Esophageal Adenocarcinoma Methods and Protocols

Table 1 Major phase III clinical studies of target therapy in gastric and esophagogastric junction adenocarcinoma

(see

Notes 3 and 4)

Study

Phase

N

Experimental arm

Control arm OS HR OS Exp OS CON OS ab. diff PFS HR PFS Exp PFS CON PFS ab. diff

First lineToGA (2010) [

8 ]

III

584 Trastuzumab

+^

PF/PX

PF/PX

0.74

13.8

11.1

2.7

0.71

6.7

5.5

1.2

Subgroup: IHC2+ and FISH+/IHC3+

0.65

16.0

11.8

4.2

NR

NR

NR

NR

LOGiC (2016) [

9 ]

III

545 Lapatinib

+

CAPOX

CAPOX

0.91

12.2

10.5

1.7

0.82

6

5.4

0.6

Subgroups

Asian

0.68

16.5

10.9

5.6

Patients <60

years old

0.69

12.9

9.0

3.9

EXPNAD (2013) [

19

]

III

994 Cetuximab

+

PX

PX

1

9.4

10.7

−1.3

1.09

4.4

5.6

−1.2

REAL3 (2013) [

20

]

III

553 Panitumumab

+

EOC EOC

1.37

8.8

11.3

−2.5

1.22

6.0

7.4

−1.4

AVAGAST (2011) [

22

]

III

774 Bevacizumab

+

PX

PX

0.87

12.1

10.1

2.0

0.80

6.7

5.3

1.4

RILOMET-1 (2015) [

41

] III

609 Rilotumumab

+

ECX ECX

1.37

9.6

11.5

−1.9

1.30

5.7

5.7

0

MetGastric (2015) [

42

]

III

562 Onartumumab

+mFOLFOX6

mFOLFOX6 0.82

11

11.3

−0.3

0.90

6.7

6.8

−0.1

Subgroup: MET2+/3+

0.64

11

9.7

1.3

0.79

6.9

5.7

1.2

Second lineRAINBOW (2014) [

26

]

III

665 Ramucirumab

+^

paclitaxel

Paclitaxel

0.81

9.6

7.4

2.2

0.64

4.4

2.9

1.5

GATSBY (2017) [

18

]

II/III

345 TDM-1

Paclitaxel

1.15

7.9

8.6

−0.7

1.13

2.7

2.9

−0.2

TyTAN (2014) [

14

]

III

261 Lapatinib

+^

paclitaxel

Paclitaxel

0.84

11

8.9

2.1

0.85

5.4

4.4

1.0 (continued)