高风险视网母细胞瘤的化学治疗周期为3次或6次:随机临床试验
Huijing Ye1, Kang Xue2, Ping Zhang1
1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
JAMA
|October 21, 2024
概括
对于高风险视网膜母细胞瘤,三轮CEV化疗 (碳酸,乙氧化物和温克里斯) 不低于六轮. 这一发现支持较少的密集治疗方案,减少不良事件和成本.
科学领域:
- 儿童瘤学
- 眼科 眼科
- 临床试验
背景情况:
- 辅助化疗对于视网膜母细胞瘤治疗至关重要.
- 在有限的对比试验中,对高风险病例进行了不同CEV化疗周期的比较.
研究的目的:
- 为了确定CEV化疗的3个周期是否不低于具有高风险病理特征的无核单边视网膜母细胞瘤的6个周期.
主要方法:
- 一个随机的,开放的,非劣势性试验,涉及187名核化单侧视网膜母细胞瘤患者.
- 患者接受了3个或6个循环的CEV化疗.
- 主要终点是没有疾病的5年生存期.
主要成果:
- 3个周期的无病生存率为90. 4%,而6个周期的无病生存率为89. 2%,符合非劣质性标准.
- 三周期组的副作用较少,生活质量更好,成本更低.
- 随访时间中位数为79个月.
结论:
- 对于高风险视网膜母细胞瘤,三轮CEV化疗是一种可行的,不低于六轮的替代方案.
- 这支持缓解化疗方法,改善患者的治疗结果,减少医疗负担.
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