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Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China

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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 [4]Guangdong General Hospital, Guangzhou, China [5]West China Hospital,Sichuan University, Chengdu, China [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 [11]Xinqiao Hospital, Third Military Medical University, Chongqing, China [12]TheFirst Affiliated Hospital, Zhejiang University, Hangzhou, China [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 [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 [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 [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 [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 [41]The First Affiliated Hospital of Harbin Medical University, Harbin, China [42]Peking University Shenzhen Hospital, Shenzhen, China [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
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关键词: Chidamide Peripheral T cell lymphoma Treatment Chemotherapy

摘要:
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.

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出版当年[2017]版:
大类 | 2 区 医学
小类 | 2 区 血液学 2 区 肿瘤学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 血液学 1 区 肿瘤学
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出版当年[2017]版:
Q1 ONCOLOGY Q1 HEMATOLOGY
最新[2023]版:
Q1 HEMATOLOGY Q1 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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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
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