- Where we are now (2025):
- In carefully selected cT1 to cT2, cN0 patients with negative pre-op axillary US:
- Omitting SLNB is non-inferior to SLNB for disease endpoints and reduces arm morbidity:
- SOUND Trial , INSEMA Trial; endorsed in ASCO 2025
- Omitting SLNB is non-inferior to SLNB for disease endpoints and reduces arm morbidity:
- If SLN is positive (≤ 2 nodes) after lumpectomy + WBRT:
- Omit ALND (ACSOG Z0011, 10-yr)
- For micrometastases:
- IBCSG 23-01 supports no ALND
- AMAROS:
- Axillary RT ≈ ALND for control with less lymphedema
- Post-NAC cN1→cN0:
- SLNB / TAD feasible if you remove the clipped node, use dual tracers, and retrieve ≥2–3 SLNs:
- Lower FNR:
- ACSOG Z1071 / SENTINA / SN-FNAC
- Lower FNR:
- SLNB / TAD feasible if you remove the clipped node, use dual tracers, and retrieve ≥2–3 SLNs:
- Persistent cN+ → ALND
- Radiation interfaces (2025 ASTRO-ASCO-SSO PMRT update) – Clarify when RNI / PMRT substitutes for completion ALND after positive SLN, and after NAC:
- What de-escalation buys you:
- Meaningfully less lymphedema and arm morbidity:
- AMAROS 5-year lymphedema: 23% ALND vs 11% axillary RT; SLNB is lower still; omission (SOUND / INSEMA) lowest
- INSEMA: omission vs SLNB—lower arm symptoms; 5-yr iDFS 91.9% vs 91.7% (HR 0.91; NI met).
- Meaningfully less lymphedema and arm morbidity:
- What de-escalation buys you:
- In carefully selected cT1 to cT2, cN0 patients with negative pre-op axillary US:
- Trial data:
- Upfront surgery, cN0:
- SOUND (JAMA Oncol 2023) – negative axillary US, tumor ≤ 2 cm
- Design: SLNB vs no axillary surgery
- Outcome: Non-inferior 5-yr distant DFS
- Omission safe when nodal information won’t alter plan
- Multinational, 18 centers (Italy / Spain / Switzerland / Chile)
- INSEMA (NEJM 2025) – mostly BCS, cT1 to 2 cN0
- Primary: 5-yr iDFS non-inferiority met (No axillary surgery 91.9% vs SLNB 91.7%; HR 0.91 [0.73–1.14])
- OS ~ 98% vs 97%
- Less arm morbidity if omitted
- SOUND (JAMA Oncol 2023) – negative axillary US, tumor ≤ 2 cm
- ASCO 2025 SLNB guideline update:
- Allows omission of routine SLNB in selected stage I to II patients: ≥ 50 y, HR+ / HER2−, ≤ 2 cm, G1 to G2, negative axillary imaging, BCS + adjuvant therapy, and when nodal status won’t change systemic / RT
- Shared decision-making emphasized
- Limited SLN positivity (upfront):
- ACSOG Z0011 (10-yr) – lumpectomy + WBRT, 1 to 2 positive SLN
- 10-yr OS: 86.3% SLNB-alone vs 83.6% ALND
- Regional failures < 1%
- ALND not routine recommended
- IBCSG 23-01 (10-yr) – SLN micromets ≤ 2 mm:
- No difference DFS; non-inferior to omit ALND
- Axillary recurrences ~ 1.7% without cALND at 10 yrs
- AMAROS – SLN+ randomized to ALND vs axillary RT:
- Comparable control
- Less lymphedema with RT (≈ 11% vs 23% at 5 yrs)
- Consider RT instead of ALND
- Neoadjuvant setting:
- Z1071 / SENTINA / SN-FNAC – initially cN1→NAC→ycN0
- FNR reduced by: clip + retrieve positive node (TAD), dual tracer, and retrieving ≥ 2 to 3 SLNs
- If still cN+, ALND remains standard.
- Radiation guidance (2025)
- ASTRO-ASCO-SSO PMRT update (2025)
Clarifies PMRT / RNI after upfront surgery and after NAC - Indicates when axillary RT is reasonable alternative to ALND in select SLN+ scenarios
- Encourages moderate hypofractionation, details target volumes/boost
- ASTRO-ASCO-SSO PMRT update (2025)
- ACSOG Z0011 (10-yr) – lumpectomy + WBRT, 1 to 2 positive SLN
- Allows omission of routine SLNB in selected stage I to II patients: ≥ 50 y, HR+ / HER2−, ≤ 2 cm, G1 to G2, negative axillary imaging, BCS + adjuvant therapy, and when nodal status won’t change systemic / RT
- Practical algorithms (evidence-based):
- Upfront cN0 (exam + negative axillary US):
- Meets ASCO 2025 “omission” profile (≥ 50, HR+ / HER2−, ≤ 2 cm, G1 to G2) and BCS planned → Discuss omitting SLNB (SOUND Trial /INSEMA Trial)
- Not low-risk or mastectomy planned → SLNB (can later omit ALND depending on path)
- SLNB results (upfront surgery):
- 0 nodes+ → No further axillary surgery
- 1 to 2 nodes+, lumpectomy + WBRT → Omit ALND (Z0011) or Axillary RT (AMAROS) if nodal coverage desired
- Micromets (≤ 2 mm) → No ALND (IBCSG 23-01)
- > 2 nodes+, gross ENE, no RT planned /possible, inflammatory BC, or T3 / T4 → ALND (plus consider RNI / PMRT)
- NAC pathway:
- Biopsy-proven cN1 → Clip positive node pre-NAC:
- ycN0 after NAC → TAD (SLNB + clipped node removal) using dual tracer, aim ≥ 2 to 3 SLNs
- If any positive or clip not retrieved, strong consideration for ALND (or RNI per MDT)
- ycN+ → ALND (then RNI per PMRT guideline)
- Biopsy-proven cN1 → Clip positive node pre-NAC:
- Upfront cN0 (exam + negative axillary US):
- Numbers and pearls slide:
- INSEMA:
- 5-yearr iDFS 91.9% (omit) vs 91.7% (SLNB); HR 0.91 (NI met)
- Lower arm morbidity with omission
- SOUND:
- Negative US + small tumors → no axillary surgery non-inferior to SLNB for distant DFS at 5 yrs
- Z0011 (10-yr):
- OS 86.3% SLNB-alone vs 83.6% ALND; regional recurrence < 1%
- IBCSG 23-01 (10-yr):
- Micromets – no ALND
- Axillary recurrence ≈ 1.7% without cALND
- AMAROS:
- Lymphedema 23% ALND vs 11% axillary RT (5 yrs)
- Similar control
- Post-NAC accuracy:
- TAD + dual tracer + ≥ 2 to 3 SLNs lowers FNR (vs SLNB alone)
- ASTRO-ASCO-SSO 2025 PMRT:
- When SLN+ and no ALND, RNI/PMRT often appropriate; specifics by burden / response
- INSEMA:
- Upfront surgery, cN0:
- Review Questions:
- Can I omit SLNB in a 62-year-old, HR+ / HER2−, 1.3 cm IDC, negative axillary US, BCS?
- Yes, option to omit per ASCO 2025 (criteria met) informed by SOUND and INSEMA; confirm that nodal information won’t change systemic / RT plan
- What if the same patient is having a mastectomy
- Generally perform SLNB (you lose SLNB opportunity later; pathology could upstage; influences RNI / PMRT)
- Patient with 2 SLN+ undergoing lumpectomy – ALND or RT?
- No routine ALND (Z0011)
- Consider axillary RT (AMAROS) if you want nodal coverage with less lymphedema than ALND
- Post-NAC cN1→ycN0 – how do I minimize FNR?
- Do TAD: clip and retrieve the index node, dual tracers, retrieve ≥ 2 to 3 SLNs
- If clip not found or any positive nodes → ALND (or RNI per MDT)
- Which patients still truly need ALND today
- Inflammatory BC
- Persistent cN+ after NAC
- > 2 SLN+ upfront
- Gross ENE
- When WBRT / RNI not feasible but regional control is required
- How do the new PMRT guidelines affect axillary surgery choices?
- 2025 ASTRO-ASCO-SSO:
- Clearer indications for RNI / PMRT after upfront surgery and after NAC
- Can replace ALND in select SLN+ cases – coordinate with radiation oncology
- 2025 ASTRO-ASCO-SSO:
