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Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993)

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Abstract

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.

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Conflict of interest

There are no conflicts of interest to disclose for any of the authors.

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Authors and Affiliations

  1. Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA

    Pamela J. Atherton, Kelli N. Burger & Jeff A. Sloan

  2. Medical Oncology, Mayo Clinic, Rochester, MN, USA

    Charles L. Loprinzi & Aminah Jatoi

  3. Radiation Oncology, Mayo Clinic, Rochester, MN, USA

    Michelle A. Neben Wittich & Robert C. Miller

Authors
  1. Pamela J. Atherton
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  2. Kelli N. Burger
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  3. Charles L. Loprinzi
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  4. Michelle A. Neben Wittich
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  5. Robert C. Miller
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  6. Aminah Jatoi
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  7. Jeff A. Sloan
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Corresponding author

Correspondence to Pamela J. Atherton.

Additional information

This work was funded by the National Cancer Institution Community Clinical Oncology Program (CCOP) grant CA37404 and the North Central Cancer Treatment Group (NCCTG) grant (CA25224).

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Atherton, P.J., Burger, K.N., Loprinzi, C.L. et al. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer 20, 1729–1735 (2012). https://doi.org/10.1007/s00520-011-1266-x

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  • DOI: https://doi.org/10.1007/s00520-011-1266-x

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