SWOG Statistics and Data Management Center, Seattle, Washington.
Fred Hutchinson Cancer Research Center, Seattle, Washington.
JAMA Oncol. 2019 Mar 1;5(3):326-333. doi: 10.1001/jamaoncol.2018.5953.
The American Society of Clinical Oncology (ASCO), Friends of Cancer Research, and the US Food and Drug Administration recently recommended modernizing criteria related to comorbidities routinely used to exclude patients from cancer clinical trials. The goal was to design clinical trial eligibility such that trial results better reflect real-world cancer patient populations, to improve clinical trial participation, and to increase patient access to new treatments in trials. Yet despite the assumed influence of comorbidities on trial participation, the relationship between patients' comorbidity profile at diagnosis and trial participation has not been explicitly examined using patient-level data.
To investigate the association between comorbidities, clinical trial decision-making, and clinical trial participation; and to estimate the potential impact of reducing comorbidity exclusion criteria on trial participation, to provide a benchmark for changing criteria.
DESIGN, SETTING, AND PARTICIPANTS: A national survey was embedded within a web-based cancer treatment-decision tool accessible on multiple cancer-oriented websites. Participants must have received a diagnosis of breast, lung, colorectal, or prostate cancer. In total, 5499 surveyed patients who made a treatment decision within the past 3 months were analyzed using logistic regression analysis and simulations.
Cancer diagnosis and 1 or more of 18 comorbidities.
Patient discussion of a clinical trial with their physician (yes vs no); if a trial was discussed, the offer of trial participation (yes vs no); and, if trial participation was offered, trial participation (yes vs no).
Of the 5499 patients who participated in the survey, 3420 (62.6%) were women and 2079 (37.8%) were men (mean [SD] age, 56.63 [10.05] years). Most patients (65.6%; n = 3610) had 1 or more comorbidities. The most common comorbid condition was hypertension (35.0%; n = 1924). Compared with the absence of comorbidities, the presence of 1 or more comorbidities was associated with a decreased risk of trial discussions (44.1% vs 37.2%; OR, 0.86; 95% CI, 0.75-0.97; P = .02), trial offers (21.7% vs 15.7%; OR, 0.82; 95% CI, 0.70-0.96; P = .02), and trial participation (11.3% vs 7.8%; OR, 0.76; 95% CI, 0.61-0.94; P = .01). The removal of the ASCO-recommended comorbidity restrictions could generate up to 6317 additional patient trial registrations every year.
Independent of sociodemographic variables, the presence of comorbidities is adversely associated with trial discussions, trial offers, and trial participation itself. Updating trial eligibility criteria could provide an opportunity for several thousand more patients with well-managed comorbidities to participate in clinical trials each year.
美国临床肿瘤学会（ASCO）、癌症研究之友和美国食品和药物管理局最近建议对常用于排除癌症临床试验患者的合并症相关标准进行现代化。其目标是设计临床试验资格，使试验结果更好地反映现实世界中的癌症患者群体，提高临床试验参与率，并增加患者在试验中获得新治疗方法的机会。尽管合并症被认为会影响试验参与，但患者诊断时的合并症特征与试验参与之间的关系尚未通过患者水平的数据进行明确检查。
调查合并症、临床试验决策和临床试验参与之间的关联；并估计降低合并症排除标准对试验参与的潜在影响，为改变标准提供基准。
设计、设置和参与者：一项全国性调查嵌入在一个基于网络的癌症治疗决策工具中，该工具可在多个面向癌症的网站上使用。参与者必须被诊断患有乳腺癌、肺癌、结直肠癌或前列腺癌。共有 5499 名在过去 3 个月内做出治疗决策的接受调查的患者使用逻辑回归分析和模拟进行分析。
癌症诊断和 1 种或多种 18 种合并症。
患者与医生讨论临床试验（是与否）；如果讨论了临床试验，提供试验参与（是与否）；如果提供了试验参与，实际参与试验（是与否）。
在参与调查的 5499 名患者中，3420 名（62.6%）为女性，2079 名（37.8%）为男性（平均[标准差]年龄，56.63[10.05]岁）。大多数患者（65.6%；n=3610）有 1 种或多种合并症。最常见的合并症是高血压（35.0%；n=1924）。与没有合并症相比，存在 1 种或多种合并症与降低讨论试验的风险相关（44.1%比 37.2%；比值比，0.86；95%置信区间，0.75-0.97；P=.02）、提供试验的可能性（21.7%比 15.7%；比值比，0.82；95%置信区间，0.70-0.96；P=.02）和实际参与试验（11.3%比 7.8%；比值比，0.76；95%置信区间，0.61-0.94；P=.01）。取消 ASCO 推荐的合并症限制每年可增加多达 6317 名患者参加临床试验。
独立于社会人口统计学变量，合并症的存在与讨论试验、提供试验和试验本身的参与呈负相关。更新试验资格标准每年可为数千名合并症管理良好的患者提供参与临床试验的机会。
