伊沙佐米全口服方案治疗复发难治多发性骨髓瘤的疗效分析

Efficacy of total oral regimens containing ixazomib in patients with relapsed and refractory multiple myeloma

观察伊沙佐米为主的全口服方案居家治疗多药耐药的复发/难治多发性骨髓瘤(MM)的疗效及安全性。回顾分析2018年8月至2020年1月于苏州大学附属第一医院就诊并接受伊沙佐米为主的全口服方案化疗的复发/难治MM患者38例,观察治疗后的疗效及不良反应。在多药耐药的复发难治MM患者中,伊沙佐米联合全口服方案的总体反应率(ORR)为36.8%,其中非常好的部分缓解(VGPR)以上23.7%,完全缓解(CR)5.3%。伊沙佐米联合来那度胺及地塞米松(IRD)方案组ORR为41.7%。所有患者的中位无进展生存(PFS)为5个月,中位总生存(OS)期为7.5个月。伊沙佐米联合全口服方案二线治疗有效缓解率为50%,三线治疗有效缓解率为40%;四线及以上有效缓解率仅为12.5%。硼替佐米耐药组的有效缓解率达29.0%,来那度胺耐药组的有效率较高38.0%,而双重耐药组的缓解率仍达到了21.4%。伊沙佐米治疗中发生3~4级血液学不良反应的发生率为21%(8例),主要血液学毒性为血小板及白细胞计数降低,非血液学不良反应主要为乏力和腹泻。在多药耐药复发/难治MM患者治疗上,以伊沙佐米为主的全口服方案居家治疗具有可靠的疗效及安全性。首次复发和二次复发使用明显优于4线以上治疗的晚期患者。

To investigate the efficacy and safety of total oral regimen containing ixazomib in multidrug-resistant relapsed and refractory multiple myeloma(RRMM).A total of 38 patients were retrospectively analyzed from August 2018 to January 2020 in the First Affiliated Hospital of Soochow University.The overall response rate(ORR)was 36.8%.Among them,the very good partial response(VGPR)or better rate was 23.7%,and the complete response(CR)rate was 5.3%.The ORR was 41.7%in patients receiving ixazomib-lenalidomide-dexamethasone(IRD)regimen.Median PFS was 5 months and median OS was 7.5 months.The ORR was 50%after second-line therapy,40%after third-line therapy and 12.5%after forth-line therapy or more.The ORR was 29.0%in bortezomib-refractory patients,38.0%in lenalidomide-refractory patients,21.4%in bortezmoib&lenalidomide dual refractory patients.Grade 3-4 hematological adverse events(AEs)were reported in 21%patients.Common hematological AEs included lymphopenia,neutropenia,thrombocytopenia.Other usual AEs were fatigue and diarrhea.No grade 3-4 peripheral neuropathy was recorded.In the treatment of relapsed/refractory multiple myeloma patients with multidrug resistance,the total oral regimens containing ixazomib demonstrate reliable efficacy and safety.Early administration of ixazomib at first or second relapse is suggested for more favorable clinical outcome.