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文章:

临床研究之外接受治疗的多发性骨髓瘤高龄患者结局分析:聚焦治疗耐受性与疗效

The Outcome of Octogenarian Patients with Multiple Myeloma Treated Outside Clinical Studies, Focusing on Tolerability and Efficacy of Treatment

原文发布日期:29 September 2024

DOI: 10.3390/cancers16193329

类型: Article

开放获取: 是

 

英文摘要:

Background:Data on the outcome of octogenarian multiple myeloma (MM) patients (pts), especially if treated outside clinical studies, are scanty.Aims and Methods: MM pts ≥ 80 years, treated at TASMC with first-line therapy between 2010 and 2023, were reviewed. Characteristics and outcomes were analyzed.Results:A total number of 101 pts, of whom 54 were males with a median age of 84 years (80–98), were included. Among them, 67.4% had a Charlson comorbidity index of ≥5, 37% had ISS-3 (International staging system) and 20% had Revised-ISS-3. In our study, 44.5% received doublets and 50.5% received triplets/quadruplets. A bortezomib-based regimen was applied in 87%, and IMiDs were used in 27.7%. Despite an upfront employment of a low lenalidomide dose, dose reductions were required in 48%. Grade ≥ 3 adverse events (AEs) (mainly infections) were documented in 36.6% of patients, including grade 5 events in 9%, all attributed to infections. The overall response rate was 69%, including 31% ≥ VGPRs (Very good partial response). Sixty-seven percent (67%) received second-line therapy, administered within a median period of 12 months (1–84). Within a median follow-up period of 36 m (1–141), the median overall survival (OS) approached 42 m (range: 1–141); being shorter in pts > 84 years (HR = 1.7,p= 0.03), pts with lung disease (HR = 1.8,p= 0.044) and pts with ISS = 3 and R-ISS = 3 (HR = 1.65,p= 0.0016 and HR = 2.45,p= 0.006, respectively);Conclusions: Octogenarians treated outside clinical studies often have a lower tolerance to treatment. Nevertheless, upfront administration of low doses of anti-MM agents provided a response in the majority of patients, translated into impressive OS. Nevertheless, mortality due to AEs was high, emphasizing the need for new, “octogenarian-oriented” treatment protocols.

 

摘要翻译: 

背景:关于80岁以上多发性骨髓瘤(MM)患者(尤其是非临床研究治疗者)预后的数据较为匮乏。目的与方法:回顾性分析2010年至2023年间在TASMC接受一线治疗的≥80岁MM患者,对其临床特征及治疗结局进行评估。结果:共纳入101例患者,其中男性54例,中位年龄84岁(范围80-98岁)。67.4%的患者查尔森合并症指数≥5,37%为ISS-3分期,20%为R-ISS-3分期。治疗方案方面,44.5%接受双药联合,50.5%接受三药/四药联合。87%采用含硼替佐米方案,27.7%使用免疫调节剂。尽管初始即采用低剂量来那度胺治疗,仍有48%患者需进一步减量。36.6%患者发生≥3级不良事件(主要为感染),其中9%为5级事件(均归因于感染)。总体缓解率达69%,其中≥VGPR(非常好的部分缓解)者占31%。67%患者接受二线治疗,中位起始时间为12个月(范围1-84)。中位随访36个月(范围1-141)期间,中位总生存期(OS)达42个月(范围1-141);年龄>84岁(HR=1.7,p=0.03)、合并肺部疾病(HR=1.8,p=0.044)以及ISS=3与R-ISS=3分期(HR=1.65,p=0.0016;HR=2.45,p=0.006)的患者OS显著缩短。结论:非临床研究治疗的80岁以上MM患者常表现出较低治疗耐受性。尽管如此,初始采用低剂量抗MM药物治疗仍可使多数患者获得缓解,并转化为显著的总生存获益。然而治疗相关不良事件导致的死亡率较高,提示亟需制定针对高龄患者的个体化治疗方案。

 

原文链接:

The Outcome of Octogenarian Patients with Multiple Myeloma Treated Outside Clinical Studies, Focusing on Tolerability and Efficacy of Treatment

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