SURPASS Retrospective Study
- Conditions
- Breast MRISentinel Lymph NodeBreast CancerNeoadjuvant Systemic Therapy
- Interventions
- Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissection
- Registration Number
- NCT05779982
- Lead Sponsor
- Gangnam Severance Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
- 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.
- case with unavailable data for breast MRI and operation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Multicenter retrospective cohort Sentinel lymph node biopsy followed by axillary lymph node dissection This study included patients diagnosed with breast cancer who received neoadjuvant systemic therapy (NAST) followed by curative surgery between January 2013 and December 2018. All patients were cN1-3 breast cancer at initial presentation confirmed by any imaging studies (either ultrasonography or MRI) or pathological examination using ultrasonography-guided needle biopsy of suspicious axillary lymph nodes. The clinical nodal stage was determined based on findings from physical examination, with imaging studies such as ultrasonography or MRI taken into account, according to the American Join Committee on Cancer guidelines (7th edition). In addition, all patients underwent sentinely lymph node biopsy (SLNB) followed by axillary lymph node dissection. SLNB was performed using a radioactive marker, blue dye, or both (dual tracers).
- Primary Outcome Measures
Name Time Method False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype 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
- Secondary Outcome Measures
Name Time Method False negative rate of sentinel lymph node biopsy according to clinical nodal stage up to 1 month after the breast surgery False negative rate of sentinel lymph node biopsy according to clinical nodal stage
Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes up to 1 month after the breast surgery Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes