Messaggi chiave
- Lo studio di coorte Oncoplastic Breast Consortium-05/ICARO ha analizzato retrospettivamente i dati di pazienti affette da carcinoma mammario in stadio I-III con cellule tumorali isolate (ITC) nei linfonodi sentinella dopo chemioterapia neoadiuvante (ypN0i+). L’obiettivo era accertare la frequenza di riscontro di ulteriori linfonodi positivi alla dissezione del cavo ascellare (ALND) e gli esiti oncologici delle pazienti avviate o meno a ALND.
- L’analisi ha incluso un totale di 583 pazienti (ALND di completamento sì/no: 31/69%). Le pazienti avviate a ALND presentavano più frequentemente una malattia cN2/3 (17 vs 7%, p <0,001), con ITC rilevate su sezione congelata (62 vs 8%, p <0,001) e invasione linfovascolare (38 vs 24%, p <0,001) e sono state più frequentemente sottoposte a radioterapia adiuvante sulla parete toracica (89 vs 78%, p = 0,024) e sui linfonodi (82 vs 75%, p = 0,038).
- All’ALND, ulteriori linfonodi positivi sono stati riscontrati nel 30% delle pazienti, con presenza di macrometastasi solo nel 5% dei casi. I tassi a 3 anni di recidiva ascellare e qualsiasi recidiva invasiva sono risultati pari al 2% (IC 95%, 0,95-3,6) e 11% (IC 95%, 8-14), rispettivamente, senza differenze significative in funzione del tipo di chirurgia ascellare.
- In questo studio, il carico linfonodale in pazienti con ypN0(i+) è stato basso e le recidive ascellari rare in caso di omissione della ALND, a suggerire che il riscontro di ITC non dovrebbe influire sulla gestione del cavo ascellare e che la ALND andrebbe riservata ai casi di malattia localmente avanzata con coinvolgimento linfonodale macroscopico.
Abstract
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 <0.001), have ITCs detected on frozen section (62% v 8%, p <0.001), have lymphovascular invasion (38% v 24%, p <0.001), and receive adjuvant chest wall (89% v 78%, p = 0.024) and nodal radiation (82% v 75%, p = 0.038).
- 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.
Conclusions
- 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+).