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Principal Investigator: THERESA E HAHN
Organization: ROSWELL PARK CANCER INSTITUTE CORP
Fiscal Year: 2024
Award: $735,428
Funding agency: National Cancer Institute
ABSTRACT
Immune checkpoint inhibitors (ICIs) have markedly transformed the therapeutic landscape for many types of
advanced malignancies over the past decade. A sizable proportion of patients with advanced cancer derive
durable benefits from ICIs and achieve longer periods of progression-free survival or remission than previously
possible. Yet we still know little about the determinants of durable response to ICI treatment and the symptom
trajectory and survivorship needs of this growing patient population. We thus propose a multi-institute study
with two sister cohorts of patients living with advanced cancers. First, a retrospective EHR data-only cohort will
include 8,860 patients with advanced disease, inclusive of all cancer types, who have been treated with ICI-
based immunotherapy in 2014-2022. This large cohort will allow us to identify and study durable responders to
ICIs, defined as patients who achieve partial or complete response to ICI treatment and live at least one year
after ICI treatment initiation. Second, a prospective cohort will enroll and actively follow an estimated 1,200
patients with durable response to ICI treatment for advanced lung cancer, kidney cancer, and melanoma, the
three most common cancers treated with ICIs. Clinical and patient-reported outcome data will be collected at
baseline and every 6 months during follow up. This prospective cohort will allow us to study long-term survival
and physical and psychosocial symptom trajectories in patients with durable response to ICIs, and to identify
clinical and modifiable behavioral factors predictive of long-term survival and common side effects of ICI
treatment. The predictors identified in these analyses will be independently validated in the DiRECT Cohort, a
large ongoing study of racial disparities in ICI treatment led by the study team. Our Specific Aims are:
1. In the retrospective EHR data-only cohort, 1a) Determine the proportion of patients who had durable
response to ICI treatment (partial/complete response and alive ≥1 year since initial ICI treatment) and chart
their survival trajectory; 1b) Identify clinical predictors for durable response to ICI treatment; 1c). In the
independent DiRECT Cohort, validate the clinical predictors for durable response to ICI treatment.
2. In the prospective cohort, 2a) Identify long-term survival and longitudinal trajectories of patients' physical
and psychosocial symptoms after ICI treatment; 2b) Investigate the relationships of long-term survival and
common side effects from ICI treatment with multidimensional predictors; 2c). In the independent DiRECT
Cohort, validate the predictors for survival and common side effects in patients with durable response.
Findings from our study will provide much-needed data that can inform new evidence-based intervention
strategies as the next step to optimize survivorship care and extend and improve quality of life for the growing
population of survivors living after a diagnosis of advanced cancer due to ICI treatment.
Terms: <Active Follow-up><Address><Adopted><Advanced Cancer><Advanced Malignant Neoplasm><Age><B7-H1><B7H1><Behavioral><Biological Markers><Body Composition><CD274><California><Cancer Center><Cancer Treatment><Cancers><Caring><Checkpoint inhibitor><Clinical><Companions><Comprehensive Cancer Center><Data><Diagnosis><Dimensions><Disease><Disease remission><Disorder><Disseminated Malignant Neoplasm><Enrollment><Ethnic Origin><Ethnicity><Evidence based intervention><FDA approved><Genetic Alteration><Genetic Change><Genetic defect><Health behavior><Immune checkpoint inhibitor><Immune mediated therapy><Immune response><Immunological response><Immunologically Directed Therapy><Immunotherapeutic agent><Immunotherapy><In complete remission><Inferior><Infusion><Infusion procedures><Intervention><Intervention Strategies><Kidney Cancer><Kidney Carcinoma><Learning><Length><Life Style><Lifestyle><Longitudinal Studies><Maintenance Therapy><Malignant Melanoma><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Lung><Malignant neoplasm of lung><Melanoma><Melanoma Metastasis><Metastatic Cancer><Metastatic Malignant Neoplasm><Metastatic Melanoma><Modeling><Mutation><PD-L1><PDL-1><PDL1><Patient Outcomes Assessments><Patient Reported Measures><Patient Reported Outcomes><Patients><Phase><Population><Predictive Factor><Preparation><Prognosis><Programmed Cell Death 1 Ligand 1><Programmed Death Ligand 1><Progression-Free Survivals><Prospective cohort><Psychosocial Factor><Pulmonary Cancer><Pulmonary malignant Neoplasm><QOL><Quality of life><Race><Races><Remission><Renal Cancer><Renal Carcinoma><Sister><Survivors><Symptoms><Therapeutic><Universities><Unresectable><Yervoy><active followup><advanced disease><advanced illness><ages><anti-cancer immunotherapy><anti-cancer therapy><anticancer immunotherapy><behavioral health><bio-markers><biologic marker><biomarker><cancer diagnosis><cancer immunotherapy><cancer survivor care><cancer survivorship care><cancer therapy><cancer type><cancer-directed therapy><check point immunotherapy><check point inhibitor therapy><check point inhibitory therapy><check point therapy><checkpoint immunotherapy><checkpoint inhibitor therapy><checkpoint inhibitory therapy><checkpoint therapy><clinical practice><clinical predictors><cohort><community academic collaboration><community academic partnership><community academic research partnership><community university partnership><complete response><demographics><design><designing><disparities in race><disparity due to race><enroll><follow up><follow-up><followed up><followup><genome mutation><health related behavior><host response><immune check point inhibitor><immune check point therapy><immune checkpoint therapy><immune drugs><immune system response><immune therapeutic approach><immune therapeutic interventions><immune therapeutic regimens><immune therapeutic strategy><immune therapy><immune-based cancer therapies><immune-based therapeutics><immune-based therapies><immune-based treatments><immuno therapy><immunologic therapeutics><immunoresponse><immunotherapeutics><immunotherapy agent><immunotherapy for cancer><immunotherapy of cancer><improved><inequality due to race><inequity due to race><infusions><interventional strategy><ipilimumab><long-term study><longitudinal outcome studies><longterm study><lung cancer><malignancy><neoplasm/cancer><partial response><patient population><predictive biomarkers><predictive marker><predictive molecular biomarker><preparations><programmed cell death ligand 1><programmed cell death protein ligand 1><protein death-ligand 1><psychosocial><psychosocial variables><psychosocial well-being><psychosocial wellbeing><psychosocial wellness><race based disparity><race based inequality><race based inequity><race disparity><race related disparity><race related inequality><race related inequity><racial><racial background><racial disparity><racial inequality><racial inequity><racial origin><racially unequal><response><sex><side effect><survival prediction><survivorship><tumor>