人们对早期临床试验 (EP-CT) 参与者的经济毒性知之甚少。本研究旨在描述 EP-CT 参与者的财务毒性，并评估与患者特征和患者报告结果 (PRO) 的关联。从 2021 年 4 月到 2023 年 1 月对前瞻性入组的 EP-CT 参与者进行随访。参与者完成了财务综合评分治疗时的毒性（<26=经济毒性）。对生活质量 (QOL)、症状、应对方式和资源问题进行了调查。探讨了财务毒性与患者特征、PRO 和临床结果的关联。在 261 名符合条件的患者中，197 名完成了基线评估（75.5%，中位年龄 = 63.4 岁 [31.8-88.6]，57.4% 为女性）。最常见的癌症是胃肠道癌症（33.0%）和乳腺癌（20.8%）。超过三分之一 (34.0%) 的患者报告了经济毒性。患有经济毒性的患者更有可能年龄<65岁（70.2% vs 48.5%，p = .004）、失业（45.5% vs 16.9%，p < .001）、没有上过大学（53.1% vs 26.4%， p = .002），收入 < 60,000 美元（59.7% vs 25.4%，p < .001）。在调整后的模型中，患有财务毒性的患者报告生活质量较低（B = -6.66，p = .004）和接受度较低（B = -0.78，p = .002），并且自责增加（B = 0.87，p < .001） ）。他们更有可能担心住房（10.6% vs 2.3%，p = .025）、账单（31.8% vs 3.8%，p < .001）、食物（9.1% vs 0.8%，p = .006）、和就业（21.2% vs 1.5%，p < .001）。试验时间（风险比，1.03；p = .860）或生存率（风险比，1.16；p = .496）没有差异。超过三分之一的 EP-CT 参与者报告了财务毒性。确定了与经济毒性相关的因素，以及经济毒性与生活质量、应对方式和资源问题之间的新关联，强调了解决该人群经济毒性的必要性。© 2024 美国癌症协会。

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.© 2024 American Cancer Society.