Jo, J.C., Hong, Y.S., Kim, K.P., Lee, J.L., Kim, H.J., Lee, M.W., ... Kim, T.W. (2013). Topical vitamin K1 may not be effective in preventing acneiform rash during cetuximab treatment in patients with metastatic colorectal cancer. European Journal of Dermatology, 23(1), 77–82.
To investigate the efficacy and safety of vitamin K1 cream for cetuximab-associated acneiform rash
All participants in the research arm were given vitamin K1 (phytomenadione 0.1%, Reconval® K1, manufactured by DRODERM® in Slovenia) before initiating cetuximab therapy. A participant was to apply vitamin K1 to his or her face, anterior, and posterior trunk twice daily on day 1 and throughout therapy. Concomitant oral antibiotics were allowed for grades ≥ 2 acneiform rashes. Evaluation of compliance and observance of rashes took place at each clinic visit. The study population was compared to a historical control group that had received cetuximab-containing chemotherapy with or without oral antibiotics but without topical K1 cream. A dermatologist graded rash severity.
Non-randomized, open-label, interventional study with historical control
In the historical control, acneiform rash of any grade occurred in 97.5% of patients. In the experimental group, 88.5% of patients experienced any grade of rash. No significant difference was found between the groups. There was no significant difference between groups for the median time to rashes grades ≥ 1 or time to rashes grades ≥ 2. There was no significant difference in the overall occurrence of rashes grades ≥ 2 between the groups at any point. There was no significant difference in the time to improvement from grades ≥ 2 to grades ≥ 1 rashes.
Vitamin K1 is not an effective prophylactic treatment of acneiform rash associated with cetuximab treatment.
Nurses should be aware that using topical vitamin K1 for prophylaxis of cetuximab-associated acneiform rash is not an effective treatment. Other interventions should be considered for patients receiving EGFR therapy for the management of acneiform rash.