TY  - JOUR
A1  - Gaiser, Maria
A1  - Lorenzen, Sylvie
A1  - Merx, Kirsten
A1  - Trojan, Jörg
A1  - Ocvirk, Janja
A1  - Ettrich, Thomas Jens
A1  - Batran, Salah-Eddin al-
A1  - Schulz, Holger
A1  - Homann, Nils
A1  - Feustel, Hans‐Peter
A1  - Schatz, Michael
A1  - Kripp, Melanie
A1  - Schulte, Nadine
A1  - Heeger, Steffen
A1  - Vlassak, Soetkin
A1  - Koch, Winfried
A1  - Hofheinz, Ralf-Dieter
T1  - Evaluation of EGFR inhibitor‐mediated acneiform skin toxicity within the double‐blind randomized EVITA trial: A thorough gender‐specific analysis using the WoMo score
T2  - Cancer medicine
N2  - 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.
KW  - acneiform skin toxicity
KW  - EGFR inhibitor
KW  - women
KW  - WoMo score
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53550
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-535503
SN  - 2045-7634
N1  - This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
VL  - 8
IS  - 9
SP  - 4169
EP  - 4175
PB  - Wiley
CY  - Hoboken, NJ
ER  -