Oncological outcomes with and without axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy (OPBC-07/microNAC): an international, retrospective cohort study.
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Montagna Giacomo, Alvarado Michael, Myers Sara, Mrdutt Mary M, Sun Susie X, Sevilimedu Varadan, Barrio Andrea V, van den Bruele Astrid Botty, Boughey Judy C, Boyle Marissa K, Crown Angelena, Kesmodel Susan B, King Tari A, Kuerer Henry M, Leisha Elmore C, Moo Tracy-Ann, Weiss Anna, Williams Austin D, Parmar Priyanka, Diskin Brian, Hlavin Callie, Diego Emilia J, Polidorio Natália, Abdelwahab Khaled, Banys-Paluchowski Maggie, Kurzeder Christian, Heidinger Martin, Goldschmidt Maite, Schulz Alexandra, Heil Jörg, Karadeniz Cakmak Güldeniz, Pislar Nina, Riis Margit, Prakash Ipshita, Ovalle Valentina, Ugurlu M Umit, Franceschini Gianluca, Sergeevich Emelyanov Alexander, Morales Javier, Lee Han-Byoel, Galimberti Viviana, Ahn Sung Gwe, Ryu Jai Min, Muslumanoglu Mahmut, Cabıoğlu Neslihan, Yoo Tae-Kyung Robyn, Vrancken Peeters Marie-Jeanne, Ferrucci Massimo, Morrow Monica, Weber Walter P, microNAC Study Group
Аннотация
METHODS: OPBC-07/microNAC was a retrospective cohort study, using data obtained from the institutional databases of 84 cancer centres in 30 countries. Patients aged 18 years or older with clinical T1-4, N0-3 breast cancer at diagnosis treated with neoadjuvant chemotherapy followed by surgery between Jan 1, 2013, and May 31, 2023, who were found to have residual micrometastases (metastasis measuring >0·2 mm or >200 cells, not exceeding 2·0 mm in size) on frozen section or on final paraffin sections as determined by sentinel lymph node biopsy, targeted axillary dissection (sentinel lymph node biopsy with single or dual-tracer mapping plus image-guided localisation of the initially biopsy-proven and clipped node), or the marking axillary lymph nodes with radioactive iodine seeds (MARI) procedure were eligible for inclusion. The primary endpoint was the 5-year rate of any axillary recurrence (isolated or combined with local or distant recurrence) stratified by type of axillary surgery. Given the median follow-up, here we report 3-year rates and exploratory 5-year estimates. This study was registered with ClinicalTrials.gov, NCT06529302.
FINDINGS: 1585 female patients with ypN1mi disease were analysed, of whom 804 (50·7%) underwent ALND and 781 (49·3%) did not. Of 1585 women, 238 (15·0%) self-identified as Asian, 65 (4·1%) as Black, 200 (12·6%) as Hispanic, 968 (61·1%) as White, and 114 (7·2%) as unknown race and ethnicity. 925 (58·4%) of 1585 women had cT2 tumours, 1054 (66·5%) were node positive, and 1267 (79·9%) received nodal radiotherapy. The median follow-up was 3·1 years (IQR 1·8-5·2). The 3-year rate of any axillary recurrence (isolated or combined with local or distant recurrence) for the entire cohort was 2·0% (95% CI 1·3-2·9), with no statistical difference identified by extent of axillary surgery. However, patients with triple-negative disease who did not receive ALND had significantly higher rates of any axillary recurrence than women treated with ALND (8·7% [95% CI 4·4-15·0] vs 2·4% [95% CI 0·7-6·5], p=0·018). On multivariable analysis, triple-negative breast cancer (hazard ratio 3·83 [95% CI 1·72-8·52]) and omission of nodal radiotherapy (2·62 [1·19-5·73]) but not omission of ALND (0·86 [0·37-2·00]) were independently associated with an increased risk of any axillary recurrence.
INTERPRETATION: Overall, these results do not support ALND for all patients with ypN1mi on sentinel lymph node biopsy treated with nodal radiotherapy; however, tumour biology should be taken into account when considering ALND omission.
FUNDING: US National Institutes of Health, National Cancer Institute.