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随机的第三期研究比较新辅助化疗后手术与化疗在IB2-IIB宫癌阶段:EORTC-55994

Gemma G Kenter¹, Stefano Greggi², Ignace Vergote³

¹Center for Gynaecologic Oncology Amsterdam, Amsterdam University Medical Center, Netherlands Cancer Institute, Amsterdam, the Netherlands.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|September 1, 2023

概括

手术前的新辅助化疗与化疗和放射治疗相比,没有改善IB2-IIB期子宫癌的存活率. 在这个多中心试验中,这两种治疗都显示出可以接受的副作用和生活质量.

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:

关于治疗IB2-IIB期子宫癌的最佳治疗方法,存在相互矛盾的证据.
术后的新辅助化疗 (NACT-S) 和同时进行的化疗放射治疗 (CCRT) 都是标准的治疗选择.

研究的目的:

为了比较NACT-S与标准CCRT在患有IB2-IIB期子宫癌的患者中的疗效和安全性.
评估5年总生存期 (OS) 作为主要终点.

主要方法:

一个多中心随机试验,涉及626名患有IB2-IIB期子宫癌的患者.
患者被分配到NACT-S (n=314) 或CCRT (n=312).
主要终点:五年后的生存率. 二级终点:无进展的生存率,正常运行,毒性和与健康有关的生活质量 (HRQOL).

主要成果:

随访时间中位数为8.7年;发生198例死亡 (31.6%).
五年后的OS率相似:72% (NACT-S) 与76% (CCRT) 相比.
短期不良事件 (≥3级) 在NACT-S治疗中更频繁 (41%vs23%),而长期不良事件在CCRT治疗中更频繁 (21%vs15%).

结论:

在治疗宫癌IB2-IIB阶段的5年生存期方面,NACT-S并未显示其优于CCRT.
这两种治疗策略都导致了可接受的发病率和与健康有关的生活质量.
进一步的研究可能会探索优化治疗顺序或患者选择.

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