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一项对胰腺癌试验入组情况的全国性分析揭示了差异和参与问题。

A nationwide analysis of pancreatic cancer trial enrollment reveals disparities and participation problems.

作者信息

Hue Jonathan J, Katayama Erryk S, Markt Sarah C, Elshami Mohamedraed, Saltzman Joel, Bajor David, Hosmer Amy, Mok Shaffer, Dumot John, Ammori John B, Rothermel Luke D, Hardacre Jeffrey M, Winter Jordan M, Ocuin Lee M

机构信息

Department of Surgery, Division of Surgical Oncology, University Hospitals Cleveland Medical Center, OH.

Case Western Reserve University, Cleveland, OH.

出版信息

Surgery. 2022 Jul;172(1):257-264. doi: 10.1016/j.surg.2021.10.023. Epub 2021 Nov 26.

Abstract

BACKGROUND

Our research group recently surveyed the clinical trial landscape in pancreatic adenocarcinoma and identified 430 active trials. These represent an opportunity to expand treatment options for patients with pancreatic adenocarcinoma. Our primary objective was to detail clinical trial participation among patients with pancreatic adenocarcinoma. Our secondary objective was to evaluate survival.

METHODS

We queried the National Cancer Database (2004-2016) for patients with pancreatic adenocarcinoma. Patients were stratified by trial participation: clinical trial or non-trial. Multivariable logistic regression was used to identify variables associated with trial participation. The Kaplan-Meier method and multivariable Cox hazards regression were used to analyze survival.

RESULTS

In total, 261,483 patients were included: 1,110 (0.4%) were enrolled in a clinical trial. A total of 57 Black patients participated in a clinical trial (0.19% of Black patients). This was lower compared to White patients (n = 955, 0.49% of White patients, P < .001). After adjusting for demographic and clinical factors, Black patients were less likely to be enrolled in a clinical trial (odds ratio = 0.387, P < .001). Patients treated at nonacademic medical centers were less likely to be in a clinical trial. Trial participation was associated with an increased median survival relative to non-trial patients (stage IV: 9.0 vs 3.8 months, P < .001), and this association remained on multivariable regression (hazard ratio = 0.779, P < .001).

CONCLUSION

Fewer than 1% of patients with pancreatic adenocarcinoma participated in a clinical trial. There are racial and sociodemographic disparities in clinical trial enrollment. An association was observed between clinical trial participants and prolonged survival.

摘要

背景

我们的研究小组最近调查了胰腺癌的临床试验情况,确定了430项正在进行的试验。这些试验为扩大胰腺癌患者的治疗选择提供了机会。我们的主要目标是详细了解胰腺癌患者参与临床试验的情况。次要目标是评估生存率。

方法

我们查询了国家癌症数据库(2004 - 2016年)中胰腺癌患者的信息。患者按是否参与试验分层:临床试验组或非试验组。采用多变量逻辑回归来确定与试验参与相关的变量。使用Kaplan - Meier方法和多变量Cox风险回归分析生存率。

结果

总共纳入了261,483名患者:1110名(0.4%)参与了临床试验。共有57名黑人患者参与了临床试验(占黑人患者的0.19%)。这一比例低于白人患者(n = 955,占白人患者的0.49%,P <.001)。在调整人口统计学和临床因素后,黑人患者参与临床试验的可能性较小(优势比 = 0.387,P <.001)。在非学术性医疗中心接受治疗的患者参与临床试验的可能性较小。与未参与试验的患者相比,参与试验的患者中位生存期有所延长(IV期:9.0个月对3.8个月,P <.001),并且在多变量回归分析中这种关联仍然存在(风险比 = 0.779,P <.001)。

结论

不到1%的胰腺癌患者参与了临床试验。临床试验入组存在种族和社会人口统计学差异。观察到参与临床试验与生存期延长之间存在关联。

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