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
9P - XRCC1 Arg194Trp, Palb2 T1100T (3300T>G), HMMR V353A, TNF aG308A polymorphisms as diagnostic and prognostic markers of breast cancer in the Kyrgyz ethnic group
Presenter: Aigul Semetei kyzy
Session: Poster display session
Resources:
Abstract
232P - Early Results from the Phase I Study of SY-1365, a Potent and Selective CDK7 inhibitor, in Patients with Ovarian Cancer and Advanced Solid Tumors
Presenter: Debra Richardson
Session: Poster display session
Resources:
Abstract
382P - Drug metabolizing enzymes pharmacogenomic: Biomarkers for improved chemotherapy in head and neck cancer squamous cell carcinoma
Presenter: Sunishtha Bhatia
Session: Poster display session
Resources:
Abstract
401P - Women in oncology: Alarming figures from India
Presenter: Sharada Mailankody
Session: Poster display session
Resources:
Abstract
416P - Multidisciplinary management of sarcomas of the head and neck: An institutional experience
Presenter: Kavitha Jain
Session: Poster display session
Resources:
Abstract
523P - Co-morbilities and survival of patients initially diagnosed with extensive-stage small cell lung cancer: Impact of hypertension, diabetes and chronic hepatitis B viral infection
Presenter: Weigang Xiu
Session: Poster display session
Resources:
Abstract
529P - Osimertinib for patients with EGFR-mutant advanced NSCLC and asymptomatic brain metastases: An open-label, two-arm, phase II study
Presenter: Roni Gillis
Session: Poster display session
Resources:
Abstract