Reducing Chemotherapy Toxicity in Older Adults

描述（由申请人提供）：项目概述：超过60%的癌症发生在老年人中，随着人口老龄化，老年癌症患者的数量预计会增加。老年癌症患者治疗并发症的风险增加，并且没有标准的方法来减少化疗毒性。几项研究，包括癌症和衰老研究小组（CARG）在500名患者中进行的研究，已经证明50%的老年患者在治疗开始后3个月内有严重的化疗毒性，并且老年评估（GA）中的措施，一种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。尽管老年评估在改善老年癌症患者的不良结局方面具有很大的潜力，但大多数肿瘤学家尚未采用GA，主要是因为缺乏如何将GA最好地纳入临床护理的知识。这项拟议研究的总体假设是，为肿瘤学家提供来自老年评估的信息，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，老年肿瘤学家和通过CARG组建的研究团队有能力成功完成这项高影响力的研究。本研究将分2个阶段进行。在I期研究中，将招募年龄在70岁及以上、计划在罗切斯特大学社区临床肿瘤项目（CCOP）研究中心接受一线化疗的转移性实体瘤恶性肿瘤患者（n=240），为期1年。将收集“医疗保健”实践，包括医生特征、处方模式、患者和医生开始化疗的决策以及化疗毒性。在II期研究中，我们将利用CCOP研究中心进行一项双臂随机分组研究。在开始化疗前，70岁及以上的转移性实体瘤恶性肿瘤患者（n=688）将完成GA。随机分配至第1组的研究中心的肿瘤学家将收到GA结果总结以及考虑实施的靶向干预措施。在组2中，肿瘤学家将仅从GA接收关于重度抑郁或认知障碍的信息。主要结局将是比较化疗开始后3个月发生重度化疗毒性的患者比例。次要结果将包括生存率的比较，两组中实施的干预措施的数量，以及化疗的决策。探索性目标将评估GA加靶向干预是否可以减缓晚期癌症老年患者的功能和身体衰退。关于预期结果，该提案将填补有关GA是否可以改善老年癌症患者的结果以及GA如何改善生活质量的机制（决策，GA驱动的干预措施）的知识空白。这些数据将通过提供将GA纳入常规临床肿瘤学护理的实用机制来改善老年转移性癌症患者的结局，从而产生积极的影响。

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.