Although antiangiogenic therapy is effiective in advanced lung, breast, renal, hepatic, and colon cancers, limited is known about its value in the cancer of the Head and Neck. Apatinib is an oral, highly potent tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2). This prospective phase II study (NCT02989259) aims to investigate the efficacy and safety of apatinib in heavily pretreated patients (pts) with metastatic adenocarcinoma of the Head and Neck.
This study enrolled pts with metastatic adenocarcinoma of the Head and Neck, who failed in the metastatic setting at least one prior chemotherapy regimen. The primary end point of this study was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Patients were treated with apatinib 500 mg daily. Efficacy was assessed every 6 weeks.
From December 2016, we recruited 10 pts, including 8 males and 2 females, with a median age of 53 years (26-71). Median number of previous chemotherapy regimens for the metastatic diseases was 2 (1-3). Median follow-up time was 4.3 months. 8 pts were eligible for efficacy analysis. ORR was 25% (2/8). DCR was 87.5% (7/8). Median PFS and median OS were not reached. The most common adverse events (AEs) of all grade were hypertension (n = 5), nausea (n = 4), fatigue (n = 4) and hand-foot syndrome (n = 3). The most common grade 3/4 AEs were hypertension (n = 2), thrombocytopenia (n = 1) and oral mucositis (n = 1). Toxicities were tolerable and manageable.
Our results so far indicated that apatinib exhibited objective efficacy in heavily pretreated, metastatic adenocarcinoma of the Head and Neck with acceptable safety.
Clinical trial identification
the trial protocol number: NCT02989259 release date: December 2016
Legal entity responsible for the study
The Institutional Review Board of the Cancer Institute/Hospital, CAMS & PUMC Institutional Review Board of the Cancer Institute/Hospital, CAMS & PUMC
All authors have declared no conflicts of interest.