Xie L N, Wang X, He Q, Wang H, Ma J, Zhang H Y, Liu N, Jie G T, Xiao T W, Zhang H, Zhang H G, Li Z J, Xing L J
Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
Department of Hematology, Linyi City People's Hospital, Linyi 276003, China.
Zhonghua Xue Ye Xue Za Zhi. 2024 Jun 14;45(6):571-576. doi: 10.3760/cma.j.cn121090-20231217-00318.
To explore the efficacy and safety of domestic bortezomib in combination with lenalidomide and dexamethasone in the treatment of newly diagnosed multiple myeloma (NDMM) . This multicenter, prospective, single-arm clinical study included 126 patients with NDMM admitted to seven hospitals between December 2019 and January 2022. All patients received domestic bortezomib in combination with lenalidomide and dexamethasone (BLD regimen), and the efficacy, prognostic factors, and safety were analyzed. Among the 126 patients with NDMM, 118 completed four cycles of treatment, with an overall response rate (ORR) of 93.22% (110/118) and a ≥very good partial response (VGPR) rate of 68.64% (81/118). Ultimately, 114 patients completed at least eight cycles of treatment, with an ORR of 92.98% (106/114) and a ≥VGPR rate of 77.19% (88/114). Eighteen patients underwent autologous hematopoietic stem cell transplantation after completing 6-8 cycles of the BLD regimen, with an ORR of 100% (18/18) and a ≥VGPR rate of 88.9% (16/18). The proportion of patients achieving ≥VGPR increased with the treatment duration, and factors such as staging and age did not significantly affect efficacy. Single-factor analysis showed that R2-ISS stage Ⅲ/Ⅳ, blood calcium >2.27 mmol/L, and failure to achieve VGPR after six cycles were adverse prognostic factors for progression-free survival (PFS) (<0.05), whereas failure to achieve VGPR after six cycles was an adverse prognostic factor for overall survival (OS) (<0.001). Multifactor analysis demonstrated that failure to achieve VGPR after six cycles is an independent adverse prognostic factor for PFS (=0.002). The incidence of hematologic adverse reactions was 16.7% (19/114), and nonhematologic adverse reactions were mainly mild to moderate, with no significant cardiac or renal adverse reactions observed. The BLD regimen is effective in treating NDMM, in which patients with high-risk genetic features are still achieving a high ≥VGPR rate, and the overall safety is good.
探讨国产硼替佐米联合来那度胺和地塞米松治疗新诊断多发性骨髓瘤（NDMM）的疗效和安全性。本多中心、前瞻性、单臂临床研究纳入了2019年12月至2022年1月期间在7家医院收治的126例NDMM患者。所有患者均接受国产硼替佐米联合来那度胺和地塞米松（BLD方案）治疗，并对疗效、预后因素和安全性进行分析。在126例NDMM患者中，118例完成了4个周期的治疗，总缓解率（ORR）为93.22%（110/118），≥非常好的部分缓解（VGPR）率为68.64%（81/118）。最终，114例患者完成了至少8个周期的治疗，ORR为92.98%（106/114），≥VGPR率为77.19%（88/114）。18例患者在完成6 - 8个周期的BLD方案后接受了自体造血干细胞移植，ORR为100%（18/18），≥VGPR率为88.9%（16/18）。达到≥VGPR的患者比例随治疗疗程增加而升高，分期和年龄等因素对疗效无显著影响。单因素分析显示，R2-ISSⅢ/Ⅳ期、血钙>2.27 mmol/L以及6个周期后未达到VGPR是无进展生存期（PFS）的不良预后因素（<0.05），而6个周期后未达到VGPR是总生存期（OS）的不良预后因素（<0.001）。多因素分析表明，6个周期后未达到VGPR是PFS的独立不良预后因素（=0.002）。血液学不良反应发生率为16.7%（19/114），非血液学不良反应主要为轻至中度，未观察到明显的心脏或肾脏不良反应。BLD方案治疗NDMM有效，其中具有高危遗传特征的患者仍可获得较高的≥VGPR率，且总体安全性良好。
