Noninferior five-year regional recurrence rates and regional recurrence-free survival reported with omission of SLNB
THURSDAY, Dec. 11, 2025 (HealthDay News) — For patients with clinically T1-2 node-negative (cN0) breast cancer, the omission of sentinel lymph node biopsy (SLNB) results in noninferior five-year regional recurrence rates (RR) and regional recurrence-free survival (RRFS), according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio.
Robert-Jan Schipper, M.D., Ph.D., from Catharina Hospital in Eindhoven, Netherlands, and colleagues examined whether omission of SLNB in patients with cN0 breast cancer treated with breast-conserving surgery and whole-breast irradiation is safe with respect to regional RR and RRFS in a multicenter, noninferiority phase 3 trial. Patients were randomly assigned to SLNB or omission of SLNB (749 and 825 patients, respectively) and were followed for a median of five years.
The researchers found that micrometastatic and macrometastatic disease was detected in 6.0 and 7.7 percent of patients, respectively, in the SLNB arm. At a median follow-up of five years, the estimated probability of RR was 0.5 and 1.2 percent in the SLNB and no-SLNB arms, respectively, corresponding to an absolute difference of 0.7 percent (95 percent confidence interval, −0.3 to 1.7). The 5 percent noninferiority margin was not exceeded. The five-year RRFS was 96.6 and 94.2 percent in the SLNB and no-SLNB arms, respectively.
“In addition to having a positive impact on patients, the omission of SLNB is cost-effective, results in shorter patient care, and avoids complications — this can lead to better patient-reported outcomes and a smoother recovery overall,” coauthor Marjolein Smidt, M.D., Ph.D., from Maastricht University Medical Center in the Netherlands, said in a statement.
One author disclosed ties to the pharmaceutical industry.
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