Esophageal Adenocarcinoma Methods and Protocols

(sharon) #1
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

Subgroup: Chinese

NR

9.7

7.6

2.1

NR

7.2

4.7

2.5

GOLD (2016) [

35

]

III

525 Olaparib

+^

Paclitaxel

Paclitaxel

0.79

8.8

6.9

1.9

0.84

3.7

3.2

0.5

Subgroup: ATM-ve

0.73

12.0

10.0

2

0.74

5.3

3.7

1.6

REGARD (2014) [

25

]

III

355 Ramucirumab

Placebo

0.78

5.2

3.8

1.4

0.48

2.1

1.3

0.8

GRANITE-1 (2013) [

32

] III

656 Everolimus

Placebo

0.90

5.4

4.3

1.1

0.66

1.7

1.4

0.3

APATINIB (2016) [

27

]

III

267 Apatinib

Placebo

0.71

6.5

4.7

1.8

0.44

2.6

1.8

0.8

ONO4538 (2017) [

53

]

III

493 Nivolumab

Placebo

0.63

5.3

4.1

1.2

0.60

1.6

1.5

0.1

Abbreviations:

N

number of patients,

CON

control,

OS

overall survival (in months),

HR

hazard ratio,

OS (Exp)

overall survival in the experimental arm,

OS (ab. diff.)

absolute differ





ence of overall survival in two study arms (experimental


control),

PFS

progression-free survival,

PFS (Exp)

progression-free survival (in months) the experimental arm,

PFS (ab. diff.)

absolute difference of progression-free survival in two study arms (experimental


control),

PF

cisplatin

+

5FU,

PX

cisplatin

+ capecitabine,

IHC

immunohistochemistry,

FISH

flores-

cence in situ hybridization,

CAPOX

capecitabine

+

oxaliplatin,

EOC

epirubicin

+

oxaliplatin

+^

capecitabine,

ECX

epirubicin

+

cisplatin

+

capecitabine

Table 1(continued)

Free download pdf