title: Topical vitamin K1 may not be effective in preventing acneiform rash during cetuximab treatment in patients with metastatic colorectal cancer.
abstract: BACKGROUND
  Several studies have described the efficacy of topical vitamin K1 cream in the prevention and treatment of acneiform rash during cetuximab treatment.
  
  
  OBJECTIVE
  An interventional study with a historical control was conducted to investigate the efficacy of vitamin K1 cream for acneiform rash associated with cetuximab.
  
  
  METHODS
  For the historical control, data were collected from 40 patients with metastatic colorectal cancer who had participated in a previous clinical trial of cetuximab plus irinotecan. The experimental group consisted of 61 patients who were instructed to prophylactically apply topical vitamin K1 cream beginning on the first day of cetuximab treatment. The incidence, severity, and time to occurrence of acneiform rash were compared between groups.
  
  
  RESULTS
  The incidence of grade≥2 acneiform rash after 4 weeks of cetuximab treatment was 42.5% in the historical control group and 55.5% in the experimental group. The median time to grade≥2 rash in the experimental group was 4 weeks compared to 6 weeks in the historical control group (p=0.340). By multivariate analysis, male gender was the only independent risk factor for grade 2 or worse acneiform rash (HR=2.49; 95% CI, 1.27-4.88; p=0.007). Prophylactic application of topical vitamin K1 cream did not decrease the risk of acneiform rash (HR=1.33; 95% CI, 0.57-3.10; p=0.507).
  
  
  CONCLUSIONS
  The prophylactic application of topical vitamin K1 cream did not translate into clinically meaningful benefit in terms of reducing acneiform rash in patients with metastatic colorectal cancer treated with cetuximab.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jae-Cheol
authors.initials: JC
authors.lastname: Jo
authors.forename: Yong Sang
authors.initials: YS
authors.lastname: Hong
authors.forename: Kyu-pyo
authors.initials: KP
authors.lastname: Kim
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Hwa Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Mi-Woo
authors.initials: MW
authors.lastname: Lee
authors.forename: Seok-Byung
authors.initials: SB
authors.lastname: Lim
authors.forename: Chang Sik
authors.initials: CS
authors.lastname: Yu
authors.forename: Jin Cheon
authors.initials: JC
authors.lastname: Kim
authors.forename: Jong Hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
mesh_terms: D017486:Acneiform Eruptions / Q000139:chemically induced / Q000517:prevention & control*; D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003875:Drug Eruptions / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012720:Severity of Illness Index; D012737:Sex Factors; D063465:Skin Cream / Q000627:therapeutic use; D013997:Time Factors; D017211:Treatment Failure; D010837:Vitamin K 1 / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D014815:Vitamins; D010837:Vitamin K 1; D000068818:Cetuximab