Article Abstract

Preliminary study of the treatment effect of apatinib mesylate upon malignant ascites and its safety

Authors: Changmin Liu, Shaoshui Chen, Ping Wang, Dianzhong Geng, Weiming Zhang, Jing Yang, Judong Luo, Fangling Ning


Background: This paper reports the effect of combining oral apatinib and abdominal cavity perfusion with cis-platinum for malignant ascites and its safety.
Methods: Seventeen malignant ascite patients were treated with oral apatinib (500 mg/d) and abdominal cavity perfusion of 60 mg/m2 cis-platinum (apatinib group), and 12 patients were treated with cis-platinum (60 mg/m2) only (control group). Twenty-one days was deemed as a cycle for both groups. Short-term treatment effects, quality of life (QOL), and toxicity were evaluated. Enzyme-linked immunosorbent assay (ELISA) was used to determine the vascular endothelial growth factor (VEGF) level in ascites.
Results: The response rates in apatinib and control groups were 70.6% and 33.3% (P<0.05), respectively. After treatment, the VEGF level of the apatinib group decreased dramatically (P<0.01) and was lower than that of the control group. Initial VEGF level in peritoneal fluid was significantly different between the SD (stable disease) + PD (progressive disease) and CR (complete response) groups (P<0.01). Emotion health as well as overall health conditions and appetite of the apatinib group after treatment improved in comparison with those before treatment (P<0.05). The patients felt more fatigue after treatment (P<0.05), but no statistically significant change was found in other symptoms (P>0.05). In the control group, no statistical difference was found in any parameter (P>0.05). The most common grade 3 or more severe adverse effects (AEs) in the apatinib group were fatigue and hypertension with 70.6% and 41.2% incidence rates, respectively. In the apatinib group, four patients suffered from intestinal obstruction, with two developing complete intestinal obstruction. However, in the control group, none suffered from intestinal obstruction.
Conclusions: A combination of apatinib and cis-platinum can improve short-term response rate of malignant ascites, enhance QOL and control adverse drug effects. VEGF level in the abdominal cavity may be a good predictor of treatment efficacy.