학술논문
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.
Document Type
Article
Author
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
Source
Subject
*CYCLIN-dependent kinase inhibitors
*HORMONE therapy
*BREAST cancer
*METASTATIC breast cancer
*TUMOR classification
*EPIDERMAL growth factor
*CYCLIN-dependent kinases
*ESTROGEN
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Language
ISSN
2075-4426
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. [ABSTRACT FROM AUTHOR]