ACOSOG Z0011
Can ALND be omitted in selected women with T1–2 cN0 breast cancer and 1–2 positive sentinel nodes undergoing breast-conserving therapy?
Population: 891 women with T1–2 invasive breast cancer, no palpable adenopathy and 1–2 metastatic SLNs; all had lumpectomy, whole-breast RT and systemic therapy.
Intervention: SLND alone.
Comparator: SLND + ALND.
Sample / endpoint: NNT: not appropriate for a non-inferiority surgical de-escalation endpoint. NNH: approximately 10 for the 11-point excess in 1-year subjective lymphedema with ALND.
Non-inferiority was demonstrated.
HR 0.85 (95% CI 0.62–1.17; P=.32).
10-year OS HR 0.85; one-sided 95% CI upper bound 1.16; non-inferiority P=.02. Locoregional recurrence remained very low.
Subjective lymphedema at 1 year was 2% with SLND alone versus 13% with ALND; adverse surgical effects were 25% versus 70%.
NNT/NNH: NNT: not appropriate for a non-inferiority surgical de-escalation endpoint. NNH: approximately 10 for the 11-point excess in 1-year subjective lymphedema with ALND.
Applicability requires breast conservation, tangential whole-breast RT and 1–2 positive SLNs; higher-risk axillary presentations were excluded.
Not applicable to palpable nodes, >2 positive SLNs, mastectomy or many neoadjuvant settings. Radiation-field details matter.
In carefully selected Z0011-eligible patients, omission of ALND preserves long-term survival while reducing axillary morbidity.
Each dot represents one patient. Dark dots represent benefit; grey dots represent additional harm.