Janelsins Michelle C, Van Dyk Kathleen, Hartman Sheri J, Koll Thuy T, Cramer Christina K, Lesser Glenn J, Barton Debra L, Mustian Karen M, Wagner Lynne I, Ganz Patricia A, Cole Peter D, Bakos Alexis, Root James C, Hardy Kristina, Magnuson Allison, Ferguson Robert J, McDonald Brenna C, Saykin Andrew J, Gonzalez Brian D, Wefel Jeffrey S, Morilak David A, Dahiya Saurabh, Heijnen Cobi J, Conley Yvette P, Morgans Alicia K, Mabbott Donald, Monje Michelle, Rapp Stephen R, Gondi Vinai, Bender Catherine, Embry Leanne, McCaskill Stevens Worta, Hopkins Judith O, St Germain Diane, Dorsey Susan G
Division of Supportive Care in Cancer, Department of Surgery, University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, NY, USA.
Department of Psychiatry, David Geffen Scholl of Medicine, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.
J Natl Cancer Inst. 2025 Feb 1;117(2):217-228. doi: 10.1093/jnci/djae209.
Cancer-related cognitive impairment is a broad term encompassing subtle cognitive problems to more severe impairment. The severity of this impairment is influenced by host, disease, and treatment factors, and the impairment affects patients before, during, and following cancer treatment. The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee (SxQoL SC) convened a clinical trial planning meeting to review the state of the science on cancer-related cognitive impairment and develop phase II/III intervention trials aimed at improving cognitive function in cancer survivors with non-central nervous system disease and longitudinal studies to understand the trajectory of cognitive impairment and contributing factors. Participants included experts in the field of cancer-related cognitive impairment, members of the SxQoL SC, patient advocates, representatives from all 7 NCI Community Oncology Research Program research bases, and the NCI. Presentations focused on the following topics: measurement, lessons learned from pediatric and geriatric oncology, biomarker and mechanism endpoints, longitudinal study designs, and pharmacological and behavioral intervention trials. Panel discussions provided guidance on priority cognitive assessments, considerations for remote assessments, inclusion of relevant biomarkers, and strategies for ensuring broad inclusion criteria. Three clinical trial planning meeting working groups (longitudinal studies as well as pharmacological and behavioral intervention trials) convened for 1 year to discuss and report on top priorities and to design studies. The meeting experts concluded that sufficient data exist to advance phase II/III trials using selected pharmacological and behavioral interventions for the treatment of cancer-related cognitive impairment in the non-central nervous system setting, with recommendations included herein.
癌症相关认知障碍是一个宽泛的术语，涵盖从轻微认知问题到更严重障碍的情况。这种障碍的严重程度受宿主、疾病和治疗因素影响，且在癌症治疗前、治疗期间及治疗后都会对患者产生影响。美国国立癌症研究所（NCI）症状管理与健康相关生活质量指导委员会（SxQoL SC）召开了一次临床试验规划会议，以审查癌症相关认知障碍的科学现状，并开展旨在改善非中枢神经系统疾病癌症幸存者认知功能的II/III期干预试验以及纵向研究，以了解认知障碍的发展轨迹及相关因素。参会人员包括癌症相关认知障碍领域的专家、SxQoL SC成员、患者权益倡导者、NCI社区肿瘤学研究项目所有7个研究基地的代表以及NCI。会议报告聚焦于以下主题：测量方法、儿科和老年肿瘤学的经验教训、生物标志物和机制终点、纵向研究设计以及药物和行为干预试验。小组讨论为优先认知评估、远程评估的注意事项、纳入相关生物标志物以及确保广泛纳入标准的策略提供了指导。三个临床试验规划会议工作组（纵向研究以及药物和行为干预试验）开展了为期1年的工作，以讨论并报告首要优先事项并设计研究。会议专家得出结论，现有足够数据推进II/III期试验，采用选定的药物和行为干预措施治疗非中枢神经系统疾病背景下的癌症相关认知障碍，并在此列出相关建议。
