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Table 2 Clinicopathological parameters in HR + cohorts and association with HER2-low status by local assessment in the WSG-ADAPT-HR + /HER2- trial and by first central assessment WSG-PlanB trial

From: HER2-low status as a distinct breast cancer subtype: myth or truth? Analysis of the WSG trials WSG-ADAPT-HR+/HER2-, WSG-PlanB, and WSG-ADAPT-TN

Characteristic

WSG-ADAPT-HR + /HER2- trial

WSG-PlanB trial

HER2-zero, N = 2475

HER2-low, N = 3096

Overall, N = 5571*

p-value**

HER2-zero, N = 1468

HER2-low, N = 601

Overall, N = 2069***

p-value****

Age (years)

 Mean (SD)

55.3 (10.3)

54.6 (10.4)

54.9 (10.4)

.038

55.8 (10.1)

55.4 (9.7)

55.7 (10.0)

.432

 Median (min, max)

54 (23, 84)

54 (20, 85)

54 (20, 85)

 

55.5 (27, 77)

55 (25, 76)

55 (25, 77)

 

Estrogen receptor (%)

 Mean (SD)

90.4 (17.3)

90.7 (16.8)

90.6 (17.1)

.557

90.6 (21.1)

92.4 (17.8)

91.1 (20.2)

.042

 Median (min, max)

100 (0, 100)

100 (0, 100)

100 (0, 100)

 

100 (0, 100)

100 (0, 100)

100 (0, 100)

 

 Missing

295 (11.9%)

344 (11.1%)

639 (11.5%)

 

7 (0.5%)

0 (0.0%)

7 (0.3%)

 

Progesterone receptor (%)

 Mean (SD)

64.4 (36.6)

62.2 (36.7)

63.2 (36.6)

.031

62.7 (41.7)

62.9 (40.4)

62.8 (41.3)

.948

 Median (min, max)

80 (0, 100)

80 (0, 100)

80 (0, 100)

 

80 (0, 100)

80 (0, 100)

80 (0, 100)

 

 Missing

288 (11.6%)

348 (11.2%)

636 (11.4%)

 

11 (0.8)

3 (0.5%)

14 (0.7%)

 

Ki-67, baseline (%)

 Mean (SD)

22.5 (14.9)

22.2 (14.3)

22.3 (14.6)

.436

15.8 (11.0)

16.9 (11.1)

16.1 (11.0)

.057

 Median (min, max)

20 (0, 95)

20 (0, 100)

20 (0, 100)

 

15 (1, 95)

15 (1, 80)

15 (1, 95)

 

 Missing

413 (16.7%)

452 (14.6%)

865 (15.5%)

 

83 (5.7%)

18 (3.0%)

101 (4.9%)

 

Ki-67, week 3 (%)

 Mean (SD)

12.5 (13.2)

12.4 (12.2)

12.4 (12.6)

.713

NA

NA

NA

NA

 Median (min, max)

10 (0, 95)

10 (0, 90)

10 (0, 95)

 

NA

NA

NA

 

 Missing

577 (23.3%)

710 (22.9%)

1287 (23.1%)

 

NA

NA

NA

 

RS

 Mean (SD)

19.2 (10.9)

20.3 (10.8)

19.8 (10.9)

 < .001

18.9 (10.1)

20.1 (10.1)

19.2 (10.1)

.016

 Median (min, max)

17 (0, 75)

18 (0, 76)

18 (0, 76)

 

18 (0, 69)

18 (0, 99)

18 (0, 99)

 

 Missing

282 (11.4%)

324 (10.5%)

606 (10.9%)

 

47 (3.2%)

13 (2.2%)

60 (2.9%)

 

ERBB2 mRNA by Oncotype DX

 Mean (SD)

9.1 (0.7)

9.3 (0.7)

9.2 (0.7)

 < .001

8.8 (0.7)

9.2 (0.7)

8.9 (0.7)

 < .001

 Median (min, max)

9.1 (6.9, 11.9)

9.4 (7.6, 12.9)

9.2 (6.9, 12.9)

 

8.9 (5.5, 12.7)

9.2 (6.9, 11.7)

9 (5.5, 12.7)

 

 Missing

611 (24.7%)

793 (25.6%)

1404 (25.2%)

 

62 (4.2%)

15 (2.5%)

77 (3.7%)

 

ERBB2 mRNA by PAM50*****

 Mean (SD)

NA

NA

NA

NA

-1.8 (0.8)

-0.3 (1.3)

-1.4 (1.1)

.005

 Median (min, max)

NA

NA

NA

 

-1.9 (-2.8, 0.8)

-0.5 (-1.6, 2.0)

-1.7 (-2.8, 2.0)

 

 Missing

NA

NA

NA

 

1448 (98.6%)

595 (99.0%)

2043 (98.7%)

 

Histology Type

 NST

1749 (80.6%)

2304 (84.1%)

4053 (82.5%)

.014

1226 (83.7%)

519 (86.4%)

1745 (84.5%)

.304

 ILC

367 (16.9%)

383 (14.0%)

750 (15.3%)

 

201 (13.7%)

70 (11.7%)

271 (13.1%)

 

 Mucinous

31 (1.4%)

30 (1.1%)

61 (1.2%)

 

0 (0.0%)

0 (0.0%)

0 (0.0%)

 

 Other

24 (1.1%)

23 (0.8%)

47 (1.0%)

 

38 (2.6%)

12 (2.0%)

50 (2.4%)

 

 Missing

304 (12.3%)

356 (11.5%)

660 (11.9%)

 

3 (0.2%)

0 (0.0%)

3 (0.1%)

 

Histological grade

 0–1

146 (8.1%)

171 (7.6%)

317 (7.8%)

.687

83 (5.7%)

33 (5.5%)

116 (5.6%)

.063

 2

979 (54.2%)

1260 (55.9%)

2239 (55.2%)

 

919 (62.6%)

348 (57.9%)

1267 (61.2%)

 

 3

682 (37.7%)

822 (36.5%)

1504 (37.0%)

 

466 (31.7%)

220 (36.6%)

686 (33.2%)

 

 Missing

668 (27.0%)

843 (27.2%)

1511 (27.1%)

 

0 (0.0%)

0 (0.0%)

0 (0.0%)

 

Tumor stage******

 0/is

26 (1.3%)

10 (0.4%)

36 (0.8%)

.984

0 (0.0%)

0 (0.0%)

0 (0.0%)

.161

 1

1081 (52.5%)

1366 (53.7%)

2447 (53.2%)

 

785 (53.6%)

339 (56.6%)

1124 (54.5%)

 

 2

856 (41.6%)

1059 (41.6%)

1915 (41.6%)

 

611 (41.7%)

238 (39.7%)

849 (41.2%)

 

 3–4

97 (4.7%)

108 (4.3%)

205 (4.5%)

 

68 (4.6%)

22 (3.7%)

90 (4.4%)

 

 Missing

415 (16.8%)

553 (17.9%)

968 (17.4%)

 

4 (0.3%)

2 (0.3%)

6 (0.3%)

 

Nodal stage******

 0

1674 (67.6%)

2060 (66.6%)

3734 (67.0%)

.773

817 (55.7%)

354 (58.9%)

1171 (56.6%)

.044

 1

612 (24.7%)

817 (26.4%)

1429 (25.7%)

 

539 (36.7%)

218 (36.3%)

757 (36.6%)

 

 2–3

189 (7.6%)

218 (7.0%)

407 (7.3%)

 

112 (7.6%)

29 (4.8%)

141 (6.8%)

 

 Missing

0 (0.0%)

1 (0.0%)

1 (0.0%)

 

0 (0.0%)

0 (0.0%)

0 (0.0%)

 

pCR (ypT0/is, ypN0), neoadjuvant treated patients only

 No

299 (79.5%)

417 (85.8%)

716 (83.1%)

.015

NA

NA

NA

NA

 Yes

77 (20.5%)

69 (14.2%)

146 (16.9%)

 

NA

NA

NA

 

 Missing

2099 (84.8%)

2610 (84.3%)

4709 (84.5%)

 

NA

NA

NA

 
  1. Percentages for categories other than missing were obtained among non-missing observations and they sum up to 100%
  2. *27 patients (0.5%) were classified as having unclear HER2 status and were excluded from the analyses
  3. **P-values were obtained with a t-test (continuous variables) and a Pearson’s Chi-square test or a linear-by-linear test (categorical variables)
  4. ***28 patients (1.3%) were classified as HER2-positive, and 65 (3.0%) patients were classified as having unclear HER2 status and were excluded from the analyses
  5. ****P-values were obtained with a t-test or Mann–Whitney-U test (continuous variables) and a Pearson’s Chi-square test or a linear-by-linear test (categorical variables). Missing categories were excluded from statistical testing
  6. *****ERBB2 mRNA levels were analyzed by PAM50 in locally or centrally HR- cases in the WSG-PlanB trial
  7. ******Denotes composite tumor or nodal stage for WSG-ADAPT-HR + /HER2- trial (clinical stage in patients randomized to neoadjuvant treatment, pathological stage in patients after primary surgery); pathological tumor or nodal stage in WSG-PlanB trial
  8. NST, non-special type carcinoma; ILC, invasive lobular carcinoma
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Breast Cancer Research

ISSN: 1465-542X

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