在局部晚期子宫癌中Endostar加化学放射治疗的有效性:一个多中心的II期随机试验
Fang Wu1, Xiaobi Tang2, Wenqi Liu3
1Department of Radiation Oncology, First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Therapeutic advances in medical oncology
|October 6, 2025
概括
将Endostar添加到并发化学辐射疗法 (CCRT) 显著改善了全方位响应率,并减少了局部区域高级宫癌 (LACC) 患者的远程转移. 这种组合疗法在不增加毒性的情况下显示出有希望的结果,为LACC提供了潜在的新治疗选择.
科学领域:
- 在瘤学瘤学.
- 辐射疗法 辐射疗法
- 医学瘤学 医学瘤学
背景情况:
- 宫癌是妇女死亡的主要原因,70%的病例被诊断为局部晚期 (LACC).
- 同时化学放射治疗 (CCRT) 是LACC的标准,但超过30%的患者出现复发或转移.
- 改善LACC的治疗结果是一个关键的全球卫生目标.
研究的目的:
- 评估将Endostar纳入LACC患者的CCRT中的安全性和有效性.
- 为了确定Endostar是否与单独使用CCRT相比,改善了治疗反应和生存结果.
主要方法:
- 一个多中心的,随机的,受控的II期试验,涉及120名LACC患者.
- 患者被分配给单独的CCRT或CCRT加Endostar.
- 恩多斯塔尔每15天服用7.5mg/m2/天10天,每15天一次,从CCRT前5天开始.
主要成果:
- CCRT加Endostar组显示出显著更高的完全响应率 (68.3%对35.0%,p=0.001).
- 远程无转移存活 (DMFS) 显著改善了CCRT加Endostar (5年:88.0%对比67.0%,p=0.029).
- 没有观察到总体存活率,无进展存活率或局部无复发存活率的显著差异;不同组的不良事件相似.
结论:
- 将Endostar添加到CCRT显著增强瘤反应,并减少LACC患者的远程转移,而不会增加毒性.
- 患有状细胞癌,瘤直径大于4厘米或IB2/IIA2-IIB阶段疾病的患者特别受益于组合治疗方案.
- 需要在III期试验中进一步验证,以确定这种组合作为LACC的新标准治疗方法.
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