硼替佐米单新药为主初始化疗序贯来那度胺持续治疗在未移植的初治多发性骨髓瘤的疗效评估

Bortezomib-based regimens sequential lenalidomide therapy in newly diagnosed multiple myeloma

目的回顾性分析初始选择硼替佐米为主(不含来那度胺)的联合化疗序贯来那度胺联合地塞米松的(Rd)持续治疗在新诊断多发性骨髓瘤(NDMM)中的疗效及安全性。方法回顾性分析我中心2017—2019年收治的40例NDMM患者,初始选择硼替佐米为主单新药方案,在取得部分缓解(PR)以上疗效后,续贯Rd持续治疗,直至疾病复发、进展。观察患者疗效及安全性。结果硼替佐米为主单新药的初始联合化疗序贯Rd持续治疗,总有效率(ORR)87.5%,无进展生存(PFS)50%;45.0%取得完全缓解(CR),30.0%获得非常好的部分缓解(VGPR);仅30.0%有3~4级以上药物相关不良反应。与EVOLUTION研究相比,本研究有更晚期的疾病分期(P=0.037),更差的体能状态(P=0.003),但有着更高比例ORR(P<0.001)、≥VGPR(P<0.001)及12个月的PFS(P=0.011)。而且不良反应更少。结论对于非移植NDMM患者,硼替佐米为主单新药的初始联合化疗序贯来那度胺联合地塞米松的(Rd)持续治疗可能是VRD方案的一线替代选择。

Objective To analyze the efficacy and safety of the sequential therapy with bortezomib-based triplet regimens excluding lenalidomide followed by continuous lenalidomide and dexamethasone(Rd)in newly diagnosed multiple myeloma(NDMM).Methods Forty NDMM patients were included in this study who were admitted to our center from 2017 to 2019.Bortezomib-based triplet regimens were initially selected and followed by Rd continuous treatment once partial remission(PR)or better was achieved.Efficacy and safety were observed and compared.Results The overall survival rate was 87.5%(35/40),and progression-free survival(PFS)was 50%(20/40)after administration of the sequential strategy.Best outcome assessment achieved during follow-up:45.0%(18/40)achieved complete response(CR),and 30.0%(12/40)achieved very good partial response(VGPR).30.0%(12/40)had grade 3-4 or higher drug-related adverse reactions,mainly hematological toxicity,accounting for 25%(10/40).No patients died of adverse reactions.Compared with EVOLUTION trial,this study had more advanced disease stage(ISS stageⅲ40.0%vs 19.0%,P=0.037),worse physical status(KPS score 50-6025.0%vs 2.0%,P=0.003).But there was a higher proportion of ORR(100%vs 73%,P<0.001),VGPR or better(75%vs 32%,P<0.001),and PFS at 12 months(90%vs 68%,P=0.011).Conclusion Bortezomib-based PXD regimens sequential with lenalidomide continuous treatment maybe not be inferior to VRD for first-line treatment in NDMM patients.