1. Apatinib in patients with extensive-stage small-cell lung cancer after second-line or third-line chemotherapy: a phase II, single-arm, multicentre, prospective study.
- Author
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Xu, Yanjun, Huang, Zhiyu, Lu, Hongyang, Yu, Xinming, Li, Yuping, Li, Wenfeng, Chen, Jun, Chen, Ming, Gong, Lei, Chen, Kaiyan, Qin, Jin, Xu, Xiaoling, Jin, Ying, Zhao, Jun, Shi, Xun, Han, Na, Xie, Fajun, Zhang, Peng, Xu, Weizhen, and Fan, Yun
- Abstract
Background: Small-cell lung cancer (SCLC) remains an aggressive cancer with short-term survival due to limited therapeutic options. Apatinib is a small-molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor-2. This study aimed to investigate the efficacy and safety of apatinib in patients with extensive-stage (EC) SCLC who had progressed after two or three previous therapies.Methods: Eligible patients were histologically confirmed ES-SCLC after two or three previous treatments, including a platinum-based regimen. Patients received apatinib at an initial dose of 500âmg once daily. The primary endpoint was the objective response rate.Results: Forty patients were enrolled. At the data cut-off time (November 15, 2018), the median follow-up was 7.4 months; no patients remained on treatment, and five were still in follow-up. An objective response was achieved in 7 of 40 patients (17.5%) in the intention-to-treat population, and 7 of 38 patients (18.4%) in the per-protocol population. The median progression-free survival and overall survival were 3.0 months and 5·8 months, respectively. The most commonly observed grade 3 or greater treatment-related adverse events were hypertension, hand-foot syndrome, increased L-gamma-glutamyltransferase.Conclusions: Apatinib exhibited efficacy and an acceptable safety profile in previously heavily-treated ES-SCLC patients. Further exploration of apatinib in phase III trials is warranted.Trial Registration: NCT02945852. [ABSTRACT FROM AUTHOR]- Published
- 2019
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