在Desmoid瘤中,TGF-β抑制剂Vactosertib与伊马替尼结合的临床活性:多中心Ib/II期研究
Jin-Hee Ahn1, Jeeyun Lee2, Changhee Park3
1Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
概括
瓦克托塞蒂布和伊马替尼布的组合显示出有前途的活性,并且在患有desmoid瘤的患者中耐受良好. 这种新的TGF-β抑制剂组合为这种罕见的癌症提供了新的治疗选择.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 德斯莫伊德瘤是罕见的,局部具有侵略性的瘤,治疗选择有限.
- 转化生长因子-β (TGF-β) 信号传递与desmoid瘤的发病因子有关.
研究的目的:
- 为了评估vactosertib的安全性和有效性,一个TGF-β抑制剂,在患有desmoid瘤的患者中与意马替尼结合使用.
- 为了确定该组合治疗的推的II期剂量 (RP2D).
主要方法:
- 一个由研究者发起的,开放的,多中心的Ib/II期试验.
- 患者在Ib阶段每天接受400毫克伊马替尼,并增加100毫克或200毫克的vactosertib剂量,以确定RP2D.
- 第二阶段评估了疗效,以16周的无进展率 (PFR) 为主要终点.
主要成果:
- 确定的RP2D是每天400毫克伊马替尼和200毫克瓦克托塞提布 (每天两次,5天/2天休息).
- 在27名患者中,96.3%的患者实现了16周的PFR,一年后的PFR为81.0%.
- 在25.9%的患者中观察到部分反应,在70.4%的患者中观察到稳定疾病.
- 最常见的毒性包括肌痛,贫血和恶心;3-4级毒性是中性质减退和贫血.
结论:
- 瓦克托塞蒂布和伊马替尼布的组合显示出有前途的临床活性,并且在患有进展性desmoid瘤的患者中耐受良好.
- 这项研究代表了首次研究TGF-β抑制剂与伊马替尼结合用于desmoid瘤的研究,提供了一个新的治疗策略.
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