作者
Jeffrey E Lancet, Geoffrey L Uy, Laura F Newell, Tara L Lin, Ellen K Ritchie, Robert K Stuart, Stephen A Strickland, Donna Hogge, Scott R Solomon, Dale L Bixby, Jonathan E Kolitz, Gary J Schiller, Matthew J Wieduwilt, Daniel H Ryan, Stefan Faderl, Jorge E Cortes
发表日期
2021/7/1
期刊
The Lancet Haematology
卷号
8
期号
7
页码范围
e481-e491
出版商
Elsevier
简介
Background
Daunorubicin and cytarabine are used as standard induction chemotherapy for patients with acute myeloid leukaemia. CPX-351 is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio. Primary analysis of the phase 3 trial in adults aged 60–75 years with newly diagnosed high-risk or secondary acute myeloid leukaemia provided support for approval of CPX-351 by the US Food and Drug Administration and European Medicines Agency. We describe the prospectively planned final 5-year follow-up results.
Methods
This randomised, open-label, multicentre, phase 3 trial was done across 39 academic and regional cancer centres in the USA and Canada. Eligible patients were aged 60–75 years and had a pathological diagnosis of acute myeloid leukaemia according to WHO 2008 criteria, no previous induction therapy for acute myeloid leukaemia, and an …
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JE Lancet, GL Uy, LF Newell, TL Lin, EK Ritchie… - The Lancet Haematology, 2021