Randomized Controlled Trial
Copyright ©The Author(s) 2017.
World J Gastrointest Oncol. Aug 15, 2017; 9(8): 333-340
Published online Aug 15, 2017. doi: 10.4251/wjgo.v9.i8.333
Table 1 Patient characteristics n (%)
AdenoSCCTotal
No. of patients841132973
Median age (range)62 (22-84)60 (37-77)61 (22-84)
Gender
Male730 (87)95 (72)825 (85)
Female111 (13)37 (28)148 (15)
Performance status1
0223 (27)33 (25)256 (26)
1489 (58)75 (57)564 (58)
2127 (15)23 (18)150 (15)
Sub-site
Oesophagus438 (52)117 (89)555 (57)
OGJ403 (48)15 (11)418 (43)
Extent of disease2
Locally advanced219 (26)36 (27)255 (26)
Metastatic622 (74)95 (72)717 (74)
Location of metastases
Liver340 (46)46 (35)386 (40)
Peritoneum41 (5)4 (3)45 (4.5)
Lung136 (16)18 (14)154 (16)
Table 2 Multivariate analyses of overall survival
FactorsUnivariate analysis
Multivariate analysis
HR95%CIP valueHR95%CIP value
Overall survival
Histological armAdenocarcinoma (r)1.000
SCC1.1960.972-1.4710.089
SexFemale (r)1.000
Male0.9830.807-1.1960.983
SubsiteOesophagus (r)1.000
OGJ0.9880.853-1.1450.876
Liver metsNo (r)1.0001.000
Yes1.6711.433-1.948< 0.0011.5811.341-1.863< 0.001
Peritoneal metsNo (r)1.0001.000
Yes2.2901.583-3.314< 0.012.1901.503-3.191< 0.001
ALP< 100 U/I (r)1.0001.000
≥ 100 U/I1.6081.357-1.908< 0.0011.2871.072-1.5440.007
Performance score0-1 (r)1.0001.000
2-32.1401.754-2.611< 0.0011.7031.374-2.110< 0.001
Treatment armEOX (r)1.000
EOF1.1220.848-1.4840.420
ECX1.1390.862-1.5050.361
ECF1.1750.916-1.5060.204
MCF1.1760.870-1.5890.291
PVI 5FU + MMC2.1071.461-3.040< 0.001
PVI 5FU2.1321.481-3.067< 0.001
Overall< 0.001
StudyTrial 3[10] (r)1.0001.000
Trial 1[15]0.9930.804-1.2280.9511.0340.830-1.2880.763
Trial 2[16]1.8501.432-2.390< 0.0011.7361.326-2.271< 0.001
Overall< 0.001< 0.001
Table 3 Objective response rates and toxicity composite endpoint n (%)
AdenoSCC
No. of patients841132
Complete response48 (6)7 (5)
Partial response323 (38)36 (27)
Stable disease224 (30)35 (27)
Progressive disease157 (19)38 (29)
Objective response rate (95%CI)371 (44) 41%-48%43 (33) 25%-41% P = 0.01
Toxicity composite endpoint (95%CI)381 (45) 42%-49%58 (44) 35%-53% P = 0.77