526P - A phase II study of apatinib in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC)

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.