IBCSG 23-01

Design, population and eligibility

Treatment and comparator

Intervention: No completion axillary lymph-node dissection after sentinel-node biopsy.

Comparator: Completion axillary lymph-node dissection.

Primary endpoint: Disease-free survival; non-inferiority of omission.

Key efficacy outcomes

10-year DFS: 76.8% without ALND vs 74.9% with ALND HR 0.85 (95% CI 0.65–1.11); superiority p=0.24; non-inferiority p=0.0024.

Any-grade lymphoedema: 4% vs 13% Long-term surgical morbidity.

Sensory neuropathy: 13% vs 19%

Motor neuropathy: 3% vs 9%

Absolute outcome visualization

Ten-year disease-free survival and long-term lymphoedema, reported by randomized group.

Bars show the source-reported endpoint values; they are not adjusted or reconstructed from median survival. For single-arm studies, no comparative effect is implied.

NNT / NNH and absolute benefit–harm balance

No NNT for DFS: the trial established non-inferiority, not superiority. The observed absolute 9-point reduction in any-grade lymphoedema corresponds to approximately 12 patients managed without ALND to avoid one case over the reported long-term follow-up (crude reciprocal of the observed difference; not a prespecified NNT).

No comparative NNH is supported for the primary efficacy endpoint. The morbidity balance favoured omission: sensory and motor neuropathy were also less frequent without ALND.

Toxicity, grade 3–5 harms and treatment burden

Any-grade lymphoedema 4% versus 13%; sensory neuropathy 13% versus 19%; motor neuropathy 3% versus 9%. One serious postoperative infection/inflamed axilla requiring admission was attributed to ALND. Grade 3–5 event rates were not reported in the abstracted long-term summary.

Omission avoids a second axillary operation and its recovery burden. Systemic treatment and radiotherapy were delivered according to local standards; treatment allocation was not blinded.

Quality of life and patient-reported outcomes

The trial's long-term report primarily quantifies surgical morbidity. A formal global QoL comparison is not available in the cited 10-year abstract.

Subgroups and applicability

The result applies to minimal sentinel-node tumour burden ≤2 mm. It should not be extrapolated to macrometastases, clinically node-positive disease or gross extranodal extension.

Critical appraisal and limitations

Low-volume sentinel-node disease; open-label design; DFS difference was not superior; the trial predates some current systemic and regional nodal treatment patterns. Event numbers were limited.

Clinical interpretation

For appropriately selected patients with sentinel-node micrometastases, omission of completion ALND preserves 10-year DFS within the prespecified non-inferiority framework and reduces arm morbidity. Do not generalize this result to macrometastatic disease.

Contemporary-practice note (8 November 2026): This page separates the historical randomized or prospective study result from current treatment selection. A full guideline-level freshness review has not been completed for this batch; local decisions should be checked against current disease-specific guidance and multidisciplinary context.

Primary sources and related publications

• Galimberti et al. Lancet Oncology 2018; 10-year IBCSG 23-01 analysis (PMID 30196031)
• ClinicalTrials.gov NCT00072293

All numerical claims above are linked to the primary publication or explicitly identified follow-up / meeting abstract. Missing data are not imputed.