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

Yuankai Shi, Bo Jia, Wei Xu, Wenyu Li, Ting Liu, Peng Liu, Weili Zhao, Huilai Zhang, Xiuhua Sun, Haiyan Yang, Xi Zhang, Jie Jin, Zhengming Jin, Zhiming Li, Lugui Qiu, Mei Dong, Xiaobing Huang, Yi Luo, Xiaodong Wang, Xin Wang, Jianqiu Wu, Jingyan Xu, Pingyong Yi, Jianfeng Zhou, Hongming He, Lin Liu, Jianzhen Shen, Xiaoqiong Tang, Jinghua Wang, Jianmin Yang, Qingshu Zeng, Zhihui Zhang, Zhen Cai, Xiequn Chen, Kaiyang Ding, Ming Hou, Huiqiang Huang, Xiaoling Li, Rong Liang, Qifa Liu, Yuqin Song, Hang Su, Yuhuan Gao, Lihong Liu, Jianmin Luo, Liping Su, Zimin Sun, Huo Tan, Huaqing Wang, Jingwen Wang, Shuye Wang, Hongyu Zhang, Xiaohong Zhang, Daobin Zhou, Ou Bai, Gang Wu, Liling Zhang, Yizhuo Zhang

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.