Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score
Abstract Acne‐like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double‐blind...
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doaj-fff0c41466f24d5cbeb88fb44afecf152020-11-25T02:20:47ZengWileyCancer Medicine2045-76342019-08-01894169417510.1002/cam4.2132Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo scoreMaria R. Gaiser0Sylvie Lorenzen1Kirsten Merx2Jörg Trojan3Janja Ocvirk4Thomas J. Ettrich5Salah‐Eddin Al‐Batran6Holger Schulz7Nils Homann8Hans‐Peter Feustel9Michael Schatz10Melanie Kripp11Nadine Schulte12Steffen Heeger13Soetkin Vlassak14Winfried Koch15Ralf‐Dieter Hofheinz16Department of Dermatology, Venereology and Allergology University Medical Center Mannheim, Ruprecht‐Karl University of Heidelberg Mannheim GermanyMedical Clinic III University of Munich Munich GermanyInterdisciplinary Tumor Center Mannheim University Medical Center Mannheim, Ruprecht‐Karl University of Heidelberg Mannheim GermanyMedical Clinic I University Hospital Frankfurt Frankfurt GermanyInstitute of Oncology Ljubljana SloveniaMedical Clinic I University Hospital Ulm Ulm GermanyInstitute of Clinical Cancer Research (IKF) at Nordwest Hospital UCT‐University Cancer Center Frankfurt GermanyOncological Practice Frechen GermanyMedical Clinic II Wolfsburg Wolfsburg GermanyHämatologisch‐Onkologische Praxis Speyer GermanyMedizinische Klinik II, ViDia Christliche Kliniken Karlsruhe Karlsruhe GermanyInterdisciplinary Tumor Center Mannheim University Medical Center Mannheim, Ruprecht‐Karl University of Heidelberg Mannheim GermanyInterdisciplinary Tumor Center Mannheim University Medical Center Mannheim, Ruprecht‐Karl University of Heidelberg Mannheim GermanyMannheim GermanyNeervelp BelgiumBDS Koch Schwetzingen GermanyInterdisciplinary Tumor Center Mannheim University Medical Center Mannheim, Ruprecht‐Karl University of Heidelberg Mannheim GermanyAbstract Acne‐like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double‐blind randomized phase II trial (EVITA) in patients with metastatic colorectal cancer receiving cetuximab. EVITA demonstrated a trend towards less severe skin rash in Reconval K1‐treated patients using the tripartite WoMo skin reaction grading score as a thorough tool for quantification of drug related skin reactions. This gender‐specific analysis of the EVITA trial evaluated the application of the WoMo score for assessment of epidermal growth factor receptor (EGFR)‐related skin toxicities according to treatment arm and gender. To show the robustness of results parametric and non‐parametric statistical analyses were conducted. All three parts of the WoMo score independently demonstrated the superiority of the treatment arm (Reconval K1) regarding a significant reduction in acneiform skin reactions in women. Men did not benefit from Reconval K1 cream at any time point in none of the WoMo score analyses. The treatment effect in women was confirmed by the use of skin rash categories based on the final WoMo overall score and mixed effect longitudinal multiple linear regression analysis. The WoMo score represents a sensitive tool for studies exploiting treatments against EGFR mediated acne‐like skin rash. Part C of the WoMo score seems to be sufficient for quantification of drug related skin toxicities in further studies. Standard WoMo skin reaction score values for future studies are provided.https://doi.org/10.1002/cam4.2132acneiform skin toxicityEGFR inhibitorwomenWoMo score |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Maria R. Gaiser Sylvie Lorenzen Kirsten Merx Jörg Trojan Janja Ocvirk Thomas J. Ettrich Salah‐Eddin Al‐Batran Holger Schulz Nils Homann Hans‐Peter Feustel Michael Schatz Melanie Kripp Nadine Schulte Steffen Heeger Soetkin Vlassak Winfried Koch Ralf‐Dieter Hofheinz |
spellingShingle |
Maria R. Gaiser Sylvie Lorenzen Kirsten Merx Jörg Trojan Janja Ocvirk Thomas J. Ettrich Salah‐Eddin Al‐Batran Holger Schulz Nils Homann Hans‐Peter Feustel Michael Schatz Melanie Kripp Nadine Schulte Steffen Heeger Soetkin Vlassak Winfried Koch Ralf‐Dieter Hofheinz Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score Cancer Medicine acneiform skin toxicity EGFR inhibitor women WoMo score |
author_facet |
Maria R. Gaiser Sylvie Lorenzen Kirsten Merx Jörg Trojan Janja Ocvirk Thomas J. Ettrich Salah‐Eddin Al‐Batran Holger Schulz Nils Homann Hans‐Peter Feustel Michael Schatz Melanie Kripp Nadine Schulte Steffen Heeger Soetkin Vlassak Winfried Koch Ralf‐Dieter Hofheinz |
author_sort |
Maria R. Gaiser |
title |
Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score |
title_short |
Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score |
title_full |
Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score |
title_fullStr |
Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score |
title_full_unstemmed |
Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score |
title_sort |
evaluation of egfr inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized evita trial: a thorough gender‐specific analysis using the womo score |
publisher |
Wiley |
series |
Cancer Medicine |
issn |
2045-7634 |
publishDate |
2019-08-01 |
description |
Abstract Acne‐like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double‐blind randomized phase II trial (EVITA) in patients with metastatic colorectal cancer receiving cetuximab. EVITA demonstrated a trend towards less severe skin rash in Reconval K1‐treated patients using the tripartite WoMo skin reaction grading score as a thorough tool for quantification of drug related skin reactions. This gender‐specific analysis of the EVITA trial evaluated the application of the WoMo score for assessment of epidermal growth factor receptor (EGFR)‐related skin toxicities according to treatment arm and gender. To show the robustness of results parametric and non‐parametric statistical analyses were conducted. All three parts of the WoMo score independently demonstrated the superiority of the treatment arm (Reconval K1) regarding a significant reduction in acneiform skin reactions in women. Men did not benefit from Reconval K1 cream at any time point in none of the WoMo score analyses. The treatment effect in women was confirmed by the use of skin rash categories based on the final WoMo overall score and mixed effect longitudinal multiple linear regression analysis. The WoMo score represents a sensitive tool for studies exploiting treatments against EGFR mediated acne‐like skin rash. Part C of the WoMo score seems to be sufficient for quantification of drug related skin toxicities in further studies. Standard WoMo skin reaction score values for future studies are provided. |
topic |
acneiform skin toxicity EGFR inhibitor women WoMo score |
url |
https://doi.org/10.1002/cam4.2132 |
work_keys_str_mv |
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