Division of Medical Oncology, Ottawa General Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada.
Department of Oncology, Tom Baker Cancer Centre, University of Calgary, 1331 29 ST NW, Calgary, AB T2N 4N2, Canada.
J Geriatr Oncol. 2020 Apr;11(3):455-462. doi: 10.1016/j.jgo.2019.08.004. Epub 2019 Aug 28.
Older adults (OA), aged 65 years and over, are under-represented in studies. Strict exclusion criteria have been identified as a potential barrier to accrual of OA. This study aims to determine: 1) whether accrual of OA to trials led by the Canadian Cancer Trials Group (CCTG) has increased since 2003; 2) whether exclusion criteria have broadened over time; 3) whether exclusion criteria are associated with lower accrual of OA.
Phase III and randomized phase II CCTG-led trials initiated from 1990 onwards were included. Trial protocols were reviewed for exclusion criteria. Associations between trial characteristics and percentage of OA accrued were compared using multivariate linear regression modelling. The frequency of exclusion criteria in trials initiated pre- and post-2003 was compared using the Chi-Square test or Fisher exact test.
Sixty-nine trials involving 34,957 patients were included. Accrual of OA to trials remained low compared to OA diagnosed with cancer in Canada (40.8% vs. 56.1%, p < .001). There was a small increase in the accrual of OA since 2003 (42.8% vs. 39.3%, p = .04). There was no relaxation of exclusion criteria over time. Studies initiated prior to 2003, breast cancer studies and studies with exclusion criteria based on renal dysfunction were associated with lower accrual of OA (p < .05). Central nervous system studies were associated with higher accrual of OA (p = .03).
OA remain under-represented in trials. While there has been minimal change in exclusion criteria over time, renal dysfunction was the only exclusion criteria associated with lower accrual of OA.
65 岁及以上的老年人（OA）在研究中代表性不足。严格的排除标准已被确定为招募 OA 的潜在障碍。本研究旨在确定：1）自 2003 年以来，加拿大癌症试验组（CCTG）领导的试验中 OA 的入组是否增加；2）排除标准是否随时间而放宽；3）排除标准是否与 OA 的入组率较低有关。
纳入了 1990 年以后启动的 III 期和随机 II 期 CCTG 主导的试验。审查了试验方案的排除标准。使用多元线性回归模型比较了试验特征与 OA 入组百分比之间的关联。使用卡方检验或 Fisher 精确检验比较了 2003 年前后启动的试验中排除标准的频率。
纳入了 69 项涉及 34957 名患者的试验。与加拿大诊断为癌症的 OA 相比，试验中 OA 的入组率仍然较低（40.8%比 56.1%，p<0.001）。自 2003 年以来，OA 的入组率略有增加（42.8%比 39.3%，p=0.04）。排除标准没有随时间放宽。与 2003 年以前启动的研究、乳腺癌研究和基于肾功能障碍的排除标准相关的研究与 OA 的低入组率相关（p<0.05）。中枢神经系统研究与 OA 的高入组率相关（p=0.03）。
OA 在试验中仍然代表性不足。虽然排除标准随时间变化很小，但肾功能障碍是唯一与 OA 入组率较低相关的排除标准。
