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在患有复发Ewing肉瘤的患者中对palbociclib和ganiitumab进行第二阶段试验

David S Shulman¹, Priscilla Merriam², Edwin Choy³

¹Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, Massachusetts, USA.

Cancer medicine

|June 12, 2023

概括

这项结合palbociclib和ganitumab治疗复发的尤文肉瘤 (EWS) 的第二阶段试验没有显示出客观反应. 组合疗法在EWS患者中显示出有限的疗效和显著的毒性.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.

背景情况:

尤文肉瘤 (EWS) 是一种具有侵略性的癌症,对于复发病例的治疗选择有限.
循环素依赖性激酶4 (CDK4) 是EWS的一个已知的基因组漏洞.
临床前研究表明,CDK4/6抑制和IGF-1R抑制之间存在协同作用.

研究的目的:

评估结合palbociclib (一种CDK4/6抑制剂) 与ganitumab (一种IGF-1R单克隆抗体) 在复发性EWS患者中的疗效和安全性.
确定这种组合治疗的客观反应率和毒性概况.

主要方法:

一个开放的,非随机的,第二阶段试验招募了10名患有复发EWS的患者.
患者在28天的周期内接受口服帕尔博西克利布和静脉注射加尼图马布.
主要终点包括RECIST的客观反应和CTCAE的毒性.

主要成果:

在10名可评估患者中没有观察到完全或部分反应.
三名患者在4个周期以上实现了稳定的疾病;两名患者在研究结束时有稳定的疾病.
六个月无进展生存率为30%. 在80%的患者中发生了3/4级不良事件,包括中性质减退症.

结论:

帕尔博西克利布和加尼图马布的组合证明了在复发性EWS中进行进一步调查的治疗活性不足.
虽然缺乏整体疗效,但一小部分患者经历了长期稳定的疾病.

关键词:

在CDK4/6中使用.尤文肉瘤 (Ewing Sarcoma) 是一种癌症.在IGF-1RR中,IGF-1R是最常见的.甘尼塔姆巴比特的意思这是palbocicliblib.

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