第I阶段临床试验,用于缓解升级的符合性辐射,以化学疗法为先进的子宫内膜癌 (DeCRESCEndo) 连续加快
Joshua P Schiff1, Silpa Raju-Salicki2, Tyler R McKinnish3
1Washington University School of Medicine, Department of Radiation Oncology, St. Louis, MO, USA; Keck School of Medicine of USC, Department of Radiation Oncology, Los Angeles, CA, USA.
International journal of radiation oncology, biology, physics
|January 23, 2026
概括
低分离辐射 (hypo-RT) 与化疗相结合是晚期子宫内膜癌的安全治疗方法. 这项研究发现严重毒性率很低,这表明可能需要进一步的试验.
科学领域:
- 妇科瘤学 妇科瘤学
- 辐射瘤学 辐射瘤学
- 医学瘤学 医学瘤学
背景情况:
- 对局部晚期子宫内膜癌的低分离辐射 (hypo-RT) 与化疗相结合的安全性和有效性在很大程度上是未知的.
- 这项研究旨在评估在该患者群体中化疗后测序的低RT的安全性.
研究的目的:
- 评估一种治疗方案的安全性和耐受性,包括辅助化疗,其次是低分离辐射疗法 (hypo-RT),用于局部晚期子宫内膜癌.
- 确定胃肠道,生殖尿道和血液系统中急性和晚期高度毒性 (G3-5) 的发生率.
主要方法:
- 一个I阶段试验招募了患有FIGO 2009阶段III-IVA子宫内膜腺癌或任何阶段的血清性,透明细胞或癌细胞瘤的患者.
- 患者接受了手术分期,辅助化疗和强度调节的辐射疗法 (25 Gy/5 分数) 到阴道袖口和盆地.
- 主要终点包括急性和晚期高度毒性;次要终点包括生活质量和生存结果.
主要成果:
- 25名患者被招募并接受了评估. 大多数完成化疗 (21/25) 和所有完成的低RT (25/25).
- 急性高度毒性为GI和GU的0%和血液的12%. 晚期高度毒性为GI和GU的0%和血液的4%.
- 没有观察到G4-5毒性. 随访时间中位数为24.7个月,复发率为4%在现场和16%远程;与癌症相关的死亡率为8%.
结论:
- 切除子宫,然后进行辅助化疗和低RT,是局部晚期子宫内膜癌的安全治疗策略.
- 该疗法显示高度毒性发生率低,表明耐受性良好.
- 这种综合模式的方法需要在随机临床试验中进一步调查,以确认有效性.
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