盐酸米托蒽醌脂质体注射液治疗外周T细胞淋巴瘤有效性和安全性的多中心、非干预性、双向性队列真实世界研究(MOMENT)  

Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas:a multicenter,non-interventional,ambispective cohort,real-world study(MOMENT)

作　　者：黄慧强[1] 李志铭[1] 刘丽宏[2] 黄亮[3] 金洁[4] 佟红艳[4] 周辉[5] 李增军[6] 黄振倩[7] 钱文斌 丁凯阳[9] 林全德[10] 侯明[11] 黄韵红 王静波[13] 贺鹏程[14] 孙秀华[15] 王晓波[16] 朱尊民[17] 刘耀 任金海[19] 吴辉菁[20] 张利玲[21] 张颢[22] 耿良权[23] 葛健[24] 白鸥[25] 苏丽萍[26] 高广勋 李昕[28] 杨艳丽[29] 陈懿建[30] 刘爱春[31] 王欣[32] 王一[33] 邹立群[34] 黄晓兵[35] 黄东平 闻淑娟[37] 赵东陆[38] 马军[38] Huang Huiqiang;Li Zhiming;Liu Lihong;Huang Liang;Jin Jie;Tong Hongyan;Zhou Hui;Li Zengjun;Huang Zhenqian;Qian Wenbin;Ding Kaiyang;Lin Quande;Hou Ming;Huang Yunhong;Wang Jingbo;He Pengcheng;Sun Xiuhua;Wang Xiaobo;Zhu Zunmin;Liu Yao;Ren Jinhai;Wu Huijing;Zhang Liling;Zhang Hao;Geng Liangquan;Ge Jian;Bai Ou;Su Liping;Gao Guangxun;Li Xin;Yang Yanli;Chen Yijian;Liu Aichun;Wang Xin;Wang Yi;Zou Liqun;Huang Xiaobing;Huang Dongping;Wen Shujuan;Zhao Donglu;Ma Jun(Department of Lymphoma,Sun Yat-Sen University Cancer Center,Guangzhou 510060,China;Department of Hematology,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,China;Department of Hematology,Tongji Hospital,Tongji Medical College of HUST,Wuhan 430030,China;Department of Hematology,the First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Lymphoma&Hematology,Hunan Cancer Hospital,Changsha 410031,China;Department of Lymphoma&Hematology,Shandong Provincial Cancer Hospital,Jinan 250117,China;Department of Hematology,the First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China;Department of Hematology,the Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Hematology,Anhui Provincial Cancer Hosptial,Hefei 230031,China;Department of Hematology,Henan Cancer Hospital,Zhengzhou 450003,China;Department of Hematology,Qilu Hospital of Shandong University,Jinan 250063,China;Department of Lymphoma,the Affiliated Cancer Hospital of Guizhou Medical University,Guiyang 550008,China;Department of Hematology,Aerospace Center Hospital,Beijing 100049,China;Department of Hematology,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;Department of Lymphoma and Head and Neck Oncology,the Second Hospital of Dalian Medical University,Dalian 116023,China;Department of Hematology,the Second Hospital of Dalian Medical University,Dalian 116023,China;Department of Hematology,Henan Provincial People's Hospital,Zhengzhou 450003,China;Hem

机构地区：[1]中山大学肿瘤防治中心淋巴瘤科,广州510060 [2]河北医科大学第四医院血液科,石家庄050011 [3]华中科技大学同济医学院附属同济医院血液科,武汉430030 [4]浙江大学医学院附属第一医院血液科,杭州310003 [5]湖南省肿瘤医院淋巴瘤血液内科,长沙410031 [6]山东省肿瘤医院淋巴血液科,济南250117 [7]广州医科大学附属第一医院血液内科,广州510120 [8]浙江大学医学院附属第二医院血液科,杭州310003 [9]安徽省肿瘤医院血液内科,合肥230031 [10]河南省肿瘤医院血液科,郑州450003 [11]山东大学齐鲁医院血液科,济南250063 [12]贵州医科大学附属肿瘤医院淋巴瘤科,贵阳550008 [13]航天中心医院血液科,北京100049 [14]西安交通大学第一附属医院血液科,西安710061 [15]大连医科大学附属第二医院淋巴瘤及头颈部肿瘤科,大连116023 [16]大连医科大学附属第二医院血液内科,大连116023 [17]河南省人民医院血液内科,郑州450003 [18]重庆大学附属肿瘤医院血液肿瘤中心,重庆400030 [19]河北医科大学第二医院血液科,石家庄050004 [20]湖北省肿瘤医院淋巴瘤科,武汉430079 [21]华中科技大学同济医学院附属协和医院淋巴瘤科,武汉430022 [22]济宁医学院附属医院血液科,济宁272007 [23]安徽省立医院血液内科,合肥230002 [24]安徽医科大学第一附属医院血液内科,合肥230002 [25]吉林大学白求恩第一医院血液科,长春130061 [26]山西省肿瘤医院、中国医学科学院肿瘤医院、山西医院山西医科大学附属肿瘤医院血液内科,太原030013 [27]空军军医大学第一附属医院血液科,西安710032 [28]中南大学湘雅三医院血液内科,长沙410013 [29]蚌埠医学院第一附属医院血液内科,蚌埠233099 [30]赣南医学院第一附属医院血液科,赣州341001 [31]哈尔滨医科大学附属肿瘤医院血液淋巴内科,哈尔滨150081 [32]山东省立医院血液科,济南250117 [33]陕西省人民医院血液�

出　　处：《白血病．淋巴瘤》2023年第8期457-464,共8页Journal of Leukemia & Lymphoma

摘　　要：目的评价真实世界中盐酸米托蒽醌脂质体注射液治疗外周T细胞淋巴瘤(PTCL)的有效性和安全性。方法本研究为双向性队列的真实世界研究(MOMENT研究)(中国临床试验注册号:ChiCTR2200062067)。收集2022年1月至2023年1月我国37家医院接受盐酸米托蒽醌脂质体注射液单药或联合治疗的198例患者临床资料,其中回顾性队列166例,前瞻性队列32例;初治10例,复发难治188例。总结患者临床特征、疗效及不良事件发生情况,分析总生存(OS)和无进展生存(PFS)情况。结果198例患者接受盐酸米托蒽醌脂质体注射液治疗的中位周期数为3个(范围1~7个);盐酸米托蒽醌脂质体注射液单药治疗28例,联合方案治疗170例。188例复发难治患者中,完全缓解(CR)45例(23.9%),部分缓解(PR)82例(43.6%),疾病稳定(SD)28例(14.9%),疾病进展(PD)33例(17.6%),客观缓解率(ORR)为67.6%(127/188);10例初治患者中,CR 4例(40.0%),PR 5例(50.0%),PD 1例(10.0%),ORR为90.0%(9/10)。中位随访时间为2.9个月(95%CI 2.4~3.7个月),复发难治组及初治组患者的中位PFS和OS时间均未达到。复发难治患者中,盐酸米托蒽醌脂质体注射液不同治疗线数患者的ORR[二线、三线、≥四线分别为74.4%(67/90)、73.9%(34/46)、50.0%(26/52)]比较,差异有统计学意义(P=0.008)。198例PTCL患者中,182例(91.9%)发生了至少1次治疗相关的不良事件,≥3级不良事件发生率为66.7%(132/198),主要以血液学不良事件为主。≥3级血液学不良事件主要包括淋巴细胞计数降低、中性粒细胞计数降低、白细胞数降低及贫血;非血液学不良事件多为1~2级,主要包括色素沉着障碍和上呼吸道感染。结论采用含盐酸米托蒽醌脂质体注射液方案治疗PTCL具有确切的疗效,且耐受性较好,是PTCL患者新的治疗选择。Objective To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma(PTCL)in a real-world setting.Methods This was a real-world ambispective cohort study(MOMENT study)(Chinese clinical trial registry number:ChiCTR2200062067).Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023,including 166 patients in the retrospective cohort and 32 patients in the prospective cohort;10 patients in the treatment-naïve group and 188 patients in the relapsed/refractory group.Clinical characteristics,efficacy and adverse events were summarized,and the overall survival(OS)and progression-free survival(PFS)were analyzed.Results All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles(range 1-7 cycles);28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy,and 170 cases were treated with the combination regimen.Among 188 relapsed/refractory patients,45 cases(23.9%)were in complete remission(CR),82 cases(43.6%)were in partial remission(PR),and 28 cases(14.9%)were in disease stabilization(SD),and 33 cases(17.6%)were in disease progression(PD),with an objective remission rate(ORR)of 67.6%(127/188).Among 10 treatment-naïve patients,4 cases(40.0%)were in CR,5 cases(50.0%)were in PR,and 1 case(10.0%)was in PD,with an ORR of 90.0%(9/10).The median follow-up time was 2.9 months(95%CI 2.4-3.7 months),and the median PFS and OS of patients in relapsed/refractory and treatment-naïve groups were not reached.In relapsed/refractory patients,the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection[ORR of the second-line,the third-line and≥the forth-line treatment was 74.4%(67/90),73.9%(34/46)and 50.0%(26/52)]was statistically significant(P=0.008).Of the 198 PTCL patients,182 cases(91.

关 键 词：淋巴瘤 T细胞 外周 盐酸米托蒽醌脂质体注射液 治疗结果 安全性 

分 类 号：R733.1[医药卫生—肿瘤]