Clinical study of apatinib in the treatment of stage IV osteogenic sarcoma after failure of chemotherapy
Clinical study of apatinib in the treatment of stage IV osteogenic sarcoma after failure of chemotherapy
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DOI：
10.20892/j.issn.2095-3941.2019.0397
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发表时间：
2020-05-01
影响因子：
5.5
通讯作者：
Yang, Jilong
中科院分区：
文献类型：
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作者：
Liao, Zhichao;Li, Ting;Yang, Jilong
目的：通过一项单臂、前瞻性、开放性的临床II期研究，分析阿帕替尼治疗化疗失败的IV期骨肉瘤的疗效和安全性。方法：收集天津医科大学肿瘤研究所和天津医科大学附属医院2015年9月至2019年12月收治的34例化疗失败的IV期骨肉瘤患者的资料，进行统计分析。受试者包括23名男性和11名女性，平均年龄35.24岁(11-73岁)。评价客观有效率(ORR)、疾病控制率(DCR)、无进展生存率(PFS)、无进展生存率(PFR)和总生存率(OS)。结果：34例患者中，33例可评价疗效。1名患者接受阿帕替尼治疗不到一个周期；因此，只进行了安全性分析。12周临床疗效评定：部分缓解(PR)2例，稳定(SD)24例，进展(PD)7例。12周时ORR为6.06%(2/33)，DCR为78.79%(26/33)，PFR为82%。随访结束时，SD 6例(18.18%，6/33)，PD 27例(81.82%，27/33)，因疾病进展死亡15例(45.45%，15/33)。ORR为0(0/33)，DCR为18.18%(6/33)，中位PFS为7.89个月(95%CI：4.56~11.21)。中位OS(MOS)为17.61个月(95%可信区间：10.85~24.37)。最常见的不良反应是手足综合征(35.29%，12/34)、蛋白尿(32.35%，11/34)和高血压(32.35%，11/34)。结论：阿帕替尼治疗IV期骨肉瘤化疗失败后疗效好，耐受性好。
Objective: To analyze the efficacy and safety of apatinib in the treatment of stage IV osteogenic sarcoma after chemotherapy failure through a single-arm, prospective, and open clinical phase II study.Methods: Information on 34 patients with stage IV osteogenic sarcoma treated with apatinib after failure of chemotherapy in Tianjin Medical University Cancer Institute and Hospital between September 2015 and December 2019 was collected and analyzed. The participants included 23 males and 11 females, with an average age of 35.24 years (11-73 years). The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), PFS rate (PFR), and overall survival (OS) were evaluated. The treatment-related adverse events (AEs) and safety of apatinib were also evaluated.Results: Of the 34 patients, 33 were able to be evaluated for efficacy. One patient received apatinib treatment for less than one cycle; therefore, only safety analysis was performed. The 12-week clinical evaluation showed that 2 patients had a partial response (PR), 24 patients had stable disease (SD), and 7 patients had progressive disease (PD). The ORR, DCR, and PFR at 12 weeks were 6.06% (2/33), 78.79% (26/33), and 82%, respectively. By the end of the follow-up, 6 patients had SD (18.18%, 6/33), 27 patients had PD (81.82%, 27/33), and 15 patients died because of disease progression (45.45%, 15/33). The ORR was 0 (0/33), the DCR was 18.18% (6/33), and the median PFS (mPFS) was 7.89 months (95% CI: 4.56-11.21). The median OS (mOS) was 17.61 months (95% CI: 10.85-24.37). The most common treatment-related AEs were hand-foot syndrome (35.29%, 12/34), proteinuria (32.35%, 11/34), and hypertension (32.35%, 11/34).Conclusions: Apatinib is effective and well tolerated in stage IV osteogenic sarcoma patients after chemotherapy failure.