Treatment results
PATHOLOGY, METASTASES
At randomization, the two different arms of axillary treatment presented a comparable SLN status, with a median number of 2 (interquartile range (i.q.r.) 1–3) removed SLNs and a median number of 1 (i.q.r. 1–1) positive SLN in each group. Overall, one patient in the ITT population had SNL micrometastasis and was treated with SLNB only. Additionally, one patient in the ITT population was incorrectly treated with ALND because no macrometastasis was found in the SLN at final pathology.In the ALND treatment group, the median number of non-SLNs identified at final pathology was 15 (i.q.r. 11–21) and 53 of 111 (47.8 per cent) patients had additional metastases in lymph nodes removed by axillary dissection. The median number of metastatic non-SLNs was 1 (i.q.r. 0–2). Axillary lymph node data are summarized in Axillary lymph node data by treatment armValues are In terms of adjuvant therapy, 38 (17 per cent) patients received RT (30 (27 per cent) and 8 (8 per cent) patients in the ALND arm and the SLNB-only arm respectively). Chemotherapy was administered to 116 (53.2 per cent) patients (63 of 111 (56.8 per cent) patients in the ALND arm and 53 of 107 (49.5 per cent) patients in the SLNB-only arm). Paclitaxel and anthracycline combination chemotherapy was the most common administered type in both groups. Trastuzumab was administered to 20 (9 per cent) patients and ribociclib was administered to 1 (1 per cent) patient. Overall, 196 (89.9 per cent) patients were treated with adjuvant endocrine treatment and most patients (46.8 per cent) received an aromatase inhibitor.