Using the Skindex-16 and CTCAE to assess rash symptoms: Results of a pooled-analysis (N0993).

Abstract

9018 Background: Historically, symptoms of rash have been measured in prospective clinical trials using the clinician- reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The patient-reported Skindex-16 measures symptoms and patient perceptions of the skin toxicity. This study was designed to compare and contrast the information provided by these two methods. Methods: Data were compiled from 3 North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) where patients received medication for rash prevention during cancer treatment. All used the Skindex-16 and CTCAE at baseline, weekly during treatment, and weekly during a minimum 2 week follow-up period. Procedures, including the Pearson correlation as primary, were utilized to determine relationships between AE grades and Skindex-16 scores. Results: 412 unique patients provided data (median age 61, 134 male). Patients' Skindex-16 total score results show an overall mean of 0.9 (range 0-6 with 6 being worse symptoms), baseline mean of 0.4 (range 0-4.3) and end of treatment mean of 1.3 (range 0-5.9). 93, 142 and 177 patients experienced a grade 0, 1 and 2+ skin toxicity, respectively, as measured by the CTCAE. Baseline Skindex-16 scores had very low Pearson correlation with CTCAE grades. Overall, the correlation of rash grade with the Skindex-16 scores ranged from r = 0.49, with the function subscale, to r = 0.63, with the symptom subscale. The highest correlations of the maximum grade of any dermatological AE with the Skindex-16 were r = 0.48, for the total Skindex-16 score, and r = 0.55, for the symptom subscale. Conclusions: The Skindex-16 and the CTCAE measure different aspects of skin toxicity and/or morbidity. This supports the inclusion of both measures in a clinical trial to assess the patient clinical trial experience. No significant financial relationships to disclose.