Understanding Treatment Tolerability in Older Patients with Cancer

了解老年癌症患者的治疗耐受性

• 批准号: 10240520
• 负责人: Supriya G. Mohile
• 金额: $ 59.06万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 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/10240520
• 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; 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; Treatment-related toxicity; Universities; adverse event risk; adverse outcome; age related; aged; base; cancer care; cancer therapy; clinically relevant; comorbidity; demographics; disability; experience; functional decline; high risk; improved; mortality; novel; older patient; programs; response; satisfaction; symposium

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.

项目摘要 这个为期五年的赠款提案的总体目标，代表罗切斯特NCI大学提交 社区肿瘤学研究计划（UR NCORP）研究基地和癌症与衰老研究 组（CARG），响应RFA-CA-17-052，是：评价患者报告的项目是否 不良事件通用术语标准（PRO-CTCAE）的结局版本为 与年龄相关的老年晚期癌症患者的治疗耐受性相关 条件（即，残疾、合并症和老年综合征）。不断增长的老年患者 在制定癌症护理标准的研究中仍然代表性不足， 结果。在我们的初步研究中，我们发现：1）接近60%的老年患者发展为3-5级 开始新治疗方案后3个月内的毒性（根据NCI CTCAE测量）; 老年评估（GA）与毒性显著相关; 2）老年晚期癌症患者 经常出现干扰功能和生活质量（QoL）的多种症状; 3）老年人 患者通常会出现毒性，导致早期停止治疗，住院治疗， mortality.我们有一个前所未有的机会来利用现有的多中心集群随机研究 目前正在招募年龄>70岁的成年人，他们患有与年龄相关的疾病，正在开始新的治疗。 UR NCORP网络中晚期癌症的治疗方案（URCC 13059/“GAP”）（n=700）。除了 基线、第4周、第3周时临床医生评定的CTCAE、GAP采集PRO指标（PRO-CTCAE、GA、满意度） 个月，以及新治疗方案开始后6个月。收集了大量临床数据， 耐受性指标，包括治疗剂量调整、住院和死亡率。我们将合作 与U 01联盟合作，以：1）开发并比较PRO-CTCAE评分和临床医生评定的 年龄相关疾病老年患者CTCAE 2-5级; 2）评价PRO-1与年龄相关疾病之间的相关性。 CTCAE评分和临床医师评定的CTCAE等级与临床耐受性指标; 3）评价相关性 PRO-CTCAE评分和临床医生评定的CTCAE等级与PRO终点（例如，功能，生活质量， 满意度）;以及4）验证一个模型，该模型识别出患有与年龄相关的疾病的老年患者， 晚期癌症治疗耐受性差的风险。与利益相关者一起开发，我们的运营 耐受性的定义是新的;它包括临床结局和PRO终点。该小组 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（由Canin领导的SCOREBoard）的合作是独一无二的 适合进行这项研究。这项研究将解决一个关键的差距，在知识如何病人报告， 毒性为晚期癌症和年龄相关疾病的老年患者的治疗耐受性提供了信息。