申曼, 李新, 张佳佳, 汤然, 詹晓凯, 范斯斌, 赵凤仪, 黄仲夏. 含脂质体阿霉素方案治疗复发难治性多发性骨髓瘤伴继发髓外病变患者的临床研究[J]. 中国肿瘤临床, 2022, 49(10): 512-518. DOI: 10.12354/j.issn.1000-8179.2022.20220224
引用本文: 申曼, 李新, 张佳佳, 汤然, 詹晓凯, 范斯斌, 赵凤仪, 黄仲夏. 含脂质体阿霉素方案治疗复发难治性多发性骨髓瘤伴继发髓外病变患者的临床研究[J]. 中国肿瘤临床, 2022, 49(10): 512-518. DOI: 10.12354/j.issn.1000-8179.2022.20220224
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Man Shen, Xin Li, Jiajia Zhang, Ran Tang, Xiaokai Zhan, Sibin Fan, Fengyi Zhao, Zhongxia Huang. Liposomal doxorubicin-based therapy for relapsed/refractory multiple myeloma with secondary extramedullary disease[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2022, 49(10): 512-518. DOI: 10.12354/j.issn.1000-8179.2022.20220224
Citation: Man Shen, Xin Li, Jiajia Zhang, Ran Tang, Xiaokai Zhan, Sibin Fan, Fengyi Zhao, Zhongxia Huang. Liposomal doxorubicin-based therapy for relapsed/refractory multiple myeloma with secondary extramedullary disease[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2022, 49(10): 512-518. DOI: 10.12354/j.issn.1000-8179.2022.20220224
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含脂质体阿霉素方案治疗复发难治性多发性骨髓瘤伴继发髓外病变患者的临床研究

Liposomal doxorubicin-based therapy for relapsed/refractory multiple myeloma with secondary extramedullary disease

    摘要
  • 摘要:
      目的  探讨复发/难治性多发性骨髓瘤（relapsed/refractory multiple myeloma，RRMM）患者伴继发髓外病变（secondary extramedullary disease，sEMD）后应用脂质体阿霉素（liposomal doxorubicin，LPD）治疗的疗效、无进展生存期（progression-free survival，PFS）与安全性，以及RRMM患者出现sEMD的总生存期（overall survival，OS）及预后因素。
      方法  回顾性分析2015年1月至2020年1月就诊于首都医科大学附属北京朝阳医院西院的40例RRMM伴sEMD、接受LPD治疗患者的临床资料。记录患者初诊基线特征，继发sEMD的临床表现。观察其应用LPD的疗效、不良反应与PFS；并根据sEMD临床特点对其进行亚组分析，多因素分析得出sEMD-OS预后因素。
      结果  多因素分析显示国际分期系统（international stage system，ISS）Ⅲ期为继发EMD的危险因素。所有患者完成中位5（3～9）个疗程的LPD治疗，2个疗程总体反应率（overall response rate，ORR）为60.0%，13例完成6个疗程及以上化疗，ORR为100%；3级以上不良反应率为5%；预计中位PFS（median PFS，mPFS）为8.0个月（95%CI：7.5～8.5），界标分析示LPD≥6个疗程组相比于<6个疗程组PFS延长（P=0.093）。预计sEMD中位OS（median OS，mOS）为22.0个月（95%CI：18.2～25.8），1年OS率为73.6%，2年OS率为38.2%。多因素回归分析显示，非骨旁sEMD与乳酸脱氢酶（lactate dehydrogenase，LDH）>250 U/L为sEMD-OS的独立预后因素。
      结论  含LPD方案治疗RRMM继发EMD短期疗效好，安全性高。非骨旁sEMD及LDH>250 U/L预后不良，此类患者需寻求其他治疗策略。

     

    Abstract:
      Objective   To assess the efficacy, progression-free survival (PFS), and safety of liposomal doxorubicin (LPD) in patients with relapsed/refractory multiple myeloma (RRMM) with secondary extramedullary disease (sEMD) and evaluate overall survival (OS) and prognostic factors after the emergence of sEMD in patients with RRMM.
      Methods  Medical records of patients with RRMM were retrospectively analyzed. Forty patients with sEMD were treated with LPD in Beijing Chao-Yang Hospital from January 2015 to January 2020. The baseline characteristics of patients with an initial diagnosis of RRMM and clinical manifestations of sEMD were recorded. Moreover, efficacy, PFS, and safety of LPD were assessed. Furthermore, the OS after sEMD (sEMD-OS) was compared based on sEMD characteristics, and prognostic factors of sEMD-OS were determined using multivariate analyses.
      Results  International stage system stage (ISS) Ⅲ was confirmed as a risk factor for sEMD. All 40 patients completed a median of 5(3-9) treatment courses, with an overall response rate (ORR) of 60% after two cycles. Thirteen patients completed six or more treatment courses, with an ORR of 100%. The rate of adverse events above grade three was 5%. The estimated median PFS (mPFS) of LPD was 8.0 (95%CI: 7.5-8.5) months. PFS was superior in the group of LPD ≥6 cycles compared to that in the group of LPD <6 cycles after the landmark analysis (P=0.093). The estimated median sEMD-OS was 22.0 (95%CI: 18.2-25.8) months, with the 1- and 2-year OS rates being 73.6% and 38.2%, respectively. Extraosseous sEMD and lactate dehydrogenase (LDH) >250 U/L were confirmed to be independent prognostic factors.
      Conclusions  LPD-based regimens have good short-term efficacy and high tolerance in the treatment of RRMM with sEMD. Extraosseous sEMD and/or LDH>250 U/L indicates poor prognosis.

     

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