Abstract 526P
Background
No standard treatment strategy for patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) experiencing progression after one or more lines of chemotherapy. The aim of this study was to assess the efficacy and safety of apatinib, an oral vascular endothelial growth factor receptor 2 (VEGFR-2) tyrosine kinase inhibitor, in patients with recurrent/metastatic ESCC for whom at least one line of prior chemotherapy had failed.
Methods
This was a phase II trial that enrolled patients with recurrent/metastatic ESCC who had evidence of disease progression after first-line or more lines chemotherapy. All patients received continuous apatinib 500mg once daily until disease progression, death, or intolerable toxicity, dose escalation was allowed. The primary end point was progression free survival (PFS).
Results
Between July 2017 and August 2018, 40 patients were recruited. Data was cutoff at June 26, 2019. Among the 40 patients, 5 patients achieved partial response while 21 had stable disease. Primary end point median PFS (mPFS) was 113 days (95% 45-180). Median OS (mOS) was 158 days (95% 101-215), Objective response rate (ORR) was 12.5%. The incidence of drug-related adverse events (AEs) was 87.5%. 40.0% patients developed severe AEs. Main AEs were Fatigue (37.5%), Hand-foot syndrome (27.5%) and Hypertension (25%). Two patients with massive hemoptysis, and two patients with tracheal esophageal fistula had the uncontrolled primary tumor or trachea/bronchi eroded.
Conclusions
The study confirmed that apatinib was effective as second-line or more lines treatment for recurrent/metastatic ESCC patients, and most adverse effect were acceptable. However, patients with uncontrolled primary tumor or trachea/bronchi eroded should been cautiously considered to use.
Clinical trial identification
NCT03274011.
Editorial acknowledgement
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
Jiangsu Hengrui Medicine.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
143P - NOTCH3 expression predicts poor survival in advanced esophageal squamous cell cancers
Presenter: Raja Pramanik
Session: Poster display session
Resources:
Abstract
144P - Severe hypovitaminosis D in metastatic gastric cancer patients from the Northern and Southern hemispheres: Data from the EXPAND phase III trial
Presenter: Radka Obermannova
Session: Poster display session
Resources:
Abstract
145P - Role of Glasgow prognostic score in chemo-naïve patients with advanced biliary tract cancer and good performance status
Presenter: Toshikazu Moriwaki
Session: Poster display session
Resources:
Abstract
146P - Anatomic versus non-anatomic resection for hepatocellular carcinoma: A meta-analysis of high-quality studies
Presenter: Bin Zhang
Session: Poster display session
Resources:
Abstract
147P - Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis
Presenter: Yingtai Chen
Session: Poster display session
Resources:
Abstract
148P - Efficacy of capecitabine and oxaliplatin versus S-1 as adjuvant chemotherapy in gastric cancer after D2 lymph node dissection according to lymph node ratio and N stage
Presenter: Seunghwan Lee
Session: Poster display session
Resources:
Abstract
150P - A Phase Ib Study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction
Presenter: Yee Chao
Session: Poster display session
Resources:
Abstract
151P - Gene expression profiling for a better understanding of gastric cancer: From the perspective of metabolic rearrangement
Presenter: Midie Xu
Session: Poster display session
Resources:
Abstract
152P - Long-term outcomes of three-dimensional conformal radiotherapy-based and intensity-modulated radiotherapy-based concurrent chemoradiotherapy in patients with thoracic esophageal squamous cell carcinoma
Presenter: Chia-Lun Chang
Session: Poster display session
Resources:
Abstract
153P - Exosomal LINC00174 facilitates epithelial-mesenchymal transition in residual hepatocellular carcinoma after insufficient radiofrequency ablation by regulating c-JUN/MYCBP/c-Myc axis
Presenter: Dening Ma
Session: Poster display session
Resources:
Abstract