早期癌症临床试验参与者的经济毒性研究

Financial toxicity in early-phase cancer clinical trial participants

CANCER

影响因子:5.1

分区:医学1区 Top / 肿瘤学2区

发表日期:2025 Jan 01

作者: Sienna M Durbin, Debra Lundquist, Andrea Pelletier, Laura A Petrillo, Viola Bame, Victoria Turbini, Hope Heldreth, Kaitlyn Lynch, Mary Boulanger, Anh Lam, Casandra McIntyre, Betty R Ferrell, Rachel Jimenez, Dejan Juric, Ryan D Nipp

DOI: 10.1002/cncr.35586

摘要

关于早期临床试验（EP-CT）参与者的经济毒性知之甚少。本研究旨在描述EP-CT参与者的经济毒性，并评估其与患者特征及患者报告结局（PROs）的关系。采用前瞻性设计，从2021年4月至2023年1月跟踪招募的EP-CT参与者。参与者在治疗时填写《经济毒性综合评分》（得分<26表示存在经济毒性）。同时调查生活质量（QOL）、症状、应对策略及资源关注。分析经济毒性与患者特征、PROs及临床结局的相关性。在261名符合条件的患者中，有197名完成基线评估（占比75.5%，中位年龄=63.4岁[31.8-88.6]），其中57.4%为女性。最常见的癌症类型为消化系统癌（33.0%）和乳腺癌（20.8%）。超过三分之一（34.0%）的患者报告有经济毒性。经济毒性患者更可能年龄<65岁（70.2%对比48.5%，p=0.004）、失业（45.5%对比16.9%，p<0.001）、未上过大学（53.1%对比26.4%，p=0.002）、收入低于6万美元（59.7%对比25.4%，p<0.001）。调整模型显示，经济毒性关联较低的QOL（B=-6.66，p=0.004）和生活接受度（B=-0.78，p=0.002），同时伴随自责感增强（B=0.87，p<0.001）。经济毒性患者更关心住房（10.6%对比2.3%，p=0.025）、账单（31.8%对比3.8%，p<0.001）、食物（9.1%对比0.8%，p=0.006）及就业（21.2%对比1.5%，p<0.001）。在试验时间（风险比1.03；p=0.860）或生存率（风险比1.16；p=0.496）方面未见差异。超过三分之一的EP-CT参与者报告存在经济毒性。识别出与经济毒性相关的因素及其对QOL、应对和资源关注的影响，强调了应对这一问题的必要性。

Abstract

Little is known about financial toxicity in early-phase clinical trial (EP-CT) participants. This study sought to describe financial toxicity in EP-CT participants and assess associations with patient characteristics and patient-reported outcomes (PROs).Prospectively enrolled EP-CT participants from were followed from April 2021 through January 2023. Participants completed the Comprehensive Score for Financial Toxicity (<26 = financial toxicity) at time of treatment. Quality of life (QOL), symptoms, coping, and resource concerns were surveyed. Associations of financial toxicity with patient characteristics, PROs, and clinical outcomes were explored.Of 261 eligible patients, 197 completed baseline assessments (75.5%, median age = 63.4 years [31.8-88.6], 57.4% female). Most common cancers were gastrointestinal (33.0%) and breast (20.8%). More than one third (34.0%) of patients reported financial toxicity. Patients with financial toxicity were more likely to be <65 years (70.2% vs 48.5%, p = .004), unemployed (45.5% vs 16.9%, p < .001), not have attended college (53.1% vs 26.4%, p = .002), and have income <$60,000 (59.7% vs 25.4%, p < .001). In adjusted models, patients with financial toxicity reported lower QOL (B = -6.66, p = .004) and acceptance (B = -0.78, p = .002), and increased self-blame (B = 0.87, p < .001). They were more likely to have concerns regarding housing (10.6% vs 2.3%, p = .025), bills (31.8% vs 3.8%, p < .001), food (9.1% vs 0.8%, p = .006), and employment (21.2% vs 1.5%, p < .001). There was no difference in time on trial (hazard ratio, 1.03; p = .860) or survival (hazard ratio, 1.16; p = .496).More than one third of EP-CT participants reported financial toxicity. Factors associated with financial toxicity and demonstrated novel associations among financial toxicity with QOL, coping, and resource concerns were identified, highlighting the need to address financial toxicity among this population.