Barriers to Clinical Trial Enrollment in Patients With Pancreatic Adenocarcinoma Eligible for Early-Phase Clinical Trials.

Rachael Galvin, Christine Chung, Ella Achenbach, Oliwier Dziadkowiec, Shiraj Sen
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引用次数: 6

Abstract

Background: Early-phase clinical trials are critical to the advancement of cancer care, especially in patients with pancreatic ductal adenocarcinoma, given its aggressive nature and limited available therapeutic options.

Methods: A retrospective chart review of all patients with refractory or metastatic pancreatic ductal adenocarcinoma, referred to the Sarah Cannon Research Institute at HealthONE between 2014 and 2019, were reviewed. Patients who completed genomic profiling and qualified for a phase 1 trial (primarily 1a but some 1b) were identified to assess barriers to trial enrollment.

Results: Of 74 identified patients, 54 patients (73%) qualified for at least 1 clinical trial based on eligibility criteria and alterations detected via molecular profiling. Up to 40 industry-sponsored clinical trials were available during this time for consideration. Of the 54, 28 patients (52%) enrolled in a clinical trial, while 26 (48%) did not enroll. The most frequently cited barriers to enrollment were concerns regarding time commitment (12%), prolonged wait time for enrollment (12%), and fear of adverse events (8%). Seven of the 26 patients (27%) were lost to follow-up or had no stated reason for declining enrollment; others did not go on trial due to death/transition to hospice (n=5; 19%) or progression of disease/declining functional status (n=4; 15%). There were few statistically significant differences between patients who chose to go on trial and those who declined.

Conclusions: An understanding of why eligible patients elect not to participate in early-phase clinical trials provides insight into the patient experience and can help identify misperceptions and areas for improvement in education and the clinical trial enrollment process.

适合早期临床试验的胰腺腺癌患者入组临床试验的障碍
背景:早期临床试验对于癌症治疗的进展至关重要,特别是对于胰腺导管腺癌患者,鉴于其侵袭性和有限的治疗选择。方法:回顾性分析2014年至2019年期间在HealthONE Sarah Cannon研究所就诊的所有难治性或转移性胰腺导管腺癌患者。完成基因组分析并符合1期试验资格的患者(主要是1a,但一些是1b)被确定以评估试验入组的障碍。结果:在74名确定的患者中,54名患者(73%)根据资格标准和通过分子谱检测到的改变符合至少1项临床试验的要求。在此期间,有多达40个行业赞助的临床试验可供考虑。在54名患者中,28名患者(52%)参加了临床试验,而26名患者(48%)没有参加临床试验。最常见的入学障碍是时间承诺(12%),入学等待时间延长(12%)和对不良事件的恐惧(8%)。26例患者中有7例(27%)没有随访或没有明确的减少入组的原因;其他人因死亡或过渡到临终关怀而没有接受审判(n=5;19%)或疾病进展/功能状态下降(n=4;15%)。选择参加试验的患者和拒绝参加试验的患者之间几乎没有统计学上的显著差异。结论:了解为什么符合条件的患者选择不参加早期临床试验,可以深入了解患者体验,并有助于识别误解和改进教育和临床试验入组过程的领域。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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