伊沙佐米联合来那度胺和地塞米松方案治疗多发性骨髓瘤的真实世界研究

Real world study of ixazomib combined with lenalidomide and dexamethasone in treatment of multiple myeloma

目的探讨伊沙佐米联合来那度胺和地塞米松(IRd)方案在真实世界中对多发性骨髓瘤(MM)患者的安全性及有效性。方法回顾性分析2019年1月至2021年1月华中科技大学同济医学院附属协和医院24例接受IRd方案治疗的MM患者临床资料,分析其疗效和不良反应。24例患者中包括复发难治患者5例(复发难治组)和硼替佐米诱导有效但因不良反应或其他原因转为IRd方案治疗的初治患者19例(转换组)。结果24例患者中位治疗4个(2~7个)周期,完全缓解(CR)8例,非常好的部分缓解(VGPR)6例,部分缓解(PR)8例,疾病进展(PD)1例,微小缓解(MR)1例,总反应率(ORR)为91.7%(22/24);中位无进展生存(PFS)时间为15个月(95%CI 6.6~23.4个月);6例CR患者微小残留病(MRD)阴性;常见不良反应为血液学不良反应、周围神经病、乏力、胃肠道反应、感染,3~4级不良反应发生率为25.0%(6/24)。复发难治组最佳疗效VGPR 1例,PR 3例,MR 1例,均因短暂缓解后PD或治疗效果不佳中途退出IRd方案治疗;转换组最佳疗效CR 8例,VGPR 5例,PR 5例,PD 1例,57.9%(11/19)患者维持原反应,36.8%(7/19)患者缓解程度加深;两组中位PFS时间差异有统计学意义(7个月比未达到,P=0.018)。结论IRd方案对MM患者安全、有效,特别是对于硼替佐米诱导有效的转换患者。既往使用多线治疗的复发难治MM患者虽对IRd方案有应答,但缓解持续时间有限。

Objective To investigate the efficacy and safety of ixazomib combined with lenalidomide and dexamethasone(IRd)regimen in treatment of multiple myeloma(MM)patients in the real world practice.Methods The clinical data of 24 MM patients treated with IRd regimen from January 2019 to January 2021 in the Union Hospital,Tongji Medical College,Huazhong University of Science and Technology were retrospectively analyzed,and their efficacy and adverse reactions were analyzed.Among the 24 patients,5 patients were relapsed and refractory(relapsed/refractory group),and 19 newly treated patients(conversion group)who responded to bortezomib induction therapy but converted to IRd regimen due to adverse reactions or other reasons.Results The 24 patients were treated for a median of 4 cycles(2-7 cycles),with 8 cases of complete remission(CR),6 cases of very good partial remission(VGPR),8 cases of partial remission(PR),1 case of disease progression(PD),1 case of minimal response(MR),and the overall response rate(ORR)was 91.7%(22/24);the median progression-free survival(PFS)time was 15 months(95%CI 6.6-23.4 months);6 CR patients were negative for minimal residual disease(MRD).The common adverse reactions were hematological adverse reactions,peripheral neuropathy,fatigue,gastrointestinal reactions,and infections.The incidence rate of grade 3-4 adverse reactions was 25.0%(6/24).In the relapsed/refractory group,the best efficacy was VGPR in 1 case,PR in 3 cases,and MR in 1 case,all patients withdrew from the IRd regimen therapy due to PD after transient remission or poor effect;in the conversion group,the best efficacy was CR in 8 cases,VGPR in 5 cases,PR in 5 cases,and PD in 1 case,57.9%(11/19)patients maintained their original best response,and 36.8%(7/19)patients improved their best response to CR;the difference in median PFS time between the two groups was statistically significant(7 months vs.not reached,P=0.018).Conclusions The IRd regimen is safe and effective for MM patients,especially for the conversion patients after effective bortezomib induction therapy.Although patients with relapsed/refractory MM who have previously used multi-line therapy respond to IRd regimen,the duration of remission is limited.