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KMID : 0620920190510020024
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Experimental & Molecular Medicine
2019 Volume.51 No. 2 p.24 ~ p.24
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Phase II trial of VEGFR2 inhibitor apatinib for metastatic sarcoma: focus on efficacy and safety
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Liao Zhichao
Li Feng
Zhang Chao
Zhu Lei
Shi Yehui
Zhao Gang
Bai Xu
Hassan Shafat
Liu Xinyue
Li Ting
Xing Peipei
Zhao Jun
Zhang Jin
Xing Ruwei
Teng Sheng
Yang Yun
Chen Kexin
Yang Jilong
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Abstract
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Apatinib (YN968D1) is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2). We conducted a single-arm, nonrandomized phase II study (NCT03121846) to assess the efficacy and safety of apatinib in patients with stage IV sarcoma. We recruited 64 patients with stage IV sarcoma who had failed chemotherapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were progression-free survival rate (PFR), objective response rate (ORR), and disease control rate (DCR) at week 12. Treatment-related adverse effects (AEs) were evaluated. Fifty-nine patients were assessed for efficacy and 64 patients for AEs. The median PFS was 7.93 months. At 12 weeks, the PFR was 74%, the ORR was 16.95% (10/59), and the DCR was 86.44% (51/59). The final ORR was 15.25% (9/59) and the DCR was 57.63% (34/59). Notably, 22 patients (34.38%) who developed hypertension, hand-foot-skin reaction, or proteinuria had significantly longer OS than those without these AEs (18.20 vs. 10.73 months; P?=?0.002). We conclude that apatinib is effective and well tolerated in patients with advanced sarcoma. The development of hypertension, hand-foot-skin reaction, or proteinuria may indicate a favorable prognosis, representing a novel finding in sarcoma patients.
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KEYWORD
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Sarcoma, Translational research
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