Clinical observation on recombinant human vascular endostatin combined wih XELOX regimen in the treatment of advanced stomach carcinoma.

Objective:To investigate the short-term effects and safety of recombinant human vascular endostatin(endostar,YH-16) combined with XELOX(oxaliplatin+capecitabine) regimen for advanced stomach carcinoma and to explore the relationship between the serum level of vascular endothelial growth factor(VEGF) and the clinical outcome.Methods:Forty-two patients with relapse of stage Ⅳ advanced stomach carcinoma were randomly divided into two groups.The testing group received YH-16 plus XELOX regimen,and the control group were given XELOX chemotherapy only.All the patients received at least 2 cycles of chemotherapy.The complete response rate(CR),partial response rate(PR),stable disease(SD),and progressive disease(PD) were observed.The CR+PR was defined as response rate(RR) and CR+PR+SD was difined as clinical benefit rate(CBR).The quality of life(QOL) was evaluated and the serum VEGF level of the two groups were measured before and after treatment.Results:The RR was 40.0% in testing group and 22.7% in control group(P0.05).The CBR was 75.0% in testing group and 59.1% in control group(P0.05).The median tumor to progression(TTP) time was 6.9 months and 3.9 months for testing group and control group,respectively(P0.05).The scores of QOL in the two groups were both increased but the increasing rate was significantly higher in testing group than that in control group(P0.05).The levels of serum VEGF in the two groups were decreased significantly after treatment and the decreasing degree was higher in testing group than that in control group(P0.05).There were no significant difference in the incidence of mode-rate to severe adverse reaction between testing group and control group.Conclusion:The rh-endostatin combined with XELOX regimen is effective,safe,and well tolerated in the treatment of advanced stomach carcinoma.It is worthy of extending its clinical application.VEGF may be a good biomarker in predicting the efficacy of the chemotherapy combined with anti-angiogenetic therapy.