Looking Into Axillary Radiotherapy vs Axillary Lymph Node Dissection in Breast Cancer
A randomized, multicenter, open-label, phase 3 non-inferiority trial enrolled patients with T1-2 primary breast cancer and no palpable lymphadenopathy to assess whether axillary radiotherapy provides comparable regional control with less side effects than dissection. The primary endpoint of the study was non-inferiority of 5-year axillary recurrence, which was to be no more than 4% for the axillary radiotherapy group compared with 2% in the axillary lymph node dissection group. Across 9 European countries, 4,806 patients were enrolled in the study with 2,404 patients randomly assigned to have axillary lymph node dissection and 2,404 randomly assigned to have axillary radiotherapy.
The median follow-up was 6.1 years for those with positive sentinel lymph nodes. Thirty-three percent of patients who were in the axillary lymph node dissection group had additional positive lymph nodes. Axillary recurrence took place in 4 of 744 patients in the axillary lymph node dissection group and 7 of the 681 patients in the axillary radiotherapy group. It was found that axillary radiotherapy results in considerably less morbidity.
Donker M, van Tienhoven G, Straver ME, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014;15(12):1303-1310. doi:10.1016/S1470-2045(14)70460-7