For patients with clinically node-negative breast cancer with sentinel-node macrometastases, the omission of completion axillary-lymph-node dissection is noninferior to more extensive surgery, according to a study published in the April 4 issue of the New England Journal of Medicine.

Jana de Boniface, M.D., Ph.D., from the Karolinska Institutet in Stockholm, and colleagues conducted a noninferiority trial involving patients with clinically node-negative primary T1 to T3 breast cancer with one or two sentinel-node macrometastases. Participants were randomly assigned to completion axillary-lymph-node dissection or its omission. A total of 2,766 patients were enrolled across five countries between January 2015 and December 2021; the per-protocol population included 2,540 patients: 1,335 and 1,205 were assigned to undergo sentinel-node biopsy only and completion axillary-lymph-node dissection, respectively.

Radiation therapy, including nodal target volumes, was administered to 89.9 and 88.4 percent of patients in the sentinel-node biopsy-only group and the dissection group, respectively. Patients were followed for a median of 46.8 months. The researchers found that 191 patients had recurrence or died. The estimated five-year recurrence-free survival was 89.7 and 88.7 percent in the sentinel-node biopsy-only group and the dissection group, respectively, with a country-adjusted hazard ratio of 0.89 (95 percent confidence interval, 0.66 to 1.19), which was significantly below the prespecified noninferiority margin.

“The estimated five-year recurrence-free survival after sentinel-node biopsy only was noninferior to that after completion axillary-lymph-node dissection among patients with breast cancer and one or two sentinel-node macrometastases,” the authors write.

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