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Title: Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience

Abstract

Purpose: To evaluate the severity of cetuximab-induced skin rash and its correlation with clinical outcome and late skin toxicity in patients with head and neck squamous cell carcinoma treated with chemoradiation therapy and cetuximab. Methods and Materials: Analysis included patients who received loading dose and ≥1 cetuximab dose concurrent with definitive chemoradiation therapy (70 Gy + cisplatin) or postoperative chemoradiation therapy (60-66 Gy + docetaxel or cisplatin). Results: Six hundred two patients were analyzed; 383 (63.6%) developed grade 2 to 4 cetuximab rash. Patients manifesting grade 2 to 4 rash had younger age (P<.001), fewer pack-years smoking history (P<.001), were more likely to be males (P=.04), and had p16-negative (P=.04) oropharyngeal tumors (P=.003). In univariate analysis, grade 2 to 4 rash was associated with better overall survival (hazard ratio [HR] 0.58, P<.001) and progression-free survival (HR 0.75, P=.02), and reduced distant metastasis rate (HR 0.61, P=.03), but not local-regional failure (HR 0.79, P=.16) relative to grade 0 to 1 rash. In multivariable analysis, HRs for overall survival, progression-free survival, distant metastasis, and local-regional failure were, respectively, 0.68 (P=.008), 0.85 (P=.21), 0.64 (P=.06), and 0.89 (P=.48). Grade ≥2 rash was associated with improved survival in p16-negative patients (HR 0.28 [95% confidence interval 0.11-0.74]) but not in p16-positive patients (HRmore » 1.10 [0.42-2.89]) (P=.05 for interaction). Twenty-five percent of patients with grade 2 to 4 acute in-field radiation dermatitis experienced grade 2 to 4 late skin fibrosis, versus 14% of patients with grade 0 to 1 acute in-field radiation dermatitis (P=.002). Conclusion: Grade 2 to 4 cetuximab rash was associated with better survival, possibly due to reduction of distant metastasis. This observation was noted mainly in p16-negative patients. Grade 2 to 4 acute in-field radiation dermatitis was associated with higher rate of late grade 2 to 4 skin fibrosis.« less

Authors:
 [1];  [2];  [3];  [1];  [4];  [5];  [6];  [4];  [7];  [8];  [9];  [10];  [11];  [2];  [12]
  1. Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States)
  2. NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States)
  3. University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin (United States)
  4. University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
  5. H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (United States)
  6. Radiological Associates of Sacramento, Sacramento, California (United States)
  7. Virginia Mason Medical Center, Seattle, Washington (United States)
  8. Mayo Clinic, Rochester, Minnesota (United States)
  9. University of Colorado Comprehensive Cancer Center, Denver, Colorado (United States)
  10. McGill University, Montreal, Quebec (Canada)
  11. University of Alabama at Birmingham, Birmingham, Alabama (United States)
  12. Stanford University Medical Center, Stanford, California (United States)
Publication Date:
OSTI Identifier:
22648753
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 95; Journal Issue: 5; Other Information: Copyright (c) 2016 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CHEMOTHERAPY; CORRELATIONS; DERMATITIS; GY RANGE 10-100; HEAD; NECK; NEOPLASMS; PATIENTS; RADIOTHERAPY; SKIN

Citation Formats

Bar-Ad, Voichita, E-mail: voichita.bar-ad@jefferson.edu, Zhang, Qiang, Harari, Paul M., Axelrod, Rita, Rosenthal, David I., Trotti, Andy, Jones, Christopher U., Garden, Adam S., Song, Guobin, Foote, Robert L., Raben, David, Shenouda, George, Spencer, Sharon A., Harris, Jonathan, and Le, Quynh-Thu. Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience. United States: N. p., 2016. Web. doi:10.1016/J.IJROBP.2016.03.011.
Bar-Ad, Voichita, E-mail: voichita.bar-ad@jefferson.edu, Zhang, Qiang, Harari, Paul M., Axelrod, Rita, Rosenthal, David I., Trotti, Andy, Jones, Christopher U., Garden, Adam S., Song, Guobin, Foote, Robert L., Raben, David, Shenouda, George, Spencer, Sharon A., Harris, Jonathan, & Le, Quynh-Thu. Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience. United States. doi:10.1016/J.IJROBP.2016.03.011.
Bar-Ad, Voichita, E-mail: voichita.bar-ad@jefferson.edu, Zhang, Qiang, Harari, Paul M., Axelrod, Rita, Rosenthal, David I., Trotti, Andy, Jones, Christopher U., Garden, Adam S., Song, Guobin, Foote, Robert L., Raben, David, Shenouda, George, Spencer, Sharon A., Harris, Jonathan, and Le, Quynh-Thu. Mon . "Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience". United States. doi:10.1016/J.IJROBP.2016.03.011.
@article{osti_22648753,
title = {Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience},
author = {Bar-Ad, Voichita, E-mail: voichita.bar-ad@jefferson.edu and Zhang, Qiang and Harari, Paul M. and Axelrod, Rita and Rosenthal, David I. and Trotti, Andy and Jones, Christopher U. and Garden, Adam S. and Song, Guobin and Foote, Robert L. and Raben, David and Shenouda, George and Spencer, Sharon A. and Harris, Jonathan and Le, Quynh-Thu},
abstractNote = {Purpose: To evaluate the severity of cetuximab-induced skin rash and its correlation with clinical outcome and late skin toxicity in patients with head and neck squamous cell carcinoma treated with chemoradiation therapy and cetuximab. Methods and Materials: Analysis included patients who received loading dose and ≥1 cetuximab dose concurrent with definitive chemoradiation therapy (70 Gy + cisplatin) or postoperative chemoradiation therapy (60-66 Gy + docetaxel or cisplatin). Results: Six hundred two patients were analyzed; 383 (63.6%) developed grade 2 to 4 cetuximab rash. Patients manifesting grade 2 to 4 rash had younger age (P<.001), fewer pack-years smoking history (P<.001), were more likely to be males (P=.04), and had p16-negative (P=.04) oropharyngeal tumors (P=.003). In univariate analysis, grade 2 to 4 rash was associated with better overall survival (hazard ratio [HR] 0.58, P<.001) and progression-free survival (HR 0.75, P=.02), and reduced distant metastasis rate (HR 0.61, P=.03), but not local-regional failure (HR 0.79, P=.16) relative to grade 0 to 1 rash. In multivariable analysis, HRs for overall survival, progression-free survival, distant metastasis, and local-regional failure were, respectively, 0.68 (P=.008), 0.85 (P=.21), 0.64 (P=.06), and 0.89 (P=.48). Grade ≥2 rash was associated with improved survival in p16-negative patients (HR 0.28 [95% confidence interval 0.11-0.74]) but not in p16-positive patients (HR 1.10 [0.42-2.89]) (P=.05 for interaction). Twenty-five percent of patients with grade 2 to 4 acute in-field radiation dermatitis experienced grade 2 to 4 late skin fibrosis, versus 14% of patients with grade 0 to 1 acute in-field radiation dermatitis (P=.002). Conclusion: Grade 2 to 4 cetuximab rash was associated with better survival, possibly due to reduction of distant metastasis. This observation was noted mainly in p16-negative patients. Grade 2 to 4 acute in-field radiation dermatitis was associated with higher rate of late grade 2 to 4 skin fibrosis.},
doi = {10.1016/J.IJROBP.2016.03.011},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 95,
place = {United States},
year = {Mon Aug 01 00:00:00 EDT 2016},
month = {Mon Aug 01 00:00:00 EDT 2016}
}