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: 10884067
• 负责人: Supriya G. Mohile
• 金额: $ 35万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-08 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10884067
• 关键词: Adult; Advanced Malignant Neoplasm; Advocate; Aging; Applications Grants; Biometry; Clinical; Clinical Trials; Clinical Trials Design; Collaborations; Common Terminology Criteria for Adverse Events; Community Clinical Oncology Program; Data; Data Science; Decision Making; Disparity; Dose; Elderly; Enrollment; Geriatric Assessment; Goals; Hospitalization; Knowledge; Malignant Neoplasms; Measurement; Measures; Methodology; Methods; Modeling; Modification; Older Population; Outcome; Patient Outcomes Assessments; Patients; Quality of life; Randomized; Reporting; Research; Site; Symptoms; Syndrome; Toxic effect; Treatment Protocols; Universities; age related; aged; base; cancer care; comorbidity; disability; experience; high risk; mortality; novel; older patient; programs; randomized, clinical trials; satisfaction

PROJECT SUMMARY The overarching goal of this grant proposal supplement, 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), is: to continue 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 continue to leverage an existing multi-site cluster randomized study that has completed 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, biostatistics and data science, PRO measurement, and collaborations with CARG 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 代表罗切斯特大学提交的本补助金提案补充的总体目标 NCI 社区肿瘤​​学研究计划 (UR NCORP) 研究基地以及癌症和衰老 研究小组（CARG）的目标是：继续评估项目是否来自患者报告的结果 不良事件通用术语标准 (PRO-CTCAE) 的版本与 患有与年龄相关的疾病的老年患者（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不足，导致结果存在显着差异。 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 级毒性（如 由 NCI 的 CTCAE 测量）在开始新的老年治疗方案后三个月内； 评估（GA）与毒性显着相关；2）老年患者经常患有晚期癌症 出现多种影响功能和生活质量 (QoL) 的症状；3) 老年患者经常出现； 经历导致早期停止治疗、住院和死亡的毒性。 这是一个前所未有的机会，可以继续利用现有的多站点集群随机研究，该研究已 已完成招募年龄 > 70 岁、患有年龄相关疾病且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、生物统计学和数据科学、PRO 测量以及与 CARG 和患者倡导者（由 Canin 领导的 SCOREBoard）非常适合开展这项研究。 研究将解决患者报告的毒性如何影响耐受性的关键知识空白 患有晚期癌症和年龄相关疾病的老年患者的治疗。

项目成果

Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer.

监督学习应用于对患有癌症的老年人中跌倒者和非跌倒者进行分类。

• 发表时间: 2023-05
• 作者: Ramsdale, Erika;Kunduru, Madhav;Smith, Lisa;Culakova, Eva;Shen, Junchao;Meng, Sixu;Zand, Martin;Anand, Ajay
• 通讯作者: Anand, Ajay