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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

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.

Keywords

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

Notes

Conflict of interest

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

References

  1. 1.
    Hopewell JW (1990) The skin: its structure and response to ionizing radiation. Int J of Radiation Biol 57:751–773CrossRefGoogle Scholar
  2. 2.
    Fu KK, Pajak TF, Trotti A et al (2000) A radiation therapy oncology group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Rad Oncol Biol Phys 48:7–16CrossRefGoogle Scholar
  3. 3.
    Archambeau JO, Pezner R, Wasserman T (1995) Pathophysiology of irradiated skin and breast. Int J Rad Oncol Biol Phys 31:1171–1185CrossRefGoogle Scholar
  4. 4.
    Herbst RS, Maddox A-M, Rothenberg ML et al (2002) Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well tolerated and has activity in non-small cell lung cancer and other solid tumors: results of a phase I trial. J Clin Oncol 20:3815–3825PubMedCrossRefGoogle Scholar
  5. 5.
    Kris M, Natale RB, Herbst RS et al (2003) Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer. J Am Med Assoc 290:2149–2158CrossRefGoogle Scholar
  6. 6.
    Saltz LB, Meropol NJ, Loehrer PJ et al (2004) Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 22:1201–1208PubMedCrossRefGoogle Scholar
  7. 7.
    Cancer Therapy Evaluation Program NCI. Common Terminology Criteria for Adverse events (CTCAE). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed 02 August 2010
  8. 8.
    Lacouture ME, Maitland ML, Sagaert S et al (2010) A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity group. Support Care Cancer 18:509–522PubMedCrossRefGoogle Scholar
  9. 9.
    Huschka MM, Mandrekar SJ, Schaefer PL et al (2007) A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer 109(4):787–795PubMedCrossRefGoogle Scholar
  10. 10.
    Chren MM, Lasek RJ, Sahay AP et al (2001) Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg 5(2):105–110PubMedCrossRefGoogle Scholar
  11. 11.
    Huschka MM, Burger KN (2006) Does QOL provide the same information as toxicity data. Curr Probl Cancer 30(6):244–254PubMedCrossRefGoogle Scholar
  12. 12.
    Basch E (2009) Patient-reported outcomes in drug safety evaluation. Ann Oncol 20:1905–1906PubMedCrossRefGoogle Scholar
  13. 13.
    Parliament MB, Danjoux CE, Clayton T (1985) Is cancer treatment toxicity accurately reported? Int J Rad Oncol Biol Phys 11(3):603–608CrossRefGoogle Scholar
  14. 14.
    Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD, Atherton PJ, Loprinzi CL, Martenson JA (2011) Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase 3 double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys 79:1460–1466PubMedCrossRefGoogle Scholar
  15. 15.
    Jatoi A, Rowland KM, Sloan JA, Gross HM, Fishkin PA, Kahanic SP, Novotny PJ, Schaefer PL, Johnson DB, Tschetter LK, Loprinzi CL (2008) Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the NCCTG (N03CB). Cancer 113:847–853PubMedCrossRefGoogle Scholar
  16. 16.
    Jatoi A (2007) Sunshine and rash: testing the role of sunscreen to prevent epidermal growth factor receptor inhibitor-induced rash. Support Cancer Therapy 4:198–202CrossRefGoogle Scholar
  17. 17.
    Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC (2011) Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys 81:397–402PubMedCrossRefGoogle Scholar
  18. 18.
    National Cancer Institute, Division of Cancer Control and Population Sciences. Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse events (PRO-CTCAE). http://outcomes.cancer.gov/tools/pro-ctcae_fact_sheet.pdf. Accessed August 2, 2010
  19. 19.
    Trotti A, Colevas AD, Setser A, Basch E (2007) Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 25(32):5121–5127PubMedCrossRefGoogle Scholar

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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