title: Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China.
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.
authors.affiliation: 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.
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authors.affiliation: Peking University Cancer Hospital and Institute, Beijing, China.
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authors.affiliation: Jiangsu Province Hospital, Nanjing, China.
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authors.affiliation: Sun Yat-Sen University Cancer Center, Guangzhou, China.
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authors.affiliation: Hematology Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
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authors.affiliation: 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.
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authors.affiliation: Sichuan Provincial People's Hospital, Chengdu, China.
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authors.affiliation: The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
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authors.affiliation: General Hospital of Nanjing Military Region, Nanjing, China.
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mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000631:Aminopyridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001549:Benzamides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002681:China; D018572:Disease-Free Survival; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D056572:Histone Deacetylase Inhibitors / Q000627:therapeutic use; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods; D013921:Thrombocytopenia / Q000139:chemically induced; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D056572:Histone Deacetylase Inhibitors; C547816:N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide
keywords: Chemotherapy; Chidamide; Peripheral T cell lymphoma; Treatment