Efficacy and safety of ruxolitinib in Asian patients with myelofibrosis

被引：35

作者：

Jung, Chul Won ^{[1
]}

Shih, Lee-Yung ^{[2
,3
]}

Xiao, Zhijian ^{[4
,5
,6
,7
]}

Jie, Jin ^{[8
]}

Hou, Hsin-An ^{[9
]}

Du, Xin ^{[10
]}

Wang, Ming-Chung ^{[11
]}

Park, Seonyang ^{[12
]}

Eom, Ki-Seong ^{[13
]}

Oritani, Kenji ^{[14
]}

Okamoto, Shinichiro ^{[15
]}

Tauchi, Tetsuzo ^{[16
]}

Kim, Jin Seok ^{[17
]}

Zhou, Daobin ^{[18
]}

Saito, Shigeki ^{[19
]}

Li, Junmin ^{[20
]}

Handa, Hiroshi ^{[21
]}

Li Jianyong ^{[22
]}

Ohishi, Kohshi ^{[23
]}

Hou, Ming ^{[24
]}

Wu Depei ^{[25
]}

Takenaka, Katsuto ^{[26
]}

Liu, Ting ^{[27
]}

Hu, Yu ^{[28
]}

Amagasaki, Taro ^{[29
]}

Ito, Kazuo ^{[29
]}

Gopalakrishna, Prashanth ^{[30
]}

Akashi, Koichi ^{[26
]}

机构：

[1] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Seoul, South Korea

[2] Chang Gung Mem Hosp LK, Chang Gung, Taiwan

[3] Chang Gung Univ, Chang Gung, Taiwan

[4] Chinese Acad Med Sci, Inst Hematol, Tianjin, Peoples R China

[5] Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China

[6] Chinese Acad Med Sci, State Key Lab Expt Hematol, Tianjin, Peoples R China

[7] Peking Union Med Coll, Tianjin, Peoples R China

[8] Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou, Zhejiang, Peoples R China

[9] Natl Taiwan Univ Hosp, Taipei, Taiwan

[10] Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China

[11] Chang Gung Mem Hosp KS, Kaohsiung, Taiwan

[12] Seoul Natl Univ Hosp, Seoul 110744, South Korea

[13] Catholic Univ Korea, Seoul St Marys Hosp, Seoul, South Korea

[14] Osaka Univ Hosp, Osaka 553, Japan

[15] Keio Univ Hosp, Tokyo, Japan

[16] Tokyo Med Univ Hosp, Tokyo, Japan

[17] Yonsei Univ, Coll Med, Severance Hosp, Seoul, South Korea

[18] Beijing Union Med Coll Hosp, Beijing, Peoples R China

[19] Nagoya Univ Hosp, Nagoya, Aichi, Japan

[20] Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Shanghai 200030, Peoples R China

[21] Gunma Univ Hosp, Gunma, Japan

[22] Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China

[23] Mie Univ Hosp, Tsu, Mie, Japan

[24] Shandong Univ, Qilu Hosp, Jinan 250100, Peoples R China

[25] Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China

[26] Kyushu Univ Hosp, Fukuoka 812, Japan

[27] Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China

[28] Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Wuhan 430074, Peoples R China

[29] Novartis Pharma KK, Tokyo, Japan

[30] Novartis Pharma AG, Basel, Switzerland

来源：

LEUKEMIA & LYMPHOMA | 2015年 / 56卷 / 07期

关键词：

Myelofibrosis; JAK1/JAK2; inhibitor; phase; 2; Asian patient population; SYMPTOM ASSESSMENT FORM; QUALITY-OF-LIFE; LEUKEMIC TRANSFORMATION; AVAILABLE THERAPY; JAK2; INHIBITOR; SURVIVAL; INCB018424; MANAGEMENT; BURDEN; TRIAL;

D O I：

10.3109/10428194.2014.969260

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

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.

引用

页码：2067 / 2074

页数：8

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