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2006 年至 2012-2013 年期间美国青少年和青年癌症患者临床试验入组率增加。

Increased clinical trial enrollment among adolescent and young adult cancer patients between 2006 and 2012-2013 in the United States.

机构信息

Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota.

National Cancer Institute, Bethesda, Maryland.

出版信息

Pediatr Blood Cancer. 2019 Jan;66(1):e27426. doi: 10.1002/pbc.27426. Epub 2018 Sep 6.

Abstract

BACKGROUND

Stagnant outcomes for adolescents and young adults (AYAs) 15-39 years of age with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA patients with cancer.

PROCEDURE

We utilized medical record data from AYAs in two population-based National Cancer Institute Patterns of Care Studies identified through the Surveillance, Epidemiology and End Results Program. Among 3135 AYAs diagnosed with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and sarcoma, we used multivariate logistic regression to evaluate patient and provider characteristics associated with clinical trial enrollment. Interaction terms evaluated variation in clinical trial enrollment across patient and provider characteristics by year of diagnosis.

RESULTS

From 2006 to 2012-2013, clinical trial participation increased from 14.8% to 17.9% (P < 0.01). Adjusting for patient and provider characteristics, we found lower clinical trial enrollment among those who were older at diagnosis, diagnosed with NHL vs ALL, treated by adult hematologist/oncologists only (vs pediatric hematologist/oncologists), and of non-Hispanic Black race/ethnicity (vs non-Hispanic White) (P < 0.05 for all). Interaction analyses indicate improved clinical trial enrollment from 2006 to 2012-2013 among young adults 25-29 years of age and the uninsured.

CONCLUSIONS

Although disparities in enrollment onto clinical trials remain for AYAs with cancer, our study identified increasing overall clinical trial participation over time. Further, we identify promising trends in enrollment uptake among AYAs 25-29 years of age and the uninsured.

摘要

背景

15-39 岁青少年和年轻成人(AYA)癌症患者的治疗效果停滞不前,部分原因是他们参与临床试验的人数较少。目前的相关举措主要集中在增加入组人数上,但人群层面的变化情况尚不清楚。本研究旨在调查 AYA 癌症患者参与临床试验的模式随时间的变化情况。

方法

我们利用了两项基于人群的美国国家癌症研究所(NCI)模式护理研究中的医疗记录数据,这些数据是通过监测、流行病学和最终结果(SEER)计划确定的。在被诊断患有非霍奇金淋巴瘤(NHL)、霍奇金淋巴瘤、急性淋巴细胞白血病(ALL)和肉瘤的 3135 名 AYA 患者中,我们使用多变量逻辑回归来评估与临床试验入组相关的患者和提供者特征。交互项评估了不同患者和提供者特征与诊断年份之间临床试验入组的差异。

结果

从 2006 年到 2012-2013 年,临床试验参与率从 14.8%增加到 17.9%(P<0.01)。在调整了患者和提供者特征后,我们发现年龄较大、诊断为 NHL 而非 ALL、仅由成人血液科医生/肿瘤学家(而非儿科血液科医生/肿瘤学家)治疗、非西班牙裔黑人(而非非西班牙裔白人)的患者参与临床试验的比例较低(所有 P<0.05)。交互分析表明,25-29 岁的年轻成年人和未参保人群的临床试验入组率从 2006 年到 2012-2013 年有所提高。

结论

尽管 AYA 癌症患者参与临床试验的差异仍然存在,但我们的研究发现,随着时间的推移,总体临床试验参与率有所增加。此外,我们还发现 25-29 岁的年轻成年人和未参保人群的入组率呈上升趋势。

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本文引用的文献

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