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在一项真实世界的美国横断面研究中,与其他 CLL 治疗相比,接受伊布替尼治疗的慢性淋巴细胞白血病(CLL)患者的健康相关生活质量和治疗满意度。

Health-related quality of life and treatment satisfaction in Chronic Lymphocytic Leukemia (CLL) patients on ibrutinib compared to other CLL treatments in a real-world US cross sectional study.

机构信息

EPI-Q, Inc., Oak Brook, Illinois, United States of America.

Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, United States of America.

出版信息

PLoS One. 2022 Oct 6;17(10):e0270291. doi: 10.1371/journal.pone.0270291. eCollection 2022.

Abstract

The objective of this study was to describe real-world health-related quality of life (HRQoL) and treatment satisfaction of ibrutinib-treated patients with CLL compared to a reference group. This study was completed in two parts. The first portion (Norming Study) was a US online survey conducted to serve as a reference population. The Norming Study included a total of 139 patients with CLL, excluding those treated with ibrutinib: 64 were treatment naive (Tx naive), 36 were 1st line (1L), and 38 were in or had completed ≥2 lines (2L+) patients with CLL. The second portion (CLL Ibrutinib Study) included 1L and 2L+ ibrutinib patients with CLL treated for ≥6 months in which 118 patients (1L n = 88 and 2L+ n = 30) completed the study. Respondents completed demographic and clinical information and the following HRQoL surveys: (Short Form-12v2® Health Survey [SF-12v2], Functional Assessment of Cancer Therapy-General [FACT-G], FACT-Leukemia [FACT-Leu] Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, and Cancer Therapy Satisfaction Questionnaire [CTSQ]). Higher scores indicate better HRQoL/treatment satisfaction. Differences in effect sizes between the two samples at the group level were calculated using Hedges' g. Medium to large positive effects were seen in the CLL Ibrutinib group on several measures compared to the Reference Study groups. The FACT-G total score was 89.2±11.1 for CLL Ibrutinib Study patients compared to 75.8±22.6 CLL Norming Tx naïve patients, 61.3±21.8 in 1L, and 61.7±20.7 in 2L+. Similar trends were seen with FACT-Leu total score and FACIT-Fatigue. CLL Ibrutinib Study patients scored higher on all CTSQ domain scores compared to the CLL Norming patients treated with other CLL therapies. We found that Ibrutinib-treatment had better HRQoL and treatment satisfaction compared to patients receiving other therapies, irrespective of line of therapy.

摘要

本研究旨在描述接受伊布替尼治疗的慢性淋巴细胞白血病(CLL)患者与参照组相比的真实世界健康相关生活质量(HRQoL)和治疗满意度。本研究分为两部分。第一部分(常模研究)是在美国进行的一项在线调查,作为参照人群。常模研究共纳入 139 例 CLL 患者,不包括接受伊布替尼治疗的患者:64 例为初治患者(Tx 初治),36 例为一线治疗(1L),38 例为接受或已完成≥2 线治疗(2L+)的 CLL 患者。第二部分(CLL 伊布替尼研究)包括接受伊布替尼治疗≥6 个月的 1L 和 2L+的 CLL 患者,其中 118 例(1L n=88,2L+ n=30)完成了研究。患者完成了人口统计学和临床信息以及以下 HRQoL 调查:(健康调查短表 12 项 v2 版 [SF-12v2],癌症治疗功能评估一般量表 [FACT-G],癌症治疗功能评估白血病量表 [FACT-Leu],慢性疾病治疗功能评估量表-FACT 疲劳量表,癌症治疗满意度问卷 [CTSQ])。得分越高表示 HRQoL/治疗满意度越高。使用 Hedges'g 计算两个样本在组间的差异大小。与参照研究组相比,伊布替尼组在几个指标上表现出较大的正效应。CLL 伊布替尼研究患者的 FACT-G 总分是 89.2±11.1,而 CLL 常模研究初治患者的总分是 75.8±22.6,1L 组的总分是 61.3±21.8,2L+组的总分是 61.7±20.7。FACT-Leu 总分和 FACIT-Fatigue 也呈现类似趋势。CLL 伊布替尼研究患者在所有 CTSQ 域评分上的得分均高于接受其他 CLL 治疗的 CLL 常模患者。我们发现,伊布替尼治疗在 HRQoL 和治疗满意度方面均优于接受其他治疗的患者,与治疗线数无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c43/9536620/2023125e846f/pone.0270291.g001.jpg

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