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阿帕替尼在标准多模式治疗失败后治疗骨肉瘤中的疗效与安全性:一项观察性研究。

Efficacy and safety of apatinib in treatment of osteosarcoma after failed standard multimodal therapy: An observational study.

作者信息

Tian Zhichao, Gu Zhiyuan, Wang Xin, Liu Zhiyong, Yao Weitao, Wang Jiaqiang, Zhang Peng, Cai Qiqing, Ge Hong

机构信息

Department of Orthopedics.

Department of Radiation Oncology, The affiliated cancer hospital of Zhengzhou University, Zhengzhou, China.

出版信息

Medicine (Baltimore). 2019 May;98(19):e15650. doi: 10.1097/MD.0000000000015650.

Abstract

Recently, apatinib has been shown to be effective in treating sarcoma. This study aimed to assess the safety and efficacy of apatinib in the treatment of patients with osteosarcoma after failed of standard multimodal therapy and to compare the therapeutic effects of apatinib on osteosarcoma between high-dose group and low-dose group.A total of 27 patients with osteosarcoma who received apatinib between January 2016 and August 2017 were retrospectively reviewed. Among the 27 patients, the objective response rate (ORR) and the disease control rate (DCR) were 25.93% and 66.67%, respectively. The median of progression-free survival (m-PFS) was 3.5 months (95% confidence interval [CI], 2.5-4.8 months), and the median of overall survival (m-OS) was 9.5 months (95% CI, 7.8-10.5 months). There was no statistically significant difference in ORR (36.36% vs 18.75%), DCR (63.64% vs 68.75%), m-PFS (4.3 months [95% CI, 1.8-7 months) vs 3.35 months (95% CI, 1.8-4 months]), and m-OS (9.5 months [95% CI, 7.8-10.5 months] vs 9.4 months [95% CI, 7.8-10.8 months]) (P > .05) between the high-dose group (the average dose was 659 mg/qd) and the low-dose group (the average dose was 516 mg/qd). Most of the adverse events (AEs) were in grade 1 or grade 2. The main AEs in grade 3 were hypertension, rash, weight loss, hand-foot syndrome, and diarrhea.Apatinib is safe and effective in the treatment of advanced osteosarcoma. We recommend that the initial dose of apatinib should be 500 mg/qd in the treatment of osteosarcoma.

摘要

最近,已证明阿帕替尼在治疗肉瘤方面有效。本研究旨在评估阿帕替尼在标准多模式治疗失败后治疗骨肉瘤患者的安全性和有效性,并比较高剂量组和低剂量组阿帕替尼对骨肉瘤的治疗效果。回顾性分析了2016年1月至2017年8月期间接受阿帕替尼治疗的27例骨肉瘤患者。在这27例患者中,客观缓解率(ORR)和疾病控制率(DCR)分别为25.93%和66.67%。无进展生存期(m-PFS)的中位数为3.5个月(95%置信区间[CI],2.5 - 4.8个月),总生存期(m-OS)的中位数为9.5个月(95%CI,7.8 - 10.5个月)。高剂量组(平均剂量为659mg/每日)和低剂量组(平均剂量为516mg/每日)在ORR(36.36%对18.75%)、DCR(63.64%对68.75%)、m-PFS(4.3个月[95%CI,1.8 - 7个月]对3.35个月[95%CI,1.8 - 4个月])和m-OS(9.5个月[95%CI,7.8 - 10.5个月]对9.4个月[95%CI,7.8 - 10.8个月])方面无统计学显著差异(P>0.05)。大多数不良事件(AE)为1级或2级。3级主要不良事件为高血压、皮疹、体重减轻、手足综合征和腹泻。阿帕替尼在治疗晚期骨肉瘤方面安全有效。我们建议在骨肉瘤治疗中阿帕替尼的初始剂量应为500mg/每日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b56b/6531132/f79400b536ee/medi-98-e15650-g003.jpg

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