Outcomes of Sentinel Node Biopsy According to MRI Response in an Association With the Subtypes in cN1-3 Breast Cancer After Neoadjuvant Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype
研究概览
简要总结
This study aimed to determine whether sentinel lymph node biopsy (SLNB) could be a reliable option for evaluating nodal status in patients who had responded well to neoadjuvant systemic therapy (NAST), even if they had initially presented with a high nodal burden. The study investigated the outcomes of SLNB followed by axillary lymph node dissection (ALND) in this patient population, taking into account the response to NAST and the breast cancer subtype.
详细描述
To determine the feasibility of sentinel lymph node biopsy (SLNB) in this study, the investigators evaluated the false-negative rate (FNR) of SLNB. The FNR was calculated as the number of patients with negative SLNs who had a residual disease in the rest of the axillary lymph nodes (ALNs) divided by the total number of patients with residual disease in either the SLNs, the rest of the ALNs, or both: FN/true-positive + FN. The investigators compared the FNR of the SLNB according to the radiologic response measured using breast MRI in each subtype. The investigators further evaluated the FNR in subgroups stratified by clinical nodal stage. Additionally, the investigators assessed additional metastatic ALNs in cases with 1-2 metastatic SLNs through the completion of ALN dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cN1-3 breast cancer at initial presentation
- •received neoadjuvant systemic therapy (NAST)
- •received sentinel lymph node biopsy (SLNB) followed by additional axillary lymph node dissection (ALND)
- •breast MRI performed at baseline and post-NAST.
排除标准
- •case with unavailable data for breast MRI and operation
结局指标
主要结局
False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype
时间窗: up to 1 month after the breast surgery
False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype
次要结局
- False negative rate of sentinel lymph node biopsy according to clinical nodal stage(up to 1 month after the breast surgery)
- Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes(up to 1 month after the breast surgery)
研究者
Sung Gwe Ahn
Professor
Gangnam Severance Hospital