<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Zhang, Wei</style></author><author><style face="normal" font="default" size="100%">Su, Liping</style></author><author><style face="normal" font="default" size="100%">Liu, Lihong</style></author><author><style face="normal" font="default" size="100%">Gao, Yuhuan</style></author><author><style face="normal" font="default" size="100%">Wang, Quanshun</style></author><author><style face="normal" font="default" size="100%">Su, Hang</style></author><author><style face="normal" font="default" size="100%">Song, Yuhuan</style></author><author><style face="normal" font="default" size="100%">Zhang, Huilai</style></author><author><style face="normal" font="default" size="100%">Shen, Jing</style></author><author><style face="normal" font="default" size="100%">Jing, Hongmei</style></author><author><style face="normal" font="default" size="100%">Wang, Shuye</style></author><author><style face="normal" font="default" size="100%">Cen, Xinan</style></author><author><style face="normal" font="default" size="100%">Liu, Hui</style></author><author><style face="normal" font="default" size="100%">Liu, Aichun</style></author><author><style face="normal" font="default" size="100%">Li, Zengjun</style></author><author><style face="normal" font="default" size="100%">Luo, Jianmin</style></author><author><style face="normal" font="default" size="100%">He, Jianxia</style></author><author><style face="normal" font="default" size="100%">Wang, Jingwen</style></author><author><style face="normal" font="default" size="100%">O’Connor, O. A.</style></author><author><style face="normal" font="default" size="100%">Zhou, Daobin</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">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</style></title><secondary-title><style face="normal" font="default" size="100%">Cancer Biology and Medicine</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2021-08-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">841-848</style></pages><doi><style  face="normal" font="default" size="100%">10.20892/j.issn.2095-3941.2020.0413</style></doi><volume><style face="normal" font="default" size="100%">18</style></volume><issue><style face="normal" font="default" size="100%">3</style></issue><abstract><style  face="normal" font="default" size="100%">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.</style></abstract></record></records></xml>