A novel detection methodology for HER2 protein quantitation in formalin-fixed, paraffin embedded clinical samples using fluorescent nanoparticles: an analytical and clinical validation study

Table 3 Neoadjuvant study, data demographics summary

Parameter	n (Average)	% (Range)
N Total	34
Age	(54)	(23–83)
Diagnosis (DX)
Invasive Ductal Carcinoma	33	97.1
Invasive Lobular Carcinoma	1	2.9
Nuclear Grade
1	2	5.9
2	7	20.6
3	25	73.5
ER Allred Score
0–2 (−)	11	32.4
3–8 (+)	23	67.6
PR Allred Score
0–2 (−)	13	38.2
3–8 (+)	21	61.8
ER/PR Status
ER+/PR+	21	61.8
ER+/PR-	2	5.9
ER-/PR+	0	0
ER-/PR-	11	32.4
HER2 IHC Score
0	1	2.9
1+	0	0
2+	10	29.4
3+	23	67.6
Pathologic Response
Partial/No Response	11	32.4
Near complete Response	11	32.4
Complete Response (pCR)	12	35.3
Residual Cancer Burden (RCB) Class
0 (pCR)	12	35.3
1	11	32.4
2	8	23.5
3	3	8.8

N: total sample size, n: subset of total sample size, ER estrogen receptor, PR progesterone receptor, IHC immunohistochemistry, pCR pathologic complete response. *1 patient presented with an IHC score of 0 but was ISH amplified and received HER2 neoadjuvant therapy and was included in the cohort.*

ISSN: 1471-2407