Department of Obstetrics and Gynecology, University of Rostock, Südring 81, 18059, Rostock, Germany.
Breast. 2023 Feb;67:124-128. doi: 10.1016/j.breast.2023.01.002. Epub 2023 Jan 9.
Local treatment of the axilla in clinically node-negative (cN0) early breast cancer patients with routine sentinel lymph node biopsy (SLNB) is debated after publication of ACOSOG Z0011 data in 2010. Currently, prospective randomized surgical trials investigating the omission of SLNB in upfront breast-conserving surgery (BCS) and in the neoadjuvant setting, respectively. Several prospective randomized trials (SOUND, INSEMA, BOOG 2013-08, and NAUTILUS) with axillary observation alone versus SLNB in cN0 patients and primary BCS have primary objectives to evaluate oncologic safety when omitting SLNB. The Italian SOUND trial was the earliest to open in 2012 and has completed accrual in 2017. First oncologic outcome data are expected soon for SOUND and at the end of 2024 for INSEMA. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to de-escalate surgery in patients who have a pCR. Two prospective single-arm trials (EUBREAST-01, ASICS) include only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) and type of surgery will be defined according to the response to NAST rather than on the classical T and N status. The ongoing trials will hopefully help us to understand whether we might take the best therapeutic decisions without the pathologic evaluation of nodal status.
2010 年 ACOSOG Z0011 数据公布后，对于临床淋巴结阴性（cN0）早期乳腺癌患者，在常规前哨淋巴结活检（SLNB）后是否对腋窝进行局部治疗存在争议。目前，正在进行前瞻性随机外科临床试验，分别研究在早期保乳手术（BCS）和新辅助治疗中省略 SLNB 的可行性。几项前瞻性随机试验（SOUND、INSEMA、BOOG 2013-08 和 NAUTILUS）采用单独腋窝观察与 cN0 患者和原发性 BCS 中的 SLNB 比较，主要目的是评估省略 SLNB 时的肿瘤安全性。意大利的 SOUND 试验最早于 2012 年开始，已于 2017 年完成入组。预计 SOUND 很快将公布首批肿瘤学结果，INSEMA 将在 2024 年底公布结果。乳腺癌的系统治疗进展提高了接受新辅助全身治疗（NAST）患者的病理完全缓解（pCR）率，为 pCR 患者提供了手术降级的机会。两项前瞻性单臂试验（EUBREAST-01、ASICS）仅包括接受 NAST 后最有可能获得 pCR 的患者（三阴性或 HER2 阳性乳腺癌），手术类型将根据 NAST 的反应而不是经典的 T 和 N 分期来确定。正在进行的试验有望帮助我们了解，在不进行淋巴结状态病理评估的情况下，我们是否可以做出最佳的治疗决策。
