Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222, Warsaw, Poland.
Department of Breast Cancer and Reconstruction Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Roentgena 5, 02-781, Warsaw, Poland.
BMC Med. 2023 Jul 3;21(1):240. doi: 10.1186/s12916-023-02947-y.
Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status.
Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression.
Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older.
Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice.
乳腺癌（BC）是女性最常见的癌症类型。本研究旨在评估 BC 近期临床试验的纳入标准，尤其是那些可能限制老年患者、合并症患者和一般状况较差患者入组的标准。
从 ClinicalTrials.gov 中提取 BC 临床试验的数据。主要结局指标是不同类型纳入标准的试验比例。使用单因素和多因素逻辑回归确定试验特征与存在某些类型纳入标准（二分类变量）之间的关联。
我们的分析包括 2020 年至 2022 年期间开始的 522 项系统抗癌治疗临床试验。522 项试验中有 204 项（39%）、404 项（77%）和 360 项（69%）分别使用了年龄上限、严格排除合并症的标准以及患者一般状况不佳的标准。总体而言，493 项试验（94%）至少有一项纳入标准。每种排除标准类型的存在几率与研究地点和试验阶段显著相关。我们还表明，与 2010 年至 2012 年期间开始的 309 项试验队列相比，最近试验队列中年龄上限和排除与一般状况相关的标准的存在几率显著更高（39%比 19%，69%比 46%；单因素和多因素分析均 p<0.001）。两个队列之间严格排除标准的试验比例相当（p>0.05）。最近的试验中只有 3 项（1%）仅纳入年龄 65 岁或 70 岁及以上的患者。
BC 的许多近期临床试验排除了大量患者，尤其是老年患者、有不同合并症的患者和一般状况较差的患者。应谨慎修改这些试验中的某些纳入标准，以便研究人员在参与者中评估研究治疗的益处和危害，这些参与者具有通常在临床实践中遇到的特征。
