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一个随机的,受控的,开放的,第三阶段的试验
Vincent Ribrag1, Serge Koscielny2, Jacques Bosq3
1Department of Medicine, Gustave Roussy, Université Paris Saclay, Villejuif, France.
Lancet (London, England)
|April 16, 2016
概括
加入化学疗法显著改善了无事件存活的成年人伯基特白血病或淋巴瘤. 在这种患者群体中,这种向治疗可以改善结果,但不会增加不良事件.
科学领域:
- 癌症学
- 临床血液学
- 免疫疗法
背景情况:
- 伯基特白血病和淋巴瘤是B细胞恶性瘤.
- 短时间的强化化疗法是成人伯基特淋巴瘤的标准治疗方法.
- 之前的研究表明,Rituximab可能会改善结果.
研究的目的:
- 为了评估Rituximab添加到标准化疗的疗效.
- 为了确定Rituximab是否能改善成年Burkitt淋巴瘤患者的无事件存活率.
- 评估与化疗相结合的利图西马布的安全性.
主要方法:
- 一个随机的,受控的,开放的,第三阶段的试验.
- 260名未经治疗的艾滋病毒阴性伯基特淋巴瘤的成年患者被纳入.
- 根据疾病扩散和年龄分类,患者接受了单独化学疗法或化学疗法.
主要成果:
- 与没有瑞图西马布组 (62%) 相比,瑞图西马布组的3年无事件生存率显著改善 (75%).
- 无事件生存的危险比为0. 59有利于Rituximab组 (p=0. 025).
- 不良事件,包括感染和中性质减退,在不同组中相似.
结论:
- 在短时间的密集化疗中添加利图西马布可以改善Burkitt白血病或淋巴瘤的成年人无事件生存率.
- 利图西玛是治疗伯基特淋巴瘤的化学疗法的安全有效补充剂.
- 这项研究支持Rituximab作为这种血液恶性瘤治疗的标准成分.
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