Must Axillary Lymph Nodes Be Removed in Breast Cancer? An Approach to Reduce Lymphedema
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BOOG 2013-08, presented at SABCS 2025, suggests selected patients may omit sentinel biopsy
A longstanding question in breast cancer surgery is: "Are the axillary lymph nodes involved?" This is often assessed with sentinel lymph node biopsy (SLNB). Although less extensive surgery, SLNB can still cause lymphedema (arm swelling), pain, sensory loss or restricted movement, affecting quality of life.
Presented at San Antonio Breast Cancer Symposium (SABCS) 2025, the Phase 3 BOOG 2013-08 trial asked: In early-stage, clinically node-negative (by examination/imaging) patients scheduled for breast-conserving surgery + whole-breast radiotherapy , does omitting SLNB increase regional recurrence within 5 years in axillary or regional nodal areas?
*RFS: regional recurrence-free survival • **Distant disease-free survival.
Study Design
A randomized Phase 3 trial in unilateral, clinically node-negative (cN0) breast cancer planned for breast conservation. Patients with cT1–T2 (≤5 cm) were assigned to SLNBor treatment without SLNB . Both groups received the contemporary standard, whole-breast radiotherapy .
The question: can axillary surgical staging be reduced while preserving regional safety over 5 years?
Who Was the Typical Participant?
Mean age: 61. Most were over 50, with predominantly grade 1–2 and cT1 smaller tumors. Findings therefore apply most directly to lower-risk early disease.
5-Year Regional Recurrence-Free Survival
Bars: % • Difference: 2.35 points (within the non-inferiority margin)What Does This Mean?
For regional recurrence at 5 years, the study supports non-inferiority of omitting SLNB . Reducing axillary intervention therefore appears feasible in appropriately selected patients.
Distant Disease-Free Survival (DDFS)
Bars: % • Absolute difference: 3.3 pointsNote: This differs from the primary regional-recurrence safety endpoint. Interpret alongside patient selection and follow-up.
Why Is Omitting SLNB Attractive?
Although smaller than axillary dissection, SLNB is not risk-free. The presenting team emphasized that omission could be cost-effective and, by avoiding lymphedema and other complications, improve quality of life .
A Critical Question: Can Radiotherapy Also Be Reduced?
Almost everyone in this study received whole-breast radiotherapy . Today, some centers increasingly use partial-breast irradiation and other reduced-field protocols. Experts at SABCS highlighted the unresolved question: Is omitting SLNB equally safe in every setting when combined with partial radiotherapy?
For now, evidence is stronger when reducing surgery is accompanied by standard radiotherapy.
DROZDOGAN Academy Commentary: Who Might Be Considered?
Based on the trial population, potentially suitable candidates for omission include:
• Age 50 or older
• Clinically node-negative (cN0)
• Small tumors (mostly cT1) and grade 1–2
• Predominantly HR+/HER2− biology
Final decisions integrate imaging, pathology, systemic treatment and especially radiotherapy strategy .
Source: SABCS 2025 Presentation Summary BOOG 2013-08 Phase 3 trial (SABCS 2025). Presented by Marjolein Smidt, MD, PhD (Maastricht UMC).
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