文章：

来那度胺与硼替佐米维持治疗在初治多发性骨髓瘤自体干细胞移植后的比较

Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma

原文发布日期：2021-01-07

DOI: 10.1038/s41408-020-00390-3

类型: Article

开放获取: 是

英文摘要：

Lenalidomide (LEN) maintenance (MT) post autologous stem cell transplantation (ASCT) is standard of care in newly diagnosed multiple myeloma (MM) but has not been compared to other agents in clinical trials. We retrospectively compared bortezomib (BTZ; n = 138) or LEN (n = 183) MT from two subsequent GMMG phase III trials. All patients received three cycles of BTZ-based triplet induction and post-ASCT MT. BTZ MT (1.3 mg/m2 i.v.) was administered every 2 weeks for 2 years. LEN MT included two consolidation cycles (25 mg p.o., days 1–21 of 28 day cycles) followed by 10–15 mg/day for 2 years. The BTZ cohort more frequently received tandem ASCT (91% vs. 33%) due to different tandem ASCT strategies. In the LEN and BTZ cohort, 43% and 46% of patients completed 2 years of MT as intended (p = 0.57). Progression-free survival (PFS; HR = 0.83, p = 0.18) and overall survival (OS; HR = 0.70, p = 0.15) did not differ significantly with LEN vs. BTZ MT. Patients with <nCR after first ASCT were assigned tandem ASCT in both trials. In patients with <nCR and tandem ASCT (LEN: n = 54 vs. BTZ: n = 84), LEN MT significantly improved PFS (HR = 0.61, p = 0.04) but not OS (HR = 0.46, p = 0.09). In conclusion, the significant PFS benefit after eliminating the impact of different tandem ASCT rates supports the current standard of LEN MT after ASCT.
 

摘要翻译： 

自体干细胞移植（ASCT）后采用来那度胺（LEN）进行维持治疗（MT）是新诊断多发性骨髓瘤（MM）的标准治疗方案，但尚未在临床试验中与其他药物进行对比。我们回顾性分析了后续两项GMMG III期试验中使用硼替佐米（BTZ；n=138）或来那度胺（LEN；n=183）维持治疗的数据。所有患者均接受三个周期基于BTZ的三联诱导治疗及ASCT后维持治疗。BTZ维持治疗方案为每2周静脉注射1.3 mg/m²，持续2年。LEN维持治疗包括两个周期的巩固治疗（28天周期中第1-21天口服25 mg），随后以10-15 mg/天的剂量持续治疗2年。由于两项试验中串联ASCT策略不同，BTZ组接受串联ASCT的比例更高（91% vs. 33%）。在LEN组和BTZ组中，分别有43%和46%的患者按计划完成了2年维持治疗（p=0.57）。两组在无进展生存期（PFS；HR=0.83，p=0.18）和总生存期（OS；HR=0.70，p=0.15）方面均无显著差异。两项试验中，首次ASCT后未达到接近完全缓解（<nCR）的患者均被分配接受串联ASCT。在这类患者中（LEN组：n=54 vs. BTZ组：n=84），LEN维持治疗显著改善了PFS（HR=0.61，p=0.04），但对OS无显著改善（HR=0.46，p=0.09）。总之，在排除不同串联ASCT率的影响后，LEN维持治疗带来的显著PFS获益支持了当前ASCT后采用LEN维持治疗的标准方案。

原文链接：

Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma