PMID- 28298231 OWN - NLM STAT- MEDLINE DCOM- 20171128 LR - 20220331 IS - 1756-8722 (Electronic) IS - 1756-8722 (Linking) VI - 10 IP - 1 DP - 2017 Mar 15 TI - Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. PG - 69 LID - 10.1186/s13045-017-0439-6 [doi] LID - 69 AB - 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. FAU - Shi, Yuankai AU - Shi Y AD - Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. syuankaipumc@126.com. FAU - Jia, Bo AU - Jia B AD - Peking University Cancer Hospital and Institute, Beijing, China. FAU - Xu, Wei AU - Xu W AD - Jiangsu Province Hospital, Nanjing, China. FAU - Li, Wenyu AU - Li W AD - Guangdong General Hospital, Guangzhou, China. FAU - Liu, Ting AU - Liu T AD - West China Hospital, Sichuan University, Chengdu, China. FAU - Liu, Peng AU - Liu P AD - Zhongshan Hospital, Shanghai, China. FAU - Zhao, Weili AU - Zhao W AD - Shanghai Ruijin Hospital, Shanghai, China. FAU - Zhang, Huilai AU - Zhang H AD - Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. FAU - Sun, Xiuhua AU - Sun X AD - The Second Hospital of Dalian Medical University, Dalian, China. FAU - Yang, Haiyan AU - Yang H AD - Zhejiang Cancer Hospital, Hangzhou, China. FAU - Zhang, Xi AU - Zhang X AD - Xinqiao Hospital, Third Military Medical University, Chongqing, China. FAU - Jin, Jie AU - Jin J AD - The First Affiliated Hospital, Zhejiang University, Hangzhou, China. FAU - Jin, Zhengming AU - Jin Z AD - The First Affiliated Hospital of Soochow University, Suzhou, China. FAU - Li, Zhiming AU - Li Z AD - Sun Yat-Sen University Cancer Center, Guangzhou, China. FAU - Qiu, Lugui AU - Qiu L AD - Hematology Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. FAU - Dong, Mei AU - Dong M AD - Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. FAU - Huang, Xiaobing AU - Huang X AD - Sichuan Provincial People's Hospital, Chengdu, China. FAU - Luo, Yi AU - Luo Y AD - Hunan Cancer Hospital, Changsha, China. FAU - Wang, Xiaodong AU - Wang X AD - Sichuan Provincial People's Hospital, Chengdu, China. FAU - Wang, Xin AU - Wang X AD - Shandong Provincial Hospital, Jinan, China. FAU - Wu, Jianqiu AU - Wu J AD - Jiangsu Cancer Hospital, Nanjing, China. FAU - Xu, Jingyan AU - Xu J AD - Nanjing Drum Tower Hospital, Nanjing, China. FAU - Yi, Pingyong AU - Yi P AD - Hunan Cancer Hospital, Changsha, China. FAU - Zhou, Jianfeng AU - Zhou J AD - Tongji Hospital, Wuhan, China. FAU - He, Hongming AU - He H AD - Fujian Provincial Cancer Hospital, Fuzhou, China. FAU - Liu, Lin AU - Liu L AD - The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. FAU - Shen, Jianzhen AU - Shen J AD - Union Hospital, Fujian Medical University, Fuzhou, China. FAU - Tang, Xiaoqiong AU - Tang X AD - The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. FAU - Wang, Jinghua AU - Wang J AD - General Hospital of Nanjing Military Region, Nanjing, China. FAU - Yang, Jianmin AU - Yang J AD - Changhai Hospital, Shanghai, China. FAU - Zeng, Qingshu AU - Zeng Q AD - The First Affiliated Hospital of Anhui Medical University, Hefei, China. FAU - Zhang, Zhihui AU - Zhang Z AD - Sichuan Cancer Hospital and Institute, Chengdu, China. FAU - Cai, Zhen AU - Cai Z AD - The First Affiliated Hospital, Zhejiang University, Hangzhou, China. FAU - Chen, Xiequn AU - Chen X AD - Xijing Hospital, The Fourth Military Medical University, Xi'an, China. FAU - Ding, Kaiyang AU - Ding K AD - Anhui Provincial Hospital, Hefei, China. FAU - Hou, Ming AU - Hou M AD - QiLu Hospital of Shandong University, Jinan, China. FAU - Huang, Huiqiang AU - Huang H AD - Sun Yat-Sen University Cancer Center, Guangzhou, China. FAU - Li, Xiaoling AU - Li X AD - Liaoning Cancer Hospital and Institute, Dalian, China. FAU - Liang, Rong AU - Liang R AD - Xijing Hospital, The Fourth Military Medical University, Xi'an, China. FAU - Liu, Qifa AU - Liu Q AD - Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Song, Yuqin AU - Song Y AD - Peking University Cancer Hospital and Institute, Beijing, China. FAU - Su, Hang AU - Su H AD - The 307th Hospital of Chinese People's Liberation Army, Beijing, China. FAU - Gao, Yuhuan AU - Gao Y AD - Fourth Hospital of Hebei Medical University (Tumor Hospital of Hebei Province), Shijiazhuang, China. FAU - Liu, Lihong AU - Liu L AD - Fourth Hospital of Hebei Medical University (Tumor Hospital of Hebei Province), Shijiazhuang, China. FAU - Luo, Jianmin AU - Luo J AD - The Second Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Su, Liping AU - Su L AD - Shanxi Provincial Cancer Hospital, Taiyuan, China. FAU - Sun, Zimin AU - Sun Z AD - Anhui Provincial Hospital, Hefei, China. FAU - Tan, Huo AU - Tan H AD - The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. FAU - Wang, Huaqing AU - Wang H AD - Tianjin People's Hospital, Tianjin, China. FAU - Wang, Jingwen AU - Wang J AD - Beijing Tongren Hospital, Beijing, China. FAU - Wang, Shuye AU - Wang S AD - The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Zhang, Hongyu AU - Zhang H AD - Peking University Shenzhen Hospital, Shenzhen, China. FAU - Zhang, Xiaohong AU - Zhang X AD - The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China. FAU - Zhou, Daobin AU - Zhou D AD - Peking Union Medical College Hospital, Beijing, China. FAU - Bai, Ou AU - Bai O AD - The First Hospital of Jilin University, Changchun, China. FAU - Wu, Gang AU - Wu G AD - Wuhan Union Hospital of China, Wuhan, China. FAU - Zhang, Liling AU - Zhang L AD - Wuhan Union Hospital of China, Wuhan, China. FAU - Zhang, Yizhuo AU - Zhang Y AD - Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. LA - eng PT - Letter PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20170315 PL - England TA - J Hematol Oncol JT - Journal of hematology & oncology JID - 101468937 RN - 0 (Aminopyridines) RN - 0 (Benzamides) RN - 0 (Histone Deacetylase Inhibitors) RN - 87CIC980Y0 (N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Aminopyridines/*administration & dosage/adverse effects/therapeutic use MH - Anemia/chemically induced MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use MH - Benzamides/*administration & dosage/adverse effects/therapeutic use MH - China MH - Disease-Free Survival MH - Fatigue/chemically induced MH - Female MH - Histone Deacetylase Inhibitors/therapeutic use MH - Humans MH - Lymphoma, T-Cell, Peripheral/complications/*drug therapy MH - Male MH - Middle Aged MH - Neutropenia/chemically induced MH - Recurrence MH - Remission Induction/methods MH - Salvage Therapy/adverse effects/methods MH - Thrombocytopenia/chemically induced MH - Young Adult PMC - PMC5351273 OTO - NOTNLM OT - Chemotherapy OT - Chidamide OT - Peripheral T cell lymphoma OT - Treatment EDAT- 2017/03/17 06:00 MHDA- 2017/11/29 06:00 PMCR- 2017/03/15 CRDT- 2017/03/17 06:00 PHST- 2017/01/16 00:00 [received] PHST- 2017/03/07 00:00 [accepted] PHST- 2017/03/17 06:00 [entrez] PHST- 2017/03/17 06:00 [pubmed] PHST- 2017/11/29 06:00 [medline] PHST- 2017/03/15 00:00 [pmc-release] AID - 10.1186/s13045-017-0439-6 [pii] AID - 439 [pii] AID - 10.1186/s13045-017-0439-6 [doi] PST - epublish SO - J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.