Muslumanoglu Mahmut, Cabioglu Neslihan, Igci Abdullah, Karanlık Hasan, Kocer Havva Belma, Senol Kazim, Mantoglu Baris, Tukenmez Mustafa, Çakmak Guldeniz Karadeniz, Ozkurt Enver, Gulcelik Mehmet Ali, Emiroglu Selman, Mollavelioglu Baran, Yildirim Nilufer, Bademler Suleyman, Zengel Baha, Trabulus Didem Can, Ugurlu Mustafa Umit, Uras Cihan, Ilgun Serkan, Akgul Gokhan Giray, Akcan Alper, Yormaz Serdar, Ersoy Yeliz Emine, Ozbas Serdar, Dilege Ece, Citgez Bulent, Bolukbasi Yasemin, Altınok Ayse, Dag Ahmet, Basaran Gül, Utkan Nihat Zafer, Ozcinar Beyza, Arici Cumhur, AlJorani Israa, Kara Halil, Yigit Banu, Sen Ebru, Erozgen Fazilet, Soyder Aykut, Celik Burak, Kilic Halime Gul, Zer Leyla, Sakman Gürhan, Yeniay Levent, Atahan Kemal, Varol Ecenur, Veliyeva Vefa, Goktepe Berk, Velidedeoglu Mehmet, Karaman Niyazi, Soran Atilla, Aydiner Adnan, Yılmaz Ravza, Ibis Kamuran, Ozmen Vahit
Department of General Surgery, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
Surgical Oncology Unit, Institute of Oncology, Istanbul University, Istanbul, Turkey.
Cancer. 2025 Jan 1;131(1):e35610. doi: 10.1002/cncr.35610. Epub 2024 Oct 30.
The omission of axillary lymph node dissection (ALND) remains controversial for patients with residual axillary disease after neoadjuvant chemotherapy (NAC), regardless of the residual burden. This study evaluated the oncologic safety and factors associated with outcomes in patients with residual axillary disease. These patients were treated solely with sentinel lymph node biopsy (SLNB) or targeted axillary dissection (TAD), without ALND, after NAC.
A joint analysis of two different multicenter cohorts-the retrospective cohort registry MF18-02 and the prospective observational cohort registry MF18-03 (NCT04250129)-was conducted between January 2004 and August 2022. All patients received regional nodal irradiation.
Five hundred and one patients with cT1-4, N1-3M0 disease who achieved a complete clinical response to NAC underwent either SLNB alone (n = 353) or TAD alone (n = 148). At a median follow-up of 42 months, axillary and locoregional recurrence rates were 0.4% (n = 2) and 0.8% (n = 4). No significant difference was found in disease-free survival (DFS) and disease-specific survival (DSS) rates between patients undergoing TAD alone versus SLNB alone, those with breast positive versus negative pathologic complete response, SLN methodology, total metastatic LN of one versus ≥2, or metastasis types as isolated tumor cells with micrometastases versus macrometastases. In the multivariate analysis, patients with nonluminal pathology were more likely to have a worse DFS and DSS, respectively, without an increased axillary recurrence.
The omission of ALND can be safely considered for patients who achieve a complete clinical response after NAC, even if residual disease is detected by pathologic examination. Provided that adjuvant radiotherapy is administered, neither the SLNB method nor the number of excised LNs significantly affects oncologic outcomes.
对于新辅助化疗（NAC）后腋窝仍有残留病灶的患者，无论残留负担如何，省略腋窝淋巴结清扫术（ALND）仍存在争议。本研究评估了腋窝残留病灶患者的肿瘤学安全性及与预后相关的因素。这些患者在NAC后仅接受前哨淋巴结活检（SLNB）或靶向腋窝清扫术（TAD），未进行ALND。
在2004年1月至2022年8月期间，对两个不同的多中心队列进行了联合分析——回顾性队列登记MF18 - 02和前瞻性观察队列登记MF18 - 03（NCT04250129）。所有患者均接受区域淋巴结放疗。
501例cT1 - 4、N1 - 3M0疾病且对NAC达到完全临床缓解的患者，单独接受了SLNB（n = 353）或单独接受了TAD（n = 148）。中位随访42个月时，腋窝和局部区域复发率分别为0.4%（n = 2）和0.8%（n = 4）。单独接受TAD与单独接受SLNB的患者、病理完全缓解为阳性与阴性的患者、SLN方法、总转移淋巴结数为1个与≥2个的患者，或转移类型为孤立肿瘤细胞伴微转移与宏转移的患者之间，无病生存率（DFS）和疾病特异性生存率（DSS）无显著差异。在多变量分析中，非腔面病理类型的患者DFS和DSS分别更有可能较差，且腋窝复发未增加。
对于NAC后达到完全临床缓解的患者，即使病理检查发现有残留病灶，也可安全地考虑省略ALND。只要给予辅助放疗，SLNB方法和切除淋巴结的数量均不会显著影响肿瘤学结局。
