西达本胺在外周T细胞淋巴瘤维持治疗中的有效性及安全性  

The efficacy and safety of thioamide in maintenance therapy for peripheral T-cell lymphoma

作　　者：尹华 梁金花[1] 吴佳竹[1] 李悦[1] 张馨予[1] 孔祎琳 潘必慧 王莉[1] 李建勇[1] 徐卫[1] 申浩睿 Yin Hua;Liang Jinhua;Wu Jiazhu;Li Yue;Zhang Xinyu;Kong Yilin;Pan Bihui;Wang Li;Li Jianyong;Xu Wei;Shen Haorui(Department of Hematology,the First Affiliated Hospital of Nanjing Medical University(Jiangsu Province Hospital),Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院(江苏省人民医院)血液科,南京210029

出　　处：《中华血液学杂志》2024年第12期1091-1097,共7页Chinese Journal of Hematology

基　　金：国家自然科学基金(82370194);江苏省科技厅项目(BE2023780);中国博士后科学基金(2023M741463);江苏省人民医院临床能力提升工程项目(JSPH-MC-2022-13、JSPH-MC-2022-21、JSPH-MC-2023-10);南京医科大学第一附属医院青年基金培育计划(PY2021028);江苏省高层次创新创业人才引进计划(双创博士)。

摘　　要：目的研究旨在评估西达本胺作为外周T细胞淋巴瘤(PTCL)一线或挽救治疗后口服药物维持的疗效和安全性。方法回顾性分析2015年1月至2022年7月期间南京医科大学第一附属医院(江苏省人民医院)血液内科收治的58例PTCL患者的临床资料,所有患者均口服西达本胺作为一线或挽救治疗后的维持治疗。分析58例患者启动化疗后的无进展生存(PFS)期、总生存(OS)期以及评估西达本胺药物的安全性。结果58例PTCL患者,男43例,女15例,中位年龄为66(29~83)岁。39例接受西达本胺作为一线维持治疗方案,19例患者接受西达本胺作为挽救性维持治疗方案。中位维持治疗时间16(1~72)个月,中位PFS期为33(2~74)个月,中位OS期未达到。接受西达本胺作为一线维持治疗方案的患者PFS和OS优于接受西达本胺作为挽救性维持治疗方案的患者(中位PFS期:未达到对7个月,P<0.001;中位OS期:未达到对67个月,P=0.009)。最常见的不良反应是血液学不良反应(77.6%)。12例(20.7%)患者在治疗期间进行了剂量下调,3例患者因不良反应停止治疗。结论西达本胺在PTCL的维持治疗中具有较好的疗效,特别是作为一线维持治疗具有较好的PFS和OS,且安全性良好。Objective This study aimed to assess the efficacy and safety of thioamide as a maintenance therapy for peripheral T-cell lymphoma(PTCL).Methods This study retrospectively analyzed the data from 58 patients with PTCL who were treated in the Department of Hematology at the First Affiliated Hospital of Nanjing Medical University from January 2015 to July 2022.Chidamide was orally administered as a maintenance therapy after first-line or salvage treatment.Progression-free survival(PFS),overall survival(OS),and safety were analyzed.Results Among the 58 patients with PTCL,43 were males and 15 were females,and the median age was 66(range:29-83)years.Thirty-nine patients received thioamide as first-line maintenance therapy,and 19 patients received thioamide as maintenance therapy after salvage treatment.The median maintenance therapy duration was 16 months(range:1-72 months),with a median PFS time of 33(2-74)months,and the median OS time had not been reached.Patients who received first-line maintenance therapy with thioamide demonstrated superior PFS and OS outcomes compared with patients who received thioamide maintenance therapy after salvage treatment(median PFS time:not reached vs 7 months,P<0.001;median OS time:not reached vs 67 months,P=0.009).The most prevalent adverse reaction was a hematologic adverse reaction(77.6%).Twelve(20.7%)patients underwent a dose reduction and three patients discontinued treatment.Conclusion Patients receiving thioamide maintenance therapy demonstrated a promising PFS and OS with a manageable safety profile,especially as the first-line maintenance therapy.

关 键 词：淋巴瘤 T细胞 外周 西达本胺 维持治疗 

分 类 号：R733.1[医药卫生—肿瘤]