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monarchE 招募了 5637 名患者。在总体人群中，有 4425 名患者的未经治疗的乳腺组织样本可供 Ki-67 检测。 Ki-67 分析中的人群包括

• ITT人群中有2498名Ki-67≥20%的患者，称为ITT Ki-67高表达人群
• 来自队列 1 的 2003 名患者的 Ki-67 ≥20%，称为队列 1 Ki-67 高表达，并且
• 来自队列 1 的 1914 名患者 Ki-67 <20%，称为队列 1 Ki-67 低表达。^1-4

ITT、ITT Ki-67 高表达、队列 1 Ki-67 高表达和队列 1 Ki-67 低表达组的基线特征总结于表 1。

所有随机分组患者中有 21.5% (n=1212) 的 Ki-67 结果缺失。²

表 1. monarchE Ki-67 人群的基线特征⁵

缩略词: ITT = 意向治疗。

上次审阅日期：2024年1月30日

参考文献

1. Harbeck N, Johnston S, Fasching P, et al. High Ki-67 as a biomarker for identifying patients with high risk early breast cancer treated in monarchE. Cancer Res. 2021;81(4 suppl):PD2-01. San Antonio Breast Cancer Symposium abstract PD2-01. https://doi.org/10.1158/1538-7445.SABCS20-PD2-01

2. Harbeck N, Johnston S, Fasching P, et al. High Ki-67 as a biomarker for identifying patients with high risk early breast cancer treated in monarchE. Poster presented at: 43rd Annual San Antonio Breast Cancer Symposium (SABCS Virtual); December 8-11, 2020. Accessed October 3, 2021. http://www.sabcs.org/Portals/SABCS2016/PD2%2001%20Nadia%20Harbeck.pdf?ver=2021-08-29-125001-927

3. Johnston SRD, Toi M, O'Shaughnessy J, et al; monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90. https://doi.org/10.1016/S1470-2045(22)00694-5

4. Rastogi P, O'Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol. 2024;42(9):987-993. https://doi.org/10.1200/jco.23.01994

5. Harbeck N, Rastogi P, Martin M, et al; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021;32(12):1571-1581. https://doi.org/10.1016/j.annonc.2021.09.015