Cyclin-dependent kinase 4/6 抑制剂（CDKi）已改变激素受体阳性、人类表皮生长因子受体2 呈阴性转移性乳腺癌（HR+/HER- MBC）患者的治疗方案。但是CDKi进展后的下一线治疗策略尚未优化。我们在HR+/HER2- MBC病人的一个单一机构的队列中，报告了临床和基因因素对CDKi治疗后结果的影响。 我们回顾了在我们机构于2014年4月1日至2019年12月1日之间接受CDKi治疗的HR+/HER2- MBC病人的病历记录。数据使用描述性统计学、Kaplan-Meier方法和回归模型进行总结。 我们确定了140名接受CDKi治疗的HR+/HER2- MBC病人。80％的病人因疾病进展而停止治疗，中位进展无病生存期（PFS）为6.0个月（95％ CI，5.0-7.1），而停止CDKi治疗的其他原因的病人的PFS为11.3个月（95％ CI，4.6-19.4）（危险比（HR）2.53，95％ CI，1.50-4.26 [P = .001]）。112名在CDKi治疗期间进展的病人的CDKi治疗后6个月的累计进展或死亡发生率为51％。 在CDKi治疗前携带PTEN突变的病人的临床结果较野生型PTEN的病人差。 本研究强调了CDKi治疗后结果和进一步的分子特征化和新型治疗方法的需求，以改善HR+/HER2- MBC病人的治疗。 ©作者（2023年）由牛津大学出版社出版。

Cyclin-dependent kinase 4/6 inhibitors (CDKi) have changed the landscape for treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER-) metastatic breast cancer (MBC). However, next-line treatment strategies after CDKi progression are not yet optimized. We report here the impact of clinical and genomic factors on post-CDKi outcomes in a single institution cohort of HR+/HER2- patients with MBC.We retrospectively reviewed the medical records of patients with HR+/HER2- MBC that received a CDKi between April 1, 2014 and December 1, 2019 at our institution. Data were summarized using descriptive statistics, the Kaplan-Meier method, and regression models.We identified 140 patients with HR+/HER2- MBC that received a CDKi. Eighty percent of patients discontinued treatment due to disease progression, with a median progression-free survival (PFS) of 6.0 months (95% CI, 5.0-7.1), whereas those that discontinued CDKi for other reasons had a PFS of 11.3 months (95% CI, 4.6-19.4) (hazard ratio (HR) 2.53, 95% CI, 1.50-4.26 [P = .001]). The 6-month cumulative incidence of post-CDKi progression or death was 51% for the 112 patients who progressed on CDKi. Patients harboring PTEN mutations pre-CDKi treatment had poorer clinical outcomes compared to those with wild-type PTEN.This study highlights post-CDKi outcomes and the need for further molecular characterization and novel therapies to improve treatments for patients with HR+/HER2- MBC.© The Author(s) 2023. Published by Oxford University Press.