国际肿瘤学杂志

国际肿瘤学杂志 ›› 2022, Vol. 49 ›› Issue (5): 286-291.doi: 10.3760/cma.j.cn371439-20211202-00053

• 论著 • 上一篇    下一篇

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

高珊, 陆敏秋, 石磊, 褚彬, 房立娟, 项秋晴, 王宇彤, 丁月华, 鲍立()   

  1. 北京积水潭医院血液科,北京 100096
  • 收稿日期:2021-12-02 修回日期:2022-03-19 出版日期:2022-05-08 发布日期:2022-05-31
  • 通讯作者: 鲍立,孙娜 E-mail:baolilq909@sina.com
  • 基金资助:
    北京市优秀人才培养资助青年骨干个人项目(2018000021469G223)

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

Gao Shan, Lu Minqiu, Shi Lei, Chu Bin, Fang Lijuan, Xiang Qiuqing, Wang Yutong, Ding Yuehua, Bao Li()   

  1. Department of Hematology, Beijing Jishuitan Hospital, Beijing 100096, China
  • Received:2021-12-02 Revised:2022-03-19 Online:2022-05-08 Published:2022-05-31
  • Contact: Bao Li E-mail:baolilq909@sina.com
  • Supported by:
    Beijing Municipal Excellent Talents Training Fund Youth Backbone Individual Project(2018000021469G223)

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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。

关键词: 多发性骨髓瘤, 伊沙佐米, 复发难治, 有效性, 安全性

Abstract:

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.

Key words: Multiple myeloma, Ixazomib, Relapsed or refractory, Efficacy, Safety