硼替佐米维持治疗25例非移植多发性骨髓瘤患者疗效的临床观察

Clinical Analysis of 25 Non-Transplanted Multiple Myeloma Patients Treated with Bortezomib Maintenance

目的:探讨应用硼替佐米对非移植多发性骨髓瘤(MM)患者进行维持治疗的疗效、生存及不良反应。方法:回顾性分析2004年6月至2015年11月北京朝阳医院西院收治的25例初治/复发MM患者的临床资料,应用硼替佐米联合地塞米松(PD)方案维持治疗,其用法为硼替佐米1.3 mg/m^2,地塞米松20 mg,每程d 1、8、15、22,3个月为1疗程。结果:截至2017年11月1日,25例MM患者中,严格完全缓解(sCR)5例,完全缓解(CR)8例,良好部分缓解(VGPR)7例,部分缓解(PR)4例,稳定(SD)1例。25例患者经过维持治疗,21例(84%)疗效保持在PR以上,其中1例CR改善为sCR;4例疾病进展后调整方案,所有患者维持治疗疗程中位数为9(6-31)个疗程,中位维持治疗时间27(18-97)个月,中位随访时间73(25-171)个月,中位无进展生存期为30(9-105)个月,中位总生存期为57(27-160)个月。截至2019年11月1日,3年生存率为84%(21/25),5年生存率为72%(13/18)。最常见的不良反应为一过性白细胞减少血小板降低及周围神经病变,经预防与治疗均可耐受。结论:鉴于其安全性及有效性,非自体干细胞移植的MM患者可选用PD方案用于维持治疗。

Objective:To investigate the efficacy,survival and adverse effects of non-transplanted multiple myeloma(MM)patients treated with bortezomib maintenance.Methods:A total of 25 newly diagnosed/relapsed non-transplanted MM patients treated in West District of Beijing Chaoyang Hospital from June 2004 to November 2015 were analyzed retrospectively.All patients received PD regimen(bortezomib and dexamethasone),including bortezomib at a dose of 1.3 mg/m^2 and dexamethasone 20 mg on days 1,8,15,22 in a 3-month cycle.Results:Till November 1,2017,5 patients achieved stringent complete response(sCR),8 patients achieved complete response(CR),7 patients achieved very good partial response(VGPR),4 patients achieved partial reponse(PR),while 1 patient achieved stable disease(SD).After maintenance therapy,21 patients maintained the efficacy above PR,of which 1 patient was improved from CR to sCR;4 patients adjusted chemotherapy after disease progressed.Median maintenance therapy was 9 cycles(range from 6 to 31),and the median maintenance time was 27 months(range from 18 to 97).Median follow-up time was 73 months(range from 25 to 171).Median progress-free survival(PFS)time was 30 months(range from 9 to 105)and overall survival(OS)time was 57 months(range from 27 to 160).Till November 1,2019,3-year survival rate was 84%(21/25),and 5-year survival rate was 72%(13/18).The most common adverse events were transient leukopenia,thrombocytopenia and peripheral neuropathy,which the patients could tolerate after the prevention and treatment.Conclusion:Bortezomib-based maintenance therapy for non-transplanted MM patients can be an option in consideration of its safety and efficacy.