伊布替尼治疗淋巴浆细胞淋巴瘤/华氏巨球蛋白血症的疗效及安全性  

The efficacy and safety of ibrutinib in the treatment of lymphoplasmacytic lymphoma/Waldenström macroglobulinemia

作　　者：黄燕姗 熊文婕 原菁菁 于颖 李雨曦 阎禹廷 王婷玉 吕瑞 刘薇 安刚 赵耀中 邹德慧 邱录贵 易树华 Huang Yanshan;Xiong Wenjie;Yuan Jingjing;Yu Ying;Li Yuxi;Yan Yuting;Wang Tingyu;Lyu Rui;Liu Wei;An Gang;Zhao Yaozhong;Zou Dehui;Qiu Lugui;Yi Shuhua(State Key Laboratory of Experimental Hematology,National Clinical Research Center for Blood Diseases,Haihe Laboratory of Cell Ecosystem,Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Tianjin 300020,China;Tianjin Institutes of Health Science,Tianjin 301600,China)

机构地区：[1]中国医学科学院血液病医院(中国医学科学院血液学研究所),实验血液学国家重点实验室,国家血液系统疾病临床医学研究中心,细胞生态海河实验室,天津300020 [2]天津医学健康研究院,天津301600

出　　处：《中华血液学杂志》2024年第8期755-760,共6页Chinese Journal of Hematology

基　　金：国家自然科学基金(82200215、82170193、82370197);中国医学科学院医学与健康科技创新工程(2022-I2M-1-022、2021-I2M-C&T-B-081)。

摘　　要：目的探索伊布替尼治疗初治及复发难治(R/R)淋巴浆细胞淋巴瘤(LPL)/华氏巨球蛋白血症(WM)的疗效及安全性。方法收集2016年3月至2023年6月在中国医学科学院血液病医院接受伊布替尼治疗的98例初治及R/R LPL/WM患者的临床资料,回顾性分析其疗效及安全性。结果共纳入98例LPL/WM患者,初治患者45例,R/R患者53例,男74例(75.5%),中位年龄64(42~87)岁。88例患者可进行疗效评估,中位治疗时间20.8(2.1~55.0)个月,主要缓解率(MRR)为78.4%,总缓解率(ORR)为85.2%。初治患者的MRR和ORR分别为78.4%和86.5%,R/R患者的MRR和ORR分别为78.4%和84.3%,初治与R/R患者MRR和ORR的差异均无统计学意义(P值均>0.05)。中位随访29.1(2.9~50.3)个月,初治和R/R患者的中位总生存时间均未达到,中位无进展生存时间分别为23.5(95%CI 10.5~36.5)个月和45.0(95%CI 34.0~56.0)个月,差异均无统计学意义(P值均>0.05)。死亡患者25例,未出现因应用伊布替尼死亡事件,伊布替尼的主要不良反应为血小板减少(5.1%)、肺炎(8.1%)及高尿酸血症(21.4%),心房颤动的发生率为2.0%。结论伊布替尼对于初治及R/R LPL/WM患者有良好的疗效及安全性。Objective To explore the efficacy and safety of ibrutinib for the treatment of newly treated and relapsed refractory(R/R)lymphoplasmacytic lymphoma(LPL)/Waldenström macroglobulinemia(WM).Methods Retrospectively collected clinical data of 98 cases of newly treated and R/R LPL/WM patients who received ibrutinib treatment at the Hematology&Blood Diseases Hospital of the Chinese Academy of Medical Sciences from March 2016 to June 2023,and analyzed their efficacy and safety.Results A total of 98 LPL/WM patients were included,which consisted of 45 newly treated patients and 53 R/R patients.Of these,74 were males(75.5%)and the cohort had a median age of 64(42-87)years.Eighty-eight patients were eligible for efficacy evaluation with a median treatment time of 20.8(2.1-55.0)months,a major remission rate(MRR)of 78.4%,and an overall response rate(ORR)of 85.2%.The MRR and ORR of the newly treated patients were 78.4%and 86.5%,respectively,whereas the MRR and ORR of the R/R patients were 78.4%and 84.3%,respectively.There were no statistically significant differences in MRR and ORR between the initial treatment and R/R patients(all P values>0.05).The median follow-up period was 29.1(2.9-50.3)months and the median overall survival time for newly treated and R/R patients was not reached.The median progression-free survival time was 23.5(95%CI 10.5-36.5)months and 45.0(95%CI 34.0-56.0)months,respectively,with no statistically significant differences(all P values>0.05).There were 25 deceased patients and no deaths were related to ibrutinib treatment.The main adverse reactions of ibrutinib were thrombocytopenia(5.1%),pneumonia(8.1%),and hyperuricemia(21.4%).The incidence of atrial fibrillation was 2.0%.Conclusion Ibrutinib exhibits good efficacy and safety for newly treated and R/R LPL/WM patients.

关 键 词：WALDENSTROM巨球蛋白血症 淋巴瘤 伊布替尼 治疗结果 

分 类 号：R733.1[医药卫生—肿瘤]