Project Details
Description
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.
Status | Finished |
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Effective start/end date | 4/1/17 → 3/31/24 |
Funding
- National Cancer Institute: $365,812.00
- National Cancer Institute: $385,278.00
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