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    Breast cancer recurrence in initially clinically node-positive patients undergoing sentinel lymph node biopsy after neoadjuvant chemotherapy in the NEOSENTITURK-Trials MF18-02/18-03
    (2024) Cabıoğlu, Neslihan; Karanlık, Hasan; İğci, Abdullah; Müslümanoğlu, Mahmut; Gülçelik, Mehmet Ali; Uras, Cihan; Koçer, Havva Belma; Trabulus, Didem Can; Özkurt, Enver; Çakmak, Güldeniz Karadeniz; Tükenmez, Mustafa; Bademler, Süleyman; Yıldırım, Nilüfer; Akgül, Gökhan Giray; Şen, Ebru; Şenol, Kazım; Emiroğlu, Selman; Çitgez, Bülent; Ersoy, Yeliz Emine; Dağ, Ahmet; Zengel, Baha; Başaran, Gül; Kara, Halil; Dilege, Ece; Uğurlu, M. Ümit; Çelik, Atilla; İlgün, Serkan; Bölükbaşı, Yasemin; Karaman, Niyazi; Sakman, Gürhan; Özbaş, Serdar; Kılıç, Halime Gül; Polat, Ayfer Kamalı; Özemir, İbrahim Ali; Kılıç, Berkay; Altınok, Ayşe; Varol, Ecenur; Doğan, Lütfi; Akcan, Alper; Özçınar, Beyza; Zer, Leyla; Soyder, Aykut; Velidedeoğlu, Mehmet; Erözgen, Fazilet; Göktepe, Berk; Doğan, Mutlu; Kebudi, Abut; Yiğit, Banu; Çelik, Burak; Yormaz, Serdar; Arıcı, Cumhur; Ağcaoğlu, Orhan; Sevinç, Ali İbrahim; Atahan, M. Kemal; Valiyeva, Vafa; Baran, Elif; Aljorani, Israa; Utkan, Zafer; Yeniay, Levent; Kıvılcım, Taner; Soran, Atilla; Aydıner, Adnan; İbiş, Kamuran; Özmen, Vahit
    Background: This study aims to identify factors predicting recurrence and unfavorable prognosis in cN+ patients who have undergone sentinel lymph node biopsy (SLNB) following neoadjuvant chemotherapy (NAC). Methods: The retrospective multi-centre "MF18-02" and the prospective multi-centre cohort registry trial "MF18-03" (NCT04250129) included patients with cT1-4N1-3M0 with SLNB+/- axillary lymph node dissection (ALND) post-NAC. Results: A total of 2407 cN+ patients, who later achieved cN0 status after NAC and subsequently underwent SLNB, were studied. The majority had cT1-2 (79.1%) and N1 (80.7%). After a median follow-up time of 41 months, the rates of locoregional recurrence and axillary recurrence (AR) were 1.83% and 0.37%, respectively. No significant difference in locoregional recurrence or AR rates was observed between the SLNB/targeted axillary dissection-only (n = 1470) and ALND (n = 937) groups. Factors significantly linked with AR included age younger than 45 years, nonpathological complete response (non-pCR) in the breast, and nonluminal pathology. Locoregional recurrences were associated with nonluminal or HER2(+) pathology, non-pCR in the breast, and ALND. Poor prognostic factors for disease-free survival (DFS) included having cT3-T4, no breast pCR (non-pCR), ypN(+), and nonluminal pathology. No significant difference was found in DFS or disease-specific survival (DSS) rates among ypN0, ypN-isolated tumour cells, ypNmic, and ypN1. However, significant decreases in DFS and DSS rates were observed when comparing ypN2 or ypN3 disease with ypN0. Conclusions: The present large registry data indicate that younger patients (<45), those with nonluminal pathology, and those who only partially respond in the breast are more susceptible to axillary and locoregional recurrences.
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    De-escalation of nodal surgery in clinically node-positive breast cancer
    (2025) Cabioğlu, Neslihan; Koçer, Havva Belma; Karanlık, Hasan; Gülçelik, Mehmet Ali; İğci, Abdullah; Müslümanoğlu, Mahmut; Uras, Cihan; Mantoğlu, Barış; Trabulus, Didem Can; Akgül, Giray; Tükenmez, Mustafa; Şenol, Kazım; Özkurt, Enver; Şen, Ebru; Karadeniz Çakmak, Güldeniz; Bademler, Süleyman; Emiroğlu, Selman; Yıldırım, Nilüfer; Kara, Halil; Dağ, Ahmet; Dilege, Ece; Altınok, Ayşe; Başaran, Gül; Varol, Ecenur; Uğurlu, Ümit; Bölükbaşı, Yasemin; Ersoy, Yeliz Emine; Zengel, Baha; Karaman, Niyazi; Özbaş, Serdar; Zer, Leyla; Kılıç, Halime Gül; Ağcaoğlu, Orhan; Sakman, Gürhan; Utkan, Zafer; Soyder, Aykut; Akcan, Alper; Ergün, Sefa; Yılmaz, Ravza; Aydıner, Adnan; Soran, Atilla; İbiş, Kamuran; Özmen, Vahit
    Importance: Increasing evidence supports the oncologic safety of de-escalating axillary surgery for patients with breast cancer after neoadjuvant chemotherapy (NAC). Objective: To evaluate the oncologic outcomes of de-escalating axillary surgery among patients with clinically node (cN)-positive breast cancer and patients whose disease became cN negative after NAC (ycN negative). Design, setting, and participants: In the NEOSENTITURK MF-1803 prospective cohort registry trial, patients from 37 centers with cT1-4N1-3M0 disease treated with sentinel lymph node biopsy (SLNB) or targeted axillary dissection (TAD) alone or with ypN-negative or ypN-positive disease after NAC were recruited between February 15, 2019, and January 1, 2023, and evaluated. Exposure: Treatment with SLNB or TAD after NAC. Main outcomes and measures: The primary aim of the study was axillary, locoregional, or distant recurrence rates; disease-free survival; and disease-specific survival. Number of axillary lymph nodes removed was also evaluated. Results: A total of 976 patients (median age, 46 years [range, 21-80 years]) with cT1-4N1-3M0 disease underwent SLNB (n = 620) or TAD alone (n = 356). Most of the cohort had a mapping procedure with blue dye alone (645 [66.1%]) with (n = 177) or without (n = 468) TAD. Overall, no difference was found between patients treated with TAD and patients treated with SLNB in the median number of total lymph nodes removed (TAD, 4 [3-6] vs SLNB, 4 [3-6]; P = .09). Among patients with ypN-positive disease, those who underwent TAD were more likely to have a lower median lymph node ratio (TAD, 0.28 [IQR, 0.20-0.40] vs SLNB, 0.33 [IQR, 0.20-0.50]; P = .03). At a median follow-up of 39 months (IQR, 29-48 months), no significant difference was found in the rates of ipsilateral axillary recurrence (0.3% [1 of 356] vs 0.3% [2 of 620]; P ≥ .99) or locoregional recurrence (0.6% [2 of 356] vs 1.1% [7 of 620]; P = .50) between the TAD and SLNB groups, with an overall locoregional recurrence rate of 0.9% (9 of 976). The initial clinical tumor stage, pathologic complete response, and use of blue dye alone as a mapping procedure were not associated with the outcome. Even though patients with TAD demonstrated an increased disease-free survival rate compared with the SLNB group, this difference did not reach statistical significance (94.9% vs 92.6%; P = .07). Factors associated with decreased 5-year disease-specific survival were cN2-3 axillary stage (cN1, 98.7% vs cN2-3, 96.8%; P = .03) and nonluminal type tumor pathologic characteristics (luminal, 98.9% vs nonluminal, 96.9%; P = .007). Conclusions and relevance: The short-term results suggest very low rates of axillary and locoregional recurrence in a select group of patients with cN-negative disease after NAC treated with TAD alone or SLNB alone followed by regional nodal irradiation regardless of the SLNB technique or nodal pathology. Whether TAD might provide a clear survival advantage compared with SLNB remains to be proven in studies with longer follow-up.