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Table 2 Progression-free survival by HER2 expression subgroups

From: Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer

 

Trastuzumab + taxane (Control)

T-DM1

T-DM1 + pertuzumab

(T-DM1)

(T-DM1 + P)

No. patients / No. patients with PFS event

Median PFS (mo)

No. patients / No. patients with PFS event

Median PFS (mo)

HR vs. trastuzumab + taxane (97.5% CI)a

No. patients / No. patients with PFS event

Median PFS (mo)

HR vs. trastuzumab + taxane (97.5% CI)a

HR vs. T-DM1 + placebo (97.5% CI)a

All patientsb

 

 IHC 3+

333/209

14.4

340/215

14.6

0.93

331/195

16.7

0.83

0.90

(0.75–1.16)

(0.67–1.04)

(0.72–1.12)

 IHC 2+

27/19

12.6

25/20

7.3

1.13

29/20

8.3

1.25

0.98

(0.55–2.32)

(0.61–2.59)

(0.48–2.02)

IHC 2+/3+ patients combinedc

 Focal IHC 2+/3+ (10–29%)d

14/8

12.4

12/10

6.4

1.51

15/12

7.5

1.41

1.00

(0.52–4.40)

(0.50–3.94)

(0.38–2.65)

 Heterogeneous IHC 2+/3+ (30–79%)

35/27

10.6

37/25

8.3

1.04

33/20

6.3

1.11

0.91

(0.57–2.17)

(0.46–1.78)

(0.55–1.94)

 Homogeneous IHC 2+/3+ (≥80%)

311/193

14.6

316/200

14.7

0.92

312/183

17.8

0.82

0.89

(0.65–1.04)

(0.71–1.13)

(0.74–1.16)

IHC 3+ patients only

 Focal IHC 3+ (10–29%)d

9/5

8.3

11/7

8.3

1.20

8/7

4.2

5.11

2.28

(0.32–4.50)

(0.99–26.40)

(0.60–8.71)

 Heterogeneous IHC 3+ (30–79%)

44/29

10.5

45/34

10.0

1.15

29/16

17.8

0.79

0.65

(0.65–2.03)

(0.39–1.60)

(0.33–1.29)

 Homogeneous IHC 3+ (≥80%)

280/175

14.6

284/174

15.2

0.89

294/172

17.7

0.82

0.92

(0.70–1.14)

(0.65–1.05)

(0.73–1.17)

  1. aUnstratified hazard ratiob Five patients with IHC 0/1+ and five patients with unknown IHC status are not included in this table
  2. cCategories were based on IHC subgroup and then combined
  3. dCompared with the overall population, samples with focal HER2 expression were more likely to express mutated PIK3CA and lower levels of HER2 mRNA
  4. CI confidence interval, HER2 human epidermal growth factor receptor 2, HR hazard ratio, IHC immunohistochemistry, NE not estimable, P pertuzumab, PFS progression-free survival, PIK3CA phosphoinositide 3-kinase catalytic subunit alpha, T-DM1 trastuzumab emtansine
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BMC Cancer

ISSN: 1471-2407

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