Reducing Chemotherapy Toxicity in Older Adults

描述(由申请人提供)：项目摘要：超过60%的癌症发生在老年人中，预计随着人口老龄化，老年癌症患者的数量将会增加。老年癌症患者治疗并发症的风险增加，而且没有标准的方法来降低化疗毒性。多项研究，包括癌症和老龄化研究小组(CARG)对500名患者的研究表明，50%的老年患者在开始治疗后3个月内因化疗而出现严重毒性，老年评估(GA)是评估老年人健康状况的有效方法，可以预测严重的化疗毒性。尽管老年评估具有改善老年癌症患者不良结局的巨大潜力，但大多数肿瘤学家没有采用GA，主要是因为缺乏关于如何最好地将GA结合到临床护理中的知识。这项拟议研究的总体假设是，为肿瘤学家提供老年评估信息，并在GA指导下对老年患者进行有针对性的干预可以降低化疗毒性的风险。首席研究员、一名老年肿瘤学家和通过CAG组建的研究团队处于有利地位，可以成功完成这项高影响的研究。研究将分两个阶段进行。在第一阶段，计划在罗切斯特大学社区临床肿瘤学计划(CCOP)地点接受一线化疗的70岁及以上转移性实体肿瘤恶性肿瘤患者(n=240)将在一年内招募。“常规护理”的做法，包括医生的特点，处方模式，病人和医生的决策化疗开始，以及化疗毒性将被捕获。在第二阶段，我们将利用CCOP站点进行一项双臂整群随机研究。在化疗开始之前，70岁及以上的转移性实体肿瘤患者(n=688)将完成GA。随机分配到ARM 1的地点的肿瘤学家将收到GA结果的摘要以及考虑实施的有针对性的干预措施。在ARM 2中，肿瘤学家将只从GA收到关于严重抑郁症或认知障碍的信息。主要结果将是比较化疗开始后3个月出现严重化疗毒性的患者的比例。次要结果将包括两组患者存活率、实施干预措施的数量以及化疗决策的比较。一个探索性的目标是评估GA加有针对性的干预是否可以减缓老年晚期癌症患者的功能和身体衰退。在预期结果方面，这项建议将填补关于GA是否可以改善老年癌症患者的结果以及GA如何提高生活质量的机制(决策、GA驱动的干预)的重要知识空白。这些数据将产生积极的影响，提供一种实用的机制，将GA纳入常规的临床肿瘤学护理，以改善老年转移性癌症的预后。

DESCRIPTION (provided by applicant): Project Summary: Over 60% of cancers occur in older persons, and the number of older cancer patients is expected to grow as the population ages. Older cancer patients are at increased risk of treatment complications, and there is no standard approach for reducing chemotherapy toxicity. Several studies, including a Cancer and Aging Research Group (CARG) study in 500 patients, have demonstrated that 50% of older patients have severe toxicity from chemotherapy within 3 months of treatment initiation and that measures within a geriatric assessment (GA), a validated approach to assessing health status in older persons, can predict severe chemotherapy toxicities. Although geriatric assessment has great potential to improve adverse outcomes of older adults with cancer, the majority of oncologists have not adopted GA, largely because of lack of knowledge on how to best incorporate GA into clinical care. The overall hypothesis of this proposed research is that providing oncologists with information from geriatric assessment with and targeted interventions guided by GA for older patients can reduce the risk of chemotherapy toxicity. The principal investigator, a geriatric oncologist, and the research team assembled through CARG are well positioned to successfully complete this high-impact research. The study will be conducted in 2 phases. In Phase 1, patients aged 70 and over (n=240) with metastatic solid tumor malignancies who are planning to receive first-line chemotherapy at University of Rochester Community Clinical Oncology Program (CCOP) sites will be recruited over the course of 1 year. "Usual-care" practices including physician characteristics, prescribing patterns, patient and physician decision-making for chemotherapy initiation, and chemotherapy toxicity will be captured. In Phase 2, we will conduct a 2-armed cluster randomized study utilizing CCOP sites. Prior to chemotherapy initiation, patients aged 70 and over (n=688) with metastatic solid tumor malignancies will complete a GA. The oncologists at sites randomized to Arm 1 will receive a summary of GA results plus targeted interventions to consider for implementation. In Arm 2, oncologists will only receive information from GA regarding severe depression or cognitive impairment. The primary outcome will be a comparison of the proportion of patients who have severe chemotherapy toxicity at 3 months after chemotherapy initiation. Secondary outcomes will include comparisons of survival, the number of interventions implemented in both groups, and decision-making for chemotherapy. An exploratory aim will evaluate whether or not GA plus targeted interventions can slow functional and physical decline in older patients with advanced cancer. With regard to expected outcomes, this proposal will fill vital gaps in knowledge regarding whether GA can improve outcomes of older cancer patients and the mechanisms of how GA can improve quality of life (decisions, GA-driven interventions). These data will have a positive impact by providing a pragmatic mechanism for incorporating GA into routine clinical oncology care to improve outcomes of older adults with metastatic cancer.