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多发性骨髓瘤虚弱和中度适合患者的生活质量获益:前瞻性 HOVON123 临床试验的结果。

Quality of life gains in frail and intermediate-fit patients with multiple Myeloma: Findings from the prospective HOVON123 clinical trial.

机构信息

Hematology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlandsī.

Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlandsī.

出版信息

Eur J Cancer. 2024 Aug;207:114153. doi: 10.1016/j.ejca.2024.114153. Epub 2024 Jun 6.

DOI:
10.1016/j.ejca.2024.114153
PMID:38870747
Abstract

BACKGROUND

Frailty in newly-diagnosed multiple myeloma (NDMM) patients is associated with treatment-related toxicity, which negatively affects health-related quality of life (HRQoL). Currently, data on changes in HRQoL of frail and intermediate-fit MM patients during active treatment and post-treatment follow-up are absent.

METHODS

The HOVON123 study (NTR4244) was a phase II trial in which NDMM patients ≥ 75 years were treated with nine dose-adjusted cycles of Melphalan-Prednisone-Bortezomib (MPV). Two HRQoL instruments (EORTC QLQ-C30 and -MY20) were obtained before start of treatment, after 3 and 9 months of treatment and 6 and 12 months after treatment for patients who did not yet start second-line treatment. HRQoL changes and/or differences in frail and intermediate-fit patients (IMWG frailty score) were reported only when both statistically significant (p < 0.005) and clinically relevant (>MID).

RESULTS

137 frail and 71 intermediate-fit patients were included in the analysis. Compliance was high and comparable in both groups. At baseline, frail patients reported lower global health status, lower physical functioning scores and more fatigue and pain compared to intermediate-fit patients. Both groups improved in global health status and future perspective; polyneuropathy complaints worsened over time. Frail patients improved over time in physical functioning, fatigue and pain. Improvement in global health status occurred earlier than in intermediate-fit patients.

CONCLUSION

HRQoL improved during anti-myeloma treatment in both intermediate-fit and frail MM patients. In frail patients, improvement occurred faster and, in more domains, which was retained during follow-up. This implies that physicians should not withhold safe and effective therapies from frail patients in fear of HRQoL deterioration.

摘要

背景

新诊断多发性骨髓瘤(NDMM)患者的虚弱与治疗相关毒性有关,这会对健康相关生活质量(HRQoL)产生负面影响。目前,关于虚弱和中度适合 MM 患者在积极治疗和治疗后随访期间 HRQoL 变化的数据尚缺乏。

方法

HOVON123 研究(NTR4244)是一项 II 期试验,其中≥75 岁的 NDMM 患者接受了 9 个剂量调整的 Melphalan-Prednisone-Bortezomib(MPV)周期治疗。对于尚未开始二线治疗的患者,在开始治疗前、治疗后 3 个月和 9 个月以及治疗后 6 个月和 12 个月时,使用两个 HRQoL 工具(EORTC QLQ-C30 和 -MY20)获得 HRQoL 变化和/或虚弱和中度适合患者(IMWG 虚弱评分)的差异报告,仅当具有统计学意义(p<0.005)和临床相关(>MID)时。

结果

137 名虚弱患者和 71 名中度适合患者被纳入分析。两组的依从性均较高且相似。在基线时,与中度适合患者相比,虚弱患者报告的总体健康状况较低,身体功能评分较低,疲劳和疼痛更多。两组患者的总体健康状况和未来前景均有所改善;多发性神经病的投诉随着时间的推移而恶化。虚弱患者的身体功能、疲劳和疼痛随时间改善。虚弱患者的总体健康状况改善早于中度适合患者。

结论

在抗骨髓瘤治疗期间,中度适合和虚弱的 MM 患者的 HRQoL 均得到改善。在虚弱患者中,改善发生得更快,在更多领域,并且在随访期间得到保留。这意味着医生不应因担心 HRQoL 恶化而拒绝为虚弱患者提供安全有效的治疗。

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