👉The AMAROS trial is a phase III non-inferiority study comparing ALND with axillary radiation therapy in patients with T1 to T2 clinically node-negative breast cancer patients with a positive sentinel node.
👉The primary endpoint was axillary recurrence.
👉The trial showed low 5-year rates of regional recurrence in the ALND and axillary radiation therapy groups (0.43% vs 1.19%, respectively), but the risk of patient perceived (subjective) or measured (objective) lymphedema was twice as high in the ALND arm compared to the radiation arm (subjective, 23% vs 11%; objective, 13% vs 5%) after 5 years of follow-up.
- Rutgers EJ, Donker M, Straver ME. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer patients: final analysis of the EORTC AMAROS trial (10981/22023). J Clin Oncol. 2013;31 (suppl; abstr LBA1001). Available at: http://meetinglibrary.asco.org/content/109779-132. Accessed November 7, 2013.
- Straver ME, Meijnen P, van Tienhoven G, et al. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010;17:1854-1861.