摘要
目的分析一线含CD38单抗方案治疗原发浆细胞白血病(pPCL)的有效性和安全性。方法回顾性纳入北京大学人民医院、首都医科大学附属复兴医院、青岛市立医院、中国医科大学附属盛京医院、邯郸市中心医院、哈尔滨医科大学附属第一医院、河北医科大学第四医院、宁夏医科大学总医院2018年12月1日至2023年7月26日接受一线含CD38单抗(即达雷妥尤单抗)方案治疗的pPCL连续病例24例,包括男13例,女11例,年龄[M(Q_(1),Q_(3))]为60(57,70)岁。根据外周血浆细胞比例将患者分为两组:浆细胞比例5%~19%组(n=14)和浆细胞比例≥20%组(n=10)。末次随访日期为2023年9月26日,随访时间为9.1(4.2,15.5)个月。收集患者临床基线特点、疗效、生存率、安全性等相关数据,采用Cox风险回归模型分析与生存相关的危险因素。结果24例pPCL患者中,确诊时合并贫血患者16例(66.7%),合并血小板减少患者13例(54.2%),基线估算的肾小球滤过率(eGFR)<40 ml·min-1·(1.73m 2)-1患者8例(33.3%),合并乳酸脱氢酶(LDH)升高患者13例(54.2%)。外周血浆细胞比例[M(Q_(1),Q_(3))]为16%(8%,26%)。荧光原位杂交(FISH)检测提示伴有17p缺失、t(4;14)或t(14;16)患者分别为6例(25.0%)、4例(16.7%)、4例(16.7%)。总缓解率为83.3%(20/24),无进展生存时间(PFS)为20.5(95%CI:15.8~25.2)个月,总生存时间(OS)未达到。预计1年PFS率和OS率分别为75.0%和89.1%,预计2年PFS率和OS率分别为37.5%和53.4%。外周血浆细胞比例5%~19%组和外周血浆细胞比例≥20%组患者的PFS分别为未达到和20.5(95%CI:15.7~25.3)个月,OS分别为17.8个月和未达到,两组PFS和OS差异均无统计学意义(均P>0.05)。多因素Cox回归模型分析显示,1p32缺失是与PFS相关的危险因素(HR=7.7,95%CI:1.1~54.9,P=0.043)。共17例(70.8%)患者合并3~4级血液学不良反应,12例(50.0%)患者合并3~4级血小板减少,16例(66.7%)患者合并临床判定的感染,所有血液学不良反应和感染�
Objective To analyze the efficacy and safety of first-line treatment with an anti-CD38 monoclonal antibody regimen for primary plasma cell leukemia(pPCL).Methods Patients diagnosed with pPCL from December 1 st,2018 to July 26 th,2023,receiving first-line treatment of anti-CD38 monoclonal antibody-based regimens across multiple centers including Peking University People′s Hospital,Fuxing Hospital of Capital Medical University,Qingdao Municipal Hospital,Shengjing Hospital of China Medical University,Handan Central Hospital,the First Affiliated Hospital of Harbin Medical University,the Fourth Hospital of Hebei Medical University and General Hospital of Ningxia Medical University were consecutively included.A total of 24 pPCL patients were included with thirteen being male and eleven being female.The median age[M(Q_(1),Q_(3))]was 60(57,70)years.Patients were grouped according to peripheral blood plasma cell(PBPC)percentage[5%-19%(n=14)vs≥20%(n=10)].Last follow-up date was September 26 th,2023.The median follow-up period was 9.1(4.2,15.5)months.Patients′data related with clinical baseline characteristics,efficacy,survival and safety were retrospectively collected.Cox proportional hazards regression model was used to analyze risk factors associated with survival.Results Among 24 pPCL patients,16(66.7%)patients had anemia at diagnosis,13(54.2%)patients had thrombocytopenia,8(33.3%)patients had a baseline estimated glomerular filtration rate(eGFR)<40 ml·min-1·(1.73m 2)-1,13(54.2%)patients had elevated lactate dehydrogenase(LDH)levels.The median PBPC percentage was 16%(8%,26%).Fluorescence in situ hybridization testing indicated that patients harboring 17p deletion,t(4;14)or t(14;16)were 6(25.0%),4(16.7%)and 4(16.7%),respectively.The overall response rate was 83.3%(20/24).The median progression-free survival(PFS)was 20.5(95%CI:15.8-25.2)months,and the median overall survival(OS)was not reached.Estimated 1-year and 2-year PFS and OS rates were 75.0%and 89.1%,37.5%and 53.4%,respectively.The median PFS and OS for pat
作者
窦雪琳
刘瑞霞
刘扬
彭楠
温磊
武悦
李茜
钟玉萍
周霞
廖爱军
蒋卉男
马晓军
董会会
范圣瑾
赵艳秋
胡代宏
路瑾
Dou Xuelin;Liu Ruixia;Liu Yang;Peng Nan;Wen Lei;Wu Yue;Li Qian;Zhong Yuping;Zhou Xia;Liao Aijun;Jiang Huinan;Ma Xiaojun;Dong Huihui;Fan Shengjin;Zhao Yanqiu;Hu Daihong;Lu Jin(Department of Hematology,Peking University People′s Hospital,Peking University Institute of Hematology,National Clinical Research Center for Hematologic Disease,Beijing 100044,China;Department of Hematology,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050010,China;Department of Hematology,Fuxing Hospital,Capital Medical University,Beijing 100044,China;Department of Hematology,Qingdao Municipal Hospital,Qingdao 266011,China;Department of Hematology,Shengjing Hospital of China Medical University,Shenyang 110004,China;Department of Hematology,Handan Central Hospital,Handan 056001,China;Department of Hematology,the First Affiliated Hospital of Harbin Medical University,Harbin 150001,China;Department of Hematology,General Hospital of Ningxia Medical University,Yinchuan 750004,China)
出处
《中华医学杂志》
CAS
CSCD
北大核心
2024年第7期499-506,共8页
National Medical Journal of China
基金
首都卫生发展科研专项(2020-2-4082)
