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Topical vitamin K1 may not be effective in preventing acneiform rash during cetuximab treatment in patients with metastatic colorectal cancer.

  • 2013-01
  • European journal of dermatology : EJD 23(1)
    • Jae-Cheol Jo
    • Yong Sang Hong
    • Kyu-pyo Kim
    • Jae-Lyun Lee
    • Hwa Jung Kim
    • Mi-Woo Lee
    • Seok-Byung Lim
    • Chang Sik Yu
    • Jin Cheon Kim
    • Jong Hoon Kim
    • Tae Won Kim

Study Design

Type
Clinical Trial
Sample size
n = 61
Population
61 patients with metastatic colorectal cancer (experimental group) and 40 patients with metastatic colorectal cancer (historical control)
Methods
Interventional study with a historical control; prophylactic application of topical vitamin K1 cream beginning on the first day of cetuximab treatment
Blinding
Open-label
Duration
4 weeks

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.

Research Insights

  • Vitamin K1→Increased Time to Acneiform Rash Onset

    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).

    Effect
    Neutral
    Effect size
    Small
  • Vitamin K1→Reduced Acneiform Rash

    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).

    Effect
    Neutral
    Effect size
    Small
  • Vitamin K1→Reduced Acneiform Rash Incidence

    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. 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).

    Effect
    Neutral
    Effect size
    Small

Adverse Events Reported

  • Vitamin K1→Overall tolerability

    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).

    Finding
    No significant difference
    Magnitude
    HR=1.33; 95% CI, 0.57-3.10; p=0.507
    Significant
    No
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