Results of a randomized and controlled clinical trial evaluating the efficacy and safety of combination therapy with Endostar and S-1 combined with oxaliplatin in advanced gastric cancer.
OBJECTIVE
We aimed to evaluate the efficacy and safety of combination therapy of Endostar (recombinant human endostatin) and S-1 combined with oxaliplatin (SOX) in patients with advanced gastric cancer.


METHODS
In this randomized, controlled trial, 165 late-stage gastric cancer patients were assigned to the experimental arm with Endostar in combination with SOX (80 patients) and the control arm with SOX alone (85 patients). The end points of this study included progression-free survival, response rate, and disease-control rate.


RESULTS
There was no statistically significant difference in response rate between the experimental arm and the control arm (53.8% vs 42.4%, P=0.188). The difference in disease-control rate was also statistically insignificant between the two arms (85.0% vs 72.9%, P=0.188). Progression-free survival in the experimental arm was significantly higher than that in the control arm (15.0 months vs 12.0 months, P=0.0001). Common adverse events included immunosuppression, gastrointestinal distress, and neuropathy. There was no statistical difference in the incidences of adverse events.


CONCLUSIONS
Combination therapy of Endostar and SOX provides therapeutic benefits to advanced gastric cancer patients, with tolerable adverse effects.
Department of Medical Oncology, People's Hospital of Xinjiang, Urumqi, People's Republic of China.
Rong
R
Xu
Nan
N
Ma
Fang
F
Wang
Lei
L
Ma
Rui
R
Chen
Ru
R
Chen
Mijiti
M
Kebinu
Lili
L
Ma
Zhongcheng
Z
Han
Ayixiamu
Mahemiti
M
Mayier
Pengcheng
P
Su
Yiming
Y
Naman
Haliyazimu
H
Jieensi
Haixuan
H
Yang
Abulizi
A
Adili
Saiding
S
Aili
Jiang
J
Liu
Endostar; S-1; SOX; endostatin; gastric cancer; oxaliplatin