BACKGROUND: Historically, skin toxicity has been assessed 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 perceptions of toxicity. This study was designed to compare information provided by these two measures. METHODS: Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) having rash prevention as the primary objective. All used the Skindex-16 and CTCAE at baseline, weekly during treatment and during a minimum 2-week follow-up period. Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores. RESULTS: Four hundred and twelve individual patients provided data (median age, 61; 134 male). Patients' Skindex-16 score results show a 0.9 overall mean (range 0-6 with 6 being worse symptoms), a 0.4 baseline mean (range, 0-4.3) and a 1.3 end-of-treatment mean (range, 0-5.9). Ninety-three, 142 and 177 patients experienced a grade 0, 1 and 2+ CTCAE skin toxicity, respectively. Baseline Skindex-16 scores had relatively low correlation with CTCAE grades. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 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 score and r = 0.55 for the symptom subscale. CONCLUSIONS: The data reported support the decision to include both measures in a clinical trial to assess the patient experience, as each measure may specifically target varying symptoms and intensities.
BACKGROUND: Historically, skin toxicity has been assessed 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 perceptions of toxicity. This study was designed to compare information provided by these two measures. METHODS: Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) having rash prevention as the primary objective. All used the Skindex-16 and CTCAE at baseline, weekly during treatment and during a minimum 2-week follow-up period. Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores. RESULTS: Four hundred and twelve individual patients provided data (median age, 61; 134 male). Patients' Skindex-16 score results show a 0.9 overall mean (range 0-6 with 6 being worse symptoms), a 0.4 baseline mean (range, 0-4.3) and a 1.3 end-of-treatment mean (range, 0-5.9). Ninety-three, 142 and 177 patients experienced a grade 0, 1 and 2+ CTCAE skin toxicity, respectively. Baseline Skindex-16 scores had relatively low correlation with CTCAE grades. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 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 score and r = 0.55 for the symptom subscale. CONCLUSIONS: The data reported support the decision to include both measures in a clinical trial to assess the patient experience, as each measure may specifically target varying symptoms and intensities.
Authors: Michelle A Neben-Wittich; Pamela J Atherton; David J Schwartz; Jeff A Sloan; Patricia C Griffin; Richard L Deming; Jon C Anders; Charles L Loprinzi; Kelli N Burger; James A Martenson; Robert C Miller Journal: Int J Radiat Oncol Biol Phys Date: 2010-10-01 Impact factor: 7.038
Authors: K K Fu; T F Pajak; A Trotti; C U Jones; S A Spencer; T L Phillips; A S Garden; J A Ridge; J S Cooper; K K Ang Journal: Int J Radiat Oncol Biol Phys Date: 2000-08-01 Impact factor: 7.038
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Authors: Thomas M Atkinson; Sean J Ryan; Antonia V Bennett; Angela M Stover; Rebecca M Saracino; Lauren J Rogak; Sarah T Jewell; Konstantina Matsoukas; Yuelin Li; Ethan Basch Journal: Support Care Cancer Date: 2016-06-03 Impact factor: 3.603
Authors: Terence T Sio; Pamela J Atherton; Brandon J Birckhead; David J Schwartz; Jeff A Sloan; Drew K Seisler; James A Martenson; Charles L Loprinzi; Patricia C Griffin; Roscoe F Morton; Jon C Anders; Thomas J Stoffel; Robert E Haselow; Rex B Mowat; Michelle A Neben Wittich; James D Bearden; Robert C Miller Journal: Support Care Cancer Date: 2016-04-14 Impact factor: 3.603
Authors: A González-Sanchís; A Vicedo-González; L Brualla-González; J C Gordo-Partearroyo; R Iñigo-Valdenebro; J Sánchez-Carazo; D Granero-Cabañero; J Roselló-Ferrando; J López-Torrecilla Journal: Clin Transl Oncol Date: 2014-03-19 Impact factor: 3.405