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 Yuhuan, Liu Lihong, Luo Jianmin, Su Liping, Sun Zimin, Tan Huo, Wang Huaqing, Wang Jingwen, Wang Shuye, Zhang Hongyu, Zhang Xiaohong, Zhou Daobin, Bai Ou, Wu Gang, Zhang Liling, Zhang Yizhuo
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.
Peking University Cancer Hospital and Institute, Beijing, China.
J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.
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.
新型亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂西达本胺的疗效和安全性已在一项关键的II期临床试验中得到证实，并且西达本胺已获中国食品药品监督管理总局（CFDA）批准用于治疗复发或难治性外周T细胞淋巴瘤（PTCL）。本研究旨在进一步评估2015年4月至2016年2月期间中国大陆383例复发或难治性PTCL患者中西达本胺的实际应用情况。对于接受西达本胺单药治疗的患者（n = 256），总缓解率（ORR）和疾病控制率（DCR）分别为39.06%和64.45%。对于接受西达本胺联合化疗的患者（n = 127），ORR和DCR分别为51.18%和74.02%。对于接受西达本胺单药治疗和西达本胺联合化疗的患者，单药治疗组的中位无进展生存期（PFS）为129天（95%CI 82至194天），联合治疗组为152天（95%CI 93至201天）（P = 0.3266）。大多数不良事件（AE）为1至2级。接受西达本胺单药治疗的患者中≥5%发生的3级或更高等级AE包括血小板减少症（10.2%）和中性粒细胞减少症（6.2%）。对于接受西达本胺联合化疗的患者，≥5%患者发生的3至4级AE包括血小板减少症（18.1%）、中性粒细胞减少症（12.6%）、贫血（7.1%）和疲劳（5.5%）。这项大型真实世界研究表明，西达本胺对于难治性和复发性PTCL患者具有良好的疗效和可接受的安全性。西达本胺联合化疗可能是难治性和复发性PTCL患者的一种新的治疗选择，但需要进一步研究。
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