Title | Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China |
Authors | Shi, Yuankai Jia, Bo Xu, Wei Li, Wenyu Liu, Ting Liu, Peng Zhao, Weili Zhang, Huilai Sun, Xiuhua Yang, Haiyan Zhang, Xi Jin, Jie Jin, Zhengming Li, Zhiming Qiu, Lugui Dong, Mei Huang, Xiaobing Luo, Yi Wang, Xiaodong Wang, Xin Wu, Jianqiu Xu, Jingyan Yi, Pingyong Zhou, Jianfeng He, Hongming Liu, Lin Shen, Jianzhen Tang, Xiaoqiong Wang, Jinghua Yang, Jianmin Zeng, Qingshu Zhang, Zhihui Cai, Zhen Chen, Xiequn Ding, Kaiyang Hou, Ming Huang, Huiqiang Li, Xiaoling Liang, Rong Liu, Qifa Song, Yuqin Su, Hang Gao, Y |
Affiliation | Chinese Acad Med Sci, Natl Canc Ctr, Beijing Key Lab Clin Study Anticancer Mol Targete, Dept Med Oncol,Canc Hosp, Beijing 100021, Peoples R China. Peking Union Med Coll, Beijing 100021, Peoples R China. Peking Univ, Canc Hosp & Inst, Beijing, Peoples R China. Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China. Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China. Sichuan Univ, West China Hosp, Chengdu, Peoples R China. Zhongshan Hosp, Shanghai, Peoples R China. Shanghai Ruijin Hosp, Shanghai, Peoples R China. Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China. Dalian Med Univ, Hosp 2, Dalian, Peoples R China. Zhejiang Canc Hosp, Hangzhou, Zhejiang, Peoples R China. Third Mil Med Univ, Xinqiao Hosp, Chongqing, Peoples R China. Zhejiang Univ, Affiliated Hosp 1, Hangzhou, Zhejiang, Peoples R China. Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China. Sun Yat Sen Univ, Ctr Canc, Guangzhou, Guangdong, Peoples R China. Chinese Acad Med Sci, Hematol Inst & Hosp, Tianjin, Peoples R China. Peking Union Med Coll, Tianjin, Peoples R China. Sichuan Prov Peoples Hosp, Chengdu, Peoples R China. Hunan Canc Hosp, Changsha, Hunan, Peoples R China. Shandong Prov Hosp, Jinan, Peoples R China. Jiangsu Canc Hosp, Nanjing, Jiangsu, Peoples R China. Nanjing Drum Tower Hosp, Nanjing, Jiangsu, Peoples R China. Tongji Hosp, Wuhan, Peoples R China. Fujian Prov Canc Hosp, Fuzhou, Peoples R China. Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China. Fujian Med Univ, Union Hosp, Fuzhou, Peoples R China. Gen Hosp Nanjing Mil Reg, Nanjing, Jiangsu, Peoples R China. Changhai Hosp, Shanghai, Peoples R China. Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China. Sichuan Canc Hosp & Inst, Chengdu, Peoples R China. Fourth Mil Med Univ, Xijing Hosp, Xian, Peoples R China. Anhui Prov Hosp, Hefei, Peoples R China. Shandong Univ, QiLu Hosp, Jinan, Peoples R China. Liaoning Canc Hosp & Inst, Dalian, Peoples R China. Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China. Chinese Peoples Liberat Army, Hosp 307, Beijing, Peoples R China. Hebei Med Univ, Tumor Hosp Hebei Prov, Hosp 4, Shijiazhuang, Peoples R China. Hebei Med Univ, Hosp 2, Shijiazhuang, Peoples R China. Shanxi Prov Canc Hosp, Taiyuan, Peoples R China. Guangzhou Med Univ, Affiliated Hosp 1, Guangzhou, Guangdong, Peoples R China. Tianjin Peoples Hosp, Tianjin, Peoples R China. Beijing Tongren Hosp, Beijing, Peoples R China. Harbin Med Univ, Affiliated Hosp 1, Harbin, Peoples R China. Peking Univ, Shenzhen Hosp, Shenzhen, Peoples R China. Zhejiang Univ, Sch Med, Affiliated Hosp 2, Hangzhou, Zhejiang, Peoples R China. Beijing Union Med Coll Hosp, Beijing, Peoples R China. Jilin Univ, Hosp 1, Changchun, Peoples R China. Wuhan Union Hosp China, Wuhan, Peoples R China. Chinese Acad Med Sci, Natl Canc Ctr, Beijing Key Lab Clin Study Anticancer Mol Targete, Dept Med Oncol,Canc Hosp, Beijing 100021, Peoples R China. Shi, YK (reprint author), Peking Union Med Coll, Beijing 100021, Peoples R China. |
Keywords | Chidamide Peripheral T cell lymphoma Treatment Chemotherapy OPEN-LABEL PHASE-II CLASSIFICATION THERAPY |
Issue Date | 2017 |
Publisher | JOURNAL OF HEMATOLOGY & ONCOLOGY |
Citation | JOURNAL OF HEMATOLOGY & ONCOLOGY.2017,10. |
Abstract | The efficacy and safety of chidamide, a new subtype-selective histone deacetylase (HDAC) inhibitor, have been demonstrated in a pivotal phase II clinical trial, and chidamide has been approved by the China Food and Drug Administration (CFDA) as a treatment for relapsed or refractory peripheral T cell lymphoma (PTCL). This study sought to further evaluate the real-world utilization of chidamide in 383 relapsed or refractory PTCL patients from April 2015 to February 2016 in mainland China. For patients receiving chidamide monotherapy (n = 256), the overall response rate (ORR) and disease control rate (DCR) were 39.06 and 64.45%, respectively. The ORR and DCR were 51. 18 and 74.02%, respectively, for patients receiving chidamide combined with chemotherapy (n = 127). For patients receiving chidamide monotherapy and chidamide combined with chemotherapy, the median progression-free survival (PFS) was 129 (95% CI 82 to 194) days for the monotherapy group and 152 (95% CI 93 to 201) days for the combined therapy group (P = 0.3266). Most adverse events (AEs) were of grade 1 to 2. AEs of grade 3 or higher that occurred in >= 5% of patients receiving chidamide monotherapy included thrombocytopenia (10.2%) and neutropenia (6.2%). For patients receiving chidamide combined with chemotherapy, grade 3 to 4 AEs that occurred in >= 5% of patients included thrombocytopenia (18.1%), neutropenia (12.6%), anemia (7.1%), and fatigue (5.5%). This large real-world study demonstrates that chidamide has a favorable efficacy and an acceptable safety profile for refractory and relapsed PTCL patients. Chidamide combined with chemotherapy may be a new treatment choice for refractory and relapsed PTCL patients but requires further investigation. |
URI | http://hdl.handle.net/20.500.11897/474578 |
ISSN | 1756-8722 |
DOI | 10.1186/s13045-017-0439-6 |
Indexed | SCI(E) |
Appears in Collections: | 北京肿瘤医院 深圳医院 |