Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients With Early Stage Breast Cancer

Abstract

Objective Assess the performance characteristics of axillary ultrasound (AUS) for accurate exclusion of clinically significant axillary lymph node (ALN) disease. Background Sentinel lymph node biopsy (SLNB) is currently the standard of care for staging the axilla in patients with clinical T1–T2, N0 breast cancer. AUS is a noninvasive alternative to SLNB for staging the axilla. Methods Patients were identified using a prospectively maintained database. Sensitivity, specificity, and negative predictive value (NPV) were calculated by comparing AUS findings to pathology results. Multivariate analyses were performed to identify patient and/or tumor characteristics associated with false negative (FN) AUS. A blinded review of FN and matched true negative cases was performed by two independent medical oncologists to compare treatment recommendations and actual treatment received. Recurrence-free survival was described using Kaplan-Meier product limit methods. Results 647 patients with clinical T1–T2, N0 breast cancer underwent AUS between January, 2008 and March, 2013. AUS had a sensitivity of 70%, NPV of 84% and PPV of 56% for the detection of ALN disease. For detection of clinically significant disease (> 2.0 mm), AUS had a sensitivity of 76% and NPV of 89%. FN AUS did not significantly impact adjuvant medical decision making. Patients with FN AUS had recurrence-free survival equivalent to patients with pathologic N0 disease. Conclusions AUS accurately excludes clinically significant ALN disease in patients with clinical T1–T2, N0 breast cancer. AUS may be an alternative to SLNB in these patients where axillary surgery is no longer considered therapeutic, and predictors of tumor biology are increasingly used to make adjuvant therapy decisions.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

“…In the pilot phase of the randomized controlled trial, the median size of a missed axillary metastasis was < 2.0 mm. This is consistent with our retrospective study and others demonstrating that patients with a false negative AUS typically have minimal disease in the axilla [38, 39]. Of note, micrometastatic disease in the axilla (disease < 2.0 mm) has almost no impact on prognosis and medical decision making [40-45].…”

“…In Arm 2, the NPV of AUS for identification of any axillary disease was 90.6%, and the NPV for identification of clinically significant disease > 2.0 mm was 96.9%. These findings confirm the results of our retrospective study demonstrating the ability of AUS to accurately exclude clinically significant disease in the axilla [38]. In the pilot phase of the randomized controlled trial, the median size of a missed axillary metastasis was < 2.0 mm.…”

“…However, following publication of the ACOSOG Z0011 trial results, the role of AUS in axillary staging has become less clear [36, 37]. We recently completed a retrospective study specifically focused on the ability of AUS to accurately exclude clinically significant disease in the axilla [38]. AUS had a sensitivity of 76% and a negative predictive value (NPV) of 89% for the detection of clinically significant disease (> 2.0 mm).…”

Ultrasound Imaging for Detecting Metastasis to Level II and III Axillary Lymph Nodes after Axillary Lymph Node Dissection for Invasive Breast Cancer

“…As an alternative, ultrasound (US) is generally used for the follow‐up of patients for both breast cancer and axillary metastasis in China because it is inexpensive and has good soft tissue resolution and can be performed in real time. Numerous studies have analyzed the diagnostic efficiency of axillary US for lymph nodes, but most them primarily focused on preoperative examinations. There are very few reports on the use of axillary US in the postoperative follow‐up of patients .…”

Preoperative prediction nomogram based on primary tumor miRNAs signature and clinical‐related features for axillary lymph node metastasis in early‐stage invasive breast cancer

“…The combined analysis of a panel of biomarkers, rather than individual analyses, as a nomogram is the most promising approach that is powerful enough to change clinical management . Although classifier models based on clinical‐associated factors, such as axillary ultrasound (AUS) and tumor size, have been investigated and demonstrated to be useful for ALN metastasis prediction in patients with BC, an optimal approach that combines multiple miRNAs biomarkers as a predictive signature has yet to be developed . To the best of our knowledge, there is no literature that has determined whether a miRNAs signature would enable superior prediction of ALN status.…”