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: 10005899
• 负责人: Supriya G. Mohile
• 金额: $ 60.46万
• 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/10005899
• 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; 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 该五年赠款提案的总体目标是代表罗切斯特大学NCI大学提交的 社区肿瘤研究计划（UR NCORP）研究基础和癌症与衰老研究 响应RFA-CA-17-052的组（CARG）是：评估患者报告的项目是否 不良事件的共同术语标准的结果版本（Pro-CTCAE）为 与年龄相关的老年患者治疗晚期癌症治疗的耐受性 条件（即残疾，合并症和老年综合症）。老年患者人口不断增长 在制定癌症护理标准的研究中仍然不足，导致大量分布 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3-5级 毒性（由NCI的CTCAE衡量）在开始新的治疗方案后的三个月内；项目 老年评估（GA）与毒性显着相关； 2）晚期癌症患者 经常出现多种症状，这些症状会干扰生活质量和生活质量（QOL）； 3）年龄较大 患者经常经历毒性，导致早期终止治疗，住院和 死亡。我们有前所未有的机会来利用现有的多站点群集随机研究 目前正在招募年龄> 70岁的成年人，他们正在开始新的治疗 UR NCORP网络中晚期癌症方案（URCC 13059/“ GAP”）（n = 700）。此外 基线，4周，3 新治疗方案开始后的几个月和6个月。广泛的数据是关于临床的 可耐受性指标，包括治疗剂量修改，住院和死亡率。我们将合作 使用U01联盟为：1）开发和比较pro-CTCAE评分和临床评分的轨迹 患有年龄相关的老年患者的CTCAE级2-5级； 2）评估支持之间的关联 CTCAE评分和临床评级的CTCAE等级，具有临床耐受性指标； 3）评估关联 在Pro-CTCAE评分和具有Pro终点的临床评级CTCAE等级之间（例如，功能，QOL， 满意）; 4）验证一个模型，该模型识别患有年龄相关的老年患者 治疗晚期癌症的耐受性差的风险。与利益相关者一起开发，我们的运营 耐受性的定义是新颖的。它包括临床结果和Pro端点。团队，哪个 包括临床试验的专业知识（Mohile，Morrow，Janelsins，Kamen），生物统计学和数据科学 （Culakova，Heckler，Pandya，Ramsdale，Zand），Pro Measurement（Mohile，Duberstein，Chapman，Flannery）， 与卡格（Hurria，dale）和患者倡导者（由Canin领导）的合作是独特的 适合进行这项研究。这项研究将解决有关患者报告的知识的关键差距 老年患者患有晚期癌症和与年龄相关的老年患者的毒性信息耐受性。