TY - JOUR
T1 - Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer
T2 - 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial
AU - Bartels, Sanne A. L.
AU - Donker, Mila
AU - Poncet, Coralie
AU - Sauvé, Nicolas
AU - Straver, Marieke E.
AU - van de Velde, Cornelis J. H.
AU - Mansel, Robert E.
AU - Blanken, Charlotte
AU - Orzalesi, Lorenzo
AU - Klinkenbijl, Jean H. G.
AU - van der Mijle, Huub C. J.
AU - Nieuwenhuijzen, Grard A. P.
AU - Veltkamp, Sanne C.
AU - van Dalen, Thijs
AU - Marinelli, Andreas
AU - Rijna, Herman
AU - Snoj, Marko
AU - Bundred, Nigel J.
AU - Merkus, Jos W. S.
AU - Belkacemi, Yazid
AU - Petignat, Patrick
AU - Schinagl, Dominic A. X.
AU - Coens, Corneel
AU - van Tienhoven, Geertjan
AU - van Duijnhoven, Frederieke
AU - Rutgers, Emiel J. T.
N1 - Funding Information:
The content of this report is the sole responsibility of the authors and does not necessarily reflect the official views of the Kankerbestrijding/KWF. The authors thank the patients who participated in the study; all the doctors, nurses, and data managers involved in the EORTC AMAROS trial for their participation; the independent data monitoring committee for monitoring the trial during the accrual period; the independent imbalance committee for investigating the imbalance in sentinel node outcome; and C. Hurkmans for the quality assurance of the radiotherapy. Nicolas Sauvé's work as fellow at EORTC Headquarters was supported by a grant from the EORTC Cancer Research Fund (ECRF) and Sanne Bartels' work as fellow is supported by the EORTC Breast Cancer Group (BCG) and the Netherlands Cancer Institute.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/4/20
Y1 - 2023/4/20
N2 - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.PURPOSEThe European Organisation for Research and Treatment of Cancer 10981-22023 AMAROS trial evaluated axillary lymph node dissection (ALND) versus axillary radiotherapy (ART) in patients with cT1-2, node-negative breast cancer and a positive sentinel node (SN) biopsy. At 5 years, both modalities showed excellent and comparable axillary control, with significantly less morbidity after ART. We now report the preplanned 10-year analysis of the axillary recurrence rate (ARR), overall survival (OS), and disease-free survival (DFS), and an updated 5-year analysis of morbidity and quality of life.METHODSIn this open-label multicenter phase III noninferiority trial, 4,806 patients underwent SN biopsy; 1,425 were node-positive and randomly assigned to either ALND (n = 744) or ART (n = 681).RESULTSPer intention-to-treat analysis, 10-year ARR cumulative incidence was 0.93% (95% CI, 0.18 to 1.68; seven events) after ALND and 1.82% (95% CI, 0.74 to 2.94; 11 events) after ART (hazard ratio [HR], 1.71; 95% CI, 0.67 to 4.39). There were no differences in OS (HR, 1.17; 95% CI, 0.89 to 1.52) or DFS (HR, 1.19; 95% CI, 0.97 to 1.46). ALND was associated with a higher lymphedema rate in updated 5-year analyses (24.5% v 11.9%; P <.001). Quality-of-life scales did not differ by treatment through 5 years. Exploratory analysis showed a 10-year cumulative incidence of second primary cancers of 12.1% (95% CI, 9.6 to 14.9) after ART and 8.3% (95% CI, 6.3 to 10.7) after ALND.CONCLUSIONThis 10-year analysis confirms a low ARR after both ART and ALND with no difference in OS, DFS, and locoregional control. Considering less arm morbidity, ART is preferred over ALND for patients with SN-positive cT1-2 breast cancer.
AB - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.PURPOSEThe European Organisation for Research and Treatment of Cancer 10981-22023 AMAROS trial evaluated axillary lymph node dissection (ALND) versus axillary radiotherapy (ART) in patients with cT1-2, node-negative breast cancer and a positive sentinel node (SN) biopsy. At 5 years, both modalities showed excellent and comparable axillary control, with significantly less morbidity after ART. We now report the preplanned 10-year analysis of the axillary recurrence rate (ARR), overall survival (OS), and disease-free survival (DFS), and an updated 5-year analysis of morbidity and quality of life.METHODSIn this open-label multicenter phase III noninferiority trial, 4,806 patients underwent SN biopsy; 1,425 were node-positive and randomly assigned to either ALND (n = 744) or ART (n = 681).RESULTSPer intention-to-treat analysis, 10-year ARR cumulative incidence was 0.93% (95% CI, 0.18 to 1.68; seven events) after ALND and 1.82% (95% CI, 0.74 to 2.94; 11 events) after ART (hazard ratio [HR], 1.71; 95% CI, 0.67 to 4.39). There were no differences in OS (HR, 1.17; 95% CI, 0.89 to 1.52) or DFS (HR, 1.19; 95% CI, 0.97 to 1.46). ALND was associated with a higher lymphedema rate in updated 5-year analyses (24.5% v 11.9%; P <.001). Quality-of-life scales did not differ by treatment through 5 years. Exploratory analysis showed a 10-year cumulative incidence of second primary cancers of 12.1% (95% CI, 9.6 to 14.9) after ART and 8.3% (95% CI, 6.3 to 10.7) after ALND.CONCLUSIONThis 10-year analysis confirms a low ARR after both ART and ALND with no difference in OS, DFS, and locoregional control. Considering less arm morbidity, ART is preferred over ALND for patients with SN-positive cT1-2 breast cancer.
UR - http://www.scopus.com/inward/record.url?scp=85152618833&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.01565
DO - 10.1200/JCO.22.01565
M3 - Article
C2 - 36383926
SN - 0732-183X
VL - 41
SP - 2159
EP - 2165
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -