早期癌症临床试验参与者的时间毒性。

IF 4.7 3区 医学 Q1 ONCOLOGY JCO oncology practice Pub Date : 2024-09-01 Epub Date: 2024-06-10 DOI:10.1200/OP.23.00811
Sienna M Durbin, Debra M Lundquist, Andrea Pelletier, Rachel Jimenez, Laura Petrillo, Janice Kim, Kaitlyn Lynch, Megan Healy, Andrew Johnson, Nicholas Ollila, Vaishnavi Yalala, Benjamin Malowitz, Allison Kehlmann, Nicholas Chevalier, Victoria Turbini, Viola Bame, Hope Heldreth, Jenipher Silva, Casandra McIntyre, Dejan Juric, Ryan D Nipp
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引用次数: 0

摘要

目的:早期临床试验(EP-CT)旨在确定新型癌症治疗药物的最佳剂量、耐受性和初步活性。人们对患者在参与这些研究时与医疗系统的互动时间(如毒性时间)知之甚少:我们回顾性地查看了 2017 年至 2019 年连续入组 EP-CT 患者的电子健康记录,以获得基线特征和医疗相关天数(定义为试验期间的所有住院和门诊就诊)。我们使用单变量和多变量分析来确定时间毒性增加的预测因素,时间毒性被定义为医疗相关天数在试验总天数中所占的比例。为便于解释,我们创建了一个二分变量,将高时间毒性定义为试验期间与医疗相关的天数≥20%,并使用回归模型评估时间毒性与临床结果之间的关系:在 408 名 EP-CT 参与者(平均年龄 60.5 岁[标准差,SD,12.6];56.5% 为女性;88.2% 为白人;96.0% 为非西班牙裔)中,患者在试验期间的平均医疗相关天数为 22.5%(标准差,13.8%)。消化道癌(B = 0.07;P = .002)、头颈癌(B = 0.09;P = .004)和乳腺癌(B = 0.06;P = .015)患者以及表现状态较差(B = 0.04;P = .017)和接受靶向治疗(B = 0.04;P = .014)的患者的时间毒性较高。高时间毒性与疾病应答率下降(几率比,0.07;P < .001)、无进展生存期(危险比 [HR],2.10;P < .001)和总生存期(HR,2.16;P < .001)相关:在这组 EP-CT 参与者中,患者在试验期间与医护人员接触的天数超过五分之一。我们确定了与较高时间毒性相关的特征,并发现高毒性与较差的临床结果相关。这些数据有助于为患者与医生之间关于 EP-CT 的讨论提供信息,指导未来的试验设计,并识别高危患者。
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Time Toxicity Experienced by Early-Phase Cancer Clinical Trial Participants.

Purpose: Early-phase clinical trials (EP-CTs) are designed to determine optimal dosing, tolerability, and preliminary activity of novel cancer therapeutics. Little is known about the time that patients spend interacting with the health care system (eg, time toxicity) while participating in these studies.

Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 to obtain baseline characteristics and number of health care-associated days, defined as all inpatient and outpatient visits while on trial. We used univariable and multivariable analyses to identify predictors of increased time toxicity, defined as the proportion of health care-associated days among total days on trial. For ease of interpretation, we created a dichotomous variable, with high time toxicity defined as ≥20% health care-associated days during time on trial and used regression models to evaluate relationships between time toxicity and clinical outcomes.

Results: Among 408 EP-CT participants (mean age, 60.5 years [standard deviation, SD, 12.6]; 56.5% female; 88.2% White; 96.0% non-Hispanic), patients had an average of 22.5% health care-associated days while on trial (SD, 13.8%). Those with GI (B = 0.07; P = .002), head/neck (B = 0.09; P = .004), and breast (B = 0.06; P = .015) cancers and those with worse performance status (B = 0.04; P = .017) and those receiving targeted therapies (B = 0.04; P = .014) experienced higher time toxicity. High time toxicity was associated with decreased disease response rates (odds ratio, 0.07; P < .001), progression-free survival (hazard ratio [HR], 2.10; P < .001), and overall survival (HR, 2.16; P < .001).

Conclusion: In this cohort of EP-CT participants, patients spent more than one-fifth of days on trial with health care contact. We identified characteristics associated with higher time toxicity and found that high toxicity correlated with worse clinical outcomes. These data could help inform patient-clinician discussions about EP-CTs, guide future trial design, and identify at-risk patients.

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