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Observational Study
. 2025 Jan 1;131(1):e35610.
doi: 10.1002/cncr.35610. Epub 2024 Oct 30.

Combined analysis of the MF18-02/MF18-03 NEOSENTITURK studies: ypN-positive disease does not necessitate axillary lymph node dissection in patients with breast cancer with a good response to neoadjuvant chemotherapy as long as radiotherapy is provided

Mahmut Muslumanoglu  1 , Neslihan Cabioglu  1 , Abdullah Igci  1 , Hasan Karanlık  2 , Havva Belma Kocer  3 , Kazim Senol  4 , Baris Mantoglu  5 , Mustafa Tukenmez  1 , Guldeniz Karadeniz Çakmak  6 , Enver Ozkurt  7 , Mehmet Ali Gulcelik  8 , Selman Emiroglu  1 , Baran Mollavelioglu  1 , Nilufer Yildirim  9 , Suleyman Bademler  2 , Baha Zengel  10 , Didem Can Trabulus  11 , Mustafa Umit Ugurlu  12 , Cihan Uras  13 , Serkan Ilgun  14 , Gokhan Giray Akgul  8 , Alper Akcan  15 , Serdar Yormaz  16 , Yeliz Emine Ersoy  17 , Serdar Ozbas  18 , Ece Dilege  19 , Bulent Citgez  20 , Yasemin Bolukbasi  21 , Ayse Altınok  22 , Ahmet Dag  23 , Gül Basaran  24 , Nihat Zafer Utkan  25 , Beyza Ozcinar  1 , Cumhur Arici  26 , Israa AlJorani  4 , Halil Kara  13 , Banu Yigit  27 , Ebru Sen  28 , Fazilet Erozgen  29 , Aykut Soyder  30 , Burak Celik  19 , Halime Gul Kilic  1 , Leyla Zer  7 , Gürhan Sakman  31 , Levent Yeniay  32 , Kemal Atahan  33 , Ecenur Varol  25 , Vefa Veliyeva  34 , Berk Goktepe  32 , Mehmet Velidedeoglu  35 , Niyazi Karaman  36 , Atilla Soran  37 , Adnan Aydiner  38 , Ravza Yılmaz  39 , Kamuran Ibis  40 , Vahit Ozmen  1
Affiliations
Observational Study

Combined analysis of the MF18-02/MF18-03 NEOSENTITURK studies: ypN-positive disease does not necessitate axillary lymph node dissection in patients with breast cancer with a good response to neoadjuvant chemotherapy as long as radiotherapy is provided

Mahmut Muslumanoglu et al. Cancer. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: axillary lymph node dissection; breast cancer; neoadjuvant chemotherapy; sentinel lymph node biopsy; targeted axillary dissection.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Study flowchart. NAC indicates neoadjuvant chemotherapy; SLNB, sentinel lymph node biopsy; TAD, targeted axillary dissection.
See this image and copyright information in PMC

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