Nodal burden and oncologic outcomes in patients with residual isolated tumor cells after neoadjuvant chemotherapy (ypN0i+): The OPBC-05/ICARO study Journal Article
| Authors: | Montagna, G.; Laws, A.; Ferrucci, M.; Mrdutt, M. M.; Sun, S. X.; Bademler, S.; Balbaloglu, H.; Balint-Lahat, N.; Banys-Paluchowski, M.; Barrio, A. V.; Benson, J.; Bese, N.; Boughey, J. C.; Boyle, M. K.; Diego, E. J.; Eden, C.; Eller, R.; Goldschmidt, M.; Hlavin, C.; Heidinger, M.; Jelinska, J.; Karadeniz Cakmak, G.; Kesmodel, S. B.; King, T. A.; Kuerer, H. M.; Loesch, J.; Milardi, F.; Murawa, D.; Moo, T. A.; Menes, T. S.; Passeri, D.; Pastoriza, J. M.; Perhavec, A.; Pislar, N.; Polidorio, N.; Rami, A.; Ryu, J. M.; Schulz, A.; Sevilimedu, V.; Ugurlu, M. U.; Uras, C.; Van Hemert, A.; Wong, S. M.; Yoo, T. K. R.; Zhang, J. Q.; Karanlik, H.; Cabioǧlu, N.; Peeters, M. J. V.; Morrow, M.; Weber, W. P.; on behalf of the ICARO Study Group |
| Article Title: | Nodal burden and oncologic outcomes in patients with residual isolated tumor cells after neoadjuvant chemotherapy (ypN0i+): The OPBC-05/ICARO study |
| 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 <.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+). © 2025 American Society of Clinical Oncology. |
| Keywords: | immunohistochemistry; adult; controlled study; human tissue; treatment outcome; aged; middle aged; surgical technique; retrospective studies; major clinical study; clinical trial; cancer recurrence; doxorubicin; systemic therapy; paclitaxel; radiation dose; chemotherapy, adjuvant; neoadjuvant therapy; cancer staging; follow up; lymph node metastasis; lymph node dissection; lymph nodes; lymphatic metastasis; neoplasm staging; prospective study; sentinel lymph node; lymph node excision; sentinel lymph node biopsy; carboplatin; neoplasm recurrence, local; breast cancer; mastectomy; epidermal growth factor receptor 2; tumor differentiation; cohort analysis; cyclophosphamide; pathology; breast neoplasms; retrospective study; risk assessment; docetaxel; axillary lymph node; cancer center; radioactive iodine; minimal residual disease; neoplasm, residual; multicenter study; tumor recurrence; adjuvant chemotherapy; breast tumor; lymph node; tumor cell; micrometastasis; recurrent disease; hormonal therapy; neoadjuvant chemotherapy; axilla; drug therapy; trastuzumab; anthracycline; frozen section; breast surgery; therapy; pertuzumab; axillary lymph node dissection; clinical outcome; breast-conserving surgery; pirarubicin; lymph vessel metastasis; human epidermal growth factor receptor 2 positive breast cancer; humans; human; female; article; pembrolizumab; hormone receptor positive breast cancer; human epidermal growth factor receptor 2 negative breast cancer |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 43 |
| Issue: | 7 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2025-03-01 |
| Start Page: | 810 |
| End Page: | 820 |
| Language: | English |
| DOI: | 10.1200/jco.24.01052 |
| PUBMED: | 39509672 |
| PROVIDER: | scopus |
| PMCID: | PMC11856002 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF -- Source: Scopus |
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