The standard treatment for young patients with untreated PTCLs is based on anthracycline containing-regimens followed by high-dose-chemotherapy and stem-cell-transplantation (HDT + SCT), but only 40% of them can be cured. Romidepsin, a histone-deacetylase inhibitor, showed promising activity in relapsed PTCLs; in first line, Romidepsin was added with CHOP. We designed a study combining romidepsin and CHOEP as induction before HDT + auto-SCT in untreated PTCLs (PTCL-NOS, AITL/THF, ALK-ALCL), aged 18–65 years. A phase Ib/II trial was conducted to define the maximum tolerated dose (MTD) of Ro-CHOEP, and to assess efficacy and safety of 6 Ro-CHOEP as induction before HDT. The study hypothesis was to achieve a 18-month PFS of 70%. Twenty-one patients were enrolled into phase Ib; 7 dose-limiting toxicities were observed, that led to define the MTD at 14 mg/ms. Eighty-six patients were included in the phase II. At a median follow-up of 28 months, the 18-month PFS was 46.2% (95%CI:35.0–56.7), and the 18-month overall survival was 73.1% (95%CI:61.6–81.7). The overall response after induction was 71%, with 62% CRs. No unexpected toxicities were reported. The primary endpoint was not met; therefore, the enrollment was stopped at a planned interim analysis. The addition of romidepsin to CHOEP did not improve the PFS of untreated PTCL patients.

对于未经治疗的年轻 PTCL 患者，标准治疗是基于含蒽环类药物的治疗方案，然后是大剂量化疗和干细胞移植 (HDT + SCT)，但只有 40% 的患者能够治愈。罗米地辛 (Romidepsin) 是一种组蛋白脱乙酰酶抑制剂，在复发性 PTCL 中显示出良好的活性；在第一线中，罗米地辛与 CHOP 一起添加。我们设计了一项研究，在未经治疗的 PTCL（PTCL-NOS、AITL/THF、ALK-ALCL）中，年龄 18-65 岁，将罗米地辛和 CHOEP 结合作为 HDT 前诱导 + 自动 SCT。进行了 Ib/II 期试验，以确定 Ro-CHOEP 的最大耐受剂量 (MTD)，并评估 6 Ro-CHOEP 作为 HDT 诱导前的有效性和安全性。研究假设是 18 个月的 PFS 达到 70%。21 名患者被纳入 Ib 期；观察到 7 种剂量限制性毒性，这导致将 MTD 定义为 14 mg/ms。86 名患者被纳入 II 期研究。中位随访 28 个月时，18 个月 PFS 为 46.2%（95%CI：35.0–56.7），18 个月总生存率为 73.1%（95%CI：61.6–81.7）。诱导后的总体缓解率为 71%，CR 为 62%。没有报告意外的毒性。未达到主要终点；因此，在计划的中期分析中停止了招募。在 CHOEP 中添加罗米地辛并没​​有改善未经治疗的 PTCL 患者的 PFS。未达到主要终点；因此，在计划的中期分析中停止了招募。在 CHOEP 中添加罗米地辛并没​​有改善未经治疗的 PTCL 患者的 PFS。未达到主要终点；因此，在计划的中期分析中停止了招募。在 CHOEP 中添加罗米地辛并没​​有改善未经治疗的 PTCL 患者的 PFS。