Abstract：
In this prospective, multicenter, Phase 2 clinical trial (NCT02987244), patients with peripheral T-cell lymphomas (PTCLs) who had responded to first-line chemotherapy with cyclophosphamide, doxorubicin or epirubicin, vincristine or vindesine, etoposide, and prednisone (Chi-CHOEP) were treated by autologous stem cell transplantation (ASCT) or with chidamide maintenance or observation. A total of 85 patients received one of the following interventions: ASCT (n = 15), chidamide maintenance (n = 44), and observation (n = 26). estimated 3 PFS and OS rates were 85.6%, 80.8%, and 49.4% (P = 0.001). The two-year OS rates were 85.6%, 80.8%, and 69.0% (P = 0.075).The ASCT and chidamide maintenance groups had significantly better progression-free survival (PFS) than the observation group (P = 0.001, and P = 0.01, respectively). The overall survival (OS) differed significantly between the chidamide maintenance group and the observation group ( P = 0.041). The multivariate and propensity score matching analyses for PFS revealed better outcomes in the subjects in the chidamide maintenance than observation groups (P = 0.02). The ASCT and chidamide maintenance groups had significant survival advantages over the observation group. In the post-remission stage of the untreated PTCL patients, single-agent chidamide maintenance demonstrated superior PFS and better OS than observation. Our findings highlight the potential benefit of chidamide in this patient subset, warranting further investigation through larger prospective trials. Clinical trial registration: clinicaltrial.gov, NCT02987244. Registered 8 December 2016, http://www.clinicaltrials.gov/ct2/show/NCT02987244 .
摘要：
在这个前景中，多中心，2期临床试验（NCT02987244），对环磷酰胺一线化疗有反应的外周T细胞淋巴瘤（PTCL）患者，阿霉素或表阿霉素，长春新碱或长春地辛，依托泊苷,和泼尼松（Chi-CHOEP）通过自体干细胞移植（ASCT）或西达胺维持或观察治疗。共有85例患者接受了以下干预措施之一：ASCT（n=15），西达胺维持（n=44），和观察（n=26）。估计3个PFS和OS率为85.6%，80.8%,49.4%(P=0.001)。两年OS率为85.6%,80.8%,69.0%(P=0.075)。ASCT和西达本胺维持组的无进展生存期(PFS)明显优于观察组(P=0.001,P=0.01)。西达本胺维持组与观察组的总生存期(OS)差异有统计学意义(P=0.041)。PFS的多变量和倾向评分匹配分析显示，西达本胺维持组受试者的预后优于观察组（P=0.02）。ASCT和西达本胺维持组较观察组有显著的生存优势。在未经治疗的PTCL患者的缓解后阶段，单剂西达本胺维持显示优于观察的PFS和更好的OS。我们的发现强调了西达胺在该患者亚组中的潜在益处，保证通过更大的前瞻性试验进行进一步调查。临床试验注册：clinicaltrial.gov，NCT02987244。注册2016年12月8日，http://www.clinicaltrials.gov/ct2/show/NCT02987244.
