Immune-Related Adverse Events in Melanoma Patients Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
接受辅助免疫检查点抑制剂治疗的黑色素瘤患者的免疫相关不良事件
基本信息
- 批准号:10282855
- 负责人:
- 金额:$ 11.39万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-08-18 至 2026-07-31
- 项目状态:未结题
- 来源:
- 关键词:AcuteAdjuvantAdjuvant TherapyAdverse effectsAdverse eventAdvisory CommitteesAreaAutoimmuneAutoimmune DiseasesAutoimmunityBehavioralBehavioral SciencesBenefits and RisksBiological MarkersBiological Response ModifiersBiometryCancer CenterCancer PatientCancer SurvivorCancer SurvivorshipCaringCell TherapyCellsChronicClinicalClinical ImmunologyClinical ManagementClinical ResearchClinical TrialsClinical assessmentsCommittee MembersComplementDataData CollectionDevelopmentDevelopment PlansDiseaseEcological momentary assessmentEffectivenessEnvironmentEpidemiologistEpidemiologyFatigueFoundationsFutureGenesGeneticGenetic MarkersGenetic RiskGoalsImmuneImmune checkpoint inhibitorImmune systemImmunobiologyImmunologic AdjuvantsImmunologicsImmunologyIncidenceInflammationInflammatoryInflammatory ResponseInterleukin-6InterventionLinkMalignant NeoplasmsMeasurementMeasuresMedical OncologyMental DepressionMentorsMentorshipMethodsOralOrganOutcome MeasureOutcomes and Health Services ResearchPathogenesisPathway interactionsPatient Outcomes AssessmentsPatientsPhenotypePhysician ExecutivesPlayPopulationPreventionProspective StudiesProspective cohortProspective cohort studyQuality of lifeRecommendationReportingResearchResectedRheumatologyRiskRoleSecondary toSeveritiesSingle Nucleotide PolymorphismSleep disturbancesSolidSolid NeoplasmSpecific qualifier valueSymptomsT-LymphocyteTechnology AssessmentTestingTherapeuticTherapy trialTimeToxic effectTrainingTranslational ResearchWritingacute toxicityadverse event riskanticancer researchassociated symptombody systemcareer developmentcheckpoint therapyclinical careclinical phenotypeclinical practicecytokineexperiencefollow-uphigh riskimmune activationimmune-related adverse eventsinnovationinstrumentmelanomamid-career facultymobile computingneoplasm immunotherapypractice settingprofessorprospectivesocialstatisticssurgical risktumor immunology
项目摘要
PROJECT SUMMARY: Immune checkpoint inhibitors (ICIs) have transformed the treatment of melanoma, significantly
enhancing overall survival. The exponential increase in their use after being approved for melanoma in the adjuvant setting
is significantly changing the lanscape of cancer survivorship. Inspite of the survival benefits, the use of ICI can be limited
by off-target inflammatory responses and autoimmunity in various organs. The clinical phenotypes of the acute immune
toxicities have been clearly documented in trials. Yet, their potential long-term adverse effects, and their impact quality of
life (QOL) are still undetermined. The overall goal of the proposed study is to understand the full impact of adjuvant ICI
therapy, including its potential toxicity/symptom burden and its immune correlates in melanoma patients receiving regular
clinical care. We hypothesize that: adverse events and sustained inflammation induced by adjuvant ICIs increase symptom
burden and negatively impact function and QOL in a subset of melanoma patients receiving therapy, and that elevated
expression of pro-inflammatory cytokines and T-cell signatures during therapy correlate with the toxicity and symptom
burden. We will test this hypothesis in a prospective cohort of 240 melanoma patients from the initiation of adjuvant ICI
therapy through 2 years of follow-up. We will determine the incidence, clinical phenotypes, timing, and severity of irAEs,
and will longitudinally assess patients reported outcomes through 2 years of follow-up. We will use validated instruments
and ecological momentary assessments technology to assess adverse events and symptom burden in real time via patient-
initiated reports. Lastly, we will characterize patient immune signatures (immune cell phenotypes and inflammatory
cytokines) from baseline through 2 years of follow-up and evaluate their association with irAEs and symptom burden.
CAREER DEVELOPMENT PLAN: The primary objective of this application is to support Dr. Abdelwahab’s career
development into an independent immuno-epidemiologist with a focus on autoimmunity arising in the context of cancer or
its therapy. Dr. Abdelwahab proposed training in four areas 1) immunology, 2) epidemiology and biostatistics, 3) health
services and outcomes research, and 4) scientific writing and oral presentations. Dr. Abdelwahab has assembled an
outstanding mentorship team led by Dr. Cassian Yee, Professor in Melanoma Medical Oncology and Director of Solid
Tumor Cell Therapy in the Center for Cancer Immunology Research, and Dr. Annemieke Kavelaars, Professor in Symptom
Research at MD Anderson Cancer Center (MDACC) as co-primary mentors. This is complemented by mentoring advisory
committee members including Dr. Adi Diab, Associate Professor in Melanoma Medical Oncology with expertise in tumor
immunology and immunotherapy, Dr. Suarez-Almazor, Professor of Rheumatology and Clinical Immunology, Dr. Susan
Peterson, Professor in Behavioral Science and Director of the Assessment, Intervention and Measurement Facility, and Dr.
Sanjay Shete, Chief of Behavioral and Social Statistics. MDACC, a leading center in cutting edge of cancer research, care,
and prevention, is an excellent training environment for Dr. Abdelwahab.
项目总结:免疫检查点抑制剂(ICIs)已经显著地改变了黑色素瘤的治疗
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Noha Abdelwahab Hassan Ali Hassan其他文献
Noha Abdelwahab Hassan Ali Hassan的其他文献
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{{ truncateString('Noha Abdelwahab Hassan Ali Hassan', 18)}}的其他基金
Immune-Related Adverse Events in Melanoma Patients Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
接受辅助免疫检查点抑制剂治疗的黑色素瘤患者的免疫相关不良事件
- 批准号:
10664973 - 财政年份:2021
- 资助金额:
$ 11.39万 - 项目类别:
Immune-Related Adverse Events in Melanoma Patients Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
接受辅助免疫检查点抑制剂治疗的黑色素瘤患者的免疫相关不良事件
- 批准号:
10471406 - 财政年份:2021
- 资助金额:
$ 11.39万 - 项目类别:
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