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 MD, Neslihan Cabioglu MD, Abdullah Igci MD, Hasan Karanlık MD, Havva Belma Kocer MD, Kazim Senol MD, Baris Mantoglu MD, Mustafa Tukenmez MD, Guldeniz Karadeniz Çakmak MD, Enver Ozkurt MD, Mehmet Ali Gulcelik MD, Selman Emiroglu MD, Baran Mollavelioglu MD, Nilufer Yildirim MD, Suleyman Bademler MD, Baha Zengel MD, Didem Can Trabulus MD, Mustafa Umit Ugurlu MD, Cihan Uras MD, Serkan Ilgun MD, Gokhan Giray Akgul MD, Alper Akcan MD, Serdar Yormaz MD, Yeliz Emine Ersoy MD, Serdar Ozbas MD, Ece Dilege MD, Bulent Citgez MD, Yasemin Bolukbasi MD, Ayse Altınok MD, Ahmet Dag MD, Gül Basaran MD, Nihat Zafer Utkan MD, Beyza Ozcinar MD, Cumhur Arici MD, Israa AlJorani MD, Halil Kara MD, Banu Yigit MD, Ebru Sen MD, Fazilet Erozgen MD, Aykut Soyder MD, Burak Celik MD, Halime Gul Kilic MD, Leyla Zer MD, Gürhan Sakman MD, Levent Yeniay MD, Kemal Atahan MD, Ecenur Varol MD, Vefa Veliyeva MD, Berk Goktepe MD, Mehmet Velidedeoglu MD, Niyazi Karaman MD, Atilla Soran MD, Adnan Aydiner MD, Ravza Yılmaz MD, Kamuran Ibis MD, Vahit Ozmen MD
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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.
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