Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases

Jana de Boniface*, Tove Filtenborg Tvedskov, Lisa Rydén, Robert Szulkin, Toralf Reimer, Thorsten Kühn, Michalis Kontos, Oreste D. Gentilini, Roger Olofsson Bagge, Malin Sund, Dan Lundstedt, Matilda Appelgren, Johan Ahlgren, Sophie Norenstedt, Fuat Celebioglu, Helena Sackey, Inge Scheel Andersen, Ute Hoyer, Per F. Nyman, Eva Vikhe PatilElinore Wieslander, Henrik Dahl Nissen, Sara Alkner, Yvette Andersson, Birgitte V. Offersen, Leif Bergkvist, Jan Frisell, Peer Christiansen, SENOMAC Trialists’ Group

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

5 Citationer (Scopus)

Abstract

BACKGROUND: Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups.

METHODS: We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44.

RESULTS: Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy-only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy-only group and 88.7% (95% CI, 86.3 to 91.1) in the dissection group, with a country-adjusted hazard ratio for recurrence or death of 0.89 (95% CI, 0.66 to 1.19), which was significantly (P<0.001) below the prespecified noninferiority margin.

CONCLUSIONS: The omission of completion axillary-lymph-node dissection was noninferior to the more extensive surgery in patients with clinically node-negative breast cancer who had sentinel-node macrometastases, most of whom received nodal radiation therapy. (Funded by the Swedish Research Council and others; SENOMAC ClinicalTrials.gov number, NCT02240472.).

OriginalsprogEngelsk
TidsskriftThe New England Journal of Medicine
Vol/bind390
Udgave nummer13
Sider (fra-til)1163-1175
Antal sider13
ISSN0028-4793
DOI
StatusUdgivet - 3 apr. 2024

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