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Multicenter Study
. 2017 Mar 15;10(1):69.
doi: 10.1186/s13045-017-0439-6.

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

Yuankai Shi  1 , Bo Jia  2 , Wei Xu  3 , Wenyu Li  4 , Ting Liu  5 , Peng Liu  6 , Weili Zhao  7 , Huilai Zhang  8 , Xiuhua Sun  9 , Haiyan Yang  10 , Xi Zhang  11 , Jie Jin  12 , Zhengming Jin  13 , Zhiming Li  14 , Lugui Qiu  15 , Mei Dong  16 , Xiaobing Huang  17 , Yi Luo  18 , Xiaodong Wang  17 , Xin Wang  19 , Jianqiu Wu  20 , Jingyan Xu  21 , Pingyong Yi  18 , Jianfeng Zhou  22 , Hongming He  23 , Lin Liu  24 , Jianzhen Shen  25 , Xiaoqiong Tang  24 , Jinghua Wang  26 , Jianmin Yang  27 , Qingshu Zeng  28 , Zhihui Zhang  29 , Zhen Cai  12 , Xiequn Chen  30 , Kaiyang Ding  31 , Ming Hou  32 , Huiqiang Huang  14 , Xiaoling Li  33 , Rong Liang  30 , Qifa Liu  34 , Yuqin Song  2 , Hang Su  35 , Yuhuan Gao  36 , Lihong Liu  36 , Jianmin Luo  37 , Liping Su  38 , Zimin Sun  31 , Huo Tan  39 , Huaqing Wang  40 , Jingwen Wang  41 , Shuye Wang  42 , Hongyu Zhang  43 , Xiaohong Zhang  44 , Daobin Zhou  45 , Ou Bai  46 , Gang Wu  47 , Liling Zhang  47 , Yizhuo Zhang  8
Affiliations
Multicenter Study

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

Yuankai Shi et al. J Hematol Oncol. .

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.

Keywords: Chemotherapy; Chidamide; Peripheral T cell lymphoma; Treatment.

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Fig. 1
Fig. 1
Progression-free survival for patients receiving chidamide monotherapy and patients receiving chidamide combined with chemotherapy
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