Palliating EGFR Inhibitor Rash in African American and Other Cancer Patients

缓解非裔美国人和其他癌症患者的 EGFR 抑制剂皮疹

• 批准号: 10381450
• 负责人: Aminah Jatoi
• 金额: $ 35.35万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10381450
• 关键词: Adverse event; African American; Androgen Antagonists; Androgen Receptor; Androgens; Antineoplastic Agents; Biopsy; Cancer Patient; Cetuximab; Clinical Data; Clinical Trials; Colorectal Cancer; Conscious; Cutaneous; Data; Development; Distress; Double-Blind Method; Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor; Exanthema; Face; Feasibility Studies; Friends; Genes; Goals; Head and Neck Cancer; Hormones; Hospitalization; Interview; Investigation; Ketoconazole; Lead; Learning; Life; Limb structure; Malignant Neoplasms; Malignant neoplasm of lung; Mediating; Methodology; Morbidity - disease rate; National Comprehensive Cancer Network; Pain; Patients; Pharmaceutical Preparations; Pigments; Pruritus; Published Comment; Publishing; Qualitative Methods; Qualitative Research; Quality of life; Race; Randomized; Reporting; Research Personnel; Risk; Skin; Social isolation; Symptoms; Testing; Time; United States Food and Drug Administration; Visit; androgen sensitive; cancer therapy; cohort; double-blind placebo controlled trial; emotional distress; epidemiology study; ethnic difference; experience; high risk; improved; mRNA sequencing; male; melanocyte; men; novel; novel therapeutics; overexpression; palliate; palliative; patient oriented; psychologic; psychological distress; psychosocial; racial diversity; randomized placebo controlled study; side effect; social

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.

摘要