Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study on the Efficacy and Safety of Vitamin K1 Ointment for Cetuximab or Panitumumab-Induced Acneiform Eruptions-VIKTORIA Study.

PURPOSE: Skin toxicities associated with anti-epidermal growth factor receptor(EGFR)antibodies, have a profound effect on the continuation of treatment. We assessed the efficacy and safety of vitamin K1(VK1)ointment for acneiform eruptions induced by anti-EGFR antibody treatment.

METHODS

The VK1 ointment was applied to one-half of an affected area and placebo ointment was applied to the other half twice a day for 8 weeks, with photography and clinical evaluation being performed every 2 weeks. The primary endpoint was the change of the VK1/placebo ratio for the number of acneiform eruptions counted by an independent dermatologist between the onset and end of the treatment period.

RESULTS

A total of 30 patients were enrolled. The mean VK1/placebo ratio for the number of acneiform eruptions between the onset and end of the treatment period was -0.158±0.680 and 0.146±0.575, respectively, which was not statistically significant(p=0.069). The mean number of acneiform eruptions at each treatment period at the VK1 and placebo application sites was gradually decreased according to the treatment period.

CONCLUSION

VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab. Reassessment of the VK1 concentration in the ointment and the endpoint of skin lesions is required before designing further studies.