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
41P - Clinical verification on the relationship between serum lipid metabolism and the immune microenvironment in breast cancer patients
Presenter: Wataru Goto
Session: Poster display session
Resources:
Abstract
42P - Genome wide copy number analysis of circulating tumour cells in breast cancer liver metastasis
Presenter: Saber Imani
Session: Poster display session
Resources:
Abstract
43P - A hotspot variants p.H1047R and p.H1047L in p110α/ΔNp63α complex affects structure, function and contributes to susceptibility metastatic breast cancer
Presenter: Zou Linglin
Session: Poster display session
Resources:
Abstract
44P - Correlation of circulating tumour cells with PET-CT in metastatic breast cancer
Presenter: Venkata Pradeep Babu Koyyala
Session: Poster display session
Resources:
Abstract
45P - The challenge of evaluating new targeted therapies: Opportunities in stratifying the therapeutic response per tumour location
Presenter: Hubert Beaumont
Session: Poster display session
Resources:
Abstract
46P - Plasma soluble CD36 of breast cancer based on pathological and clinical characteristics
Presenter: Aditia Romadhoni
Session: Poster display session
Resources:
Abstract
47P - Investigation of the use of a novel S-1 administration method for treating metastatic and recurrent breast cancer
Presenter: MAYUKO MIKI
Session: Poster display session
Resources:
Abstract
48P - Development of MDA-MB-231-3D-Spheroid as a reliable model for studying Nav1.5 and nNav1.5-mediated breast cancer metastasis
Presenter: Ahmad Murtadha
Session: Poster display session
Resources:
Abstract
49P - Biochemical study on modifying role of variants of leptin gene and its receptor on serum leptin levels in breast cancer
Presenter: Alshimaa Alhanafy
Session: Poster display session
Resources:
Abstract
50P - Prognostic factors of recurrence or distant metastasis in elderly breast cancer patients
Presenter: Seungju Lee
Session: Poster display session
Resources:
Abstract