Effects of bortezomib at difrerent doses in combination with dexamethasone in treatment of relapsed or refractory multiple myeloma:a comparative study

目的 评价硼替佐米联合地塞米松方案治疗难治复发多发性骨髓瘤(MM)的有效性和安全性.方法 前瞻性设计2种剂量的硼替佐米联合地塞米松的化疗方案,随机分组对照治疗难治复发MM患者23例,1O例患者应用硼替佐米1.0 mg/m2,第1、4,8、11天给药,地塞米松20 mg/d,第1～4天;标准剂量组(13例):硼替佐米1.3 mg/m2,地塞米松40 mg/d,第1、4、8、11天给药,均21 d为1个疗程.采用欧洲造血干细胞移植合作组织(EBMT)标准观察疗效.结果 中位随访9.5(3-15)个月.硼替佐米1.0 mg/m2组与1.3 mg/m2组相比:有效率分别为70.O%和61.5%(P>0.05);缓解率分别为20.O%和38.5%(P>0.05).硼替佐米1.0 mg/m2组仅1例CTCAE 3级以上不良反应,硼替佐米1.3 mg/m2组感染性发热发生率38.5%(5/13),治疗相关死亡率15.4%(2/13).结论 硼替佐米1.3 mg/m2与1.0 mg/m2组相比有效率相似,缓解率较高,而毒副作用明显增加.To investigate the efficacy and toxicity of bortezomib of different doses in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma (MM).23 patients with relapsed or refractory MM, 10 males and 13 females, aged 65 (42-86), were randomized to 2 groups: low dose group receiving intravenous 1.0 mg/m2 bortezomib (n=10) on days 1, 4, 6, and 11 (twice weekly) combined with dexamethasone 20 mg/d on days 1-4, with 3 weeks as a course of treatment, and (20 standard dose group: receiving intravenous 1.3 mg/m2 bortezomib (n=13) combined with dexamethasone. The patients were followed up for 9.5 (3-15) months. The effect was determined using modified European Group for Blood and Marrow Transplantation (EBMT) criteria.The complete response (CR) + partial response (PR) rate of the 1.0 mg/m2 bortezomib group was 70.0%, not significantly different from that of the 1.3 mg/m2 bortezomib group (61.5%, P > 0.05). The relief rate (CR + near CR rate) of the 1.0 mg/m2 bortezomib group was 20.0% not significantly different from that of the 1.3 mg/m2 bortezomib group (38.5%, P > 0.05). Only 1 case of adverse event over the grade 3 of National Cancer Institute Common Terminology Criteria for Adverse Events occurred in the 1.3 mg/m2 bortezomib group. Five cases of infectious fever and 2 cases of treatment-associated death occurred in the 1.3 mg/m2 bortezomib group.Bortezomib at the dose of 1.3 mg/m2 is more effective in treatment of relapsed or refractory MM than that at the dose of 1.3 mg/m2 and has more side effects.卫生部医药卫生科技发展研究基金PubMed中文核心期刊要目总览(PKU)中国科技核心期刊(ISTIC)中国科学引文数据库(CSCD)0261829-18318