R01CA260689

(PQ3) Addressing Cancer Treatment Disparities for Persons with HIV - Project Summary/Abstract

The introduction of combination antiretroviral therapy (ART) has led to a dramatic decline in AIDS-associated mortality. However, as persons with HIV (PWH) age, mortality from non-AIDS-defining cancer (NADC) continues to increase and is now the leading cause of death for PWH.

Recent studies have demonstrated persistent disparities in both initiation of cancer therapy and survival among PWH and cancer compared with the general population. This may be due in part to medical and radiation oncologists' concerns regarding the safety and efficacy of cancer treatment for PWH. Alternatively, it is possible that chemotherapy with radiation therapy (CRT) and radiation therapy (RT) alone may be less effective in PWH or associated with greater toxicity.

It is well established that positive cancer outcomes are dependent on successful navigation of all steps in the cancer care delivery process, including: timely treatment initiation, treatment completion, and treatment safety, defined by avoidance of serious adverse events (SAEs). It is also critical to evaluate the ongoing health needs of cancer survivors with HIV, including the risk of long-term chronic health conditions (i.e., late adverse effects) after cancer treatment.

Prior studies have evaluated cancer treatment initiation rates for certain cancers, however, there have been no published studies that have comprehensively evaluated differences in outcomes at other key steps in the cancer care delivery process for PWH compared with people without HIV (HIV-), nor have there been studies that have evaluated patient- and provider-factors that might contribute to disparities at each step.

We propose the following specific aims which will address these critical knowledge gaps for the four most common NADCs in PWH treated with CRT/RT (anal, head and neck, lung, or prostate cancer):

Aim 1: To evaluate differences in the timing of cancer treatment initiation between PWH and matched HIV- with cancer, and risk factors for delayed treatment in PWH.

Aim 2: To evaluate disparities in short-term SAEs and cancer treatment completions between PWH and matched HIV- patients who initiated CRT/RT.

Aim 3: To evaluate the long-term risk of mortality and cancer recurrence comparing PWH with cancer and matched HIV- patients.

Aim 4: To compare risk of chronic health conditions among PWH with cancer, with (a) HIV- with cancer and (b) PWH without cancer.

In addition to evaluating differences in outcomes between PWH and HIV- patients with cancer, study aims will also evaluate the impacts of key potential risk factors, including: ART regimens, immunosuppression, and treatment dosage and completion, which may be associated with CRT/RT outcomes.

This observational cohort study will identify >3,000 PWH diagnosed with cancer, 1:1 matched HIV- persons with the same cancers, and 4:1 matched PWH without cancer who have received care from the Veteran's Administration or Kaiser Permanente, the two largest single-payer integrated healthcare systems in the United States.

Study findings will provide data to provide targets for cancer care delivery and treatment interventions, and inform HIV-specific cancer treatment guidelines to improve cancer survival among PWH.

Kaiser Foundation Hospitals

TO DEVELOP THE MEANS TO CURE AS MANY CANCER PATIENTS AS POSSIBLE AND TO CONTROL THE DISEASE IN THOSE PATIENTS WHO ARE NOT CURED. CANCER TREATMENT RESEARCH INCLUDES THE DEVELOPMENT AND EVALUATION OF IMPROVED METHODS OF CANCER TREATMENT THROUGH THE SUPPORT AND PERFORMANCE OF BOTH FUNDAMENTAL AND APPLIED LABORATORY AND CLINICAL RESEARCH. RESEARCH IS SUPPORTED IN THE DISCOVERY, DEVELOPMENT, AND CLINICAL TESTING OF ALL MODES OF THERAPY INCLUDING: SURGERY, RADIOTHERAPY, CHEMOTHERAPY, AND BIOLOGICAL THERAPY INCLUDING MOLECULARLY TARGETED THERAPIES, BOTH INDIVIDUALLY AND IN COMBINATION. IN ADDITION, RESEARCH IS CARRIED OUT IN AREAS OF NUTRITIONAL SUPPORT, STEM CELL AND BONE MARROW TRANSPLANTATION, IMAGE GUIDED THERAPIES AND STUDIES TO REDUCE TOXICITY OF CYTOTOXIC THERAPIES, AND OTHER METHODS OF SUPPORTIVE CARE THAT MAY SUPPLEMENT AND ENHANCE PRIMARY TREATMENT. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.395 - Cancer Treatment Research

National Cancer Institute (NCI) [HHS - NIH]

Pleasanton, California 945882761 United States

Single Zip Code

Provocative Questions (PQs) in Cancer with an Underlying HIV Infection (R01 Clinical Trial Optional) (RFA-CA-19-032)

Amendment Since initial award the total obligations have increased 400% from $807,377 to $4,038,411.