机构:[1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Studyon Anticancer Molecular Targeted Drugs, National Cancer Center/CancerHospital, Chinese Academy of Medical Sciences and Peking Union MedicalCollege, Beijing 100021, China[2]Peking University Cancer Hospital andInstitute, Beijing, China[3]Jiangsu Province Hospital, Nanjing, China江苏省人民医院[4]Guangdong General Hospital, Guangzhou, China广东省人民医院[5]West China Hospital,Sichuan University, Chengdu, China四川大学华西医院[6]Zhongshan Hospital, Shanghai, China[7]Shanghai Ruijin Hospital, Shanghai, China[8]Tianjin Medical University CancerInstitute and Hospital, Tianjin, China[9]The Second Hospital of Dalian MedicalUniversity, Dalian, China[10]Zhejiang Cancer Hospital, Hangzhou, China浙江省肿瘤医院[11]Xinqiao Hospital, Third Military Medical University, Chongqing, China[12]TheFirst Affiliated Hospital, Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[13]The FirstAffiliated Hospital of Soochow University, Suzhou, China[14]Sun Yat-SenUniversity Cancer Center, Guangzhou, China[15]Hematology Institute andHospital, Chinese Academy of Medical Sciences and Peking Union MedicalCollege, Tianjin, China[16]Sichuan Provincial People’s Hospital, Chengdu,China四川省人民医院[17]Hunan Cancer Hospital, Changsha, China[18]Shandong ProvincialHospital, Jinan, China[19]Jiangsu Cancer Hospital, Nanjing, China[20]NanjingDrum Tower Hospital, Nanjing, China[21]Tongji Hospital, Wuhan, China华中科技大学同济医学院附属同济医院[22]Fujian Provincial Cancer Hospital, Fuzhou, China[23]The First AffiliatedHospital of Chongqing Medical University, Chongqing, China[24]UnionHospital, Fujian Medical University, Fuzhou, China[25]General Hospital ofNanjing Military Region, Nanjing, China[26]Changhai Hospital, Shanghai,China[27]The First Affiliated Hospital of Anhui Medical University, Hefei, China[28]Sichuan Cancer Hospital and Institute, Chengdu, China四川省肿瘤医院[29]Xijing Hospital,The Fourth Military Medical University, Xi’an, China[30]Anhui ProvincialHospital, Hefei, China[31]QiLu Hospital of Shandong University, Jinan, China[32]Liaoning Cancer Hospital and Institute, Dalian, China[33]Nanfang Hospital,Southern Medical University, Guangzhou, China[34]The 307th Hospital ofChinese People’s Liberation Army, Beijing, China[35]Fourth Hospital of HebeiMedical University (Tumor Hospital of Hebei Province), Shijiazhuang, China河北医科大学第四医院[36]The Second Hospital of Hebei Medical University, Shijiazhuang, China[37]Shanxi Provincial Cancer Hospital, Taiyuan, China[38]The First AffiliatedHospital of Guangzhou Medical University, Guangzhou, China[39]TianjinPeople’s Hospital, Tianjin, China[40]Beijing Tongren Hospital, Beijing, China首都医科大学附属北京同仁医院首都医科大学附属同仁医院[41]The First Affiliated Hospital of Harbin Medical University, Harbin, China[42]Peking University Shenzhen Hospital, Shenzhen, China北京大学深圳医院深圳医学信息中心[43]The SecondAffiliated Hospital Zhejiang University School of Medicine, Hangzhou, China[44]Peking Union Medical College Hospital, Beijing, China[45]The First Hospitalof Jilin University, Changchun, China[46]Wuhan Union Hospital of China,Wuhan, China华中科技大学同济医学院附属协和医院
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.
第一作者机构:[1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Studyon Anticancer Molecular Targeted Drugs, National Cancer Center/CancerHospital, Chinese Academy of Medical Sciences and Peking Union MedicalCollege, Beijing 100021, China
通讯作者:
推荐引用方式(GB/T 7714):
Yuankai Shi,Bo Jia,Wei Xu,et al.Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China[J].JOURNAL OF HEMATOLOGY & ONCOLOGY.2017,10:doi:10.1186/s13045-017-0439-6.
APA:
Yuankai Shi,Bo Jia,Wei Xu,Wenyu Li,Ting Liu...&Yizhuo Zhang.(2017).Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China.JOURNAL OF HEMATOLOGY & ONCOLOGY,10,
MLA:
Yuankai Shi,et al."Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China".JOURNAL OF HEMATOLOGY & ONCOLOGY 10.(2017)