少数民族、青少年和年轻成年人在临床试验中失去了跟踪:来自儿童肿瘤学组的报告。
Loss to follow-up of minorities, adolescents, and young adults on clinical trials: A report from the Children's Oncology Group.
发表日期:2023 Feb 22
作者:
Vidya Puthenpura, Lingyun Ji, Xinxin Xu, Michael E Roth, David R Freyer, A Lindsay Frazier, Asher M Marks, Farzana D Pashankar
来源:
CANCER
摘要:
儿童癌症幸存者数量的增加需要持续跟踪以监测长期并发症。儿科临床试验中随访损失的不平等情况尚未得到良好的研究。本文对21,084名居住在美国、于2000年1月1日至2021年3月31日期间参加第2/3相和第3相儿童肿瘤协作组(COG)试验的患者进行了回顾性研究。使用对数秩检验和多变量Cox比例风险回归模型评估了COG的随访损失率及调整后的危险比(HR),人口统计特征包括试验时的年龄、种族、族裔和邮政编码级别的社会经济数据。在诊断时年龄为15-39岁的青少年和年轻成人(AYA)患者的随访丢失危险比与0-14岁的患者相比增加了(危险比为1.89,95%置信区间(CI)为1.76-2.02)。在整个队列中,非西班牙裔黑人的随访丢失风险比非西班牙裔白人高(HR,1.56;95% CI,1.43-1.70)。在AYA中,非西班牙裔黑人(69.8%±3.1%)、生殖细胞瘤试验的患者(78.2%±9.2%)以及诊断时住在家庭收入中位数≤联邦贫困线150%的邮政编码地区的患者(66.7%±2.4%)的随访丢失率最高。AYA、种族和族裔少数患者以及居住在低社会经济地位区域的人在临床试验参与者中的随访丢失率最高。有针对性的干预措施是必要的,以确保公平的随访和改善长期结果的评估。关于儿科癌症临床试验参与者的随访丧失差距目前仍知之甚少。本研究发现,年龄较大、种族和/或民族少数人、或住在诊断时社会经济状况较低地区的参与者与更高的随访丢失率有关。因此,评估他们的长期生存、治疗相关的健康状况和生活质量的能力受到了阻碍。这些发现表明有必要针对不利条件的儿科临床试验参与者实施有针对性的干预措施,以改善长期随访。© 2023美国癌症协会。
The increasing number of childhood cancer survivors necessitates continued follow-up to monitor for long-term complications. Inequities in loss to follow-up for patients enrolled on pediatric clinical trials have not been well studied.This was a retrospective study of 21,084 patients residing in the United States enrolled on phase 2/3 and phase 3 Children's Oncology Group (COG) trials between January 1, 2000 and March 31, 2021. Rates of loss to follow-up to COG were evaluated using log-rank tests and multivariable Cox proportional hazards regression models with adjusted hazard ratios (HRs). Demographic characteristics included age at enrollment, race, ethnicity, and zip code level socioeconomic data.Adolescent and young adult (AYA) patients 15-39 years old at diagnosis had an increased hazard of loss to follow-up compared to patients 0-14 years old (HR, 1.89; 95% confidence interval (CI), 1.76-2.02). In the overall cohort, non-Hispanic Blacks were found to have an increased hazard of loss to follow-up compared to non-Hispanic Whites (HR, 1.56; 95% CI, 1.43-1.70). Among AYAs, the highest loss to follow-up rates were among non-Hispanic Blacks (69.8% ± 3.1%), patients on germ cell tumor trials (78.2% ± 9.2%), and patients living in zip codes with a median household income ≤150% of the federal poverty line at diagnosis (66.7% ± 2.4%).AYAs, racial and ethnic minority patients, and those living in lower socioeconomic status areas had the highest rates of loss to follow-up among clinical trial participants. Targeted interventions are warranted to ensure equitable follow-up and improved assessment of long-term outcomes.Little is known about disparities in loss to follow-up for pediatric cancer clinical trial participants. In this study, we found that participants who were adolescents and young adults when treated, those who identified as a racial and/or ethnic minority, or those residing in areas with lower socioeconomic status at diagnosis were associated with higher rates of loss to follow-up. As a result, the ability to assess their long-term survival, treatment-related health conditions, and quality of life is hindered. These findings suggest the need for targeted interventions to improve long-term follow-up among disadvantaged pediatric clinical trial participants.© 2023 American Cancer Society.