Abstract：
As older adults with cancer are underrepresented in randomized clinical trials (RCT), there is limited evidence on which to rely for treatment decisions for this population. Commonly used RCT endpoints for the assessment of treatment efficacy are more often tumor-centered (e.g., progression-free survival). These endpoints may not be as relevant for the older patients who present more often with comorbidities, non-cancer-related deaths, and treatment toxicity. Moreover, their expectation and preferences are likely to differ from younger adults. The DATECAN-ELDERLY initiative combines a broad expertise, in geriatric oncology and clinical research, with interest in cancer RCT that include older patients with cancer. In order to guide researchers and clinicians coordinating cancer RCT involving older patients with cancer, the experts reviewed the literature on relevant domains to assess using patient-reported outcomes (PRO) and patient-related outcomes, as well as available tools related to these domains. Domains considered relevant by the panel of experts when assessing treatment efficacy in RCT for older patients with cancer included functional autonomy, cognition, depression and nutrition. These were based on published guidelines from international societies and from regulatory authorities as well as minimum datasets recommended to collect in RCT including older adults with cancer. In addition, health-related quality of life, patients\' symptoms, and satisfaction were also considered by the panel. With regards to tools for the assessment of these domains, we highlighted that each tool has its own strengths and limitations, and very few had been validated in older adults with cancer. Further studies are thus needed to validate these tools in this specific population and define the minimum clinically important difference to use when developing RCTs in this population. The selection of the most relevant tool should thus be guided by the RCT research question, together with the specific properties of the tool.
摘要：
由于患有癌症的老年人在随机临床试验（RCT）中的代表性不足，对这一人群的治疗决定所依赖的证据有限.用于评估治疗疗效的常用RCT终点通常以肿瘤为中心(例如，无进展生存期)。这些终点可能与更经常出现合并症的老年患者无关。与癌症无关的死亡，和治疗毒性。此外，他们的期望和偏好可能与年轻人不同。DATECAN-ELDERLY计划结合了广泛的专业知识，在老年肿瘤学和临床研究中，对癌症RCT感兴趣，包括老年癌症患者。为了指导研究人员和临床医生协调涉及老年癌症患者的癌症RCT，专家们回顾了相关领域的文献，以评估使用患者报告的结果（PRO）和患者相关的结果，以及与这些领域相关的可用工具。专家小组在评估老年癌症患者的RCT治疗效果时认为相关的领域包括功能自主性，认知，抑郁症和营养这些基于国际社会和监管机构发布的指南，以及建议在RCT中收集的最低数据集，包括患有癌症的老年人。此外,与健康相关的生活质量，患者的症状，小组还考虑了满意度。关于评估这些领域的工具，我们强调每个工具都有自己的优势和局限性，很少有人在患有癌症的老年人中得到验证。因此，需要进一步的研究来验证该特定人群中的这些工具，并定义在该人群中开发RCT时使用的最小临床重要差异。因此，最相关工具的选择应以RCT研究问题为指导，以及工具的特定属性。
