Huang Y S, Xiong W J, Yuan J J, Yu Y, Li Y X, Yan Y T, Wang T Y, Lyu R, Liu W, An G, Zhao Y Z, Zou D H, Qiu L G, Yi S H
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.
Zhonghua Xue Ye Xue Za Zhi. 2024 Aug 14;45(8):755-760. doi: 10.3760/cma.j.cn121090-20240301-00077.
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) . 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. 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 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% 10.5-36.5) months and 45.0 (95% 34.0-56.0) months, respectively, with no statistically significant differences (all 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%. Ibrutinib exhibits good efficacy and safety for newly treated and R/R LPL/WM patients.
探讨伊布替尼治疗初治及复发难治性（R/R）淋巴浆细胞淋巴瘤（LPL）/华氏巨球蛋白血症（WM）的疗效和安全性。回顾性收集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，并分析其疗效和安全性。共纳入98例LPL/WM患者，其中初治患者45例，R/R患者53例。其中，男性74例（75.5%），队列的中位年龄为64（42-87）岁。88例患者符合疗效评估标准，中位治疗时间为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%，而R/R患者的MRR和ORR分别为78.4%和84.3%。初治患者与R/R患者的MRR和ORR差异无统计学意义（所有P值>0.05）。中位随访时间为29.1（2.9-50.3）个月，初治及R/R患者的中位总生存时间未达到。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，差异无统计学意义（所有P值>0.05）。有25例死亡患者，无死亡与伊布替尼治疗相关。伊布替尼的主要不良反应为血小板减少（5.1%）、肺炎（8.1%）和高尿酸血症（21.4%）。房颤发生率为2.0%。伊布替尼对初治及R/R LPL/WM患者显示出良好的疗效和安全性。
