Validation of Photograph-Based Toxicity Score for Topical 5-Fluorouracil Cream Application. Issue 5 (September 2016)

• Record Type: Journal Article
• Authors: Pomerantz, Hyemin; Korgavkar, Kaveri; Lee, Kachiu C.; Lew, Robert; Weinstock, Martin A.
• Is Part Of: Journal of cutaneous medicine and surgery. Volume 20:Issue 5(2016:Sep./Oct.)
• Page Start: 458
• Page End: 466
• Publication Date: 2016-09
• Subjects: 5-fluorouracil -- validity study -- skin cancer -- topical medication; Dermatology -- Periodicals; Skin -- Diseases -- Treatment -- Periodicals; Skin -- Surgery -- Periodicals; Dermatology -- Canada -- Periodicals; Skin -- Diseases -- Treatment -- Canada -- Periodicals; Skin -- Surgery -- Canada -- Periodicals; 616.5005
• DOI: 10.1177/1203475416643952
• Languages: English
• ISSNs: 1203-4754

Abstract

Background: An objective tool quantifying the toxicity of 5-fluorouracil (5-FU) from photographs was recently reported, and its reliability was confirmed. Objective: The aim of this study was to validate the photograph-based toxicity score. Methods: Photograph-based toxicity scores of participants assigned to the 5-FU arm of a randomized placebo-controlled trial were tested for correlations with their patient-reported symptom scores and baseline characteristics. Results: Each pair of individual and overall scores of patient-reported symptoms and photograph-based toxicity was correlated at 2 and 4 weeks (correlation coefficient range, 0.34-0.95; P < .001 for all). Older age, more actinic keratoses, previous topical 5-FU use, and more keratinocyte carcinomas on the face and ears in the previous 5 years were correlated with increased 5-FU toxicity at 2 weeks ( P < .05). An increase in the total number of 5-FU applications during the trial was correlated with less severe toxicity at 2 weeks ( P < .001), but with increased toxicity at 4 weeks ( P < .001). Conclusion: This study provides evidence for construct validity of the photograph-based 5-FU toxicity score. The tool can be used to objectively measure 5-FU toxicity in clinical or research setting, and it can be a prototype for toxicity measurements of other topical medications.