Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China.
Письмо в редакциюМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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.