Effect of region and hospital attribute on outcome of gastric patients treated with apatinib: Data from post-marketing phase IV study.

Abstract

40 Background: The single-arm, open-label, multi-center, Phase IV trial of apatinib was conducting in patients (pts) with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction with a target sample size of 2000+. We aimed to analyze the effect of region and hospital attributes on clinical outcomes. Methods: From April 2015 to July 2017, 1037 subjects were enrolled, among which 820 were evaluable in the survival analysis. Results: The incidences of adverse events (AEs) and severe AEs (SAEs) are listed in Table. Overall, both incidences were higher in Southern center compared to Northern Center (p=0.002 and <0.001). More SAEs occurred in developed cities (p=0.028) and in hospitals not specialized in oncology (p=0.028). For efficacy, the median overall survival (mOS) of subjects in Northern Center and Southern centers were 8.71 and 5.72 mos (p<0.001), and the median progression free survival (mPFS) was 5.36 and 3.25 mos (p=0.002), respectively. The mOS of subjects in developed and developing cities were 6.18 and 5.72 mos (p=0.105), and the mPFS was 3.02 and 4.73 mos (p=0.013), respectively. The mOS of subjects in hospital specialized and those not in oncology were 7.59 and 5.78 mos (p=0.014), and the mPFS was 4.73 and 3.84 mos (p=0.068), respectively. Conclusions: Region and attribute hospital can affect the safety and clinical outcome of apatinib in treating gastric cancer in the real world. Patients Northern, developing city or hospitals specialized in oncology experience less SAEs but have better clinical benefit. Clinical trial information: NCT02426034. [Table: see text]