Beyond clinical trials: CDK4/6 inhibitor efficacy predictors and nomogram model from real‐world evidence in metastatic breast cancer

作者：Binliang Liu, Zheyu Hu, Ning Xie, Liping Liu, Jing Li, Xiaohong Yang, Huawu Xiao, Xu-Ran Zhao, Can Tian, Hui Wu, Jun Lü, Jianxiang Gao, Xuming Hu, Min Cao, Zhengrong Shui, Yu Tang, Quchang Ouyang · 发表于：Cancer Innovation · 年份：2024 · DOI：10.1002/cai2.143 · 被引用次数：7 · 研究领域：Advanced Breast Cancer Therapies、Estrogen and related hormone effects、HER2/EGFR in Cancer Research

Background: CDK4/6 inhibitors (CDK4/6i) have shown promising results in the treatment of hormone receptor-positive (HR+) metastatic breast cancer (MBC) when combined with endocrine therapy (ET). It is crucial to evaluate the actual effectiveness and safety of CDK4/6i in clinical practice, as well as to analyze the factors that can predict their outcomes. Methods: Patients with HR+ MBC who received CDK4/6i-based therapy between May 2016 and May 2023 at Hunan Cancer Hospital were evaluated for progression-free survival (PFS). Adverse reactions were assessed based on the National Cancer Institute Common Toxicity Criteria (version 5.0). Results: This study included 344 patients, with a median PFS (mPFS) of 12.8 months (range: 10.4-15.2 months). After adjustment, Cox multivariate regression analysis revealed that visceral metastasis (specifically liver and brain metastases), Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥ 1, estrogen receptor ≤ 80%, progesterone receptor ≤ 10%, Ki-67 > 30%, and treatment in later stages were significant factors associated with reduced PFS. Based on this, we created a prognostic nomogram and validated its performance, obtaining a C-index of 0.714 (95% confidence interval: 0.640-0.787) as well as reliable calibration and clinical impact. The mPFS of CDK4/6i rechallenge was 7.7 months; for patients who initially discontinued CDK4/6i for reasons other than disease progression, CDK4/6i rechallenge still provided a mPFS of 11.4 months....