Background The outcome of axillary ultrasound (AUS) with fine-needle aspiration biopsy (FNAB) in the diagnostic work-up of primary breast cancer has an impact on therapy decisions. tumor and clinical characteristics. Patients with nodal disease detected by AUS-FNAB represent a group for whom neoadjuvant therapy should be considered. Axillary nodal status remains an important prognostic factor in primary breast cancer  despite the implementation of novel genomic analysis and advances in routine pathology. The method used for axillary staging has evolved from axillary lymph node dissection (ALND) to the sentinel node biopsy technique (SLNB) for clinically node-negative patients [2,3]. For patients with a benign SLNB or a minor tumor burden in the form of isolated tumor cells (ITCs) or micro-metastases [4,5], no further axillary surgery is recommended. The ACoSOG Z0011 randomized trial suggested that not performing ALND in patients with two or fewer macro-metastases did not negatively influence survival 509-20-6 IC50 compared with that of patients in whom axillary clearance was performed , and thus the value of ALND has been questioned in these patients. For patients with three or more positive SLNBs, ALND is still recommended; this is also a group of patients for whom neoadjuvant therapy is recommended [6,7]. The diagnostic work-up for primary breast cancer ideally includes routine axillary ultrasound (AUS), in which the nodes are evaluated according to established criteria for metastatic involvement, 509-20-6 IC50 including nodal size and morphology [8,9]. For patients in whom the AUS indicates metastatic nodal involvement, complementary fine-needle aspiration biopsy (FNAB) or core needle biopsy (CB) is performed. A major concern, however, is that nodal metastases that are diagnosed by ultrasound may be indicative of a high tumor burden [7,10]. Recent studies have examined the accuracy of methods for the detection of limited disease in the axilla . Other studies have been conducted to investigate whether preoperative axillary ultrasonography with or without fine-needle aspiration can reduce Rabbit Polyclonal to GPROPDR the number of sentinel lymph node procedures  and whether worrisome macro-metastases can be detected by preoperative AUS . The clinical utility of preoperative ultrasound and cytology has been questioned [13C15], including whether the technique can distinguish between patients in whom ALND is recommended and those in whom it 509-20-6 IC50 can be omitted. Of particular research interest is whether the accuracy of the method is modulated by factors including metastatic burden in the axilla, tumor size, histological grade, and obesity; results in this regard have been equivocal [16C18]. The aim of the present study was to assess the accuracy of AUS alone and in combination with FNAB in relation to nodal metastatic burden, particularized by number and size in mm of metastatic nodes, and compare axillary metastatic load in patients diagnosed by AUS and FNAB with patients diagnosed by SLNB. An additional aim was to explore putative modifying factors, such as body mass index (BMI) and tumor biology, on the diagnostic outcome in a population-based prospective cohort. Material and methods Study population Patients who underwent surgery and axillary nodal staging for primary invasive breast cancer between January 2009 and December 2012 at Sk?ne University Hospital, Lund, Sweden, were identified in a prospectively maintained pathology-based registry. The exclusion criteria were a history of previous ipsilateral axillary surgery, neoadjuvant chemotherapy regimens, and bilateral tumors. The study was approved by the regional ethical review board of Lund University (reference EPN 2012/340). Algorithm design Routine preoperative axillary ultrasonography in patients with a 509-20-6 IC50 suspicious breast malignancy was introduced in 2009 2009 at Lund University Hospital and implemented over the following years. Surgeons of the Breast Surgery Unit performed the clinical breast and axillary examinations. Patients who presented with clinical lymphadenopathy underwent further preoperative staging of the.