Background: Several studies have described the efficacy of topical vitamin K1 cream in the prevention and treatment of acneiform rash during cetuximab treatment.
Objectives: 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.
Keywords: acneiform rash; cetuximab; metastatic colorectal cancer; topical vitamin K1 cream.