在高级GIST中对Ripretinib进行大规模,多中心,前性注册表研究:来自中国的真实世界研究
Xinhua Zhang1, Peng Zhang2, Haibo Qiu3
1The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
Advances in therapy
|June 25, 2023
概括
利普雷提尼布在中国的晚期胃肠道 stromal 瘤 (GIST) 患者中显示出有效性和可容忍的安全性. 它是一种可行的第四线治疗选择,特别是在非胃肠胃结核病.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 药理学 药理学是指药理学的学科.
背景情况:
- 氨酸激酶抑制剂 (TKIs) 是晚期胃肠瘤 (GIST) 的标准药物.
- 二次突变可以导致疾病进展,尽管TKI治疗.
- 利普雷提尼布是一种新的TKI,针对各种耐药突变.
研究的目的:
- 为了评估ripretinib的实际有效性和安全性.
- 评估ripretinib作为中国患者晚期GIST的第四线治疗方法.
主要方法:
- 未来的,大规模的,现实世界的注册表研究.
- 招募的患者年龄≥18岁,患有复发性/转移性GIST.
- 关键终点:中位数无进展生存期 (mPFS),中位数整体生存期 (mOS) 和不良事件 (AE).
主要成果:
- 招募了240名患者;中位数随访时间为6.5个月.
- mPFS为7.70个月;没有达到mOS.
- 疾病控制率为73%,瘤缩率为43%. 利普雷丁尼布在基因突变子组中有效.
- 可容忍的毒性:脱发 (17.1%),手脚综合征 (15.4%).
- 与PFS相关的ECOG状态和非胃GIST.
结论:
- 利普雷提尼布在中国高级GIST患者中显示出有效性和可容忍的安全性.
- 利普雷提尼布是一种可行的第四线或后一线治疗选择.
- 非胃肠道GIST显示出优越的益处.
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