Sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients undergoing mastectomy with one to two metastatic sentinel lymph nodes: sub-analysis of the SINODAR-ONE multicentre randomized clinical trial and reopening of enrolment

Abstract

Background The initial results of the SINODAR-ONE randomized clinical trial reported that patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with breast-conserving surgery, sentinel lymph node biopsy only, and adjuvant therapy did not present worse 3-year survival, regional recurrence, or distant recurrence rates compared with those treated with axillary lymph node dissection. To extend the recommendation of axillary lymph node dissection omission even in patients treated with mastectomy, a sub-analysis of the SINODAR-ONE trial is presented here. Methods Patients with T1–2 breast cancer and no more than two metastatic sentinel lymph nodes undergoing mastectomy were analysed. After sentinel lymph node biopsy, patients were randomly assigned to receive either axillary lymph node dissection followed by adjuvant treatment (standard arm) or adjuvant treatment alone (experimental arm). The primary endpoint was overall survival. The secondary endpoint was recurrence-free survival. Results A total of 218 patients were treated with mastectomy; 111 were randomly assigned to the axillary lymph node dissection group and 107 to the sentinel lymph node biopsy-only group. At a median follow-up of 33.0 months, there were three deaths (two deaths in the axillary lymph node dissection group and one death in the sentinel lymph node biopsy-only group). There were five recurrences in each treatment arm. No axillary lymph node recurrence was observed. The 5-year overall survival rates were 97.8 and 98.7 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy-only treatment arm, respectively (P = 0.597). The 5-year recurrence-free survival rates were 95.7 and 94.1 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy treatment arm, respectively (P = 0.821). Conclusion In patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with mastectomy, the overall survival and recurrence-free survival rates of patients treated with sentinel lymph node biopsy only were not inferior to those treated with axillary lymph node dissection. To strengthen the conclusion of the trial, the enrolment of patients treated with mastectomy was reopened as a single-arm experimental study. Registration number NCT05160324 (http://www.clinicaltrials.gov)

De-escalation of axillary treatment in the event of a positive sentinel lymph node biopsy in cT1–2 N0 breast cancer treated with mastectomy: nationwide registry study (BOOG 2013-07)

“…In SINODAR ONE 33 , patients with cT1–2 N0 breast cancer and one or two macrometastatic SLNs were randomized between SLNB only and ALND. In a subanalysis limited to 218 patients who underwent mastectomy, with a median follow-up of 33 months, SLNB only was not inferior to ALND in terms of 5-year recurrence-free survival (94.1 versus 95.7%) and OS (98.7 versus 97.8%) 36 . RT (27 versus 8%) and chemotherapy (56.8 versus 49.5%) were more often administered in the ALND group.…”

Comparison of the effect of ultrasounic-harmonic scalpel and electrocautery in the treatment of axillary lymph nodes during radical surgery for breast cancer

“…The SINODAR-ONE randomized clinical trial indicated that in patients with T1-2 breast cancer treated with mastectomy and with one or two giant metastatic sentinel lymph nodes, overall survival and relapse-free survival in patients treated with only SNB were no worse than those treated with ALND. Therefore, in our study, the standard use of SNB for axillary lymph node therapy in these patients is feasible [ 14 ]. A retrospective analysis of 291 breast cancer patients undergoing Sentinel lymph node biopsy (SNB) and neo-adjuvant chemotherapy (NAC) was performed.…”

Does Breast Surgery Type Alter Incidental Axillary Irradiation? A Dosimetric Analysis of the “Sentinel Envahi et Randomisation du Curage” SERC Trial

“…A sub-analysis of this trial regarding 218 patients treated with a mastectomy found sentinel lymph node biopsy (SLNB) alone to be non-inferior to further ALND, with no axillary lymph node recurrence. However, only 8% of the patients received PMRT in the SLNB arm compared to 27% in the ALND arm, which calls for an updating of the long-term outcomes in this population [ 19 ]. Three other prospective, randomized trials, whose results are pending, will soon shed light on this topic [ 20 , 21 , 22 ].…”