Sentinel lymph node biopsy with one-step nucleic acid assay relegates the need for preoperative ultrasound-guided biopsy staging of the axilla in patients with early stage breast cancer

Avoiding axillary node clearance in patients with early stage breast cancer and low-burden node-positive axillary disease is an emerging practice. Informing the decision to adopt axillary conservation is examined by comparing routine preoperative axillary staging using ultrasound (AUS) ± AUS biopsy (AUSB) with intraoperative staging using sentinel lymph node biopsy (SLNB) and a one-step nucleic acid cytokeratin-19 amplification assay (OSNA). A single-centre, retrospective cohort study of 1,315 consecutive new diagnoses of breast cancer in 1,306 patients was undertaken in the present study. An AUS ± AUSB was performed on all patients as part of their initial assessment. Patients who had a normal ultrasound (AUS-) or negative biopsy (AUSB-) followed by SLNB with OSNA ± axillary lymph node dissection (ALND), and those with a positive AUSB (AUSB+), were assessed. Tests for association were determined using a χ(2) and Fisher's Exact test. A total of 266 (20.4%) patients with cT1-3 cN0 staging received 271 AUSBs. Of these, 205 biopsies were positive and 66 were negative. The 684 patients with an AUS-/AUSB-assessment proceeded to SLNB with OSNA. AUS sensitivity and negative predictive value (NPV) were 0.53 [0.44-0.62; 95% confidence interval (CI)] and 0.58 (0.53-0.64, 95% CI), respectively. Using a total tumour load cut-off of 15,000 copies/µl to predict ≥2 macro-metastases, the sensitivity and NPV for OSNA were 0.82 (0.71-0.92, 95% CI) and 0.98 (0.97-0.99, 95% CI) (OSNA vs. AUS P<0.0001). Of the AUSB+ patients, 51% had ≤2 positive nodes following ALND and were potentially over-treated. Where available, SLNB with OSNA should replace AUSB for axillary assessment in cT1-2 cN0 patients with ≤2 indeterminate nodes seen on AUS.