De-escalation in clinically node-negative, SLN-positive patients
primary breast cancer, node-negative, breast cancer
DISEASE, RECURRENCE, METASTASES, BREAST CANCER
In a next step, treatment de-escalation in patients with metastases in the SLN was investigated. Albeit methodological limitations have been criticized, the ACOSOG Z0011 trial remains a major landmark study in this regard. Patients with primary breast cancer ≤5 cm, palpably negative axillary LN, breast conserving surgery with adjuvant radiotherapy, and one or two SLN with metastases (i.e., micro- and macrometastases without gross extracapsular extension) in the removed lymph nodes were randomized to receive either ALND or no further axillary treatment. After 10 years, no differences in locoregional recurrence, disease-free and overall survival were noted [These trials provided evidence that the combination of modern radiotherapeutic and systemic treatment approaches may sufficiently control and treat axillary disease, obviating the need for complete surgical removal.The question, whether axillary surgery is at all necessary in selected patients with early breast cancer is addressed in the randomized-controlled SOUND trial, investigating the distant disease-free survival in patients with clinically node-negative primary BC < 2 cm, and the INSEMA trial, investigating invasive disease-free survival in clinically node-negative patients with primary BC < 5 cm. In both trials patients planning to undergo BCS and adjuvant radiotherapy are enrolled. Here, the experimental arm will forego any axillary intervention, with the control arm undergoing SLNB [