- Lymphoscintigraphy (LSG) before sentinel lymph node biopsy (SLNB) has emerged as a standard imaging staging modality to aid identification of SLN in clinically node-negative early breast cancer (eBCa).
- This randomized controlled trial finds that SLNB is similarly effective regardless of whether the surgeon has knowledge of the LSG results.
Why this matters
- Results suggest that omitting preoperative lymphoscintigraphy is a viable strategy that will expedite the preoperative workflow and lower the cost.
- Randomized, phase 3 trial (n=1198) of SLNB with surgeon's knowledge of LSG results (the LSG known group) vs without knowledge of the LSG results (the LSG unknown group).
- Patients were clinically node-negative eBCa (cT1-cT3) or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB.
- Primary outcome was the mean number of histologically detected SLNs per patient.
- Stratified 1-sided 95% CI for the difference between groups (without LSG minus with LSG) in the mean number of histologically detected SLNs had to be >−0.27 (10% infeöriority margin).
- Funding: The German Breast Group.
- No difference between groups (2.21 SLNs with LSG known minus 2.26 SLNs with LSG unknown; difference of 0.05; stratified 95% CI, −0.18 to infinity).
- Certain secondary outcomes could not be studied.