Toward omitting sentinel lymph node biopsy

after neo-adjuvant chemotherapy in patients

with clinically node-negative breast cancer

Presented to the European Breast Cancer Conference, Barcelona, Spain, March 2018; published in abstract form as
Eur J Cancer 2018; 92(Suppl 3): S14
Paper accepted 3 August 2020
Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.12026
Radical ALND SLNB Omitting ALND Future –Omitting SLNB
surgery
Introduction
Management of axilla post Nact remains a debate .

Best survival has been observed in patients with cN0 disease who receive pCR
of axillary nodes.
65-74% pathological complete response is seen in Her2 positive
50-67% in TNBC
Appropriate management of axilla in context to Neoadjuvant chemotherapy in
clinically node negative patients ??

SLNB can be performed with accuracy – Associated with lower complications

than ALNB , but still noted in 5% cases.
After NACT the rate of nodal positivity is low in clinically N0 patients .
In TNBC, Her2 pos, nodal positivity is lower than 2 % .
Aim
The association between breast pCR and ypN0 status was validated.

 Predictive characteristics of ypN0 after NACT that are known before

surgery were investigated in patients with cN0 disease.
Methods
Data from Netherlands Cancer Institute
Duration- January 2013 to June 2018
303 patients
Inclusions : Clinically T1-T3 patients who received NACT+/- Tratuzumab
F/b breast and nodal surgery
Patients underwent
Axillary ultrasound Pet ct- FNAC of suspicious node f/b NACT
Core biopsy
Axillary staging- Ultrasound , Pet Ct
Fnac was performed if the node was suspicious

After NACT
Radiological response of tumor was evaluated by MRI
Technique of SLNB
Dual dye technique
Blue dye + Tc 99m

ypN0 defined as absence of viable tumor cells

ITC, micro metastases and macro metastases
were considered residual
Statistical Analysis
Univariable analysis was carried out by calculating the percentage of patients with ypN0 status
overall and within each tumour subgroup.

To identify patients in whom SLNB potentially can be omitted after NACT, only characteristics
known before surgery were used to create a multivariable logistic regression model.

Firth’s penalization method of logistic regression was used to address the quasi-complete
separation of the SLN response (tumour-negative versus -positive).
Results
303 patients analysed

57⋅4 per cent of patients underwent lumpectomy followed by breast irradiation

 42⋅6 per cent had a mastectomy.

 Mean of 1⋅6 (range 1–5) sentinel nodes were removed.

Patients with micrometastases or macrometastases in the sentinel nodes received locoregional

radiation, whereas those with ITCs did not.
Tumor /patient characteristics No. of patients N=303
Invasive 260(85.8%)
Subtype
HR+/HER2- 136(44.9)
Her2+ 94(31.0)
TNBC 73(24.1)
Grade
2 135(44.6)
3 130(42.9)
cT2 180(59.4)
Axillary nodes on usg
Abnormal 103(34.0)
Normal 200
Nodes on Pet
Normal 194(64)
Suspect for reactive node 43(14.2)
Suspect for malignant node 18(5.9)
Not evaluable 48(15.8)
 Radiological and pathological response after
NACT
MRI showed rCR in 134 paients (44.2%) in comparison with 49.2%

Pcr 120(39⋅6 )
HR-positive/HER2-negative 6⋅2
HER2-positive 76
TNBC (P <0⋅001) 55

negative SLNs 259(85⋅5 per cent)

1positive SLN 37 (12⋅2 per cent)
2positive SLN 7(2⋅3 per cent)

Of 44 patients with ypN+ status, 20 had residual macrometastases, 13 had micrometastases and 11 had
ITCs
Predictors of ypN0
Discussion
This study identified the predictive factors for tumor negative sentinel nodes after NACT in clinically
node negative breast cancer.
Tumor subtype and radiologically complete response on MRI were strong predictors of negative SLN
after NACT.
Negative SLN were found in 97 percent HER2 positive and TNBC
95.5% with rCR had ypN0
Significant association of breast radiologically complete response on MRI with ypN0 in HER2
positive tumors.
In HR positive /her2 neg or TNBC, breast radiologically complete response was not associated with
ypN0
TNBC was a strong predictor of ypN0
 132 of132 with Her2
pos
149 of158 patients
TNBC achieved ypN0

Validated in 30821 patients from National cancer database reported nodal positivity less than 2% with cN0
HER2pos or TNBC with breast pCR

Tumor subtype strongest predictor

OR of 5⋅2 - ER-negative/HER2-
positive
3⋅9 - ER-negative/HER2-negative ,
2⋅4 - ER-positive/HER2-positive
tumours, each versus
ER-positive/HER2-negative tumours
(P <0⋅001).
Addition of axillary ultrasonography (+/– FNA) to physical examination has been shown to be
more reliable and sensitive in determining axillary lymph node status.
 PET/CT was performed in all patients in the present study, which has also been demonstrated
to be an accurate and sensitive regional staging method.
 Ability of PET/CT to identify nodal metastases is dependent on adequate FDG uptake by the
breast tumour. the breast tumour was not FDG-avid on PET/CT had a lower ypN0 rate than those
with FGD-avid tumours in the present study (75 versus 87⋅5 per cent; P= 0⋅044).
Other imaging methods, such as ultrasonography, should be considered in patients without an
FDG-avid tumour on PET/CT.
Future Trials
The prospective non-inferiority single-arm ASICS trial (Avoiding Sentinel lymph node biopsy In
select clinical node negative breast cancer patients after neoadjuvant Systemic
therapy;NCT04225858) was initiated at NKI.

EUBREAST 1 trial – Omitting SLNB in TNBC and HER2 positive cases with rCR and pCR in breast
after NACT.
TMC Data
51 patients with clinically node negative patients post NACT

2 patients were positive on SLNB

Similar as other studies, SLNB can be omitted in

selected groups esp in TNBC and HER2pos
patients
Thank You !!