Pinta, F., Ponzetti, A., Spadi, R., Fanchini, L., Zanini, M., Mecca, C., ... Racca, P. (2013). Pilot clinical trial on the efficacy of prophylactic use of vitamin K-based cream (Vigorskin) to prevent cetuximab-induced skin rash in patients with metastatic colorectal cancer. Clinical Colorectal Cancer, 13, 62–67.
To determine the efficacy of topical vitamin K1 as prophylaxis for cetuximab-induced skin rash (CISR) in patients with metastatic colorectal cancer
Prospective, single cohort study design
Overall, 34 patients (82.9%) experienced CISR of any grade. During the first eight weeks of treatment, the grade and incidence of patients’ skin toxicity was grade 0 (6 patients, 15%); grade 1 (18 patients, 45%); grade 2 (10 patients, 25%); and grade 3 (6 patients, 15%). No grade 4 CISR was reported. The mean time to development of the maximum grade of rash was 34.7 days, and the median time was 28 days (SD = 24.7). All patients with grades 2–3 rashes were managed with topical or systemic antibiotics. Dermatologic consultation was provided to all six patients with grade 3 rash.
Overall, this study found that patients with mCRC who were treated with cetuximab and used vitamin K1-based cream prophylactically experienced a lower proportion of grade 2 rash (25%) and grade 3 rash (15%), which corresponds to the lower limit reported in the literature. Also, patients tolerated this treatment well.
The topical application of vitamin K1-based cream may reduce the risk of developing skin rashes to the lower limits of rash reported elsewhere in the literature. Prophylactic use of vitamin K1 cream is tolerated well by patients receiving cetuximab therapy.