含西达本胺方案治疗复发难治性非特指型外周T细胞淋巴瘤的疗效与安全性

Efficacy and safety of chidamide-contained protocol for relapsed and refractory peripheral T-cell lymphoma,not otherwise specified

目的:探索含西达本胺(chidamide)方案治疗复发难治性非特指型外周T细胞淋巴瘤(peripheral T-cell lymphoma,not otherwise specified,PTCLNOS)的疗效与安全性。方法:回顾性分析2017年12月1日—2021年9月20日在郑州大学第一附属医院接受含西达本胺方案治疗的21例复发难治性PTCL-NOS患者的疗效、预后和不良反应。其中,7例接受西达本胺联合PD-1抑制剂+吉西他滨+来那度胺方案治疗(西达本胺联合PD-1抑制剂组),7例接受西达本胺联合泼尼松+依托泊苷+沙利度胺(prednisone+etoposide+thalidomide,PET)方案治疗(西达本胺联合PET方案组),7例接受西达本胺联合沙利度胺或来那度胺+泼尼松(thalidomide/lenalidomide+prednisone,TP/LP)方案治疗(西达本胺联合TP/LP方案组)。观察3组的近期疗效、不良反应和生存结果。结果:21例复发难治性PTCL-NOS患者中,完全缓解3例,部分缓解7例,客观缓解率为47.6%。西达本胺联合PD-1抑制剂方案组、西达本胺联合PET方案组以及西达本胺联合TP/LP方案组的客观缓解率分别为71.4%、28.6%和42.9%,3组之间的差异无统计学意义(P=0.090)。21例患者的1年总生存率和无进展生存率分别为95.8%和83.8%,2年总生存率和无进展生存率分别为71.8%和71.3%。3组的总生存和无进展生存曲线的差异均无统计学意义(P=0.367,P=0.082)。主要的不良反应为骨髓抑制和胃肠反应,大多可以通过对症治疗和调整药物剂量予以缓解。结论:含西达本胺方案可以作为复发难治性PTCL-NOS患者安全而有效的治疗选择。西达本胺联合PD-1抑制剂方案可能显示出潜在的临床效应,但其对预后的影响仍需更多临床数据的支持。

Objective:To explore the efficacy and safety of chidamide-contained regimens for relapsed and refractory peripheral T-cell lymphoma,not otherw ise specified(PTCL-NOS).Methods:Clinical efficacy,survival and adverse reactions of 21 patients with relapsed and refractory PTCL-NOS receiving chidamide-contained regimens in the First Affiliated Hospital of Zhengzhou University from December 1,2017 to September 20,2021 were retrospectively analyzed.Of 21 patients,7 patients were treated with chidamide combined with PD-1 inhibitor﹢gemcitabine﹢lenalidomide,7 patients were treated with chidamide combined with prednisone﹢etoposide﹢thalidomide(PET),and remaining 7 patients were treated with chidamide combined with thalidomide/lenalidomide﹢prednisone(TP/LP).The short-term efficacy,adverse reactions and survival results of the three groups were observed.Results:Among 21 patients with relapsed and refractory PTCL-NOS,3 patients had complete remission,7 patients had partial remission,and the objective response rate was 47.6%.The ORRs were 71.4%,28.6%and 42.9%in chidamide combined with PD-1 inhibitor,chidamide combined with PET regimen and chidamide combined with TP/LP regimen groups,respectively,and there was no significant difference among the three groups(P=0.090).The overall survival(OS)and progression-free survival(PFS)curves showed that the 1-year OS and PFS rates were 95.8%and 83.8%,respectively,and the 2-year OS and PFS rates were 71.8%and 71.3%,respectively.There were no significant differences in the OS and PFS curves among the three groups(P=0.367,P=0.082).The major adverse reactions were bone marrow suppression and gastrointestinal reactions,which could be corrected by symptomatic treatment and dose adjustment.Conclusion:Chidamide-contained regimen can be a safe and effective treatment choice for patients with relapsed and refractory PTCL-NOS.There is no significant difference in efficacy and prognosis among the three groups.Chidamide-combined PD-1 inhibitor regimen may show potential clinical activity,but its effect on prognosis needs more clinical data to support.