Understanding Treatment Tolerability in Older Patients with Cancer

了解老年癌症患者的治疗耐受性

基本信息

批准号：
9789242
负责人：
Supriya G. Mohile
金额：
$ 60.15万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-20 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9789242
关键词：
Address Adult Advanced Malignant Neoplasm Adverse event Advocate Aging Applications Grants Area Biometry Characteristics Clinic Clinical Clinical Trials Clinical Trials Design Collaborations Common Terminology Criteria for Adverse Events Communities Community Clinical Oncology Program Comorbidity Contracts Country Data Data Science Decision Making Dose Elderly Enrollment Funding Geriatric Assessment Goals High Prevalence Hospitalization Knowledge Lead Leadership Maintenance Malignant Neoplasms Measurement Measures Methodology Methods Modeling Modification Older Population Oncologist Outcome Patient Outcomes Assessments Patients Population Quality of life Randomized Randomized Clinical Trials Reporting Research Research Priority Safety Site Symptoms Syndrome Time Toxic effect Treatment Efficacy Treatment Protocols Universities adverse event risk adverse outcome age related aged base cancer care cancer therapy clinically relevant demographics disability experience functional decline high risk improved mortality novel older patient programs response satisfaction symposium

项目摘要

PROJECT SUMMARY The overarching goal of this five-year grant proposal, submitted on behalf of the University of Rochester NCI Community Oncology Research Program (UR NCORP) Research Base and the Cancer and Aging Research Group (CARG), in response to RFA-CA-17-052, is: to evaluate whether items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are associated with tolerability of treatment for advanced cancer in older patients with age-related conditions (i.e., disability, comorbidity, and geriatric syndromes). The growing population of older patients remains underrepresented in research that sets cancer care standards leading to significant disparities in outcomes. In our preliminary research, we found that: 1) close to 60% of older patients develop grade 3-5 toxicity (as measured by NCI's CTCAE) within three months of starting a new treatment regimen; items from geriatric assessment (GA) were significantly associated with toxicity; 2) older patients with advanced cancer frequently experience multiple symptoms that interfere with function and quality of life (QoL); and 3) older patients often experience toxicities that lead to early discontinuation of treatment, hospitalizations, and mortality. We have an unprecedented opportunity to leverage an existing multi-site cluster randomized study that is currently enrolling adults aged >70 years with age-related conditions who are starting a new treatment regimen for advanced cancer in the UR NCORP network (URCC 13059/“GAP”) (n=700). In addition to clinician-rated CTCAE, GAP captures PRO measures (PRO-CTCAE, GA, satisfaction) at baseline, 4 weeks, 3 months, and 6 months after the start of the new treatment regimen. Extensive data are collected on clinical tolerability metrics including treatment dose modifications, hospitalizations, and mortality. We will collaborate with the U01 consortium to: 1) develop and compare the trajectories of PRO-CTCAE scores and clinician-rated CTCAE grades 2-5 in older patients with age-related conditions; 2) evaluate associations between PRO- CTCAE scores and clinician-rated CTCAE grades with clinical tolerability metrics; 3) evaluate associations between PRO-CTCAE scores and clinician-rated CTCAE grades with PRO endpoints (e.g., function, QoL, satisfaction); and 4) validate a model that identifies older patients with age-related conditions who are at high risk for poor tolerability from treatment for advanced cancer. Developed with stakeholders, our operational definition of tolerability is novel; it includes both clinical outcomes and PRO endpoints. The team, which includes expertise in clinical trials (Mohile, Morrow, Janelsins, Kamen), biostatistics and data science (Culakova, Heckler, Pandya, Ramsdale, Zand), PRO measurement (Mohile, Duberstein, Chapman, Flannery), and collaborations with CARG (Hurria, Dale) and patient advocates (SCOREBoard led by Canin) is uniquely suited to conduct this research. This research will address a critical gap in knowledge of how patient-reported toxicity informs tolerability of treatment in older patients with advanced cancer and age-related conditions.

项目概要代表罗切斯特大学 NCI 提交的这份五年资助提案的总体目标社区肿瘤学研究计划 (UR NCORP) 研究基地和癌症与衰老研究小组 (CARG) 响应 RFA-CA-17-052 的目的是：评估患者报告的项目是否不良事件通用术语标准 (PRO-CTCAE) 的结果版本是与年龄相关的老年患者晚期癌症治疗的耐受性相关疾病（即残疾、合并症和老年综合症）。在制定癌症护理标准的研究中代表性仍然不足，导致癌症护理标准存在显着差异在我们的初步研究中，我们发现：1) 接近 60% 的老年患者出现 3-5 级。开始新治疗方案后三个月内的毒性（根据 NCI 的 CTCAE 测量）；老年评估（GA）与毒性显着相关；2）患有晚期癌症的老年患者经常出现多种影响功能和生活质量 (QoL) 的症状；3) 年龄较大；患者经常会出现毒性反应，导致提前停止治疗、住院和我们有一个前所未有的机会来利用现有的多中心整群随机研究。目前正在招募年龄 >70 岁、患有年龄相关疾病、正在开始新治疗的成年人 UR NCORP 网络 (URCC 13059/“GAP”) 中的晚期癌症治疗方案 (n=700)。临床医生评价的 CTCAE，GAP 在基线、4 周、3 时捕获 PRO 测量（PRO-CTCAE、GA、满意度）几个月和新治疗方案开始后 6 个月收集了大量的临床数据。耐受性指标，包括治疗剂量调整、住院治疗和死亡率，我们将进行合作。与 U01 联盟合作：1) 开发并比较 PRO-CTCAE 评分和临床医生评分的轨迹患有年龄相关疾病的老年患者的 CTCAE 2-5 级；2) 评估 PRO- 之间的关联； CTCAE 评分和临床医生评定的 CTCAE 等级与临床耐受性指标 3) 评估关联； PRO-CTCAE 评分与具有 PRO 终点（例如功能、生活质量、 4) 验证一个模型，该模型可识别患有与年龄相关的疾病的高龄患者我们与利益相关者共同开发了晚期癌症治疗的耐受性差的风险。耐受性的定义是新颖的；它包括临床结果和 PRO 终点。包括临床试验（Mohile、Morrow、Janelsins、Kamen）、生物统计学和数据科学方面的专业知识（Culakova、Heckler、Pandya、Ramsdale、Zand）、PRO 测量（Mohile、Duberstein、Chapman、Flannery）、与 CARG（Hurria、Dale）和患者倡导者（Canin 领导的 SCOREBoard）的合作是独一无二的适合进行这项研究，该研究将解决患者如何报告的知识空白。毒性可影响患有晚期癌症和年龄相关疾病的老年患者的治疗耐受性。