Table 1 Patients’ characteristics (all patients).

From: Prognostic impact of HER2-low positivity in patients with HR-positive, HER2-negative, node-positive early breast cancer

Category

HER2-zero

(n = 228)

HER2-low

(n = 419)

p-value

N

%

N

%

Age, years

 < 65

175

(76.8)

325

(77.6)

0.814

 ≥ 65

53

(23.3)

94

(22.4)

 

Sex

 Female

227

(99.6)

415

(99.1)

0.474

 Male

1

(0.4)

4

(1.0)

 

Menopausal status

 Pre

103

(45.2)

218

(52.0)

0.096

 Post

125

(54.8)

201

(48.0)

 

ER status

 Negative

2

(0.9)

3

(0.7)

0.823

 Positive

226

(99.1)

416

(99.3)

 

PR status

 Negative

22

(9.7)

35

(8.4)

0.579

 Positive

206

(90.4)

384

(91.7)

 

HER2 status

 IHC0

228

(100)

0

(0)

< 0.001

 IHC1+

0

(0)

292

(69.7)

 

 IHC2+/FISH−

0

(0)

127

(30.3)

 

Histological type

 IDC

180

(79.0)

354

(84.5)

0.043

 ILC

36

(15.8)

36

(8.6)

 

 IDC + ILC

3

(1.3)

6

(1.4)

 

 Others

9

(4.0)

23

(5.5)

 

HG

 1

32

(14.0)

80

(19.1)

0.254

 2

127

(55.7)

215

(51.3)

 

 3

69

(30.3)

124

(29.6)

 

Tumor size, cm

 < 2

78

(34.1)

163

(38.9)

0.196

 2–5

107

(46.9)

198

(47.3)

 

 ≥ 5

43

(18.9)

58

(13.8)

 

Number of positive lymph nodes

 1–3

157

(68.9)

306

(73.0)

0.261

 ≥ 4

71

(31.1)

113

(27.0)

 

Ki-67 index, %

 < 20

108

(47.4)

187

(44.6)

0.504

 ≥ 20

120

(52.6)

232

(55.4)

 

Breast surgery

 BCS

84

(36.8)

135

(32.2)

0.235

 TM

144

(63.2)

284

(67.8)

 

Axillary surgery

 SLNB only

17

(7.5)

48

(11.5)

0.106

 ALND

211

(92.5)

371

(88.5)

 

RT

 Yes

159

(69.7)

250

(58.7)

0.011

 No

69

(30.3)

169

(40.3)

 

CT

 Neoadjuvant

24

(10.5)

60

(14.3)

0.385

 Adjuvant

140

(61.4)

244

(58.2)

 

 No

64

(28.1)

115

(27.5)

 

ET

 Yes

214

(93.9)

408

(97.4)

0.027

 No

14

(6.1)

11

(2.6)

 

Risk group

 Cohort 1

124

(54.4)

227

(54.2)

0.660

 Cohort 2

34

(14.9)

73

(17.4)

 

 Cohort 3

70

(30.7)

119

(28.4)

 
  1. ER estrogen receptor, PR progesterone receptor, HER2 human epidermal growth factor receptor 2, IDC invasive ductal carcinoma, ILC invasive lobular carcinoma, HG histological grade, BCS breast-conserving surgery, TM total mastectomy, SLNB sentinel lymph node biopsy, ALND axillary lymph node dissection, RT radiotherapy, CT chemotherapy, ET endocrine therapy, FISH fluorescence in situ hybridization.
  2. HER2-zero group: Patients with immunohistochemistry (IHC) 0 score.
  3. HER2-low group: Patients with IHC1+ or IHC2+/FISH− scores.
  4. Cohort 1: Patients with ≥ 4 positive axillary lymph nodes (ALNs), or 1–3 positive ALNs, and either histological grade (HG) 3 or tumor size ≥ 5 cm.
  5. Cohort 2: Patients with 1–3 positive ALNs, HG < 3, tumor size < 5 cm, and high Ki-67 index (≥ 20%).
  6. Cohort 3: Patients with 1–3 positive ALNs, HG < 3, tumor size < 5 cm, and low Ki-67 index (< 20%).
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