CLIN CANCER RES:Iniparib联合同步放化疗治疗胶质母细胞瘤

2019-01-20 MedSci MedSci原创

Iniparib在胞内转化为硝基自由基离子导致细胞死亡,是一种前药,CLIN CANCER RES近期发表了一篇文章,评估iniparib联合标准放疗和替莫唑胺治疗新诊断的胶质母细胞瘤(GBM)患者的疗效和安全性。

Iniparib在胞内转化为硝基自由基离子导致细胞死亡,是一种前药,CLIN CANCER RES近期发表了一篇文章,评估iniparib联合标准放疗和替莫唑胺治疗新诊断的胶质母细胞瘤(GBM)患者的疗效和安全性。

该试验为前瞻性多中心 II期试验,与历史对照组比较中位总生存期(mOS)的情况。放射治疗+替莫唑胺+ iniparib(n = 5)的安全性验证研究后进行功效研究(n = 76),使用iniparib的推荐II期剂量(8.0 mg / kg静脉注射 每周两次联合放疗+每日替莫唑胺治疗,续贯8.6mg / kg每周两次联合每次5天的替莫唑胺治疗,28天周期)。研究结最终纳入81名患者,中位年龄为58岁(男性为63%)。87%的患者者基线KPS≥80%。mOS为22个月。2年和3年生存率分别为38%和25%。27%的患者出现治疗相关的3级不良事件(AEs); 9名患者需要停药,AE包括输液相关反应,皮疹,炎,肝酶升高和血小板减少症。

文章最后认为,新诊断的GBM患者,Iniparib联合放疗和替莫唑胺的耐受性良好,可达到每周17.2 mg / kg。与历史对照相比,mOS改善的主要目标达到,表明iniparib具有潜在的抗肿瘤活性。在进行其他的功效研究之前需要优化剂量。

原始出处:

Jaishri O. Blakeley, Stuart A. Grossman, et al. Phase II Study of Iniparib with Concurrent Chemoradiation in Patients with Newly Diagnosed Glioblastoma. CLIN CANCER RES. January 2019 doi: 10.1158/1078-0432.CCR-18-0110

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    2020-01-03 mnda
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    2019-01-22 yzh399
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