两种新诊断的尤金肉瘤患者的化疗方案的比较 (EE2012):一个开放的,随机的,第三阶段的试验
Bernadette Brennan1, Laura Kirton2, Perrine Marec-Bérard3
1Department of Paediatric Oncology and Haematology, Royal Manchester Children's Hospital, Manchester, UK.
Lancet (London, England)
|December 15, 2022
概括
与欧洲治疗方案相比,美国对尤宁肉瘤的化疗疗法改善了无事件生存率. 这种剂量密集的方法被推为新诊断的尤宁肉瘤患者的新标准护理.
科学领域:
- 儿童瘤学
- 医疗瘤学
- 临床试验
背景情况:
- 对于尤宁肉瘤,没有单一的国际化疗标准.
- 之前的治疗策略在欧洲和美国之间存在差异.
- 这项研究旨在比较这些已有的治疗方案.
研究的目的:
- 为了比较欧洲和美国新诊断的尤宁肉瘤的化疗方案的疗效和毒性.
- 确定一个潜在的新标准的护理.
主要方法:
- EURO EWING 2012 是一个在10个国家进行的第三阶段随机对照试验.
- 确诊的尤宁肉瘤患者 (2-49岁) 被随机 (1:1) 分给欧洲或美国治疗方案.
- 主要结果是无事件生存,使用贝叶斯方法进行分析.
主要成果:
- 美国治疗方案的无事件生存率为67% (组2),而欧洲治疗方案的生存率为61% (组1).
- 调整后的危险比率有利于美国治疗方案 (HR 0. 71; 95% CI 0. 55- 0. 92).
- 美国的治疗方案显示出较低的发烧性中性质丧失率和更少的血小板输血需求.
结论:
- 对于新诊断的尤宁肉瘤,剂量密集的美国化疗方案更有效,毒性更小.
- 这种治疗方案应被视为对尤宁肉瘤的新标准治疗.
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