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

Abstract

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial.

Axillary ultrasound and fine needle aspiration biopsy in the preoperative diagnosis of axillary metastases in early‑stage breast cancer

“…Some clinical trials such as the BOOG 2013-08 ( 14 ), NCT 01821768 ( 15 ), and the SOUND ( 16 ) have been conducted recently, and breast cancer patients with negative US/FNAB findings were randomly assigned to SLNB and non-SLNB groups. These clinical trials demonstrated that it was necessary to perform SLNB in patients with negative US-guided FNAB of suspicious lymph nodes.…”

Utility of Preoperative Staging of Ipsilateral Axilla with Ultrasound and Guided Needle Aspiration in Early-Stage Breast Cancer—Current Indian Scenario

“…Van Wely et al [20] also confirmed the same in their meta-analysis. Deurloo et al [8], Baruah et al [12], and Cyr et al [21] also noted that micrometastasis and isolated tumor cellpositive patients had poor identification rates in preoperative US. Pilewskie et al [22] also noted that finding an abnormal node on preoperative axillary imaging was significantly associated with having more than three total positive nodes on final pathology (p = 0.003).…”

Is axillary ultrasound imaging necessary for all patients with breast cancer?

“…Careful selection of a cohort of patients who may benefit from axillary ultrasound imaging alone and be exempt from SNB may yet be possible. Cyr and co‐workers undertook a pilot‐phase RCT comparing SNB with no further axillary staging in patients with cT1–T2 N0 breast cancer and normal axillary ultrasound findings. In 68 patients, with 34 randomized to each arm and median follow‐up of 17 (range 1–32) months, no recurrences were recorded, but there were two instances of lymphoedema, one wound infection, two seromas, one haematoma and one case of paraesthesia in the SNB arm.…”