在标准疗法失败后,在晚期或转移性固体瘤中使用乌提德隆治疗:一个前性的,多中心的,单臂试验
Guanglei Qiao1, Zimei Liu1, Honghua Ding2
1Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, China.
American journal of cancer research
|October 17, 2024
概括
乌提德隆 (UTD1) 是一种新的微管稳定剂,在先进的固体瘤中显示出有前途的抗瘤活性. 持续输液方法提高了耐受性,减少了严重的副作用,这需要进一步调查.
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:
- 对于在标准治疗失败后的晚期或转移性实体瘤,存在有限的治疗选择.
- 乌提德隆 (UTD1),一种新的微管稳定剂,在转移性乳腺癌中显示出有效性,但其在其他晚期癌症中的应用尚不清楚.
- 周围神经病变是一种与UTD1.1相关的显著不良事件.
研究的目的:
- 为了评估Utidelone (UTD1) 的疗效和安全性,在患有晚期或转移性固体瘤的患者中使用修改后的服用计划.
- 为了评估UTD1通过120小时连续静脉输注的耐受性.
- 探索UTD1在更广泛的高级固体瘤中的抗瘤活性.
主要方法:
- 一个前性的多中心单臂临床试验 (ChiCTR2300074299) 涉及50名患有晚期或转移性固体瘤的患者.
- 乌提德隆 (UTD1) 剂量为150mg/m2每21天通过120小时的连续静脉输注,单独或组合使用.
- 患者接受治疗,直到疾病进展或无法忍受的毒性.
主要成果:
- 总体中位数无进展生存期 (PFS) 为4个月.
- 客观应答率 (ORR) 为20%,疾病控制率 (DCR) 为66%.
- 3级以上的不良事件,包括外围神经病变,仅发生在4%的患者身上,这表明持续输液方法的耐受性得到改善.
结论:
- 乌提德隆 (UTD1) 在患有先进或转移性固体瘤的患者中表现出有前途的抗瘤活性,这些瘤对标准疗法不耐药.
- 与间歇输液相比,120小时的UTD1连续静脉输液是一种更耐受的注射方式.
- 这种对UTD1的修改给药需要在临床研究中对各种高级固体瘤进行进一步的研究.
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