Artigo

Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i1): The OPBC-05/ICARO Study

Autor(es): Giacomo Montagna, MD, MPH1 ; Alison Laws, MD, MPH2 ; Massimo Ferrucci, MD, PhD3 ; Mary M. Mrdutt, MD, MS4 ; Susie X. Sun, MD5 ; Suleyman Bademler, MD6 ; Hakan Balbaloglu, MD7 ; Nora Balint-Lahat, MD8,9; Maggie Banys-Paluchowski, MD, PhD10; Andrea V. Barrio, MD1 ; John Benson, MD11; Nuran Bese, MD12; Judy C. Boughey, MD4 ; Marissa K. Boyle, MD13 ; Emilia J. Diego, MD14; Claire Eden, MD15; Ruth Eller, MD16,17 ; Maite Goldschmidt, MSc16,17; Callie Hlavin, MD, MPH14; Martin Heidinger, MD16,17 ; Justyna Jelinska, MD, PhD18; Guldeniz Karadeniz Cakmak, MD, FEBS ¨ 7 ; Susan B. Kesmodel, MD19 ; Tari A. King, MD2 ; Henry M. Kuerer, MD, PhD5 ; Julie Loesch, MD16,17; Francesco Milardi, MD3 ; Dawid Murawa, MD, PhD18 ; Tracy-Ann Moo, MD1 ; Tehillah S. Menes, MD, MSc8,9 ; Daniele Passeri, MD3 ; Jessica M. Pastoriza, MD20 ; Andraz Perhavec, MD, PhD21 ; Nina Pislar, MD21; Natalia Polidorio, MD, PhD ´ 1 ; Avina Rami, BA2 ; Jai Min Ryu, MD, PhD22; Alexandra Schulz, MSc16,23; Varadan Sevilimedu, MBBS, DrPH24; M. Umit Ugurlu, MD25 ; Cihan Uras, MD12; Annemiek van Hemert, MSc26 ; Stephanie M. Wong, MD, MPH27; Tae-Kyung Robyn Yoo, MD28 ; Jennifer Q. Zhang, MD29 ; Hasan Karanlik, MD6 ; Neslihan Cabioglu, MD ˘ 30; Marie-Jeanne Vrancken Peeters, MD, PhD31 ; Monica Morrow, MD1 ; and Walter P. Weber, MD16,17 ; on behalf of the ICARO Study Group

ABSTRACT

PURPOSE: The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i1) is unknown, and axillary management is not standardized. We investigated ates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i1 treated with and without ALND.

METHODS: The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point.

RESULTS: In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor–positive/ human epidermal growth factor receptor 2–negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% v 7%, P < .001), have ITCs detected on frozen section (62% v 8%, P < .001), have lymphovascular invasion (38% v 24%, P < .001), and receive adjuvant chest wall (89% v 78%, P 5 .024) and nodal radiation (82% v 75%, P 5 .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery.

CONCLUSION: The nodal burden in patients with ypN0(i1) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i1).