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Title: 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)

Abstract

Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5-0.7, moderate; and >0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash,more » redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.« less

Authors:
 [1];  [2];  [3];  [2];  [4];  [5];  [6];  [7];  [2];  [1];  [1]
  1. Department of Radiation Oncology, Mayo Clinic, Rochester, MN (United States)
  2. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN (United States)
  3. Minneapolis Radiation Oncology, P.A., Minneapolis, MN (United States)
  4. Upstate Carolina CCOP, Spartanburg, SC (United States)
  5. Iowa Oncology Research Association CCOP, Des Moines, IA (United States)
  6. Wichita Community Clinical Oncology Program, Wichita, KS (United States)
  7. Department of Oncology, Mayo Clinic, Rochester, MN (United States)
Publication Date:
OSTI Identifier:
21587747
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 81; Journal Issue: 2; Other Information: DOI: 10.1016/j.ijrobp.2010.05.065; PII: S0360-3016(10)00816-3; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CLINICAL TRIALS; DERMATITIS; ERYTHEMA; MAMMARY GLANDS; NEOPLASMS; PATIENTS; RADIOTHERAPY; SKIN; TOXICITY; BODY; DISEASES; GLANDS; MEDICINE; NUCLEAR MEDICINE; ORGANS; RADIOLOGY; SKIN DISEASES; SYMPTOMS; TESTING; THERAPY

Citation Formats

Neben-Wittich, Michelle A., Atherton, Pamela J., Schwartz, David J., Sloan, Jeff A., Griffin, Patricia C., Deming, Richard L., Anders, Jon C., Loprinzi, Charles L., Burger, Kelli N., Martenson, James A., and Miller, Robert C., E-mail: miller.robert@mayo.edu. 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). United States: N. p., 2011. Web. doi:10.1016/j.ijrobp.2010.05.065.
Neben-Wittich, Michelle A., Atherton, Pamela J., Schwartz, David J., Sloan, Jeff A., Griffin, Patricia C., Deming, Richard L., Anders, Jon C., Loprinzi, Charles L., Burger, Kelli N., Martenson, James A., & Miller, Robert C., E-mail: miller.robert@mayo.edu. 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). United States. doi:10.1016/j.ijrobp.2010.05.065.
Neben-Wittich, Michelle A., Atherton, Pamela J., Schwartz, David J., Sloan, Jeff A., Griffin, Patricia C., Deming, Richard L., Anders, Jon C., Loprinzi, Charles L., Burger, Kelli N., Martenson, James A., and Miller, Robert C., E-mail: miller.robert@mayo.edu. Sat . "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)". United States. doi:10.1016/j.ijrobp.2010.05.065.
@article{osti_21587747,
title = {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)},
author = {Neben-Wittich, Michelle A. and Atherton, Pamela J. and Schwartz, David J. and Sloan, Jeff A. and Griffin, Patricia C. and Deming, Richard L. and Anders, Jon C. and Loprinzi, Charles L. and Burger, Kelli N. and Martenson, James A. and Miller, Robert C., E-mail: miller.robert@mayo.edu},
abstractNote = {Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5-0.7, moderate; and >0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.},
doi = {10.1016/j.ijrobp.2010.05.065},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 2,
volume = 81,
place = {United States},
year = {2011},
month = {10}
}