464P Apatinib (YN968D1) in performance status 2 or 3 patients with EGFR wild-type metastatic non-small cell lung cancer (NSCLC): A single-arm phase II study

Abstract

Background Apatinib, a small molecule inhibitor of vascular endothelial grown factor receptor-2(VEGFR-2), have demonstrated novel activities and tolerated toxicities in trials of chemotherapy-refractory advanced or metastatic gastric adenocarcinoma and non-small cell lung cancer by inhibiting tumor angiogenesis. Therefore, we conducted this phase II trial to assess the efficacy and safety of apatinib in performance status (PS) 2 or 3 patients with EGFR wild-type metastatic no-small cell lung cancer (NSCLC). Methods In this phase 2, non-randomised, a single-arm, performance status 2 or 3 patients, who have been histologically diagnosed EGFR wild-type metastatic no-small cell lung cancer and failed two or three lines of chemotherapy, received oral apatinib at a dose of 500 mg/d. The primary outcomes were the objective response rate(ORR) and disease control rate (DCR). The second outcomes were overall survival(OS) and safety. The study is on going and patients are still receiving treatment. but not enrolling patients in this cohort Results Between April 2015 and June 2016, twenty patients were enrolled, including 16 lung adenocarcinoma and 4 lung squamous cell carcinomas. All patients were eligible for assessment. Median age was 60(range 30-76). In 20 eligible patients, the overall response rate, disease control rate, and median overall survival were 30%, 85% and 4 months [95% confidence interval (CI) 1-6] months, respectively. Adverse events were predominantly grade 1 or 2, most commonly fatigue (15%), hand-foot syndrome (10%), edema (10%), and abdominal pain (10%). The common grade 3 adverse including hypertension (5%), hand-foot syndrome (5%) and hemoptysis (5%). There were no treatment-related deaths. Conclusions Apatinib demonstrated moderate efficacy and good safety in pretreated PS 2 or 3 patients with metastatic EGFR wild-type lung cancer. It can be a therapeutic option in “frail” PS 2 or 3 metastatic NSCLC patients without the indication of chemotherapy, if the patient is EGFR wild-type. Legal entity responsible for the study Si Chuan Cancer Hospital Funding N/A Disclosure All authors have declared no conflicts of interest.