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在先进的固体瘤患者中,Sorafenib与gemcitabine和carboplatin结合的I期研究

Daphne W M Voogd¹, Merel J J Lucassen², Ruud van der Noll³

¹Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.

Oncology and therapy

|May 14, 2025

概括

这一第一阶段的试验发现,将索拉费尼布与凝胺和碳白金结合在一起,在先进的固体瘤中显示出可控的毒性. 该组合显示出抗瘤活性,这表明它可能是预先治疗的患者的治疗选择.

科学领域:

在瘤学瘤学.
临床药理学临床药理学
药物开发药物开发

背景情况:

通过将向疗法与细胞毒药物结合起来,可以克服癌症中的多药性耐药性.
索拉菲尼布是一种多位激酶抑制剂,在临床前癌症模型中表现出与化疗药物的协同效应.
这项研究调查了索拉芬尼与吉姆西塔和卡博普拉丁结合的安全性和有效性.

研究的目的:

评估在患有晚期固体瘤的患者中,索拉费尼布与格姆西塔宾和卡博普拉丁结合的安全性和耐受性.
为了确定这种联合治疗的疗效和药理动力学特征.
为了确定第二阶段治疗方案的最大耐受剂量 (MTD).

主要方法:

进行了一项单中心,开放标签,I期剂量升级和剂量扩展研究.
患者具有先进的固体瘤,有资格接受gemcitabine和carboplatin的息治疗.
使用3+3剂量升级设计确定MTD,每两周期评估一次抗瘤活性.

主要成果:

确定的MTD是sorafenib400毫克每天一次,gemcitabine500毫克/m2在第1天和第8天,和carboplatinAUC3在第1天每3周.
4级毒性是血液学,发生在22%的患者中;常见的3级不良事件包括中性质衰竭 (33%) 和血小板衰竭 (31%).
18周的疾病控制率为50%,中位数无进展生存时间为5.4个月,总生存时间为10.1个月.

结论:

建议的Sorafenib,gemcitabine和carboplatin的第二阶段治疗方案显示出可管理的毒性概况.
这种组合疗法显示出作为一种有效的治疗选择,对于严重预先治疗的患有高级固体瘤的患者来说是有前途的.
需要进一步的研究来探索替代剂量计划以优化治疗结果.

关键词:

医学瘤学医学瘤学第一期临床试验临床试验.蛋白质激酶抑制剂蛋白质激酶抑制剂有针对性的治疗.

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