慢性淋巴细胞白血病治疗以可测量的残留疾病为指导
Talha Munir1, David A Cairns1, Adrian Bloor1
1From the Department of Clinical Hematology (T.M., P.H.) and the Hematological Malignancy Diagnostic Service (N.W., S.D., R.T., A.R.), Leeds Cancer Centre, and the Leeds Cancer Research UK Clinical Trials Unit (D.A.C., D.H., A.H., S.J., N.G., S.G., S.B., J.M.B.) and Leeds Institute of Medical Research (N.W., S.D., P.H.), University of Leeds, Leeds, the Christie Hospital NHS Foundation Trust and the University of Manchester, Manchester (A.B.), Hull University Teaching Hospitals NHS Trust, Hull (D.A.), University College London Hospitals NHS Foundation Trust (K.C.), the Comprehensive Cancer Centre, King's College London (P.E.M.P.), King's College Hospital NHS Foundation Trust (P.E.M.P.), and Barts Health NHS Trust (J.G.), London, the Clatterbridge Cancer Centre NHS Foundation Trust and the University of Liverpool, Liverpool (A.P.), University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.P.), Nottingham University Hospitals NHS Trust, Nottingham (C.P.F), Oxford University Hospitals NHS Foundation Trust, Oxford (T.A.E., A.S.), Cancer Sciences, Faculty of Medicine, University of Southampton and the Hematology Department, Cancer Care Directorate, University Hospital Southampton NHS Foundation Trust, Southampton (F.F.), University Hospital of Wales, Cardiff (N.E.), University Hospitals of Leicester NHS Trust, Leicester (B.K.), Worcestershire Acute Hospitals NHS Trust, Worcester (N.P.), Belfast City Hospital, Belfast (O.S.), Aberdeen Royal Infirmary, Aberdeen (G.P.), University Hospitals Dorset NHS Foundation Trust, Bournemouth (R.W.), and CLL Support, Chippenham (L.D.) - all in the United Kingdom.
与FCR相比,可测量的残留病导向易布鲁替尼-维内托克拉克斯在慢性淋巴细胞白血病 (CLL) 患者中显著改善了无进展生存期. 整体存活率也有利于易布鲁替尼-韦内托克拉克斯疗法.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 慢性淋巴细胞白血病 (CLL) 治疗结果与IBRUTINIB-VENETOCLAX组合比化疗免疫疗法有所改善.
- 在未经治疗的CLL中,MRD导向的易布鲁替尼-维内托克拉克斯治疗时间与弗鲁达拉宾-环胺-瑞图西马布 (FCR) 的疗效仍在研究中.
研究的目的:
- 在未经治疗的CLL患者中,将MRD导向的ibrutinib-venetoclax治疗与FCR的疗效进行比较.
- 评估两种治疗方案的无进展生存率,总生存率,反应率,MRD状态和安全性.
主要方法:
- 一项第三期多中心,随机,受控,开放标签试验在未经治疗的CLL患者中比较了ibrutinib-venetoclax与FCR.
- 易布鲁替尼-威尼托克拉克斯治疗包括2个月的易布鲁替尼,然后是威尼托克拉克斯,持续时间根据MRD水平进行个性化.
- 主要终点是无进展生存;次要终点包括整体生存,反应,MRD和安全.
主要成果:
- 患上IBRUTINIB-VENETOCLAX (12/523) 治疗的患者明显少于FCR (75/523) 治疗的患者 (HR 0.13,P<0.001) 发生疾病进展或死亡.
- 整体存活率有利于ibrutinib-venetoclax,这一组的死亡人数较少 (9对25).
- 使用ibrutinib-venetoclax实现了高不可检测的MRD率 (58%在3年,65.9%骨髓和92.7%周围血液在5年);感染风险类似,但心脏事件在ibrutinib-venetoclax时更高.
结论:
- 与FRC相比,MRD导向的易布鲁替尼-维内托克拉克斯在未经治疗的CLL中显著改善了无进展的存活率.
- 总体生存结果也有利于易布鲁替尼-韦内托克拉克斯疗法.
- 基于MRD的个性化治疗持续时间是优化CLL治疗的可行策略.
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