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新型药物时代 65 岁以上多发性骨髓瘤患者大剂量化疗联合自体造血干细胞移植的临床意义。

Clinical significance of high-dose chemotherapy with autologous stem cell transplantation in the era of novel agents in patients older than 65 years with multiple myeloma.

机构信息

Division of Hematology, Shonan Kamakura General Hospital, 1370-1 Okamoto, Kamakura, Kanagawa, 247-0072, Japan.

出版信息

Ann Hematol. 2023 May;102(5):1185-1191. doi: 10.1007/s00277-023-05177-7. Epub 2023 Mar 23.

DOI:10.1007/s00277-023-05177-7
PMID:36951968
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10102120/
Abstract

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard treatment for symptomatic multiple myeloma (MM) in patients under 65 years of age. However, the performing of ASCT in older patients > 65 years without comorbidities or complications is controversial. Introduction of novel drugs, such as daratumumab, has improved the long-term survival of patients with MM who are ineligible for ASCT. This retrospective study aimed to evaluate the clinical significance of ASCT in older patients, even in the era of novel drugs. A total of 55 patients aged 65-74 years (15 ASCT recipients and 40 ASCT-ineligible patients) newly diagnosed with MM between March 2013 and October 2021 at our institution were analyzed in this study. There were no significant differences in the 3-year overall survival (84.6% vs. 90.6%, p = 0.72) and progression-free survival (PFS) (61.2% vs. 75.1%, p = 0.40) between ASCT recipients and ASCT-ineligible patients. There was also no significant difference in complete response (CR) with minimal residual disease (MRD)-negative rate between the two groups (27% vs. 33%, p = 1.0). Multivariate analysis showed that CR was an independent predictor of PFS (hazard ratio [HR], 0.26; 95% confidence interval, 0.08-0.76; p = 0.01). In this retrospective study, despite patients who were determined to be intolerant to ASCT, the non-ASCT group was non-inferior to the ASCT group in PFS and overall response rate. The results of this study confirm that the significance of ASCT is diminishing in patients 65 years of age and older because newer agents can achieve good responses without ASCT.

摘要

大剂量化疗后自体造血干细胞移植(ASCT)是 65 岁以下有症状多发性骨髓瘤(MM)患者的标准治疗方法。然而,对于无合并症或并发症的 65 岁以上老年患者进行 ASCT 存在争议。达雷妥尤单抗等新型药物的引入提高了不适合 ASCT 的 MM 患者的长期生存率。本回顾性研究旨在评估即使在新型药物时代,ASCT 在老年患者中的临床意义。本研究分析了 2013 年 3 月至 2021 年 10 月期间在我院新诊断为 MM 的 55 名 65-74 岁患者(15 名接受 ASCT 治疗的患者和 40 名不适合 ASCT 治疗的患者)。ASCT 组和 ASCT 不适用组患者 3 年总生存率(84.6% vs. 90.6%,p=0.72)和无进展生存率(PFS)(61.2% vs. 75.1%,p=0.40)无显著差异。两组间完全缓解(CR)伴微小残留病灶(MRD)阴性率也无显著差异(27% vs. 33%,p=1.0)。多变量分析显示 CR 是 PFS 的独立预测因素(风险比[HR],0.26;95%置信区间,0.08-0.76;p=0.01)。在这项回顾性研究中,尽管患者被认为不能耐受 ASCT,但非 ASCT 组在 PFS 和总反应率方面并不劣于 ASCT 组。本研究结果证实,对于 65 岁及以上患者,ASCT 的意义正在减弱,因为新型药物可以在不进行 ASCT 的情况下获得良好的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/775a/10102120/fdd73f511b42/277_2023_5177_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/775a/10102120/fdd73f511b42/277_2023_5177_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/775a/10102120/fdd73f511b42/277_2023_5177_Fig1_HTML.jpg

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