Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
老年人化疗毒性的临床和生物学预测因子
基本信息
- 批准号:8188305
- 负责人:
- 金额:$ 53.16万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2011
- 资助国家:美国
- 起止时间:2011-08-15 至 2016-07-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdjuvant ChemotherapyAdjuvant StudyAdultAgeAgingAreaBiologicalBiological FactorsBiological MarkersBiometryBreast Cancer Risk FactorC-reactive proteinCDKN2A geneCancer CenterChemotherapy-Oncologic ProcedureClinicalCoagulation ProcessCommon Terminology Criteria for Adverse EventsDataDoseDose-LimitingEducational workshopElderlyEnrollmentEquationEventFibrin fragment DFutureGeriatric AssessmentGeriatricsGoalsHealthHealth PersonnelHepaticIndividualInterleukin-6Intervention StudiesJointsKidneyKnowledgeLongitudinal StudiesMalignant NeoplasmsMeasuresMethodsModelingMorbidity - disease rateOncologistOutcomePatientsPerformance StatusPhysiciansPopulationPositive Lymph NodeRelapseRelative (related person)ReportingResearchResearch PriorityRiskRisk FactorsRoleStagingTestingToxic effectToxicity due to chemotherapyTranslational ResearchWomananticancer researchbasebench to bedsidebreast cancer diagnosischemotherapyevidence baseimprovedinflammatory markerinnovationleukemiamalignant breast neoplasmmolecular markermortalityoncologypredictive modelingprospectiveresponsestandard of caresymposiumtooltumor
项目摘要
DESCRIPTION (provided by applicant): The overarching goal of this application, in response to PA 08-230 (Translational Research at the Aging Cancer Interface), is to develop a "bedside to bench" model of clinical and biological predictors for toxicity to adjuvant chemotherapy in older adults with breast cancer. This is important because the greatest risk factor for breast cancer is increasing age. Furthermore, the number of older adults with breast cancer is predicted to increase significantly with the aging of the US population. Several studies have demonstrated that older adults with breast cancer are at increased risk for chemotherapy toxicity; however, no standard method currently exists for identifying those individuals who are particularly vulnerable. In addition, little is known about the clinical factors, biological factors, or specific toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen. This proposal unites the fields of geriatrics and oncology by incorporating geriatric correlates of vulnerability, and studying their impact in an aging oncology population. The specific aims of this application are: 1) to develop a predictive model consisting of clinical and biological predictors of toxicity to adjuvant chemotherapy in older adults with breast cancer; 2) to understand the association between clinical and biological factors and reduced relative dose intensity (RDI) of the prescribed chemotherapy regimen; and 3) to identify the specific chemotherapy toxicities associated with reduced RDI of the prescribed chemotherapy regimen. These aims will be accomplished by a multi-disciplinary investigative team with expertise in geriatrics, oncology, and biostatistics. The team will perform a prospective, multicenter, longitudinal study of 500 adults age > 70 with stage I-III breast cancer who will receive adjuvant chemotherapy. Clinical factors (geriatric assessment, sociodemographic, tumor, and treatment variables) and biological factors (renal, hepatic, and hematologic function; markers of inflammation and coagulation; and a molecular marker of aging [p16INK4a]) will be captured before chemotherapy. Patients will subsequently receive standard of care adjuvant chemotherapy as prescribed by the treating physician. Patients will be followed throughout the course of chemotherapy (from start to 1 month post-completion) to capture NCI CTCAE (v4.0) grade 3-5 toxicities. Dose delays, dose reductions, and discontinuation of treatment will also be captured, along with the relationship of these events to toxicity. With regard to expected outcomes, the current project will fill vital gaps in the knowledge about clinical and biological predictors of chemotherapy toxicity for older adults with breast cancer, areas that an oncologist should assess prior to prescribing adjuvant chemotherapy for an older adult. This proposal is innovative, as our data will ultimately be used to develop an overall risk score for toxicity. Ultimately these data will serve as the basis for future intervention studies aimed at decreasing the risk of chemotherapy toxicity and maintaining the function and health of older adults with breast cancer.
PUBLIC HEALTH RELEVANCE: This proposal unites the fields of geriatrics and oncology by incorporating geriatric correlates of vulnerability and studying their impact in an aging oncology population. This study will identify clinical and biological predictors of adjuvant chemotherapy toxicity in older adults with breast cancer. These data will be used to develop a predictive equation for chemotherapy toxicity risk that can be utilized in daily oncology practice.
描述(由申请人提供):响应 PA 08-230(衰老癌症界面的转化研究),本申请的总体目标是开发佐剂毒性临床和生物预测因子的“床边到工作台”模型患有乳腺癌的老年人进行化疗。这很重要,因为乳腺癌的最大危险因素是年龄增长。此外,随着美国人口老龄化,预计患有乳腺癌的老年人数量将显着增加。多项研究表明,患有乳腺癌的老年人发生化疗毒性的风险增加;然而,目前尚无标准方法来识别那些特别脆弱的个人。此外,对于与处方化疗方案相对剂量强度降低相关的临床因素、生物因素或特定毒性知之甚少。该提案通过纳入老年脆弱性的相关性,并研究其对老龄化肿瘤学人群的影响,将老年医学和肿瘤学领域结合起来。本申请的具体目标是:1)开发一种预测模型,其中包含老年乳腺癌辅助化疗毒性的临床和生物学预测因子; 2)了解临床和生物学因素与处方化疗方案降低相对剂量强度(RDI)之间的关联; 3) 确定与处方化疗方案 RDI 减少相关的具体化疗毒性。这些目标将由具有老年学、肿瘤学和生物统计学专业知识的多学科研究团队来实现。该团队将对 500 名年龄 > 70 岁、患有 I-III 期乳腺癌且将接受辅助化疗的成年人进行一项前瞻性、多中心、纵向研究。化疗前将捕获临床因素(老年评估、社会人口统计学、肿瘤和治疗变量)和生物学因素(肾、肝和血液功能;炎症和凝血标志物;以及衰老分子标志物 [p16INK4a])。随后,患者将按照治疗医生的规定接受标准护理辅助化疗。在整个化疗过程中(从开始到完成后 1 个月)将对患者进行随访,以捕获 NCI CTCAE (v4.0) 3-5 级毒性。剂量延迟、剂量减少和治疗停止以及这些事件与毒性的关系也将被捕获。就预期结果而言,当前的项目将填补老年乳腺癌化疗毒性的临床和生物学预测因子知识方面的重要空白,这是肿瘤学家在为老年人开辅助化疗之前应评估的领域。该提案具有创新性,因为我们的数据最终将用于制定毒性的总体风险评分。最终,这些数据将作为未来干预研究的基础,旨在降低化疗毒性风险并维持患有乳腺癌的老年人的功能和健康。
公共卫生相关性:该提案通过纳入老年脆弱性的相关性并研究其对老龄化肿瘤人口的影响,将老年医学和肿瘤学领域联合起来。这项研究将确定老年乳腺癌患者辅助化疗毒性的临床和生物学预测因素。这些数据将用于开发化疗毒性风险的预测方程,可用于日常肿瘤学实践。
项目成果
期刊论文数量(0)
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ARTI HURRIA其他文献
ARTI HURRIA的其他文献
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{{ truncateString('ARTI HURRIA', 18)}}的其他基金
Geriatric Oncology: Educating nurses to improve quality care
老年肿瘤学:教育护士提高护理质量
- 批准号:
8853190 - 财政年份:2015
- 资助金额:
$ 53.16万 - 项目类别:
Geriatric Oncology: Educating nurses to improve quality care
老年肿瘤学:教育护士提高护理质量
- 批准号:
9334122 - 财政年份:2015
- 资助金额:
$ 53.16万 - 项目类别:
Geriatric Oncology: Educating nurses to improve quality care
老年肿瘤学:教育护士提高护理质量
- 批准号:
9135263 - 财政年份:2015
- 资助金额:
$ 53.16万 - 项目类别:
Physician Scientists in Aging: Developing and Activating Specialty Investigators
老龄化领域的医师科学家:培养和激活专业研究人员
- 批准号:
9282669 - 财政年份:2014
- 资助金额:
$ 53.16万 - 项目类别:
Physician Scientists in Aging: Developing and Activating Specialty Investigators
老龄化领域的医师科学家:培养和激活专业研究人员
- 批准号:
9084490 - 财政年份:2014
- 资助金额:
$ 53.16万 - 项目类别:
Technology to Assess Vulnerable Older Adults with Cancer and Their Caregivers
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- 批准号:
8663150 - 财政年份:2013
- 资助金额:
$ 53.16万 - 项目类别:
Technology to Assess Vulnerable Older Adults with Cancer and Their Caregivers
评估患有癌症的弱势老年人及其护理人员的技术
- 批准号:
8512516 - 财政年份:2013
- 资助金额:
$ 53.16万 - 项目类别:
Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
老年人化疗毒性的临床和生物学预测因素
- 批准号:
8699108 - 财政年份:2011
- 资助金额:
$ 53.16万 - 项目类别:
Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
老年人化疗毒性的临床和生物学预测因素
- 批准号:
8510541 - 财政年份:2011
- 资助金额:
$ 53.16万 - 项目类别:
Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
老年人化疗毒性的临床和生物学预测因子
- 批准号:
8319399 - 财政年份:2011
- 资助金额:
$ 53.16万 - 项目类别:
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