Sentinel lymph node (SLN) staging is currently used to avoid complete ALND in breast cancer patients. The SLN is the only site of axillary metastasis in ≥60% of cases. Therefore, the SINODAR ONE study (NCT05160324) evaluated whether SLNB is or is not inferior to ALND. The study enrolled 889 patients between 40–75 years with a primary invasive T1-T2 tumour, axillary nodes cN0, no more than 2 macro-metastatic SLNs, no distant metastasis, no neo-adjuvant therapy, and no previous invasive breast cancer. All patients underwent SLNB and were randomised 1:1 to standard (SLNB plus ALND) or experimental (only SLNB) treatment. Dr Damiano Gentile (Humanitas Research Hospital, Italy) presented the results [1].
Most patients (77.2%) received breast-conserving surgery, while 22.8% of patients underwent mastectomy. A median of 2 SLNs were removed in both arms. Overall, only 3 micro-metastatic SNLs were found: 1 in the standard arm and 2 in the experimental arm. No statistical difference was found between the 2 treatments in terms of survival and recurrence: 5-years overall survival was 98.9% versus 98.8% and 5-year recurrence-free survival was 96.3% versus 95.6% in the standard versus experimental arm, respectively (see Table).
Table: Recurrence-free survival and overall survival after SLNB versus ALND [1].
RFS, recurrence-free survival; OS, overall survival; ITT, intention-to-treat; PP, per-protocol
“We believe randomisation between ALND and SLN staging is no longer justified. We favour the omission of complete axillary dissection in international guidelines,” concluded Dr Gentile.
- Gentile D, et al. Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes. A multicenter randomized clinical trial. Sinodar One. GS4-05, SABCS 2021 Virtual Meeting, 7–10 December.
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Table of Contents: SABCS 2021
Featured articles
Early-Stage Breast Cancer
Aromatase inhibitors outperform tamoxifen in premenopausal women
Concurrent taxane plus anthracycline most beneficial in reducing risk of breast cancer
Reduced risk of recurrence with ovarian suppression plus tamoxifen/exemestane
Metformin does not improve outcomes in patients with early-stage breast cancer
Omitting sentinel lymph node biopsy improves arm symptoms
HR-positive/HER2-negative Breast Cancer
Addition of palbociclib to standard endocrine therapy does not improve outcome in adjuvant treatment
The SERD elacestrant improves outcomes for patients unresponsive to endocrine therapy
Consistent overall survival benefit of ribociclib in advanced breast cancer
Premenopausal women benefit from adjuvant chemotherapy next to endocrine therapy
Promising anti-tumour activity of the CDK7-inhibitor samuraciclib plus fulvestrant
ctDNA is prognostic and predictive for response to ribociclib plus letrozole
Early switch to fulvestrant plus palbociclib beneficial for patients with ESR1 mutation
Triple-Negative Breast Cancer
Single-cell spatial analysis can predict response to neoadjuvant immunotherapy
Neoadjuvant pembrolizumab plus chemotherapy benefits event-free survival in TNBC
Early use of ctDNA testing can identify likelihood of relapse in TNBC
Pembrolizumab plus chemotherapy benefits patients with combined positive score ≥10
Neratinib plus trastuzumab plus fulvestrant shows encouraging clinical activity
Phase 1–3 Trials
Datopotamab deruxtecan shows promising anti-tumour activity
Trastuzumab deruxtecan outperforms trastuzumab emtansine
Nivolumab plus ipilimumab serve promising dual checkpoint inhibition
Entinostat plus exemestane improves progression-free survival in Chinese patients
Efficacy of pyrotinib plus capecitabine confirmed in previously treated patients
Basic and Translational Research
Using genomics to match treatments improves outcomes
Loss of ASXL1 tumour suppressor promotes resistance to CDK4/6 inhibitors
Inducers of ferroptosis are potential drugs to target p53-mutated TNBC cells
MAPK-pathway alterations are associated with resistance to anti-HER2 therapy
Genomic signatures of DCIS define biology and correlate with clinical outcomes
BRCA2 linked to inferior outcomes with CDK4/6 inhibitors plus endocrine therapy
Miscellaneous
Olaparib is well tolerated as an additional treatment
Race effects the likelihood to develop lymphoedema following breast cancer treatment
Sentinel lymph node staging is non-inferior to complete axillary lymph node dissection
One in 7 breast cancers detected during screening are overdiagnosed
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