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Palliating EGFR Inhibitor Rash in African American and Other Cancer Patients

Award Number: R01CA207183
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2017
PERIOD OF PERFORMANCE END DATE: 09/30/2024

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Palliating EGFR Inhibitor Rash in African American and Other Cancer Patients - ABSTRACT Epidermal growth factor receptor (EGFR) inhibitors comprise a commonly prescribed class of drug that improves survival in patients with a variety of malignancies. Rash, particularly on the face, is the most common adverse event and occurs in 50-90% of patients, is severe in 10-20% of patients, lacks effective palliative options, and sometimes requires stopping cancer therapy. We have published qualitative research from patients who developed this rash and learned that it leads to cutaneous pain, psychological distress, and social isolation. One patient stated, My face looks so bad that if I go see my friends, they say, 'What happened to you.' I am self-conscious about that. Another commented, “I just told them they would be better off just calling me, don't come visit.” Another described, I can feel the itch and burn all over. Some investigators have suggested that African American patients do not suffer these symptoms. Here, we hypothesize that they do, that their pigmented skin might camoflage the rash, but that this rash still causes them physical and psychological pain. Building on our data (a 933-patient epidemiologic study that shows rash is worse in men; pilot clinical trial data that show benefit with a topical anti-androgen; and an androgen-dependent gene profile from skin biopsies from patients with EGFR inhibitor rash) and on data from others (some melanocytes overexpress androgens and androgen receptors), we hypothesize this rash is androgen-driven and that the topical antiandrogen, ketoconazole, palliates it in all patients, including African American cancer patients. In Aim #1, we will interview African American patients who have developed this rash and will use novel qualitative methods to probe into their hypothesized psychological and cutaneous distress. In Aim #2, we will conduct a randomized, double-blinded, placebo-controlled trial with ketoconazole (a topical anti- androgen) to determine whether this agent palliates rash within a racially diverse cohort and to explore whether it does so by modulating androgen-dependent genes, as alluded to above. The long-term goal of this line of investigation is to reduce suffering and improve the quality of life of all patients -- including African American patients -- who suffer from EGFR inhibitor-induced rash.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$205,314 )
2025	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	001	6	1/29/2025	NON-COMPETING CONTINUATION	$240,700
2025	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	002	6	1/29/2025	NON-COMPETING CONTINUATION	-$205,314
2025	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	6	1/29/2025	NON-COMPETING CONTINUATION	-$240,700
														Subtotal = -$205,314

Issue Date FY: 2024 ( Subtotal = -$240,700 )
2024	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	002	6	8/8/2024	NON-COMPETING CONTINUATION	$0
2024	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	001	6	8/5/2024	NON-COMPETING CONTINUATION	-$1
2024	2022	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	5	8/5/2024	NON-COMPETING CONTINUATION	-$240,699
														Subtotal = -$240,700

Issue Date FY: 2023 ( Subtotal = $1 )
2023	2023	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	6	7/7/2023	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2022 ( Subtotal = $353,510 )
2022	2022	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	5	3/31/2022	NON-COMPETING CONTINUATION	$353,510
														Subtotal = $353,510

Issue Date FY: 2021 ( Subtotal = $365,812 )
2021	2021	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	4	3/31/2021	NON-COMPETING CONTINUATION	$365,812
														Subtotal = $365,812

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	3	6/23/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1 )
2019	2019	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	3	5/23/2019	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2018 ( Subtotal = $377,127 )
2018	2018	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	2	4/19/2018	NON-COMPETING CONTINUATION	$377,127
														Subtotal = $377,127

Issue Date FY: 2017 ( Subtotal = $385,278 )
2017	2017	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cancer Treatment Research	000	1	3/20/2017	NEW	$385,278
														Subtotal = $385,278

Grand Total All Awards = $1,035,716

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Palliating EGFR Inhibitor Rash in African American and Other Cancer Patients

Award Number: R01CA207183

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2017

PERIOD OF PERFORMANCE END DATE: 09/30/2024

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