里卢与mFOLFOX6和贝瓦西祖马布联合治疗转移性结肠直肠癌患者:一期临床试验
Chunjie Li1, Anne M Noonan2, John Hays1
1The Ohio State University, Columbus, OH, United States.
概括
与化疗相结合的利卢在转移性结直肠癌中表现有前途,特别是在对先前治疗有耐药性的患者中. 这种组合疗法耐受性良好,并显示出潜在的临床活性.
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:
- 结肠直肠癌是美国癌症死亡的主要原因.
- 标准治疗方法,如5-甲 (5-FU) 与向药物结合,用于晚期疾病.
- 对于转移性结直肠癌与微卫星稳定性疾病需要新的策略.
研究的目的:
- 评估在转移性结直肠癌患者中与mFOLFOX6/bevacizumab联合使用的瑞卢的安全性和耐受性.
- 评估这种联合治疗的临床活性,特别是在先前对FOLFOX耐药的患者中.
主要方法:
- 一个单臂的第一阶段试验进行了.
- 患者在16周内与mFOLFOX6/bevacizumab一起接受了升级或降级剂量的riluzole (50-100毫克每天两次) 八个周期.
- 剂量调整和治疗的延续/切换是基于患者的反应和耐受性.
主要成果:
- 组合疗法在可评估患者中耐受良好.
- 目标应答率为16.7%,疾病控制率为91.7%.
- 中位数无进展生存时间为4.89个月,中位数总生存时间为12.98个月.
结论:
- 瑞卢与mFOLFOX6/bevacizumab是转移性结直肠癌的耐受性良好治疗方案.
- 这种组合显示出潜在的临床活性,特别是在对FOLFOX耐药性疾病的患者中.
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