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
508P - Efficacy and safety of anti-PD-1 antibody SHR-1210 combined with apatinib in first-line treatment for advanced lung squamous carcinoma: A phase II study
Presenter: Jinliang Wang
Session: Poster display session
Resources:
Abstract
525P - Retrospective analysis of outcomes of cisplatin and irinotecan combination chemotherapy for unresectable thymic carcinoma
Presenter: Akito Fukuda
Session: Poster display session
Resources:
Abstract
524P - A study in recurrent small cell lung cancer patients, comparing weekly paclitaxel, irinotecan and temozolomide in second-line: A prospective study from a south Indian tertiary cancer hospital
Presenter: LALATENDU MOHARANA
Session: Poster display session
Resources:
Abstract
505P - PD-L1 expression in ALK rearranged NSCLC: All questions answered?
Presenter: Amrith B P
Session: Poster display session
Resources:
Abstract
487P - Afatinib versus gefitinib or erlotinib in first-line setting for Malaysia patients with EGFR mutant advanced lung adenocarcinoma
Presenter: Chee Shee Chai
Session: Poster display session
Resources:
Abstract
492P - Feasibility of rebiopsy and sequential treatment of EGFR tyrosine kinase inhibitors in real world patients with EGFR mutant non-small cell lung cancer
Presenter: Heekyung Ahn
Session: Poster display session
Resources:
Abstract
513P - Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed
Presenter: Shingo Kitagawa
Session: Poster display session
Resources:
Abstract
493P - Is exon 19 deletion different from exon 21 mutation in advanced non-small cell lung cancer: A single centre experience
Presenter: Sarita Shrivastva
Session: Poster display session
Resources:
Abstract
494P - Comparison of pattern of disease progression and prevalence of acquired T790M mutation in Malaysia patients with EGFR mutant lung adenocarcinoma upon failure of first-line afatinib, gefitinib and erlotinib
Presenter: Chee Shee Chai
Session: Poster display session
Resources:
Abstract
517P - High BRCA1 expression is independently correlated with decreased overall survival in lung adenocarcinoma: Evidence from meta and bioinformatics analyses
Presenter: Fengzhu Guo
Session: Poster display session
Resources:
Abstract