Peeter Karihtala, Aglaia Schiza, Elena Fountzilas, Jürgen Geisler, Icro Meattini, Emanuela Risi, Laura Biganzoli, Antonios Valachis
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引用次数: 0
摘要
背景和目的:虽然老年乳腺癌患者的发病率在迅速增加,但这些患者在临床试验中的代表性却严重不足。我们讨论了招募老年患者参与临床试验的障碍,并就如何通过重要试验范式减轻这些挑战和设计最佳临床试验提出了解决方案:这是对当前文献的叙述性回顾,评估了将老年乳腺癌患者纳入临床试验的障碍,以及如何在务实的临床试验中实施缓解策略:公认的障碍可大致分为与试验设计相关的障碍(如采用严格的纳入标准、缺乏预先指定的特定年龄分析)、与患者相关的障碍(如缺乏知识、重视生活质量而非生存率、交通问题)或与医生相关的障碍(如担心毒性)。目前已确定了几种减少障碍的策略,在设计专门针对老年癌症患者的临床试验时应加以考虑。以老年乳腺癌患者 CDK4/6 抑制剂剂量优化为重点的务实、非集中化 IMPORTANT 试验就是采用不同缓解策略的研究设计范例:由于存在障碍,参与临床试验的老年人比临床实践中接受治疗的普通老年患者要健康得多。因此,研究结果不能推广到日常临床实践中的老年人群。更宽泛的纳入/排除标准、提供远程医疗访问、纳入患者报告的结果而不是医生报告的结果,可能会提高老年患者在临床试验中的参与度。
Clinical trials in older patients with cancer - typical challenges, possible solutions, and a paradigm of study design in breast cancer.
Background and purpose: While the prevalence of older breast cancer patients is rapidly increasing, these patients are greatly underrepresented in clinical trials. We discuss barriers to recruitment of older patients to clinical trials and propose solutions on how to mitigate these challenges and design optimal clinical trials through the paradigm of IMPORTANT trial.
Patients and methods: This is a narrative review of the current literature evaluating barriers to including older breast cancer patients in clinical trials and how mitigating strategies can be implemented in a pragmatic clinical trial.
Results: The recognized barriers can be roughly divided into trial design-related (e.g. the adoption of strict inclusion criteria, the lack of pre-specified age-specific analysis), patient-related (e.g. lack of knowledge, valuation of the quality-of-life instead of survival, transportation issues), or physician-related (e.g. concern for toxicity). Several strategies to mitigate barriers have been identified and should be considered when designing a clinical trial dedicated to older patients with cancer. The pragmatic, de-centralized IMPORTANT trial focusing on dose optimization of CDK4/6 -inhibitors in older breast cancer patients is a paradigm of a study design where different mitigating strategies have been adopted.
Interpretation: Because of the existing barriers, older adults in clinical trials are considerably healthier than the average older patients treated in clinical practice. Thus, the study results cannot be generalized to the older population seen in daily clinical practice. Broader inclusion/exclusion criteria, offering telehealth visits, and inclusion of patient-reported, instead of physician-reported outcomes may increase older patient participation in clinical trials.
期刊介绍:
Acta Oncologica is a journal for the clinical oncologist and accepts articles within all fields of clinical cancer research. Articles on tumour pathology, experimental oncology, radiobiology, cancer epidemiology and medical radio physics are also welcome, especially if they have a clinical aim or interest. Scientific articles on cancer nursing and psychological or social aspects of cancer are also welcomed. Extensive material may be published as Supplements, for which special conditions apply.