%0 Journal Article
%T 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.
%A Zhang W
%A Su L
%A Liu L
%A Gao Y
%A Wang Q
%A Su H
%A Song Y
%A Zhang H
%A Shen J
%A Jing H
%A Wang S
%A Cen X
%A Liu H
%A Liu A
%A Li Z
%A Luo J
%A He J
%A Wang J
%A O'Connor OA
%A Zhou D
%J Cancer Biol Med
%V 0
%N 0
%D Mar 2021 23
%M 33755379
%F 5.347
%R 10.20892/j.issn.2095-3941.2020.0413
%X <B>OBJECTIVE: </B>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).<BR><B>METHODS: </B>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).<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>This large cohort phase 1b/2 study showed that Chi-CHOEP was well-tolerated with modest efficacy in previously untreated PTCL patients.