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阿帕替尼治疗晚期骨肉瘤肺转移的疗效与安全性:一项单中心观察性研究。

Efficacy and safety of apatinib in advance osteosarcoma with pulmonary metastases: A single-center observational study.

作者信息

Zheng Kai, Xu Ming, Wang Lei, Yu Xiuchun

机构信息

Orthopedic Department, The General Hospital of Jinan Military Commanding Region, Jinan, China.

出版信息

Medicine (Baltimore). 2018 Aug;97(31):e11734. doi: 10.1097/MD.0000000000011734.

Abstract

This study was designed to evaluate the efficacy and safety of apatinib in patients with advanced osteosarcoma and pulmonary metastases following failed first-line chemotherapy.There were 10 patients with osteosarcoma pulmonary metastases, whose first-line chemotherapy had failed, had received apatinib treatment as a single agent. All patients had at least 1 measurable lung tumor. Progression free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse effects (AEs) were reviewed and evaluated. Tumor response was assessed by response evaluation criteria in solid tumor criteria (RECIST). The 10 patients in this study received apatinib treatment for 2 to 16 months with a median of 7.5 months. The median PFS was 7.5 months. The 6-month, 8-month, and 10-month PFS rates were 60%, 40% and 26.6%, respectively. The median OS was 14 months. After 6-month apatinib treatment, 2 patients achieved partial response and 5 patients achieved stable disease, while 3 patients were evaluated as progression of the disease. At the 6-month follow-up, the ORR was 20.0% and the DCR was 70.0%. Hand-foot syndrome with grade 1/2 was the most common treatment-related AE. No drug-related severe AEs occurred.After failed first-line chemotherapy, apatinib as a single agent exhibited efficacy and acceptable safety in patients with advanced osteosarcoma and pulmonary metastases.

摘要

本研究旨在评估阿帕替尼在一线化疗失败后的晚期骨肉瘤伴肺转移患者中的疗效和安全性。有10例骨肉瘤肺转移患者,其一线化疗失败,接受了阿帕替尼单药治疗。所有患者至少有1个可测量的肺肿瘤。对无进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)和治疗相关不良反应(AE)进行了回顾和评估。根据实体瘤疗效评价标准(RECIST)评估肿瘤反应。本研究中的10例患者接受阿帕替尼治疗2至16个月,中位时间为7.5个月。中位PFS为7.5个月。6个月、8个月和10个月的PFS率分别为60%、40%和26.6%。中位OS为14个月。阿帕替尼治疗6个月后,2例患者达到部分缓解,5例患者病情稳定,3例患者被评估为疾病进展。在6个月的随访中,ORR为20.0%,DCR为70.0%。1/2级手足综合征是最常见的治疗相关AE。未发生与药物相关的严重AE。在一线化疗失败后,阿帕替尼单药在晚期骨肉瘤伴肺转移患者中显示出疗效且安全性可接受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c9f/6081168/8a7f4b63943b/medi-97-e11734-g002.jpg

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