title: Pilot clinical trial on the efficacy of prophylactic use of vitamin K1-based cream (Vigorskin) to prevent cetuximab-induced skin rash in patients with metastatic colorectal cancer.
abstract: BACKGROUND
  Cetuximab is an effective option for the treatment of metastatic colorectal cancer in the first and subsequent lines of treatment; among its side effects, acneiform skin rash is one of the major causes of treatment delay, reduction, or interruption, with a negative effect on quality of life. No effective strategy to prevent skin rash induced by epidermal growth factor receptor inhibitors is available; however, encouraging results have come from vitamin K1, phytomenadione, applied as a topical formulation. Available studies have been conducted in heterogeneous populations and are mainly focused on the use of vitamin K1-based cream for the treatment, rather than the prophylaxis, of acneiform rash.
  
  
  METHODS
  Forty-one consecutive patients from a single center all affected by metastatic colorectal cancer and receiving cetuximab, alone or combined with chemotherapy, applied vitamin K1-based cream to prevent the occurrence of acneiform skin rash. The cream was applied twice a day on the face and trunk from the first day of administration of cetuximab.
  
  
  RESULTS
  The application of the cream was well tolerated. No grade 4 rash was reported. The proportion of grade 3 skin rash in the first 8 weeks of treatment in this population was 15%, at the lower limit of values reported in the literature, and the proportion of patients with grade 2 rash was reduced (22.5%).
  
  
  CONCLUSIONS
  This experience confirms available data in a homogeneous population, suggesting a possible benefit of topical vitamin K1 as prophylaxis for cetuximab-induced skin rash in patients with metastatic colorectal cancer.
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Francesco
authors: F
authors: Pinta
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy. Electronic address: agoponz@hotmail.com.
authors: Agostino
authors: A
authors: Ponzetti
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Rosella
authors: R
authors: Spadi
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Laura
authors: L
authors: Fanchini
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Marcello
authors: M
authors: Zanini
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Caterina
authors: C
authors: Mecca
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Cristina
authors: C
authors: Sonetto
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Libero
authors: L
authors: Ciuffreda
authors: Colorectal Cancer Unit, Medical Oncology 1 Division, San Giovanni Battista Hospital, Turin, Italy.
authors: Patrizia
authors: P
authors: Racca
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005076:Exanthema / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D010865:Pilot Projects; D063465:Skin Cream; D010837:Vitamin K 1 / Q000008:administration & dosage*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D010837:Vitamin K 1; D000068818:Cetuximab
keywords: Acneiform rash; Cetuximab plus chemotherapy; Phytomenadione; Prevention; Topical treatment