Sharman Jeff P, Cocks Kim, Nabhan Chadi, Lamanna Nicole, Kay Neil E, Grinblatt David L, Flowers Christopher R, Davids Matthew S, Kiselev Pavel, Swern Arlene S, Sullivan Kristen, Gharibo Mecide M, Flick E Dawn, Trigg Andrew, Mato Anthony
Willamette Valley Cancer Institute US Oncology Eugene Oregon USA.
Adelphi Values Bollington Cheshire UK.
EJHaem. 2020 Jul 26;1(1):188-198. doi: 10.1002/jha2.67. eCollection 2020 Jul.
Health-related quality of life (HRQoL) in patients with chronic lymphocytic leukemia (CLL) is important in guiding treatment decisions. However, the impact of CLL treatment initiation on HRQoL is unclear. We assessed HRQoL using the FACT-Leu and EQ-5D-3L questionnaires in the Connect CLL Registry, a large, US-based, multicenter, prospective observational study of CLL patients enrolled between 2010 and 2014, prior to the introduction of novel therapies. Among 889 patients initiating first-line therapy with chemoimmunotherapy or rituximab monotherapy, questionnaire completion rates were 95.7% and 95.8% at enrollment, and 70.8% and 69.4% at 12 months, for FACT-Leu Total and EQ-5D-3L, respectively. For 849 patients completing all five FACT-Leu components, average total scores were 135.7 at enrollment and 141.6 at 12 months. Among 526 patients with FACT-Leu Total scores at enrollment and 12 months, clinically meaningful (≥11-point) improvements or reductions were observed in 179 (34.0%) and 88 (16.7%) patients, respectively. Mean EQ-5D-3L index scores were 0.87 at enrollment and 12 months. Among 513 patients completing EQ-5D-3L at enrollment and 12 months, clinically meaningful (≥0.06-point) improvements or reductions were observed in 125 (24.4%) and 116 (22.6%) patients, respectively. In the Connect CLL Registry, HRQoL remained stable or slightly improved after 12 months of follow-up.
慢性淋巴细胞白血病(CLL)患者的健康相关生活质量(HRQoL)对于指导治疗决策很重要。然而,CLL治疗开始对HRQoL的影响尚不清楚。我们在Connect CLL注册研究中使用FACT-Leu和EQ-5D-3L问卷评估了HRQoL,这是一项在美国进行的大型、多中心、前瞻性观察性研究,研究对象为2010年至2014年期间入组的CLL患者,当时尚未引入新型疗法。在889例开始一线化疗免疫治疗或利妥昔单抗单药治疗的患者中,FACT-Leu总分和EQ-5D-3L在入组时的问卷完成率分别为95.7%和95.8%,在12个月时分别为70.8%和69.4%。对于849例完成所有五个FACT-Leu分量表的患者,入组时平均总分是135.7,12个月时是141.6。在526例入组和12个月时均有FACT-Leu总分的患者中,分别有179例(34.0%)和88例(16.7%)患者出现了具有临床意义(≥11分)的改善或降低。EQ-5D-3L指数评分在入组和12个月时的平均值均为0.87。在513例入组和12个月时均完成EQ-5D-3L的患者中,分别有125例(24.4%)和116例(22.6%)患者出现了具有临床意义(≥0.06分)的改善或降低。在Connect CLL注册研究中,随访12个月后HRQoL保持稳定或略有改善。