IR@PKUHSC  > 北京大学第三临床医学院  > 血液内科
学科主题临床医学
Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma
Shi, Y.1,2; Dong, M.1,2; Hong, X.3; Zhang, W.4; Feng, J.5; Zhu, J.6; Yu, L.7; Ke, X.8; Huang, H.9; Shen, Z.10; Fan, Y.11; Li, W.12; Zhao, X.13; Qi, J.14,15,16; Huang, H.17; Zhou, D.18,19; Ning, Z.20; Lu, X.20
关键词Chidamide Hdac Inhibitor Epigenetic T-cell Lymphoma Pivotal Trial
刊名ANNALS OF ONCOLOGY
2015-08-01
DOI10.1093/annonc/mdv237
26期:8页:1766-1771
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology
资助者Chipscreen Biosciences, Ltd, Shenzhen, China ; Chinese National &prime ; 863&prime ; Project ; National &prime ; New Drug Innovation&prime ; Significant Project in Biotech Field from Guangdong Province ; Shenzhen Municipal Government ; Chipscreen Biosciences, Ltd, Shenzhen, China ; Chinese National &prime ; 863&prime ; Project ; National &prime ; New Drug Innovation&prime ; Significant Project in Biotech Field from Guangdong Province ; Shenzhen Municipal Government
研究领域[WOS]Oncology
关键词[WOS]HISTONE DEACETYLASE INHIBITOR ; CANCER ; CS055/HBI-8000 ; APOPTOSIS
英文摘要

Background: Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor with unique mechanisms of action compared with marketed HDAC inhibitors. This phase II study was to evaluate the efficacy and safety of chidamide in relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population.

Patients and methods: Patients with relapsed or refractory PTCL of different subtypes received chidamide of 30 mg orally twice per week. The primary end point was overall response rate (ORR). Responding patients should be confirmed at least 4 weeks after the criteria of the response were first met, and were reviewed by an independent review committee.

Results: Eighty-three patients were enrolled and 79 patients with eligible PTCL histology were for efficacy assessments. Patients enrolled over 10% were with subtypes of PTCL not otherwise specified (34%), anaplastic large-cell lymphoma (22%), extranodal natural killer (NK)/T-cell lymphoma, nasal type (20%), or angioimmunoblastic T-cell lymphoma (AITL, 13%). The ORR was 28% (22 of 79) including 14% (11 of 79) with complete response/unconfirmed complete response (CR/CRu). Median progression-free survival and overall survival were 2.1 and 21.4 months, respectively. AITL patients tended to have higher ORR (50%) and CR/CRu rate (40%), as well as more durable responses, to chidamide treatment. Most adverse events (AEs) were grade 1 or 2, and AEs >= grade 3 that occurred in >= 10% patients were thrombocytopenia (22%), leucopenia (13%) and neutropenia (11%), respectively.

Conclusion: Chidamide represents a novel oral benzamide class of HDAC inhibitor with significant single-agent activity and manageable toxicity in relapsed or refractory PTCL, and provides a much needed treatment option in this indication in China. Results led to China Food and Drug Administration approval of chidamide in this indication.

语种英语
所属项目编号2006AA020603 ; 2008AA02Z303 ; 2009ZX09401-003 ; 2008ZX09312 ; 2012ZX09303012 ; 2011A080501009 ; 2003A10903 ; 2010-1600
资助者Chipscreen Biosciences, Ltd, Shenzhen, China ; Chinese National &prime ; 863&prime ; Project ; National &prime ; New Drug Innovation&prime ; Significant Project in Biotech Field from Guangdong Province ; Shenzhen Municipal Government ; Chipscreen Biosciences, Ltd, Shenzhen, China ; Chinese National &prime ; 863&prime ; Project ; National &prime ; New Drug Innovation&prime ; Significant Project in Biotech Field from Guangdong Province ; Shenzhen Municipal Government
WOS记录号WOS:000359312100033
引用统计
被引频次:34[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55779
专题北京大学第三临床医学院_血液内科
作者单位1.Jiangsu Canc Hosp, Dept Med Oncol, Nanjing, Jiangsu, Peoples R China
2.Beijing Caner Hosp, Dept Med Oncol, Beijing, Peoples R China
3.Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China
4.307 Hosp PLA, Dept Lymphoma, Beijing, Peoples R China
5.Chinese Acad Med Sci, Dept Med Oncol, Canc Hosp, Beijing 100021, Peoples R China
6.Peking Union Med Coll, Beijing Key Lab Clin Study Anticanc Mol Targeted, Beijing 100021, Peoples R China
7.Fudan Univ, Shanghai Canc Ctr, Dept Med Oncol, Shanghai 200433, Peoples R China
8.Chinese Peoples Liberat Army Gen Hosp, Dept Hematol, Beijing, Peoples R China
9.Peking Univ, Dept Hematol, Hosp 3, Beijing 100871, Peoples R China
10.Sun Yat Sen Univ, Dept Med Oncol, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China
11.Shanghai Jiao Tong Univ, Ruijin Hosp, Coll Med, Dept Hematol, Shanghai 200030, Peoples R China
12.Jilin Univ, Dept Hematol, Hosp 1, Changchun 130023, Peoples R China
13.Cent S Univ, Xiangya Hosp, Dept Hematol, Changsha, Hunan, Peoples R China
14.Chinese Acad Med Sci, Inst Hematol, Dept Lymphoma, Tianjin, Peoples R China
15.Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China
16.Peking Union Med Coll, Tianjin, Peoples R China
17.Zhejiang Univ, Affiliated Hosp 1, Dept Hematol, Hangzhou 310003, Zhejiang, Peoples R China
18.Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Hematol, Beijing 100730, Peoples R China
19.Peking Union Med Coll, Beijing 100021, Peoples R China
20.Chipscreen Biosci Ltd, Shenzhen, Peoples R China
推荐引用方式
GB/T 7714
Shi, Y.,Dong, M.,Hong, X.,et al. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma[J]. ANNALS OF ONCOLOGY,2015,26(8):1766-1771.
APA Shi, Y..,Dong, M..,Hong, X..,Zhang, W..,Feng, J..,...&Lu, X..(2015).Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma.ANNALS OF ONCOLOGY,26(8),1766-1771.
MLA Shi, Y.,et al."Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma".ANNALS OF ONCOLOGY 26.8(2015):1766-1771.
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