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Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
目的：国际/国家早期乳腺癌（EBC）风险分层指南推荐使用Ki-67，特别是为了定义“中间风险”，“尽管实验室间/观察者间的可变性和截止不确定性。我们调查了Ki-67(>10%-<40%，局部确定)作为EBC中/高风险的预后标志物，pN0-1患者。
方法：这种前瞻性，非干预性，真实世界研究包括≥18岁的女性，pN0/pN1mi/pN1,HR+,HER2阴性EBC,和当地确定的Ki-67范围10％-40％。主要结果是在公开OncotypeDX乳房复发评分®(RS)测定结果后治疗建议的变化。
结果：分析包括567例患者（中位年龄，57[范围，29-83]年；70%/1%/29%/患有pN0/pN1mi/pN1疾病；81%和19%的RS结果分别为0-25和26-100）。局部和中央Ki-67，局部Ki-67和RS之间的相关性，和中央Ki-67和RS结果较弱（分别为r=0.35，r=0.3和r=0.46），并且在两个方向上都注意到了差异(例如，局部Ki-67低于或高于中央Ki-67)。在披露RS后，190例患者(34%)的治疗建议发生了变化.在pN0和pN1mi/pN1患者以及集中确定的Ki-67≤10％和>10％的患者中观察到了变化。治疗变化与RS结果一致（RS结果较高的患者增加化疗，省略它以获得较低的RS结果)，他们的最终结果是辅助化疗的使用减少了8%(从RS前的32%减少到RS后的24%).
结论：OncotypeDX®分析是一种个性化治疗的工具，增加了经典的治疗决定因素。RS结果和Ki-67不可互换，和Ki-67，以及节点状态，不应被用作测试资格的看门人，避免过度和过度治疗。
方法：这种前瞻性，非干预性，真实世界研究包括≥18岁的女性，pN0/pN1mi/pN1,HR+,HER2阴性EBC,和当地确定的Ki-67范围10％-40％。主要结果是在公开OncotypeDX乳房复发评分®(RS)测定结果后治疗建议的变化。
结果：分析包括567例患者（中位年龄，57[范围，29-83]年；70%/1%/29%/患有pN0/pN1mi/pN1疾病；81%和19%的RS结果分别为0-25和26-100）。局部和中央Ki-67，局部Ki-67和RS之间的相关性，和中央Ki-67和RS结果较弱（分别为r=0.35，r=0.3和r=0.46），并且在两个方向上都注意到了差异(例如，局部Ki-67低于或高于中央Ki-67)。在披露RS后，190例患者(34%)的治疗建议发生了变化.在pN0和pN1mi/pN1患者以及集中确定的Ki-67≤10％和>10％的患者中观察到了变化。治疗变化与RS结果一致（RS结果较高的患者增加化疗，省略它以获得较低的RS结果)，他们的最终结果是辅助化疗的使用减少了8%(从RS前的32%减少到RS后的24%).
结论：OncotypeDX®分析是一种个性化治疗的工具，增加了经典的治疗决定因素。RS结果和Ki-67不可互换，和Ki-67，以及节点状态，不应被用作测试资格的看门人，避免过度和过度治疗。
