Table 3 Relation between patient RECIST 1.1 response and results of HER2 PET/CT, early FDG PET/CT and their combination.

From: Molecular imaging predicts lack of T-DM1 response in advanced HER2-positive breast cancer (final results of ZEPHIR trial)

A

Patient-based analysis of the “complete” cohort (n = 90)

Classification

n patients

RECIST 1.1 after three T-DM1 cycles

PPV

NPV

R

NR

HER2 PET/CT

+

53

41

12

77%1

 

25

4

21

 

84%2

Early FDG PET/CT

R

42

40

2

95%3

 

NR

37

6

31

 

84%4

HER2 PET/CT/Early FDG PET/CT

+/R

36

36

0

100%

 

+/NR

17

5

12

  

−/R

6

4

2

  

−/NR

19

0

19

 

100%

B

Subgroup patient-based analysis of the “expansion” cohort (n = 30)

Classification

n patients

RECIST 1.1 after three T-DM1 cycles

PPV

NPV

R

NR

HER2 PET/CT

+

14

13

1

93%1

 

9

2

7

 

78%2

Early FDG PET/CT

R

15

14

1

93%3

 

NR

8

1

7

 

88%4

HER2 PET/CT/Early FDG PET/CT

+/R

12

12

0

100%

 

+/NR

2

1

1

  

−/R

3

2

1

  

−/NR

6

0

6

 

100%

  1. Exact 95% confidence intervals as follows:1: 64–88%,2: 64–95%, 3: 84–99%, 4: 68–94%.
  2. Exact 95% confidence intervals as follows: 1: 66–100%, 2: 40–97%, 3: 68–100%, 4: 47–100%.
  3. n number, HER2+ HER2-positive patients, HER2- HER2-negative patients, R responders, NR non-responders.