PMID- 33755379
OWN - NLM
STAT- Publisher
LR  - 20240222
IS  - 2095-3941 (Print)
IS  - 2095-3941 (Linking)
VI  - 18
IP  - 3
DP  - 2021 Mar 23
TI  - The combination of chidamide with the CHOEP regimen in previously untreated 
      patients with peripheral T-cell lymphoma: a prospective, multicenter, single arm, 
      phase 1b/2 study.
PG  - 841-8
LID - j.issn.2095-3941.2020.0413 [pii]
LID - 10.20892/j.issn.2095-3941.2020.0413 [doi]
AB  - OBJECTIVE: To assess the efficacy and safety of the novel histone deacetylase 
      inhibitor, chidamide, in combination with cyclophosphamide, doxorubicin, 
      vincristine, etoposide, and prednisone (Chi-CHOEP) for untreated peripheral 
      T-cell lymphoma (PTCL). METHODS: A prospective, multicenter, single arm, phase 
      1b/2 study was conducted. A total of 128 patients with untreated PTCL (18-70 
      years of age) were enrolled between March 2016 and November 2019, and treated 
      with up to 6 cycles with the Chi-CHOEP regimen. In the phase 1b study, 3 dose 
      levels of chidamide were evaluated and the primary endpoint was determination of 
      the maximum-tolerated dose and recommended phase 2 dose (RP2D). The primary 
      endpoint of the phase 2 study was 2-year progression-free survival (PFS). 
      RESULTS: Fifteen patients were enrolled in the phase 1b study and the RP2D for 
      chidamide was determined to be 20 mg, twice a week. A total of 113 patients were 
      treated at the RP2D in the phase 2 study, and the overall response rate was 
      60.2%, with a complete response rate of 40.7%. At a median follow-up of 36 
      months, the median PFS was 10.7 months, with 1-, 2-, and 3-year PFS rates of 
      49.9%, 38.0%, and 32.8%, respectively. The Chi-CHOEP regimen was well-tolerated, 
      with grade 3/4 neutropenia occurring in approximately two-thirds of the patients. 
      No unexpected adverse events (AEs) were reported and the observed AEs were 
      manageable. CONCLUSIONS: This large cohort phase 1b/2 study showed that Chi-CHOEP 
      was well-tolerated with modest efficacy in previously untreated PTCL patients.
CI  - Copyright (c) 2021 Cancer Biology & Medicine.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Department of Hematology, Peking Union Medical College Hospital, Beijing 100730, 
      China.
FAU - Su, Liping
AU  - Su L
AD  - Department of Hematology, Shanxi Provincial Cancer Hospital, Taiyuan 030013, 
      China.
FAU - Liu, Lihong
AU  - Liu L
AD  - Department of Hematology, Fourth Hospital of Hebei Medical University, 
      Shijiazhuang 050011, China.
FAU - Gao, Yuhuan
AU  - Gao Y
AD  - Department of Hematology, Fourth Hospital of Hebei Medical University, 
      Shijiazhuang 050011, China.
FAU - Wang, Quanshun
AU  - Wang Q
AD  - Department of Hematology, Chinese PLA General Hospital, Beijing 100039, China.
FAU - Su, Hang
AU  - Su H
AD  - Department of Lymphoma, the 307 Hospital of PLA, Beijing 100071, China.
FAU - Song, Yuhuan
AU  - Song Y
AD  - Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing 
      100142, China.
FAU - Zhang, Huilai
AU  - Zhang H
AD  - Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, 
      National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention 
      and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 
      300060, China.
FAU - Shen, Jing
AU  - Shen J
AD  - Department of Hematology, Beijing Friendship Hospital, Beijing 100050, China.
FAU - Jing, Hongmei
AU  - Jing H
AD  - Department of Hematology, Peking University Third Hospital, Beijing 100191, 
      China.
FAU - Wang, Shuye
AU  - Wang S
AD  - Department of Hematology, the First Affiliated Hospital of Harbin Medical 
      University, Harbin 150081, China.
FAU - Cen, Xinan
AU  - Cen X
AD  - Department of Hematology, Peking University First Hospital, Beijing 100034, 
      China.
FAU - Liu, Hui
AU  - Liu H
AD  - Department of Hematology, Beijing Hospital, Beijing 100730, China.
FAU - Liu, Aichun
AU  - Liu A
AD  - Department of Lymphoma, Harbin Medical University Cancer Hospital, Harbin 150081, 
      China.
FAU - Li, Zengjun
AU  - Li Z
AD  - Lymphoma Diagnosis and Treatment Center, Institute of Hematology and Blood 
      Diseases Hospital, Tianjin 300052, China.
FAU - Luo, Jianmin
AU  - Luo J
AD  - Department of Hematology, Second Hospital of Hebei Medical University, 
      Shijiazhuang 050000, China.
FAU - He, Jianxia
AU  - He J
AD  - Department of Hematology, Shanxi Provincial People's Hospital, Taiyuan 030012, 
      China.
FAU - Wang, Jingwen
AU  - Wang J
AD  - Department of Hematology, Beijing Tongren Hospital, Beijing 100730, China.
FAU - O'Connor, O A
AU  - O'Connor OA
AD  - Columbia University Medical Center, New York 10032-3784, NY, USA.
FAU - Zhou, Daobin
AU  - Zhou D
AUID- ORCID: 0000-0002-1592-1932
AD  - Department of Hematology, Peking Union Medical College Hospital, Beijing 100730, 
      China.
LA  - eng
GR  - 81970188/National Natural Science Foundation of China/
GR  - 2016-12M-1-001/Chinese Academy of Medical Sciences Innovation Fund for Medical 
      Sciences/
PT  - Journal Article
DEP - 20210323
PL  - China
TA  - Cancer Biol Med
JT  - Cancer biology & medicine
JID - 101588850
SB  - IM
PMC - PMC8330529
OTO - NOTNLM
OT  - Peripheral T-cell lymphoma
OT  - chidamide
OT  - epigenetic
OT  - histone deacetylase inhibitor
COIS- No potential conflicts of interest are disclosed.
EDAT- 2021/03/24 06:00
MHDA- 2021/03/24 06:00
PMCR- 2021/08/15
CRDT- 2021/03/23 12:49
PHST- 2021/03/23 12:49 [entrez]
PHST- 2021/03/24 06:00 [pubmed]
PHST- 2021/03/24 06:00 [medline]
PHST- 2021/08/15 00:00 [pmc-release]
AID - j.issn.2095-3941.2020.0413 [pii]
AID - 10.20892/j.issn.2095-3941.2020.0413 [doi]
PST - aheadofprint
SO  - Cancer Biol Med. 2021 Mar 23;18(3):841-8. doi: 
      10.20892/j.issn.2095-3941.2020.0413.