Abstract 194P
Background
Targeted axillary dissection (TAD) has been incorporated into current guidelines for patients presenting with initially node-positive breast cancer. However, previous studies carried on strict eligibility criteria for enrolling participants focusing in cN1 patients, and limited real-world data existed regarding the clinical feasibility and oncological safety of non-radioactive TAD for patients with initially node-positive breast cancer in clinical practice.
Methods
In this prospective registry study, enrolled patients with clinically T1-4, N1-3, M0 breast cancer routinely underwent clip insertion into biopsy-confirmed lymph node. After completion of NAC, eligible patients received axillary surgery to determine pathological status. Main endpoints included the false-negative rate (FNR) of TAD and nodal recurrence rate of patients treated with TAD only.
Results
Between March 2014 and June 2021, 353 consecutive patients were enrolled. After completion of NAC, 85 patients directly proceeded to axillary lymph node dissection (ALND), furthermore, TAD with or without ALND was performed in 152 and 85 patients, respectively. Overall detection rate of clipped node was 94.1% (95%CI, 91.1%-97.1%) and FNR of TAD was 12.2% (95%CI, 5.0%-19.4%) in our study, with FNR decreasing to 6.0% (95%CI, 1.0%-11.8%) in cN1 patients. During a median follow-up of 36.6 months, a total of 28 patients developed recurrence, including 3 cases with regional lymph node recurrence (3/237 with ALND; 0/85 with TAD alone), 2 cases with local recurrence and remaining 23 cases with distant recurrence. In TAD-only group, two patients developed distant recurrence. Therefore, it yielded a 3-year freedom-from-nodal-recurrence rate of 100.0% among the TAD-only patients and 98.7% among the ALND patients with axillary pathologic complete response (P = 0.29).
Conclusions
Instead of cN2/3 patients,non-radioactive TAD is clinically feasible in cN1 breast cancer patients with biopsy-confirmed nodal metastases. Patients with negativity or a low volume of nodal positivity on TAD can safely spare ALND, with a low nodal failure rate and no recurrence-free survival compromise at 3 years.
Clinical trial identification
NCT05141630.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
the Shanghai sailing program.
Disclosure
All authors have declared no conflicts of interest.