Background: Although the ACOSOG Z0011 study showed axillary lymph node dissection (ALND) could be avoided in a specific population of sentinel lymph node positive patients, it’s not widely accepted by Chinese surgeons. We conducted a prospective single-arm study to confirm whether or not the results of Z0011 are applicable to Chinese patients.
Methods: Patients conforming to the Z0011 criteria were prospectively enrolled at the Peking University People’s Hospital Breast Center from November 2014 to June 2019. Clinicopathological features of the study group were compared with the Z0011 study. Lymphedema after surgery, incidence of local-regional recurrence, and survival were analyzed.
Results: One hundred forty-two patients who met Z0011 eligibility criteria were enrolled in this study; 115 had sentinel lymph node biopsy (SLNB) alone. When comparing with the Z0011 trial, younger patients were included (median age, 52 [26- 82] years vs 54 [25-90] years; P = 0.03). Among clinical T stage, tumor histology, hormone status, lymphovascular invasion, and the number of positive sentinel lymph nodes (SLNs), no statistically significant differences were observed. More patients received adjuvant chemotherapy and endocrine therapy (90.85% vs 58.0% and 80.99% vs 46.6% respectively, P < .001). A similar percentage of patients received radiotherapy, but more nodal radiotherapy procedures were carried out in our study (54.5% vs 16.9%). After median follow-up of 29 months, only 1 patient (0.9%) had ipsilateral breast tumor recurrence and no regional recurrence occurred.
Conclusion: Our study showed that it is achievable to avoid ALND in patients eligible for Z0011 in China.
Trial registration: ClinicalTrials Registered Number: NCT03606616. Registered 31 July 2018-Retrospectiverly registered, https://www.clinicaltrials.gov/ct2/show/NCT03606616?term=Wang+shu&draw=4&ra nk=21.