Ann Surg Oncol 2022 May 12
Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial.
Abstract
Background
The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse.
Methods
Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm).
Results
The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936).
Conclusions
The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.
Related Questions
Under what circumstances would you pursue completion ALND in a patient with multiple positive sentinel nodes after breast-conserving surgery?
For clinical/imaging node-negative disease with 1-2 positive nodes, now there are 7 plus clinical studies (ACOSOG Z0011, AMAROS, OTOASOR, SENOMAC, IBCSG 23-01, AATRM, SINODAR-ONE) which have shown no difference in axillary recurrence, DFS with dissection, but higher lymphedema as expected. The most ...
Do you recommend axillary dissection for women with ER+ breast cancer and low risk Oncotype or Mammaprint if single node positive with only 1-2 SLN removed, to ensure <4 nodes positive?
No, I see no need to do dissection in this setting. Unless there is clinical or imaging evidence of gross disease, radiation should adequately control microscopic residual disease in the axilla.
For postmastectomy patients who have >2 sentinel nodes involved, would you recommend a completion axillary dissection or proceed with PMRT?
This is a question that is still debated. I am comfortable extrapolating AMAROS/Z011 to mastectomy patients despite the limited number of patients undergoing mastectomy in AMAROS.In patients with 2-3 SLN involved (that were cN0), I would be ok with PMRT and omitting ALND as long as no ECE. If > 3 LN...