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

• 作者: Wei Zhang Liping Su Lihong Liu Yuhuan Gao Quanshun Wang Hang Su Yuhuan Song Huilai Zhang Jing Shen Hongmei Jing Shuye Wang Xinan Cen Hui Liu Aichun Liu Zengjun Li Jianmin Luo Jianxia He Jingwen Wang O.A.O'Connor Daobin Zhou
• 来源期刊: 癌症生物学与医学（英文版）
• 年，卷（期）: 2021,（3）
• 所属期刊栏目: ORIGINAL ARTICLE
• 页码范围: 841-848
• 页数: 8页
• 语种: 英文
• DOI: 10.20892/j.issn.2095-3941.2020.0413

摘要

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.