Department of Breast and Gynecological Surgery, Institut Curie, Université Paris Cité, Paris, France.
Residual Tumor & Response to Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Paris, France.
Br J Cancer. 2024 Apr;130(7):1141-1148. doi: 10.1038/s41416-024-02580-3. Epub 2024 Jan 27.
The MonarchE trial explored the use of abemaciclib, a CDK4/6 inhibitor, as an adjuvant treatment in high-risk early-stage luminal-like breast cancer. The study's inclusion criteria, especially the N2 status, may require revisiting surgical interventions, including invasive axillary lymph node dissection (ALND)-a procedure that current guidelines generally do not recommend.
We conducted a single-centre, retrospective, observational cohort study on non-metastatic breast cancer patients managed from 2002 to 2011, at the Institut Curie. Data collection involved clinical and histological characteristics plus treatment follow-up.
Out of 8715 treated patients, 721 met the inclusion criteria. Overall, 12% (87) were classified as N2 ( ≥ 4 positive lymph nodes), thus eligible for abemaciclib per "node criterion." Tumour size, positive sentinel lymph nodes, and lobular histology showed a significant correlation with N2 status. Approximately 1000 ALNDs would be required to identify 120 N2 cases and prevent four recurrences.
The MonarchE trial may significantly affect surgical practices due to the need for invasive procedures to identify high-risk patients for adjuvant abemaciclib treatment. The prospect of unnecessary morbidity demands less invasive N2 status determination methods. Surgical decisions must consider patient health and potential treatment benefits.
MonarchE 试验探讨了 CDK4/6 抑制剂 abemaciclib 作为高危早期 luminal 样乳腺癌的辅助治疗。该研究的纳入标准,特别是 N2 状态,可能需要重新考虑手术干预,包括侵袭性腋窝淋巴结清扫(ALND)——目前指南通常不推荐的一种程序。
我们对 2002 年至 2011 年在居里研究所治疗的非转移性乳腺癌患者进行了一项单中心、回顾性、观察性队列研究。数据收集包括临床和组织学特征以及治疗随访。
在 8715 名接受治疗的患者中,有 721 名符合纳入标准。总体而言,12%(87 名)被归类为 N2(≥4 个阳性淋巴结),因此符合 abemaciclib 的“节点标准”。肿瘤大小、阳性前哨淋巴结和小叶组织学与 N2 状态有显著相关性。大约需要进行 1000 次 ALND 才能发现 120 例 N2 病例并预防 4 例复发。
由于需要进行侵袭性手术来识别接受辅助 abemaciclib 治疗的高危患者,MonarchE 试验可能会对手术实践产生重大影响。不必要发病率的前景需要确定 N2 状态的侵袭性较小的方法。手术决策必须考虑患者的健康状况和潜在的治疗获益。