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.

项目总结