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来那度胺/地塞米松持续诱导与自体造血干细胞移植治疗初诊多发性骨髓瘤的比较:一种适合应答调整的方法。

Continuous induction with lenalidomide/dexamethasone versus autologous stem cell transplantation in newly diagnosed multiple myeloma: a case for response-adapted approach.

机构信息

Adult Bone Marrow Transplant Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

出版信息

Leuk Lymphoma. 2022 Sep;63(9):2126-2135. doi: 10.1080/10428194.2022.2062347. Epub 2022 Jun 1.

DOI:10.1080/10428194.2022.2062347
PMID:35648041
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9703606/
Abstract

Although upfront autologous stem cell transplantation (ASCT) generally improves progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM), the overall survival (OS) benefit and optimal timing of ASCT are not well established. Patients with early response may be able to safely continue induction and avoid ASCT without compromised outcomes. We report an extended follow-up analysis of a phase 2 trial that randomized transplant-eligible patients with NDMM who responded to induction (50/65 patients) to continued induction or ASCT; median follow-up was 8.0 years. Patients had similar 8-year PFS (55% vs. 43%), 8-year OS (83% vs. 72%), and rates of at least very good partial response (72% vs. 84%) whether continuing induction of lenalidomide and dexamethasone (Ld arm) or receiving ASCT (Ld + ASCT arm) ( = 0.5). Notably, over 50% of patients receiving continuous Ld had PFS of 5-10 years. These results suggest the need for prospective trials incorporating response-adapted therapeutic approaches to NDMM.STATEMENT OF PRIOR PRESENTATIONPresented in abstract form (interim analysis) at the 56th annual meeting of the American Society of Hematology (San Francisco, CA, 6 December 2014) and at the 57th annual meeting of the American Society of Hematology (Orlando, FL, 3 December 2015).

摘要

虽然自体干细胞移植(ASCT)能显著改善初诊多发性骨髓瘤(NDMM)患者的无进展生存期(PFS),但移植的生存获益和最佳时机尚未确定。早期应答的患者可能可以安全地继续诱导治疗,而无需进行 ASCT,也不会影响疗效。我们报告了一项 2 期临床试验的扩展随访分析,该试验将对诱导治疗有应答(50/65 例患者)的适合移植的 NDMM 患者随机分配至继续诱导治疗或 ASCT;中位随访时间为 8.0 年。患者的 8 年 PFS(55% vs. 43%)、8 年 OS(83% vs. 72%)和至少非常好的部分缓解率(72% vs. 84%)相似,无论继续接受来那度胺和地塞米松诱导治疗(Ld 组)还是接受 ASCT(Ld+ASCT 组)(=0.5)。值得注意的是,接受连续 Ld 治疗的患者中有超过 50%的患者 PFS 达到 5-10 年。这些结果表明,需要开展前瞻性试验,纳入针对 NDMM 的应答适应性治疗方法。

先前的报告形式

在美国血液学会第 56 届年会上(旧金山,CA,2014 年 12 月 6 日)和第 57 届年会上(奥兰多,FL,2015 年 12 月 3 日)以摘要形式(中期分析)报告。

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本文引用的文献

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Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.自体造血干细胞移植对比硼替佐米-美法仑-泼尼松(联合或不联合硼替佐米-来那度胺-地塞米松巩固治疗)以及来那度胺维持治疗用于新诊断的多发性骨髓瘤(EMN02/HO95):一项多中心、随机、开放标签的3期研究
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