Efficacy and safety of anlotinib in patients with unresectable or metastatic bone sarcoma: A retrospective multiple institution study.
Efficacy and safety of anlotinib in patients with unresectable or metastatic bone sarcoma: A retrospective multiple institution study.
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DOI：
10.1002/cam4.4286
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发表时间：
2021-11
期刊：
影响因子：
4
通讯作者：
Yao W
中科院分区：
文献类型：
--
作者：
Liu Z;Gao S;Zhu L;Wang J;Zhang P;Li P;Zhang F;Yao W
在前瞻性临床试验中，酪氨酸激酶抑制剂（TKIs）如卡博赞替尼（cabozantinib）、瑞戈非尼（regorafenib）在延长几种骨肉瘤实体的无进展生存期（PFS）方面显示出令人鼓舞的活性。本回顾性研究旨在分析anlotinib（一种新型多靶点TKI）在三家机构治疗局部不可切除或转移性骨肉瘤患者的安全性和有效性。从2018年6月至2020年6月，晚期骨肉瘤患者服用anlotinib 12mg，每日1次，开/停2周，直到疾病进展或治疗不耐受。主要终点为客观缓解率（ORR）和PFS。我们分析了48例患者：27例为骨原性肉瘤，9例为软骨肉瘤，8例为尤文氏肉瘤，3例为脊索瘤。中位年龄为24岁（范围16-68岁），既往治疗的中位次数为1次（范围0-4次）。直到最后随访，5名患者获得部分缓解，24名患者病情稳定。所有患者的ORR为10.4%，中位PFS为4.6个月，3个月和6个月的无进展率（PFR）分别为72.9%和35.4%。不同肿瘤亚型的ORR和中位PFS差异很大。最常见的3-4级不良事件（ae）是气胸、手足综合征、胆固醇升高、高甘油三酯血症和疲劳。在研究期间，没有患者死于与安洛替尼相关的不良事件。安洛替尼可能在不可切除或转移性骨肉瘤中显示出有希望的抗肿瘤活性。anlotnib在不同亚型肉瘤中的ORR和中位PFS与其他靶向药物相似。不良反应一般较轻，耐受性良好。需要进一步研究安洛替尼在选定亚型骨肉瘤中的作用。安洛替尼可能在不可切除或转移性骨肉瘤中显示出有希望的抗肿瘤活性。anlotnib在不同亚型肉瘤中的ORR和中位PFS与其他靶向药物相似。不良反应通常是轻微的，耐受性良好。需要进一步研究安洛替尼在选定亚型骨肉瘤中的作用。
Tyrosine kinase inhibitors (TKIs) such as cabozantinib, regorafenib have demonstrated encouraging activity in prolonging progression‐free survival (PFS) in several bone sarcoma entities in prospective clinical trials. This retrospective study aims to analyze the safety and efficacy of anlotinib, a novel multi‐target TKI, in patients with locally unresectable or metastatic bone sarcoma at three institutions. Patients with advanced bone sarcoma administered anlotinib 12 mg once daily, 2 weeks on/1 week off, from June 2018 to June 2020, until disease progression or intolerance of treatment. The primary endpoints were objective response rate (ORR) and PFS. Forty‐eight patients were analyzed: 27 have osteosarcoma, 9 have chondrosarcoma, 8 have Ewing's sarcoma, and 3 have chordoma. The median age was 24 years (range, 16–68 years), and the median number of prior regimens was 1 (range, 0–4). Until the final follow‐up, five patients obtained a partial response and while 24 achieved stable disease. The ORR in all patients was 10.4%, and the median PFS was 4.6 months, with a progression‐free rate (PFR) at 3 months and 6 months of 72.9% and 35.4%, respectively. The ORR and median PFS varied much among tumor subtypes. The most frequent grade 3–4 adverse events (AEs) were pneumothorax, hand‐foot syndrome, cholesterol elevation, hypertriglyceridemia, and fatigue. No patients died from anlotinib‐related AEs during the study period. Anlotinib may show promising antitumor activity in unresectable or metastatic bone sarcoma. The ORR and median PFS of anlotnib are similar to those of other targeted drugs in different subtypes of sarcomas. The AEs were generally mild and tolerated well. Further studies of anlotinib in selected subtypes of bone sarcoma are needed. Anlotinib may show promising antitumor activity in unresectable or metastatic bone sarcoma. The ORR and median PFS of anlotnib were similar to those of other targeted drugs in different subtypes of sarcomas. The AEs were generally mild and well tolerated. Further studies of anlotinib in selected subtypes of bone sarcoma are needed.
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