更新的整体存活率和长期安全性与ripretinib对苏尼提尼布在患有胃肠道瘤的患者:从INTRIGUE的最终整体存活分析
Michael C Heinrich1,2, Jean-Yves Blay3, Hans Gelderblom4
1Portland VA Health Care System, Portland, OR.
概括
在INTRIGUE试验中,ripretinib与sunitinib在晚期胃肠道侧面瘤中的总生存率和无进展生存率相似. 利普雷提尼布在之前接受过意马替尼布治疗的患者中显示出可比的长期安全性.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠道侧管瘤 胃肠道侧管瘤
背景情况:
- 先进的胃肠道 stromal 瘤 (GIST) 通常需要连续治疗.
- 伊马替尼是标准的第一线治疗,但耐药性需要进一步的选择.
- 利普雷提尼布和苏尼蒂尼布是用于GIST治疗的后续线路中的铁氨酸激酶抑制剂.
研究的目的:
- 报告第三阶段INTRIGUE试验的最终总生存期 (OS) 和无进展生存期 (PFS) 数据.
- 评估与sunitinib相比,ripretinib在先进的GIST患者中长期的安全性.
- 评估二线ripretinib对随后的第三线治疗PFS的影响.
主要方法:
- 第三阶段,随机对照试验 (INTRIGUE,NCT03673501) 进行.
- 以前接受过意马提尼布治疗的高级GIST的成年患者被随机分为1:1接受ripretinib或sunitinib.
- 最终分析OS和第二次PFS (第三线治疗) 和安全数据.
主要成果:
- 在整体 (35.5 vs 31.5 个月) 和KIT exon 11 (35.5 vs 32.8 个月) 两种群体中,ripretinib和sunitinib手臂之间的中位数OS相似.
- 第二次PFS的中位数在两支手臂之间也是相似的 (7.7个月与7.4个月).
- 安全概况与之前的报告一致,没有发现新的安全问题.
结论:
- 利普雷提尼布的整体存活率和无进展存活率与sunitinib作为高级GIST的二线治疗方法相似.
- 利普雷提尼布的安全性概况保持一致,支持其在该患者群体中的使用.
- 用ripretinib治疗似乎不会对随后的第三线疗法的疗效产生负面影响.
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