Clinical application of the HM-1000 image processing for HER2 fluorescence in situ hybridization signal quantification in breast cancer

Table 1 Patient characteristics by HER2 status according to routine diagnosis

	Total	HER2-positive	HER2-negative	p-value
Age, years
Median (min; max)	75.5 (51.0; 87.0)	67.0 (54.0; 86.0)	82.0 (51.0; 87.0)	0.46^a
Q1; Q3	55.5; 84.25	55.0; 79.5	61.5; 84.5	0.46^a
pT, n (%)
pT1	5 (35.7)	2 (14.3)	3 (21.4)	1.00^a
pT2	7 (50.0)	2 (14.3)	5 (35.7)
pT3	1 (7.1)	1 (7.1)	0
pT4	1 (7.1)	0	1 (7.1)
Tumor size, mm
Median (min; max)	22.5 (10.0; 70.0)	23.0 (14.0; 70.0)	22.0 (10.0; 31.0)	0.35^a
Q1; Q3	17.0; 30.3	18.0; 52.5	15.5; 28.5	0.35^a
Tumor type, n (%)
NST	11 (78.6)	5 (35.7)	6 (41.9)	0.15^b
ILC	3 (21.4)	0	3 (21.4)	0.15^b
pN, n (%)
0	8 (57.1)	3 (21.4)	5 (35.7)	0.87^b
1	6 (42.9)	2 (14.3)	4 (28.6)	0.87^b
Systemic therapy, n (%)
Response	11 (78.6)	4 (28.6)	7 (50)	0.92^b
Non-response	3 (21.4)	1 (7.1)	2 (14.3)
Follow-up status, n (%)
Relapse	2 (14.3)	0	2 (14.3)	0.23^b
Death	2 (14.3)	1 (7.1)	1 (7.1)
HER2 status (IHC), n (%)
1+	7 (50.0)	0	7 (50.0)	<0.01^b
2+	3 (21.4)	1 (7.1)	2 (14.3)
3+	4 (28.6)	4 (28.6)	0
HER2 status (SR^c), n (%)
Positive	5 (35.7)	5 (35.7)	0	<0.001^b
Negative	9 (64.3)	0	9 (64.3)	<0.001^b

FISH fluorescence in situ hybridization, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, ILC invasive lobular carcinoma, max maximum, min minimum, NST invasive carcinoma of no special type, Q1 first quartile, Q3 third quartile, SR super-resolution
Clinicopathological characteristics were compared according to HER2 status determined by routine diagnosis; IHC and conventional-resolution FISH images according to the 2018 ASCO/CAP HER2 testing guideline update
^aMann–Whitney U test
^bChi-squared test
^cHER2 status determined by super-resolution FISH images according to the 2018 ASCO/CAP HER2 testing guideline update

ISSN: 1746-1596