Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China.
National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China.
Exp Mol Med. 2019 Feb 28;51(3):1-11. doi: 10.1038/s12276-019-0221-7.
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.
阿帕替尼（YN968D1）是一种新型的针对血管内皮生长因子受体 2（VEGFR-2）的酪氨酸激酶抑制剂。我们进行了一项单臂、非随机的 II 期研究（NCT03121846），以评估阿帕替尼在晚期肉瘤患者中的疗效和安全性。我们招募了 64 名化疗失败的 IV 期肉瘤患者。主要终点是无进展生存期（PFS），次要终点是无进展生存率（PFR）、客观缓解率（ORR）和第 12 周的疾病控制率（DCR）。评估了与治疗相关的不良反应（AE）。59 名患者进行了疗效评估，64 名患者进行了 AE 评估。中位 PFS 为 7.93 个月。在 12 周时，PFR 为 74%，ORR 为 16.95%（10/59），DCR 为 86.44%（51/59）。最终 ORR 为 15.25%（9/59），DCR 为 57.63%（34/59）。值得注意的是，22 名（34.38%）发生高血压、手足皮肤反应或蛋白尿的患者的 OS 明显长于无这些 AE 的患者（18.20 与 10.73 个月；P=0.002）。我们得出结论，阿帕替尼对晚期肉瘤患者有效且耐受良好。高血压、手足皮肤反应或蛋白尿的发生可能预示着良好的预后，这是肉瘤患者的一个新发现。
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