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Efficacy and safety of ruxolitinib in Asian patients with myelofibrosis

 Chul Won Jung  ;  Lee Yung Shih  ;  Koichi Akashi  ;  Prashanth Gopalakrishna  ;  Kazuo Ito  ;  Taro Amagasaki  ;  Yu Hu  ;  Ting Liu  ;  Katsuto Takenaka  ;  Wu Depei  ;  Ming Hou  ;  Kohshi Ohishi  ;  Li Jianyong  ;  Hiroshi Handa  ;  Junmin Li  ;  Shigeki Saito  ;  Daobin Zhou  ;  Jin Seok Kim  ;  Tetsuzo Tauchi  ;  Shinichiro Okamoto  ;  Kenji Oritani  ;  Ki Seong Eom  ;  Seonyang Park  ;  Ming Chung Wang  ;  Xin Du  ;  Hsin An Hou  ;  Jin Jie  ;  Zhijian Xiao 
 LEUKEMIA & LYMPHOMA, Vol.56(7) : 2067-2074, 2015 
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Issue Date
Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group ; Female ; Follow-Up Studies ; Humans ; Janus Kinase 1/antagonists & inhibitors* ; Janus Kinase 2/antagonists & inhibitors* ; Male ; Middle Aged ; Neoplasm Staging ; Primary Myelofibrosis/drug therapy* ; Primary Myelofibrosis/pathology ; Prognosis ; Protein Kinase Inhibitors/therapeutic use* ; Pyrazoles/therapeutic use* ; Quality of Life*
Asian patient population ; JAK1/JAK2 inhibitor ; Myelofibrosis ; phase 2
Myelofibrosis is characterized by progressive cytopenias, bone marrow fibrosis, splenomegaly and severe constitutional symptoms. In the phase 3 Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment (COMFORT) studies, ruxolitinib, a potent Janus kinase 1 (JAK1)/JAK2 inhibitor, provided substantial improvements in splenomegaly, symptoms, quality-of-life measures and overall survival compared with placebo or best available therapy. No assessments of the efficacy and safety of ruxolitinib have been conducted in Asian patients. Here, we describe results from an open-label, single-arm, phase 2 trial evaluating ruxolitinib in Asian patients with myelofibrosis (n = 120). The primary endpoint was met, with 31.7% of patients achieving a ≥ 35% reduction from baseline spleen volume at week 24. As measured by the 7-day Myelofibrosis Symptom Assessment Form v2.0, 49% of patients achieved a ≥ 50% reduction from baseline in total symptom score. Adverse events were consistent with those seen in the COMFORT studies. Ruxolitinib was well tolerated in Asian patients with myelofibrosis and provided substantial reductions in splenomegaly and improvements in symptoms.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jin Seok(김진석) ORCID logo https://orcid.org/0000-0001-8986-8436
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