关键词: ASPEN trial Bruton tyrosine kinase inhibitor Waldenström macroglobulinemia health-related quality of life ibrutinib patient-reported outcomes zanubrutinib

来  源:   DOI:10.1080/14796694.2024.2355079

Abstract:
Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenström macroglobulinemia (WM). Materials & methods: Patient-reported outcomes were exploratory end points assessed using the EORTC QLQ-C30 and EQ-5D-5L VAS scores. Results: Overall, 201 patients (102 zanubrutinib; 99 ibrutinib) were enrolled. Clinically meaningful differences were observed in diarrhea and nausea/vomiting in both the intent-to-treat population and in patients attaining very good partial response (VGPR) in earlier cycles of treatment, as well as in long-term physical functioning and fatigue in patients achieving VGPR. Conclusion: Treatment with zanubrutinib was associated with greater improvements in health-related quality of life compared with ibrutinib in patients with WM and MYD88 mutations.Clinical Trial Registration: NCT03053440 (ClinicalTrials.gov).
Patient quality of life is importantWhat is this article about? This article talks about a study called the ASPEN trial, which compares two medicines used for treating a rare blood cancer that doctors call Waldenström macroglobulinemia. The medicines are called zanubrutinib (ZAN) and ibrutinib (IBR). They work in the same way, by blocking a protein called Bruton tyrosine kinase. When patients take medicines for an illness, it is important to learn about their physical, social, emotional and mental well-being (quality of life). In this study, we asked patients to fill out questionnaires about their well-being before starting the study treatment for their blood cancer, and again a few times while taking the medication, to see if there were any changes.What were the results of the study? There were two groups of patients. One group took ZAN and the other took IBR. The patients could not choose which medicine they were going to take. Results from both groups of patients were compared. Patients taking ZAN did not feel worse or better about their diarrhea and sickness, but those taking IBR said these symptoms had become worse. Both medicines improved how patients were feeling. However, improvement in tiredness and physical ability was larger in patients taking ZAN than those on IBR, especially for the patients whose cancer was getting better.What do the results mean? For patients with a rare blood cancer in this study, those taking ZAN had a better quality of life than those taking IBR.
摘要:
目的ASPEN是一个随机的,开放标签,瓦登斯特伦巨球蛋白血症(WM)患者的扎努布替尼和伊布替尼的III期研究。材料和方法:患者报告的结果是使用EORTCQLQ-C30和EQ-5D-5LVAS评分评估的探索性终点。结果:总体而言,纳入201例患者(102例扎努布替尼;99例伊布替尼)。在有意治疗人群和早期治疗周期中达到非常好的部分反应(VGPR)的患者中,在腹泻和恶心/呕吐方面观察到有临床意义的差异。以及实现VGPR的患者的长期身体功能和疲劳。结论:在WM和MYD88突变患者中,与依鲁替尼相比,扎努布替尼治疗与健康相关的生活质量有更大的改善。临床试验注册:NCT03053440(ClinicalTrials.gov)。
患者的生活质量很重要这篇文章是关于什么的?这篇文章谈到了一项名为ASPEN试验的研究,它比较了两种用于治疗罕见血癌的药物,医生称之为Waldenström巨球蛋白血症。这些药物被称为扎努布替尼(ZAN)和伊布替尼(IBR)。他们以同样的方式工作,通过阻断一种叫做布鲁顿酪氨酸激酶的蛋白质。当患者服用药物治疗疾病时,了解他们的身体很重要,社会,情感和心理健康(生活质量)。在这项研究中,我们要求患者在开始血癌研究治疗之前填写关于他们健康状况的问卷,在服药的时候又有几次,看看是否有任何变化。研究结果如何?有两组患者。一组拿了ZAN,另一组拿了IBR。患者无法选择要服用哪种药物。比较两组患者的结果。服用ZAN的患者对腹泻和疾病并没有感到更糟或更好,但是那些服用IBR的人说这些症状变得更糟了。两种药物都改善了患者的感觉。然而,服用ZAN的患者在疲劳和身体能力方面的改善大于IBR的患者,尤其是那些癌症逐渐好转的患者。结果意味着什么?对于这项研究中患有罕见血癌的患者,那些服用Zan的人比服用IBR的人有更好的生活质量。
公众号