西达本胺联合阿扎胞苷治疗复发/难治性血管免疫母细胞性T细胞淋巴瘤的前瞻性临床研究  

Chidamide combined with azacitidine in treating relapsed/refractory angioimmunoblastic T-cell lymphoma: a prospective clinical study

作　　者：魏冲[1] 赵丹青[1] 张炎[1] 王为[1] 张薇[1] 周道斌[1] WEI Chong;ZHAO Danqing;ZHANG Yan;WANG Wei;ZHANG Wei;ZHOU Daobin(Department of Hematology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China)

机构地区：[1]中国医学科学院,北京协和医学院,北京协和医院血液内科,北京100730

出　　处：《中国癌症防治杂志》2023年第1期51-55,共5页CHINESE JOURNAL OF ONCOLOGY PREVENTION AND TREATMENT

基　　金：中央高水平医院临床科研业务费资助(2022-PUMCH-A-261)。

摘　　要：目的 探讨西达本胺联合阿扎胞苷治疗复发/难治性血管免疫母细胞性T细胞淋巴瘤(angioimmunoblastic T-cell lymphoma,AITL)的疗效和安全性。方法 本研究为单中心前瞻性临床研究,研究中心为北京协和医院,入组患者均病理确诊AITL,且符合复发/难治性淋巴瘤的诊断标准。采用皮下注射阿扎胞苷(100 m/d,持续7 d)联合口服西达本胺(20 mg/次,每周2次)的治疗方案,每4周为1个周期。主要研究终点为客观有效率,次要研究终点为无进展生存时间、疗效持续时间、总生存时间、完全缓解率及安全性指标。结果 自2021年3月至2022年8月共入组7例患者,中位发病年龄为53(范围:45~75)岁,既往中位治疗线数为2(范围:1~4)线。应用西达本胺联合阿扎胞苷方案治疗后最佳疗效达完全缓解者2例,达部分缓解者3例,客观有效率为71.4%,完全缓解率为28.6%。截至2022年8月,中位随访时间为14(范围:4~17)个月。7例AITL患者中6例存活,1例死亡,整组患者的中位无进展生存时间、疗效持续时间和总生存时间均未达到,1年无进展生存率和总生存率分别为51.4%和100.0%。治疗相关不良反应主要为血液学毒性,3~4级中性粒细胞减少发生率为28.6%(2/7),3~4级血小板减少发生率为14.3%(1/7)。结论 阿扎胞苷联合西达本胺治疗复发/难治性AITL的缓解率高且安全性良好,双表观调控方案可作为AITL的二线治疗选择之一。ObjectiveTo investigate the efficacy and safety of chidamide combined with azacitidine in treating relapsed/refractory angioimmunoblastic T-cell lymphoma(AITL).MethodsThe study was a single-center prospective clinical trial at Peking Union Medical College. The eligible patients were pathologically confirmed with AITL and met the criteria for relapsed/refractory lymphoma. Treatment included subcutaneous injection of azactidine azacitidine(100 m/d for 7 d) combined with oral chidamide(20 mg/d twice weekly)in a 4 weeks cycle.ResultsA total of 7 patients were enrolled from March 2021 to August 2022. The median age of disease onset was53(range 45-75) years and the median line of previous treatment was 2(range 1-4) line. After treatment, complete remission(CR) was achieved in 2 cases and partial remission in 3 cases. The objective response rate was 71.4% and the CR rate was 28.6%. As of August2022, the median follow-up time was 14 months(range 4-17 months). 6 patients survived and 1 patient died, and the median progression-free survival(PFS), duration of response, and overall survival(OS) of the whole group were not reached. The 1-year PFS and OS rates were 51.4% and 100.0%, respectively. Treatment-related adverse events were mainly hematological toxicity. The incidence of grade 3-4 neutropenia and thrombocytopenia were 28.6%(2/7) and 14.3%(1/7), respectively.ConclusionsAzacitidine combined with chidamide has a high remission rate and safety profile in treating relapsed/refractory AITL, and dual epigenetic regulating drugs may serve as a second-line treatment option for patients with AITL.

关 键 词：血管免疫母细胞性T细胞淋巴瘤 表观调控药物 西达本胺 阿扎胞苷 前瞻性研究 

分 类 号：R730.5[医药卫生—肿瘤] R733[医药卫生—临床医学]