Abstract 913P
Background
Apatinib, an inhibitor of vascular endothelial growth factor receptor-2 with potent anti-angiogenic activity, has shown promising anticancer activity in various solid tumors. For patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have previously received standard chemotherapy or radiotherapy, there are few effective treatment options. We conducted a single-arm, multi-center, phase II trial to evaluate the efficacy and safety of apatinib for the treatment of R/M HNSCC patients who failed from one or more lines of therapies.
Methods
Patients with pathologically confirmed R/M HNSCC after the failure of at least one line of systemic therapy were recruited in this open-label exploratory study. All subjects were initially given apatinib 250mg qd until disease progression, intolerable toxicity, and death. Dose reduction to 125 mg was allowed.
Results
Between Jul 2017 and Dec 2018, 21 patients were enrolled in our study. The median age was 57 years; 79% were male. 48.62% had more than 2 lines of systemic therapies. The median OS was 6.1 months (95%CI 3.3–8.9). The 12-month OS rate was 15.8%. Most treatment-related adverse events (AEs) were in grade ½. The grade 3 AEs were bleeding (6/21, 28.57%), mouth mucositis (3/21, 14.29%), fistula (2/21, 9.52%), proteinuria (2/21, 9.52%), and hypertension (1/21, 4.76%).
Conclusions
Apatinib showed encouraging efficiency with tolerable toxicity for Rr/m HNSCC patients who failed from one or more lines of systematic therapy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.