真实世界国产硼替佐米治疗初诊多发性骨髓瘤疗效评价

Efficacy evaluation of bortezomib in the treatment of newly diagnosed multiple myeloma in the real world

目的:探讨国产硼替佐米治疗初诊多发性骨髓瘤的有效性及安全性。方法:回顾性分析2017年7月—2020年8月我院接受以国产硼替佐米为基础的联合化疗方案治疗的初诊多发性骨髓瘤患者74例,其中BD方案化疗47例,BCD方案化疗11例,BAD方案化疗16例,每2个疗程后行有效性及安全性评估。结果:截至2020年11月,4例患者出现失访,部分患者因经济原因、依从性差等原因未能返院治疗。共有74例患者完成2个疗程,治疗总反应率(ORR)为68.9%(51/74)。58例患者完成4个疗程,ORR为77.6%(45/58)。32例患者完成6个疗程治疗,ORR为81.3%(26/32)。13例患者完成8个疗程治疗,ORR为92.3%(12/13)。三药联合的BCD、BAD方案治疗2、4个疗程的ORR优于两药联合的BD方案,差异有统计学意义(P<0.05)。治疗中出现的不良反应主要为白细胞减少、血小板减少、周围神经病变、胃肠道反应、带状疱疹病毒感染等,多为Ⅰ~Ⅲ级,未见Ⅳ级血液学及非血液学不良反应。三药联合组白细胞减少发生率高于两药组(33.3%vs 12.8%,P<0.05),其余不良反应差异无统计学意义。结论:在真实世界中,以国产硼替佐米为基础的联合化疗方案治疗初诊多发性骨髓瘤患者可取得较好的临床疗效,安全可靠,尚需要大样本临床数据进行长期追踪随访来验证其远期疗效。

Objective:To investigate the efficacy and safety of bortezomib in the treatment of newly diagnosed multiple myeloma.Methods:A retrospective analysis of 74 patients with newly diagnosed multiple myeloma who received domestic bortezomib-based combined chemotherapy regimen in our hospital from July 2017 to August 2020,of which 47 were treated with BD regimen chemotherapy,11 cases of BCD regimen chemotherapy and 16 cases of BAD regimen chemotherapy.The efficacy and safety were evaluated after every 2 courses.Results:As of November 2020,4 patients were lost to follow-up,and some patients failed to return to hospital for treatment due to economic reasons,poor compliance and other reasons.A total of 74 patients completed 2 courses,with an overall response rate(ORR)of 68.9%(51/74).The ORR of 58 patients was 77.6%(45/58)after 4 courses of treatment.Thirty-two patients completed 6 courses of treatment,and the ORR was 81.3%(26/32).Thirteen patients completed 8 courses of treatment,and ORR was 92.3%(12/13).The ORR of BCD and BAD combined with three drugs in treatment of 2 and 4 courses was better than that of BD combined with two drugs,and the difference was statistically significant(P<0.05).The adverse events during the treatment were mainly leukopenia,thrombocytopenia,peripheral neuropathy,gastrointestinal tract reaction and herpes zoster virus infection,mostly gradeⅠtoⅢlevel,and gradeⅣhematology and non hematologic adverse events were not seen.The incidence of leukopenia in the three-drug combination group was higher than that in the two-drug combination group(33.3%vs 12.8%,P<0.05),and there was no difference in other adverse events.Conclusion:In the real world,bortezomib-based combined chemotherapy can achieve good clinical efficacy in the treatment of newly diagnosed multiple myeloma patients,which is safe and reliable.Long-term follow-up with large clinical data is still needed to verify its long-term efficacy.