卡博普拉丁,格姆西塔宾和米费普里斯用于晚期乳腺癌和复发性/持久性上皮卵巢癌
Erica M Stringer-Reasor1, Poornima Saha2, Masha Kocherginsky3
1Department of Medicine, Section of Hematology/Oncology, University of Alabama at Birmingham, 1720 2nd Avenue South, NP 2510, Birmingham, AL, 35294-3300, USA. esreasor@uabmc.edu.
Breast cancer research and treatment
|August 8, 2025
概括
这一第一阶段的试验结合了米费普里斯与碳波拉丁和凝在乳腺和卵巢癌患者. 通过基化G-CSF支持确定了最大耐受剂量,显示了增强化疗疗效的潜力.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 临床前研究表明,葡萄糖皮质体受体 (GR) 活性抑制了GR阳性乳腺和卵巢癌中化疗诱导的亡.
- 与米费普里斯 (Mif) 的GR对抗性已经显示出增强癌细胞细胞毒性的潜力.
研究的目的:
- 评估组合治疗的安全性和确定最大耐受剂量 (MTD).
- 该疗法包括乳腺癌 (BC) 和卵巢癌 (OC) 的患者的米费普里斯 (Mif),碳烯 (C) 和结晶 (G).
主要方法:
- 一个I期临床试验采用标准的"3+3"剂量升级设计.
- 米菲普里斯在化疗前和在化疗当天口服.
- 在21天周期的第1天和第8天静脉注射卡博普拉丁和格姆西塔宾.
主要成果:
- 招募了31名患者;25名患者可评估剂量限制性毒性 (DLT).
- 剂量降级是由于与中性质衰竭相关的DLT而发生的;DLT的定义被更新以排除血液毒性.
- 在剂量水平1时观察到三种主要反应 (1个完整反应,2个部分反应);在剂量水平-1.1时观察到一个完整反应.
结论:
- 在D1和D8上,MTD被确定为卡博普拉丁AUC2 + 凝胺600毫克/米2,在D1和D1上为米费普里斯300毫克.
- 在每一个21天周期的第9天,给患者注射化颗粒细胞殖民地刺激因子 (G-CSF).
- 评估了组合治疗的安全性和耐受性,确定了用于进一步研究的推剂量.
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