Supportive Care in Cancer

, Volume 20, Issue 8, pp 1729–1735 | Cite as

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

  • Pamela J. AthertonEmail author
  • Kelli N. Burger
  • Charles L. Loprinzi
  • Michelle A. Neben Wittich
  • Robert C. Miller
  • Aminah Jatoi
  • Jeff A. Sloan
Original Article



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.


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.


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.


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.


Skindex-16 CTCAE Dermatitis Patient-reported outcomes Cytotoxic treatment-induced dermatitis 


Conflict of interest

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


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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Pamela J. Atherton
    • 1
    Email author
  • Kelli N. Burger
    • 1
  • Charles L. Loprinzi
    • 2
  • Michelle A. Neben Wittich
    • 3
  • Robert C. Miller
    • 3
  • Aminah Jatoi
    • 2
  • Jeff A. Sloan
    • 1
  1. 1.Division of Biomedical Statistics and InformaticsMayo ClinicRochesterUSA
  2. 2.Medical OncologyMayo ClinicRochesterUSA
  3. 3.Radiation OncologyMayo ClinicRochesterUSA

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