伊沙佐米联合方案治疗复发/难治多发性骨髓瘤的疗效和安全性分析  

Clinical efficacy and safety of ixazomib-based therapy in the treatment of relapsed or refractory multiple myeloma

作　　者：高珊[1] 陆敏秋[1] 石磊[1] 褚彬[1] 房立娟[1] 项秋晴 王宇彤 丁月华 鲍立[1] Gao Shan;Lu Minqiu;Shi Lei;Chu Bin;Fang Lijuan;Xiang Qiuqing;Wang Yutong;Ding Yuehua;Bao Li(Department of Hematology,Beijing Jishuitan Hospital,Beijing 100096,China)

机构地区：[1]北京积水潭医院血液科,北京100096

出　　处：《国际肿瘤学杂志》2022年第5期286-291,共6页Journal of International Oncology

基　　金：北京市优秀人才培养资助青年骨干个人项目(2018000021469G223)。

摘　　要：目的观察伊沙佐米为主的联合方案治疗复发/难治多发性骨髓瘤(RRMM)的疗效及安全性。方法回顾性分析2018年7月8日至2020年11月30日北京积水潭医院血液科53例RRMM患者应用含伊沙佐米联合方案治疗的疗效及不良反应。其中6例应用ID方案(伊沙佐米+地塞米松),30例应用ID方案+免疫调节剂,17例应用ID方案+其他化疗药物。结果53例RRMM患者既往中位治疗线数为3线,中位治疗疗程数为6(2~30),中位随访时间21个月(2~32个月)。治疗2个疗程后总有效率(ORR)为54.7%(29/53),其中26.4%(14/53)达非常好的部分缓解(VGPR),28.3%(15/53)达部分缓解(PR)。ID方案组、ID方案+免疫调节剂组、ID方案+其他化疗组的ORR分别为83.3%(5/6)、56.7%(17/30)、41.2%(7/17),3组间差异无统计学意义(P=0.208)。53例患者中位疾病进展时间(TTP)为8个月(1~24个月)。伊沙佐米治疗最常见的不良反应为胃肠道反应如恶心、呕吐和腹泻,发生率为37.7%(20/53),其中3~4级发生率为5.7%(3/53);最常见的血液学不良反应为血小板减少(15.1%,8/53)、中性粒细胞减少(11.3%,6/53)及贫血(9.4%,5/53);仅7.5%(4/53)发生了1~2级的周围神经毒性。结论真实世界研究表明伊沙佐米联合方案治疗RRMM安全有效。Objective To investigate the clinical efficacy and safety of ixazomib-based therapy in patients with relapsed or refractory multiple myeloma(RRMM).Methods A retrospective analysis was performed on the efficacy and adverse reactions of 53 RRMM patients treated with a combined regimen containing ixazomib in the Hematology Department of Beijing Jishuitan Hospital from July 8,2018 to November 30,2020.Among them,6 patients received ID regimen(ixazomib+dexamethasone),30 patients received ID regimen+immunomodulator,and 17 patients received ID regimen+other chemotherapy drugs.Results Fifty-three patients with RRMM received ixazomib-based therapy.The median previous treatment line was 3,the median treatment course was 6(2-30),and the median follow-up time was 21 months(2-32 months).The overall response rate(ORR)was 54.7%(29/53)after 2 courses of treatment.Among them,26.4%(14/53)had very good partial response(VGPR)and 28.3%(15/53)had partial response(PR).The ORR of the ID regimen group,ID regimen+immunomodulator group and ID regimen+other chemotherapy group were 83.3%(5/6),56.7%(17/30)and 41.2%(7/17)respectively,with no statistically significant difference among the three groups(P=0.208).The median time to progression(TTP)of 53 patients was 8 months(1-24 months).The most frequent adverse events of ixazomib treatment were gastrointestinal reactions such as nausea,vomit and diarrhea,with an incidence of 37.7%(20/53),and the incidence of grade 3-4 was 5.7%(3/53).The most common hematological adverse events were thrombocytopenia(15.1%,8/53),neutropenia(11.3%,6/53)and anemia(9.4%,5/53).Grade 1-2 peripheral neurotoxicity occurred in only 7.5%(4/53)of patients.Conclusion Ixazomib has good efficacy and safety for the patients with RRMM in the real world.

关 键 词：多发性骨髓瘤 伊沙佐米 复发难治 有效性 安全性 

分 类 号：R733.3[医药卫生—肿瘤]