作者
Animesh Pardanani, Claire Harrison, Jorge E Cortes, Francisco Cervantes, Ruben A Mesa, Donald Milligan, Tamás Masszi, Elena Mishchenko, Eric Jourdan, Alessandro M Vannucchi, Mark W Drummond, Mindaugas Jurgutis, Kazimierz Kuliczkowski, Emanuil Gheorghita, Francesco Passamonti, Frank Neumann, Abhay Patki, Guozhi Gao, Ayalew Tefferi
发表日期
2015/8/1
期刊
JAMA oncology
卷号
1
期号
5
页码范围
643-651
出版商
American Medical Association
简介
Importance
Myelofibrosis (MF) is aBCR-ABL–negative myeloproliferative neoplasm characterized by anemia, splenomegaly, debilitating constitutional symptoms, and shortened survival. Fedratinib, a JAK2-selective inhibitor, previously demonstrated clinically beneficial activity in patients with MF in early-phase trials.
Objective
To evaluate the efficacy and safety of fedratinib therapy in patients with primary or secondary (post–polycythemia vera or post–essential thrombocythemia) MF.
Design, Setting, and Participants
Double-blind, randomized, placebo-controlled phase 3 study in 94 sites in 24 countries in which 289 adult patients (≥18 years of age) with intermediate-2 or high-risk primary MF, post–polycythemia vera MF, or post–essential thrombocythemia MF were randomly assigned between December 2011 and September 2012 to once-daily oral fedratinib, at a dose of 400 mg or 500 mg, or placebo, for at least 6 …
学术搜索中的文章
A Pardanani, C Harrison, JE Cortes, F Cervantes… - JAMA oncology, 2015