Inua Bello, Fung Victoria, Al-Shurbasi Nour, Howells Sarah, Hatsiopoulou Olga, Somarajan Praveen, Zardin Gregory J, Williams Norman R, Kohlhardt Stan
Department of Breast, Plastic and Reconstructive Surgery, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
Department of Breast Screening and Breast Imaging, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
Mol Clin Oncol. 2021 Mar;14(3):51. doi: 10.3892/mco.2021.2213. Epub 2021 Jan 21.
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 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.
在早期乳腺癌且腋窝淋巴结负荷低的淋巴结阳性患者中避免腋窝淋巴结清扫是一种新兴的做法。通过比较使用超声（AUS）±AUS活检（AUSB）的常规术前腋窝分期与使用前哨淋巴结活检（SLNB）和一步核酸细胞角蛋白-19扩增检测（OSNA）的术中分期，来探讨采用腋窝保留术的决策依据。本研究对1306例患者连续新诊断的1315例乳腺癌进行了单中心回顾性队列研究。作为初始评估的一部分，对所有患者进行了AUS±AUSB检查。对超声检查正常（AUS-）或活检阴性（AUSB-）随后进行SLNB并联合OSNA±腋窝淋巴结清扫（ALND）的患者，以及AUSB阳性（AUSB+）的患者进行了评估。采用χ检验和Fisher精确检验确定关联性检验。共有266例（20.4%）cT1-3 cN0分期的患者接受了271次AUSB检查。其中，205次活检为阳性，66次为阴性。684例接受AUS-/AUSB评估的患者接着进行了SLNB并联合OSNA检查。AUS的敏感性和阴性预测值（NPV）分别为0.53[0.44-0.62；95%置信区间（CI）]和0.58（0.53-0.64，95%CI）。使用15,000拷贝/微升的总肿瘤负荷截断值来预测≥2个宏观转移灶，OSNA的敏感性和NPV分别为0.82（0.71-0.92，95%CI）和0.98（0.97-0.99，95%CI）（OSNA与AUS比较，P<0.0001）。在AUSB+患者中，51%在ALND后有≤2个阳性淋巴结，可能存在过度治疗。在可行的情况下，对于AUS检查发现≤2个不确定淋巴结的cT1-2 cN0患者，SLNB联合OSNA应取代AUSB用于腋窝评估。
