points included mortality, dose reduction, and safety.

RESULTS:

The mean age of 76 patients was 57 years, and 28.9% were Black/Brown. The most prevalent comorbidity was arterial hypertension (34.7%). About 26.0% had endocrine-resistant disease, and 54.1% had more than three metastatic sites. The PFS rate was 77.6%. Three patients died (3.9%). Dose reductions occurred in 37.7% of patients. The most common adverse event was neutropenia (68.4%).

CONCLUSION:

The high-quality evidence from the BrasiLEEira study corroborates the RCTs' findings, expanding its validity to a broader spectrum and underrepresented population who may benefit from ribociclib treatment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Purinas / Neoplasias de la Mama / Inhibidores de la Aromatasa Límite: Female / Humans / Middle aged País/Región como asunto: America do sul / Brasil Idioma: En Revista: JCO Glob Oncol Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Purinas / Neoplasias de la Mama / Inhibidores de la Aromatasa Límite: Female / Humans / Middle aged País/Región como asunto: America do sul / Brasil Idioma: En Revista: JCO Glob Oncol Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos