TY - JOUR
T1 - Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+)
T2 - The OPBC-05/ICARO Study
AU - on behalf of the ICARO Study Group
AU - Montagna, Giacomo
AU - Laws, Alison
AU - Ferrucci, Massimo
AU - Mrdutt, Mary M.
AU - Sun, Susie X.
AU - Bademler, Suleyman
AU - Balbaloglu, Hakan
AU - Balint-Lahat, Nora
AU - Banys-Paluchowski, Maggie
AU - Barrio, Andrea V.
AU - Benson, John
AU - Bese, Nuran
AU - Boughey, Judy C.
AU - Boyle, Marissa K.
AU - Diego, Emilia J.
AU - Eden, Claire
AU - Eller, Ruth
AU - Goldschmidt, Maite
AU - Hlavin, Callie
AU - Heidinger, Martin
AU - Jelinska, Justyna
AU - Karadeniz Cakmak, Güldeniz
AU - Kesmodel, Susan B.
AU - King, Tari A.
AU - Kuerer, Henry M.
AU - Loesch, Julie
AU - Milardi, Francesco
AU - Murawa, Dawid
AU - Moo, Tracy Ann
AU - Menes, Tehillah S.
AU - Passeri, Daniele
AU - Pastoriza, Jessica M.
AU - Perhavec, Andraz
AU - Pislar, Nina
AU - Polidorio, Natália
AU - Rami, Avina
AU - Ryu, Jai Min
AU - Schulz, Alexandra
AU - Sevilimedu, Varadan
AU - Ugurlu, M. Umit
AU - Uras, Cihan
AU - van Hemert, Annemiek
AU - Wong, Stephanie M.
AU - Robyn Yoo, Tae Kyung
AU - Zhang, Jennifer Q.
AU - Karanlik, Hasan
AU - Cabioglu, Neslihan
AU - Vrancken Peeters, Marie Jeanne
AU - Morrow, Monica
AU - Williams, Austin D.
N1 - Publisher Copyright:
© 2025 American Society of Clinical Oncology.
PY - 2025/3
Y1 - 2025/3
N2 - PURPOSE: The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ 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 = .024) and nodal radiation (82%
v 75%,
P = .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(i+) 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(i+).
AB - PURPOSE: The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ 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 = .024) and nodal radiation (82%
v 75%,
P = .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(i+) 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(i+).
KW - Adult
KW - Aged
KW - Axilla
KW - Breast Neoplasms/pathology
KW - Chemotherapy, Adjuvant
KW - Female
KW - Humans
KW - Lymph Node Excision
KW - Lymph Nodes/pathology
KW - Lymphatic Metastasis
KW - Middle Aged
KW - Neoadjuvant Therapy
KW - Neoplasm Recurrence, Local/pathology
KW - Neoplasm Staging
KW - Neoplasm, Residual
KW - Retrospective Studies
KW - Sentinel Lymph Node Biopsy
KW - Sentinel Lymph Node/pathology
KW - Treatment Outcome
UR - https://www.scopus.com/pages/publications/85209758470
U2 - 10.1200/JCO.24.01052
DO - 10.1200/JCO.24.01052
M3 - Article
C2 - 39509672
AN - SCOPUS:85209758470
SN - 0732-183X
VL - 43
SP - 810
EP - 820
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -
SDG 3 Good Health and Well-being