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Observational Study
. 2025 May;32(5):3278-3291.
doi: 10.1245/s10434-025-16973-y. Epub 2025 Feb 13.

Oncologic Outcomes with De-Escalation of Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: Results from > 1500 Patients on the I-SPY2 Clinical Trial

Judy C Boughey  1 , Hongmei Yu  2 , Kayla Switalla  3 , Ladores Velle  3 , Alex Lopes  3 , Anne M Wallace  4 , Rachel B Lancaster  5 , Chantal R Reyna  6 , Todd M Tuttle  7 , Nora Jaskowiak  8 , Julia Tchou  9 , Roshni Rao  10 , Marie C Lee  11 , Arpana M Naik  12 , Mehra Golshan  13 , Cletus A Arciero  14 , Candice A M Sauder  15 , Cindy B Matsen  16 , Christina Yau  3 , Laura Esserman  17 , Rita A Mukhtar  3 ; I-SPY2 Locoregional Working Group
Affiliations
Observational Study

Oncologic Outcomes with De-Escalation of Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: Results from > 1500 Patients on the I-SPY2 Clinical Trial

Judy C Boughey et al. Ann Surg Oncol. 2025 May.

Abstract

Introduction: The desire to reduce patient morbidity has led to de-escalation of axillary surgery after neoadjuvant chemotherapy (NAC) for breast cancer; however, the impact of such de-escalation on oncologic outcomes is unknown.

Methods: We evaluated the relationship between axillary surgery type (sentinel lymph node [SLN] only vs. axillary lymph node dissection [ALND]) and 5-year outcomes in I-SPY2 trial patients from 2011 to 2022 who completed NAC and surgery. Rates of axillary recurrence (AxR), locoregional recurrence (LRR), distant recurrence-free survival (DRFS), and event-free survival (EFS) were compared.

Results: Of 1515 patients, SLN-only was performed in 804/1014 (79.3%) ypN0 patients and 127/501 (25.3%) ypN+ patients. Median follow-up time was 3.5 years. Most patients received adjuvant radiation (73.8% of ypN0 patients and 90.8% of ypN+ patients). In ypN0 cases, there was no difference between the SLN-only and ALND groups in 5-year estimated AxR (2.0% vs. 0.8%, p = 0.57), LRR (4.6% vs. 4.4%, p = 0.72), or EFS (88.3% vs. 86.4%, p = 0.09). On multivariable analysis, SLN-only was associated with better DRFS (90.8% vs. 87.9%; hazard ratio [HR] 0.54, p = 0.04). In ypN+ cases, there was no difference between the SLN-only and ALND groups in 5-year estimated AxR (5.2% vs. 3.6%, p = 0.81), LRR (7.7% vs. 14%, p = 0.13), DRFS (70.0% vs. 66.7%, p = 0.09), or EFS (70.4% vs. 63.2%, p = 0.07).

Conclusions: With short-term follow-up, omission of ALND in selected patients was not associated with worse AxR, LRR, DRFS, or EFS in patients with ypN0 or ypN+ disease. While prospective trial results are awaited, these data suggest that ALND may not be necessary for all patients with residual nodal disease after NAC.

Keywords: Axillary surgery; Breast cancer; De-escalation; Neoadjuvant chemotherapy; Sentinel lymph node surgery; Targeted axillary dissection.

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Conflict of interest statement

Disclosure: Judy C. Boughey reports an institutional research grant from Eli Lilly and SimBioSys; royalties from UpToDate; honoraria from EndoMag, PER, PeerView and OncLive; and travel support from EndoMag and Alliance for Clinical Trials in Oncology. She is a member of the Data Safety and Monitoring Committee for Cairns Surgical; serves on the Board of Directors for ASBS; and is an unpaid working group Chair at the Society of Surgical Oncology (SSO) Breast Disease Site. Chantal R. Reyna reports consulting fees from Elucent, honoraria for visiting professor grand rounds, and honoraria from the Japanese Team Science Oncology Program for a facilitator and leadership role for the Association of Women Surgeons Secretary. Marie C. Lee reports an institutional research grant and honoraria from Elucent Medical; participation on the Provepharm Advisory Board; and owns stock in J&J. Mehra Golshan reports funding from the Breast Cancer Research Foundation. Candice A.M. Sauder serves on the Executive Committee of the American Joint Committee on Cancer (AJCC). Cindy B. Matsen reports receiving personal research grants from the Utah Cancer Action Network (Principal Investigator [PI]), Department of Defense (co-Investigator [co-I]), and the National Institutes of Health (NIH; co-I); institutional research funding from the Department of Defense; honoraria from Memorial Sloan Kettering Cancer Center Breast Surgical Oncology Fellows; US patent no. US8207142B2; participation on the Data Safety Monitoring Board for the trial of a patient education tool for an NIH-funded trial; participation on the Ethics Committee of the American Society of Breast Surgeons; and was the SSO representative for the American Society for Radiation Oncology Guidelines Working Group. Christina Yau reports an institutional research grant from the National Cancer Institute (NCI)/NIH; salary and travel support from Quantum Leap Healthcare Collaborative; University of California Inventor Share; and the patent ‘Breast Cancer Response Prediction Subtypes’ (No. 18/174,491). Laura Esserman reports institutional research funding from Moderna for a DCIS trial; publishing royalties from UpToDate; and travel support from and participation on the Medical Advisory Board at Blue Cross Blue Shield. Rita A. Mukhtar reports research support and honoraria from GE Healthcare and the NCI; institutional research funding from the University of California San Francisco; and is an unpaid member of the Scientific Advisory Board for the Lobular Breast Cancer Alliance. Hongmei Yu, Kayla Switalla, Ladores Velle, Alex Lopes, Anne M. Wallace, Rachel B. Lancaster, Todd M. Tuttle, Nora Jaskowiak, Julia Tchou, Roshni Rao, Arpana M. Naik, and Cletus A. Arciero did not report any disclosures that may be relevant to the contents of this study.

Figures

FIG. 1
FIG. 1
Axillary recurrence outcomes by type of axillary surgery (SLN-only vs. ALND) in patients with A pathologic node-negative (ypN0) disease and B pathologic node-positive (ypN+) disease, as well as locoregional recurrence outcomes in C ypN0 and D ypN+. SLN sentinel lymph node, ALND axillary lymph node dissection, HR hazard ratio
FIG. 2
FIG. 2
Kaplan–Meier curves showing DRFS by type of axillary surgery (SLN-only vs. ALND) in patients with A pathologic node-negative (ypN0) disease and B pathologic node-positive (ypN+) disease, as well as EFS in C ypN0 and D ypN+. SLN sentinel lymph node, ALND axillary lymph node dissection, HR hazard ratio, DRFS distant recurrence-free survival, EFS event-free survival
See this image and copyright information in PMC

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