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Cyclin-Dependent Kinase 4/6 Inhibitors Plus Endocrine Therapy versus Endocrine Therapy Alone for HR-Positive, HER-2-Negative Early Breast Cancer: Meta-Analysis of Phase III Randomized Clinical Trials.
Moraes, Francisco Cezar Aquino de; de Oliveira Almeida, Gustavo; Alves, Vinícius Freire Costa; Priantti, Jonathan N; Gomes, Giovanna da Conceição; Carnevalli, Sarah Vitória Bristot; Madeira, Thiago; Vilbert, Maysa; Stecca, Carlos; Figueroa Magalhães, Maria Cristina; Fernandes, Marianne Rodrigues; Dos Santos, Ney Pereira Carneiro.
Afiliación
  • Moraes FCA; Oncology Research Center, Federal University of Pará, Belem 66073-005, Brazil.
  • de Oliveira Almeida G; School of Medicine, Federal University of Triângulo Mineiro, Uberaba 38025-180, Brazil.
  • Alves VFC; School of Medicine, University of São Paulo, São Paulo 01246-903, Brazi.
  • Priantti JN; School of Medicine, Federal University of Amazonas, Manaus 69080-900, Brazil.
  • Gomes GDC; School of Medicine, Catholic University of Minas Gerais, Belo Horizonte 32010-025, Brazil.
  • Carnevalli SVB; School of Medicine, Federal University of Santa Catarina, Florianópolis 88040-900, Brazil.
  • Madeira T; School of Medicine, Federal University of Minas Gerais, Belo Horizonte 31270-901, Brazil.
  • Vilbert M; Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON M5G 2C4, Canada.
  • Stecca C; Mackenzie Evangelical University Hospital, Curitiba 80730-150, Brazil.
  • Figueroa Magalhães MC; Mackenzie Evangelical University Hospital, Curitiba 80730-150, Brazil.
  • Fernandes MR; Oncology Research Center, Federal University of Pará, Belem 66073-005, Brazil.
  • Dos Santos NPC; Oncology Research Center, Federal University of Pará, Belem 66073-005, Brazil.
J Pers Med ; 14(5)2024 Apr 27.
Article en En | MEDLINE | ID: mdl-38793046
ABSTRACT

BACKGROUND:

Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are approved for advanced breast cancer combined with endocrine therapy (ET). The efficacy of CDK4/6 inhibitors plus ET in hormone estrogen-positive, human epidermal growth factor 2-negative (HR+/HER2-) early-stage breast cancer (esBC) is still to be confirmed.

METHODS:

We performed a systematic review and a meta-analysis to investigate the efficacy of CDK4/6i plus ET in esBC. Main outcomes included invasive disease-free survival (iDFS), distant relapse-free survival (DRFS), and overall survival (OS). We included only phase III randomized controlled trials. We used RStudio version 4.2.3, and we considered p < 0.05 to be statistically significant.

RESULTS:

Four studies were selected, including 14,168 patients, of which 7089 were treated with CDK4/6i plus ET and 7079 received ET monotherapy. Regarding patient characteristics, 6828 (48.2%) were premenopausal. Compared with ET alone, iDFS rates (HR 0.81; 95% CI 0.67, 0.98; p = 0.034) were significantly in favor of CDK4/6 inhibitors plus ET. However, there were no significant differences in DRFS (HR 0.79; 95% CI 0.58, 1.07; p = 0.132) nor OS (HR 0.96; 95% CI 0.69, 1.35; p = 0.829).

CONCLUSIONS:

Our results show that the addition of CDK4/6 inhibitors is associated with a significant benefit for HR+/HER2- esBC patients in iDFS. More studies and longer follow-up are needed to assess overall survival benefits.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Pers Med Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Pers Med Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Suiza