Author/Editor     Hofheinz, Ralf-Dieter; Lorenzen, Sylvie; Trojan, Jörg; Ocvirk, Janja; Ettrich, Thomas J.; Al-Batran, Salah Eddin; Schulz, Holger; Homann, Nils; Feustel, H. P.; Schatz, Marlene
Title     EVITA
Type     članek
Vol. and No.     Letnik 29, št. 4
Publication year     2018
Volume     str. 1010-1015
ISSN     1569-8041 - Annals of oncology : official journal of the European Society for Medical Oncology / ESMO
Language     eng
Abstract     Acne-like skin rash is a frequently occurring adverse event associated with drugs against the epidermal growth factor receptor. This randomized vehicle-controlled study investigated the addition of vitamin K1 cream to doxycycline in patients with metastatic colorectal cancer treated with cetuximab. Patients and Methods Patients receiving 1st line cetuximab + FOLFIRI were randomly assigned to prophylactic treatment with doxycylin and vitamin K1 cream or doxycycline and the vehicle. The primary end point of the study was the incidence of grade % 2 skin rash (NCI CTCAE version 4.02) during 8 weeks of skin treatment. Secondary endpoints comprised skin rash according to a more thorough tripartite skin toxicity score (WoMo), quality of life, efficacy and compliance. The study had 80% power to show a 20% reduction of the incidence of grade % 2 skin rash. Results A total of 126 patients were analyzed. The incidence of skin rash grade % 2 was comparable between the arms. Likewise, no difference was seen in the WoMo score with respect to the percentage of skin affected. However, starting in week 5 and increasing over time patients treated with vitamin K1 cream had less severe rash and fewer fissures. Quality of life as well as efficacy and compliance with study medication and anti-cancer treatment was comparable in both arms. Conclusion The primary endpoint of decreasing grade % 2 skin rash was not met. However, using vitamin K1 cream as part of prophylactic treatment decreased the severity of acne-like skin rash according to WoMo, an alternative and more thorough skin toxicity scoring tool.
Keywords     cetuksimab
rak debelega črevesa in danke
toksičnost kože
vitaminske kreme
skin toxicity
colorectal cancer
vitamin K1 cream
cetuximab