Effectiveness and Safety of Apatinib in Patients with Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction: A Prospective Observation Study.

Abstract

BACKGROUND:

Apatinib showed promising efficacy in the treatment of advanced or metastatic gastric cancer (mGC) in previous clinical studies. However, the real-world data are limited, and this study aimed to assess the effectiveness and safety of apatinib for the treatment of advanced or mGC in this setting.

METHODS:

In this prospective observational study, progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR) and treatment-related adverse events (AEs) were recorded and evaluated. Univariate and multivariate analyses were conducted to explore potential biomarkers which might be related to the effectiveness.

RESULTS:

A total of 321 mGC patients from 47 centers in China were enrolled between July 1, 2015, and March 1, 2018. Thirty-two patients achieved partial response, 155 patients achieved stable disease, and 115 patients had progressive disease, and no CR was achieved, illustrating an ORR of 10.60% and a DCR of 61.92%. The median PFS and OS were 4.0 and 8.2 months, respectively. Multivariate Cox analysis showed that the potential biomarkers associated with longer PFS were combination regimens plus taxel/docetaxel, and apatinib initial dosage ≥500mg, occurrence of AEs of leukopenia, and hand-foot syndrome. Main AEs were proteinuria (17.1%), hypertension (15.9%), and handfoot syndrome (8.7%).

CONCLUSION:

The present prospective observational study showed favorable effectiveness and safety of apatinib in real-world patients with advanced or metastatic GC in China. (A prospective, multi-center, non-intervention study of apatinib in the treatment of advanced gastric cancer-Trial Registry Number: ChiCTR-OPN-15006601).

• Authors: Bo Shen, Hua Jiang, Lin Wang, Jun Qian, Yongqian Shu, Ping Chen, Guoxin Mao, Baorui Liu, Xizhi Zhang, Chaoying Liu, Jun Wu, Xiaoqin Li, Wei Cai, Wenxiang Shen, Qiong Wang, Jingdong He, Dong Hua, Ziwen Zhang, Youcheng Zhang, Jifeng Feng
• Journal: OncoTargets and therapy (Onco Targets Ther) Vol. 13 Pg. 4457-4464 ( 2020) ISSN: 1178-6930 [Print] New Zealand
• PMID: 32547076 (Publication Type: Journal Article)
• Copyright: © 2020 Shen et al.