Department of Gynecology and Obstetrics, Sana Klinikum Offenbach GmbH, Offenbach, Germany.
OncoNet Rhein Main e. v., Frankfurt, Germany.
Breast Cancer Res Treat. 2024 Sep;207(2):263-274. doi: 10.1007/s10549-024-07390-y. Epub 2024 Jun 14.
Ki-67 is recommended by international/national guidelines for risk stratification in early breast cancer (EBC), particularly for defining "intermediate risk," despite inter-laboratory/inter-observer variability and cutoff uncertainty. We investigated Ki-67 (> 10%- < 40%, determined locally) as a prognostic marker for intermediate/high risk in EBC, pN0-1 patients.
This prospective, non-interventional, real-world study included females ≥ 18 years, with pN0/pN1mi/pN1, HR+ , HER2-negative EBC, and locally determined Ki-67 ranging 10%-40%. The primary outcome was changes in treatment recommendations after disclosing the Oncotype DX Breast Recurrence Score(RS) assay result.
The analysis included 567 patients (median age, 57 [range, 29-83] years; 70%/1%/29%/ with pN0/pN1mi/pN1 disease; 81% and 19% with RS results 0-25 and 26-100, respectively). The correlations between local and central Ki-67, local Ki-67, and the RS, and central Ki-67 and the RS results were weak (r = 0.35, r = 0.3, and r = 0.46, respectively), and discrepancies were noted in both directions (e.g., local Ki-67 was lower or higher than central Ki-67). After disclosing the RS, treatment recommendations changed for 190 patients (34%). Changes were observed in pN0 and pN1mi/pN1 patients and in patients with centrally determined Ki-67 ≤ 10% and > 10%. Treatment changes were aligned with RS results (adding chemotherapy for patients with higher RS results, omitting it for lower RS results), and their net result was 8% reduction in adjuvant chemotherapy use (from 32% pre-RS results to 24% post-RS results).
The Oncotype DX assay is a tool for individualizing treatments that adds to classic treatment decision factors. The RS result and Ki-67 are not interchangeable, and Ki-67, as well as nodal status, should not be used as gatekeepers for testing eligibility, to avoid under and overtreatment.
Ki-67 被国际/国家指南推荐用于早期乳腺癌（EBC）的风险分层，特别是用于定义“中危”，尽管存在实验室间/观察者间的变异性和临界值不确定性。我们研究了 Ki-67（局部检测>10%-<40%）作为 EBC、pN0-1 患者中中高危的预后标志物。
这是一项前瞻性、非干预性、真实世界的研究，纳入了年龄≥18 岁、局部检测 Ki-67 为 10%-40%、pN0/pN1mi/pN1、HR+、HER2 阴性的 EBC 女性患者。主要结局是在披露 Oncotype DX 乳腺癌复发评分（RS）检测结果后治疗建议的变化。
分析纳入了 567 例患者（中位年龄 57 岁[范围 29-83 岁]；70%/1%/29%患者为 pN0/pN1mi/pN1 疾病；分别有 81%和 19%的患者 RS 结果为 0-25 和 26-100）。局部和中心 Ki-67、局部 Ki-67 和 RS 以及中心 Ki-67 和 RS 结果之间的相关性较弱（r=0.35、r=0.3 和 r=0.46），且存在双向差异（例如，局部 Ki-67 低于或高于中心 Ki-67）。在披露 RS 后，190 例患者（34%）的治疗建议发生了变化。pN0 和 pN1mi/pN1 患者以及中心 Ki-67≤10%和>10%的患者治疗建议发生了变化。治疗变化与 RS 结果一致（对 RS 结果较高的患者加用化疗，对 RS 结果较低的患者停用化疗），其结果是辅助化疗使用率降低了 8%（从 RS 结果前的 32%降至 RS 结果后的 24%）。
Oncotype DX 检测是一种用于个体化治疗的工具，可补充经典的治疗决策因素。RS 结果和 Ki-67 不可互换，Ki-67 以及淋巴结状态不应作为检测资格的把关因素，以避免治疗不足和过度治疗。
