University of Alabama at Birmingham, WTI 240E, Birmingham, AL, 35294, USA.
Breast Cancer Res Treat. 2022 Jan;191(2):471-475. doi: 10.1007/s10549-021-06422-1. Epub 2021 Oct 31.
3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.
This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004 and 2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free.
102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500 μL (1%) to 1800 μL (1%), with 1500 μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%), and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer.
Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.
由于各种入组障碍，美国有 3-8%的癌症成人患者参与了临床试验。本研究旨在评估目前尚无标准指南的入组标准的可变性。
本描述性分析利用了 2004 年至 2020 年期间阿拉巴马大学伯明翰分校提供的所有治疗性乳腺癌方案。排除标准通过 OnCore 和 ClinicalTrials.gov 提取。实验室值包括肝功能检查和血液学检查。合并症包括充血性心力衰竭、心血管疾病、中枢神经系统（CNS）转移和既往癌症史。合并症进一步根据方案要求参与者从诊断或无恶化期开始的时间长短进行分析。
102 个方案符合条件。在肝脏实验室值中，胆红素（78%）在大多数方案中都有包含，范围从机构正常值上限（ULN）（9%）到 3xULN（2%），其中 1.5xULN（56%）最为常见。丙氨酸转氨酶和天冬氨酸转氨酶也观察到类似的可变性。在血液学实验室中，82%的方案定义了可接受的绝对中性粒细胞计数下限，范围从 500 μL（1%）到 1800 μL（1%），其中 1500 μL（64%）最为常见。在合并症中，充血性心力衰竭（49%）、心血管疾病的急性恶化（80%）、CNS 转移（59%）和既往癌症（66%）的排除标准各不相同。心血管疾病和既往癌症的方案允许的时间框架不同。
方案中的实验室值和合并变量之间存在很大的异质性。未来的研究应专注于定义标准化的入组标准，同时允许根据药物特异性进行偏差。
