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 s...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Drug Development
Biomarkers
Non-Small-Cell Lung Cancer, Metastatic
Presenter Zhou Ya
Citation Annals of Oncology (2016) 27 (suppl_9): ix139-ix156. 10.1093/annonc/mdw594
Authors Z.C. Ya
  • Medical Oncology, Sichuan Cancer Hospital, 610041 - Chengdu/CN

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.

Clinical trial indentification

Legal entity responsible for the study

Si Chuan Cancer Hospital

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.