Esophageal Adenocarcinoma Methods and Protocols

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Table 2 Landmark studies of chemotherapy in the palliative settingAuthor


Experimental arm

Control arm

Outcomes

% of esophageal/esophagogastric junction adenocarcinoma

Subgroup outcomes

First lineREAL-2 (2008) [

29

]

ECF

ECXEOFEOX

Noninferiority*Improved OS of EOX over ECF upon

secondary analysis (HR 0.8,

p^ =

0.02)

Esophageal/esophagogastric junction ~60%Adenocarcinoma ~90%

NR

ML 17032 (2009) [

30

]

PX

PF

Noninferiority

NR

NR

SPIRITS (2008) [

34

]

SP

S-1

Improved OS (HR 0.77,

p^ =

0.04) and PFS

(6

months vs. 4

months,

p^ <

0.0001)

NR

NR

FLAGS (2010) [

35

]

SP

PF

Superiority in OS not demonstrated

17%

NR

AIO (2008) [

38

]

FLO

FLP

Noninferiority

Esophagogastric junction ~20%

NR

SOX (2015) [

39

]

SOX

SP

Noninferiority

NR

NR

V325 (2006) [

40

]

TPF

PF

Improved TTP (HR 0.68,

p^ <

0.001) and OS

(HR 0.77,

p^ =

0.02)

22%

NR

START (2013) [

44

]

TS

S-1

Improved OS and PFSmOS: 12.5

months vs. 10.8

months (

p^ =

0.032)

mPFS: 5.3

months vs. 4.2

months (

p^ =

0.001)

NR

NR

Dank et

al. (2008) [

45

]

IF

PF

Noninferiority

20%

NR

French Intergroup Study

(2014) [

46

]

FOLFIRI

ECX

Improved TTF and safety profileTTF: 5.1

months vs. 4.2

months,

p^ =

0.008

32.7%

NR

Second line or beyondThuss-Patience

et

al. (2011) [

47

]

Irinotecan

BSC

Improved OS (HR 0.48,

p^ =

0.012)

mOS: 4

months vs. 2.4

months

42%

NR

Kang et

al. (2012) [

50

]

Docetaxel or

Irinotecan

BSC

Improved OS (HR 0.66,

p^ =

0.007)

mOS: 5.3

months vs. 3.8

months

NR

NR

Ford et

al. (2014) [

48

]

Docetaxel

BSC

Improved OS (HR 0.67,

p^ =

0.01)

mOS: 5.2

months vs. 3.6

months

55%

NR

ECF

epirubicin, cisplatin and 5FU,

ECX

epirubicin, cisplatin and capecitabine,

EOF

epirubicin, oxaliplatin and 5FU,

EOX

epirubicin, oxaliplatin and capecitabine,

OS

overall survival,

NR

not reported,

PX

cispla-

tin and capecitabine,

PF

cisplatin and 5FU,

SP

S-1 and cisplatin,

PFS

progression-free survival,

FLO

5FU, leucovorin and oxaliplatin,

FLP

5FU, leucovorin and cisplatin,

SOX

S-1 and oxaliplatin,

TPF

docetaxel,

cisplatin and 5FU,

TTP

time-to-progression,

TS

docetaxel and S-1,

IF

irinotecan and 5FU,

FOLFIRI

irinotecan, leucovorin and 5FU,

TTF

time-to-treatment failure,

BSC

best supportive care
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