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截止值是由历史数据和编写 monarchE 协议时的圣加仑共识决定的。

详细信息

在针对高风险、淋巴结阳性、激素受体阳性、人表皮生长因子受体 2 阴性、早期乳腺癌患者开展的阿贝西利联合标准辅助内分泌治疗 (ET) 对比单用标准辅助ET治疗的 monarchE 随机、开放标签、3 期研究中，使用 20% 的 Ki-67 临界值鉴别 Ki-67 高表达肿瘤患者。¹

在制定 monarchE 方案时，根据历史数据和 St. Gallen 共识界定临界值。^1-3

虽然目前尚未就区分患者疾病复发风险高低的 Ki-67 评分形成国际共识，但一般认为 20% 左右的临界值适合用来鉴别高风险人群。^2,4-7

上次审阅日期：2024年4月24日

参考文献

1. Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. https://doi.org/10.1200/JCO.20.02514

2. Vasconcelos I, Hussainzada A, Berger S, et al. The St. Gallen surrogate classification for breast cancer subtypes successfully predicts tumor presenting features, nodal involvement, recurrence patterns and disease free survival. Breast. 2016;29:181-185. https://doi.org/10.1016/j.breast.2016.07.016

3. Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies--improving the management of early breast cancer: St Gallen international expert consensus on the primary therapy of early breast cancer 2015. Ann Oncol. 2015;26(8):1533-1546. https://doi.org/10.1093/annonc/mdv221

4. Nielsen TO, Leung SC, Rimm DL, et al. Assessment of Ki67 in breast cancer: updated recommendations form the international Ki67 in breast cancer working group. J Natl Cancer Inst. 2020;113(7):808-819. https://doi.org/10.1093/jnci/djaa201

5. Fasching PA, Gass P, Häberle L, et al. Prognostic effect of Ki-67 in common clinical subgroups of patients with HER2-negative, hormone receptor-positive early breast cancer. Breast Cancer Res Treat. 2019;175(3):617-625. http://dx.doi.org/10.1007/s10549-019-05198-9

6. Gluz O, Nitz UA, Christgen M, et al. West German study group phase III PlanB trial: first prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology assessment. J Clin Oncol. 2016;34(20):2341-2349. https://doi.org/10.1200/JCO.2015.63.5383

7. Penault-Llorca F, Radosevic-Robin N. Ki67 assessment in breast cancer: an update. Pathology. 2017;49(2):166-171. https://doi.org/10.1016/j.pathol.2016.11.006