A Prospective Study of Apatinib in Patients with Extensive‐Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy

BACKGROUND: Because of rapid disease progression and lack of optimal treatment strategies beyond the second‐line, the prognosis of patients with extensive‐stage (ES) small cell lung cancer (SCLC) still remains depressing. Alternative treatment strategies are required to improve their prognosis. In this prospective clinical study, we aimed to evaluate the feasibility of single‐agent apatinib, a vascular endothelial growth factor receptor‐2 tyrosine kinase inhibitor, as a treatment option for patients with ES‐SCLC after failure of at least two prior chemotherapy regimens. MATERIALS AND METHODS: Twenty‐two patients with ES‐SCLC treated with 500 mg single‐agent apatinib as subsequent‐line regimen in our institution from November 2016 to August 2018 were enrolled in the study. The primary endpoint was progression‐free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). RESULTS: Clinical outcomes included partial response in 3 patients (13.6%), stable disease in 18 patients (81.8%), and disease progression in 1 patient (4.5%), with an ORR of 13.6% and DCR of 95.5%. The median PFS and OS were 5.4 and 10.0 months, respectively. Apatinib demonstrated a manageable toxicity profile, with grade I–III secondary hypertension and proteinuria as the most common AEs. No grade IV and V AEs were observed among the patients. Multivariate analysis revealed secondary hypertension as an independent predictor of OS (p = .047); however, the association became insignificant after Q correction (p = .455). CONCLUSIONS: Apatinib was safe and effective in the management of patients with ES‐SCLC and can be considered as a treatment option after failure of at least two prior chemotherapy regimens. http://ClinicalTrials.gov identifier. NCT02995187 IMPLICATIONS FOR PRACTICE: This study indicated the acceptable toxicity profile and promising efficacy of apatinib in the management of patients with extensive‐stage small cell lung cancer after failure from at least two prior chemotherapy regimens. Secondary hypertension can be a potential prognostic factor for apatinib treatment.