综合IIa期III研究:雷戈拉费尼布用于耐火性晚期胃癌
Nick Pavlakis1,2, Kohei Shitara3, Katrin Sjoquist4,5
1Department of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia.
概括
雷戈拉菲尼布显著改善了先进的胃和食管胃结癌 (AGOC) 患者的整体存活率,这些患者对先前的治疗不耐药. 这种口服多酶抑制剂提供了一种新的治疗选择,提高了无进展的生存率和生活质量.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 晚期胃和食管胃结癌 (AGOC) 对耐火病例的治疗选择有限.
- 作为口服的多酶抑制剂,Regorafenib在INTEGRATE I试验中先前已经证明了无进展生存率 (PFS) 的改善.
研究的目的:
- 评估regorafenib在改善耐药性晚期胃和食道结癌 (AGOC) 患者的整体生存期 (OS) 的疗效.
主要方法:
- 一项双盲,安慰剂对照,随机的III期试验 (INTEGRATE IIa) 比较了regorafenib加最佳支持性护理 (BSC) 与安慰剂加BSC.
- 参与者在至少两次先前治疗后确认了转移/晚期AGOC.
- 主要终点是整体生存 (OS),次要终点包括PFS,客观反应率,安全和生活质量 (QoL).
主要成果:
- 雷戈拉费尼布在综合总生存 (OS) 中显著改善 (HR 0.70; P = .001) 和单独在INTEGRATE IIa队列中 (HR 0.68; P = .006).
- 中位数的生存期为4.5个月,与4.0个月与安慰剂.
- 雷戈拉芬尼还显著改善了无进展生存 (PFS) (HR 0.53;P < .0001) 和延迟了QOL恶化.
结论:
- 与安慰剂相比,对于耐火性晚期胃和食管胃结癌 (AGOC) 的患者,雷戈拉菲尼布提供了生存益处.
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