PT - JOURNAL ARTICLE AU - Zhang, Wei AU - Su, Liping AU - Liu, Lihong AU - Gao, Yuhuan AU - Wang, Quanshun AU - Su, Hang AU - Song, Yuhuan AU - Zhang, Huilai AU - Shen, Jing AU - Jing, Hongmei AU - Wang, Shuye AU - Cen, Xinan AU - Liu, Hui AU - Liu, Aichun AU - Li, Zengjun AU - Luo, Jianmin AU - He, Jianxia AU - Wang, Jingwen AU - O’Connor, O. A. AU - Zhou, Daobin 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 AID - 10.20892/j.issn.2095-3941.2020.0413 DP - 2021 Aug 01 TA - Cancer Biology and Medicine PG - 841--848 VI - 18 IP - 3 4099 - http://www.cancerbiomed.org/content/18/3/841.short 4100 - http://www.cancerbiomed.org/content/18/3/841.full SO - Cancer Biol Med2021 Aug 01; 18 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.