Istinye University Ankara Liv Hospital Hematology and Stem Cell Transplantation Unit, Ankara, 06880, Turkey.
EBMT Statistical Unit, Leiden, the Netherlands.
Bone Marrow Transplant. 2024 Apr;59(4):526-533. doi: 10.1038/s41409-023-02160-8. Epub 2024 Jan 31.
Bortezomib (Vel)- Melphalan 200 mg/m2 (Mel200) (Vel-Mel) has been utilised to intensify conditioning in autologous hematopoietic stem cell transplantation (AHCT) for multiple myeloma (MM). This EBMT registry-based study compared Vel-Mel with Mel200 during upfront AHCT. Between 2010 and 2017, MM patients who received Vel-Mel (n = 292) conditioning were compared with 4,096 Mel200 patients in the same 58 centres. Pre-AHCT, compared to Mel200 patients, Vel-Mel patients had similar International Staging System (ISS) scores and cytogenetic risk profiles; a similar proportion had received bortezomib-based induction (85% and 87.3%, respectively) though they were younger with a better performance status. Vel-Mel patients were more likely to achieve CR post-induction (40.6% vs 20.3%, p < 0.001) and by day 100 of AHCT (CR/VGPR: 70.2 % vs. 57.2%, p < 0.001). There was no difference in 3-year PFS (49% vs 46%, p = 0.06) or early post-AHCT mortality. In multivariable analysis, Vel-Mel associated with inferior PFS (HR: 1.69 (1.27-2.25, p < 0.001) and OS (HR:1.46 (1.14-1.86,p = 0.002), similar to negative effects on PFS of advanced ISS (HR:1.56 (1.33-1.83, p < 0.001), high-risk cytogenetics (HR:1.43(1.18-1.74, p < 0.001) and poor post-induction response(<=PR)(HR: 1.43(1.25-1.62, p < 0.001) Overall, despite superior pre- and post-AHCT responses, there was no improvement in PFS or OS following Vel-Mel. This data supports the findings of the smaller prospective IFM study.
硼替佐米(Vel)- 美法仑 200mg/m2(Mel200)(Vel-Mel)已被用于强化自体造血干细胞移植(AHCT)治疗多发性骨髓瘤(MM)的预处理方案。这项基于 EBMT 注册的研究比较了 Vel-Mel 与 upfront AHCT 时的 Mel200。在 2010 年至 2017 年间,在相同的 58 个中心中,接受 Vel-Mel 预处理的 292 例 MM 患者与接受 Mel200 预处理的 4096 例患者进行了比较。在 AHCT 前,与 Mel200 患者相比,Vel-Mel 患者的国际分期系统(ISS)评分和细胞遗传学风险谱相似;接受硼替佐米为基础的诱导治疗的比例相似(分别为 85%和 87.3%),但 Vel-Mel 患者更年轻,身体状况更好。Vel-Mel 患者在诱导后更有可能达到完全缓解(CR)(40.6% vs. 20.3%,p<0.001)和 AHCT 第 100 天(CR/VGPR:70.2% vs. 57.2%,p<0.001)。3 年无进展生存率(PFS)(49% vs. 46%,p=0.06)或早期 AHCT 死亡率无差异。多变量分析显示,Vel-Mel 与较差的 PFS 相关(HR:1.69(1.27-2.25,p<0.001)和 OS(HR:1.46(1.14-1.86,p=0.002)),与 ISS 晚期(HR:1.56(1.33-1.83,p<0.001))、高危细胞遗传学(HR:1.43(1.18-1.74,p<0.001))和较差的诱导后反应(≤PR)(HR:1.43(1.25-1.62,p<0.001))对 PFS 的负面影响相似。总体而言,尽管在 AHCT 前和 AHCT 后有更好的反应,但 Vel-Mel 并不能改善 PFS 或 OS。这些数据支持较小的前瞻性 IFM 研究的结果。