Apatinib Plus S-1 As Second-Line Or Laterline Chemotherapy For Advanced Squamous Cell Lung Carcinoma

e21179 Background: Apatinib, an oral VEGFR2 inhibitor, has been proved a confirming activity for inhibiting tumor growth on lung cancer in vitro and in vivo tests.This prospective study tried to investigate the efficacy and safety of apatinib plus S-1 as second- or third-line treatment in patients with advanced squamous cell lung carcinoma. Methods: In this open-label single-arm study, eligible patients (pts) had histologically or cytologically confirmed advanced squamous cell lung cancer and had documented disease progression after at least one platinum-based chemotherapy. Patients were treated oral apatinib (250-500 mg daily) and S-1(60mg/m2 D1-14) (allowable dose adjustment) , repeated every 3 weeks. Treatment will be continued until disease progression or unacceptable toxicity occurs. Results: From August 19, 2016 to January 29, 2018, 27 pts were enrolled. there were 19 pts available for efficiency evaluation. Among them, 7 achieved partial response (PR),10 had stable disease (SD), and 2 had progressive disease(PD), resulting in an overall response rate of 36.8% and a disease control rate of 89.5%. The mPFS is 5.0m(95%CI:3.4-6.54), The real mPFS will be longer as this study continues. The common adverse events (AEs) were hypertension (n = 5, 18.5%), fatigue (n = 4, 14.8%), hand-foot skin syndrome (n = 6, 22.2%) and pulmonary infection (n = 4, 14.8%).In addition, serious adverse events (SAEs) were hypertension (n = 2, 7.4%),diarrhea (n = 1, 3.7%), proteinuria (n = 1, 3.7%), thrombocytopenia (n = 2, 7.4%),hand-foot skin syndrome (n = 1, 3.7%), pulmonary infection (n = 3, 11.1%). Others like hoarse voice, oral ulcers, constipation, anemia, elevated bilirubin, leukopenia appeared in 1 of 27 patients respectively and could be better controlled. Overall incidence of AEs and SAEs was 74.1%, 37.0% respectively. No treatment-related death occurred. Conclusions: Apatinib plus S-1 showed promising efficacy and acceptable toxicity in advanced squamous cell lung carcinoma. The research is still ongoing. The results are subject to the verification of phase Ⅲ randomized clinical trials. Clinical trial information: ChiCTR-OPC-16009048 Clinical trial information: ChiCTR-OPC-16009048.