SURPASS Retrospective Study

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Sentinel Lymph Node; Breast Cancer; Breast MRI; Neoadjuvant Systemic Therapy

Treatments: Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissection

Study type: Observational

Funder types: Other

Identifiers

NCT05779982

3-2022-0362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• case with unavailable data for breast MRI and operation

Trial design

500 participants in 1 patient group

Multicenter retrospective cohort

Description:

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).

Treatment:

Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissection