de Glas N A, Hamaker M E, Kiderlen M, de Craen A J M, Mooijaart S P, van de Velde C J H, van Munster B C, Portielje J E A, Liefers G J, Bastiaannet E
Department of Surgery, Leiden University Medical Center, Postzone K6-R, P.O. Box 9600, 2300 RC, Leiden, The Netherlands,
Breast Cancer Res Treat. 2014 Aug;146(3):591-7. doi: 10.1007/s10549-014-3038-z. Epub 2014 Jul 9.
With the ongoing ageing of western societies, the proportion of older breast cancer patients will increase. For several years, clinicians and researchers in geriatric oncology have urged for new clinical trials that address patient-related endpoints such as functional decline after treatment of older patients. The aim of this study was to present an overview of trial characteristics and endpoints of all currently running clinical trials in breast cancer, particularly in older patients. The clinical trial register of the United States National Institutes of Health Differences was searched for all current clinical trials on breast cancer treatment. Trial characteristics and endpoints were retrieved from the register and differences in characteristics between studies in older patients specifically (defined as a lower age-limit of 60 years or older) and trials in all patients were assessed using χ(2) tests. We included 463 clinical trials. Nine trials (2 %) specifically investigated breast cancer treatment in older patients. Ninety-one breast cancer trials included any patient-related endpoint (20 %), while five trials specifically addressing older patients included any patient-related endpoint (56 %, P = 0.02). Five of the trials in older patients incorporated a geriatric assessment (56 %). Clinical trials still rarely incorporate patient-related endpoints, even in trials that specifically address older patients. Trials that are specifically designed for older patients do not often incorporate a geriatric assessment in their design. This implicates that current clinical studies are not expected to fill the gap in knowledge concerning treatment of older breast cancer patients in the next decade.
随着西方社会老龄化进程的持续，老年乳腺癌患者的比例将会增加。多年来，老年肿瘤学的临床医生和研究人员一直呼吁开展新的临床试验，以解决与患者相关的终点问题，如老年患者治疗后的功能衰退。本研究的目的是概述目前所有正在进行的乳腺癌临床试验的特征和终点，特别是老年患者的试验。检索了美国国立卫生研究院差异临床试验注册库中所有关于乳腺癌治疗的现行临床试验。从注册库中获取试验特征和终点，并使用χ²检验评估老年患者（定义为年龄下限为60岁及以上）研究与所有患者试验之间的特征差异。我们纳入了463项临床试验。其中9项试验（2%）专门研究了老年患者的乳腺癌治疗。91项乳腺癌试验纳入了任何与患者相关的终点（20%），而5项专门针对老年患者的试验纳入了任何与患者相关的终点（56%，P = 0.02）。老年患者试验中有5项纳入了老年评估（56%）。即使在专门针对老年患者的试验中，临床试验仍很少纳入与患者相关的终点。专门为老年患者设计的试验在设计中并不经常纳入老年评估。这意味着在未来十年，目前的临床研究预计无法填补老年乳腺癌患者治疗知识方面的空白。
