Management of cutaneous side effects of cetuximab therapy with vitamin K1 crème

Background. Cetuximab is a chimeric human-murine monoclonal antibody against the epidermal growth factor receptor (EGFR). It has shown activities against multiple malignancies in clinical trials. EGFR-inhibitors often cause skin toxicity, most frequently acneiform eruption. Xerosis, eczema, fissures, teleangiectasias, nail changes and paronychia can be seen in some cases, rarely hyperpigmentation. The management of the skin toxicity helps patients to overcome cetuximab-associated skin toxicity and is of great importance for patients’ compliance. It is generally manageable with standard topical or systemic antibiotics and antiinflammatory agents. The education of patients prior to beginning the therapy and proactive intervention at the first signs of skin toxicity are keys to the successful management. The aim of our study was to investigate cutaneous side-effects of the treatment with cetuximab and to determine the efficacy of vitamin K1 crème. Methods. From September 2006 to August 2007 30 patients with metastatic colorectal cancer were treated with cetuximab in combination with chemotherapy and suffered from acne-like rash. They were followed at least 3 months, once per week. Skin care was taken with crème with urea and 0.1% K1 vitamin (Reconval K1®) topically starting after first documented cutaneous toxicity, and was evaluated according to NCI CTCAE, ver.3. Results. Of 30 patients 6 had grade 3 rash, 18 patients grade 2 and 6 patients grade 1. Reconval K1® was used twice daily. In all patients we observed the improvement of cutaneous toxicity. The median improvement was 8 days and 18 days to observe down-staging in rash at least for 1 grade. In only 3 of 6 patients with grade 3 toxicity the reduction of cetuximab dose was needed. In historical controls in all patients with grade 3 the reduction of cetuximab dose was recommended and performed. No dose reduction or delay of treatment was needed in group of patients with grade 1 and 2 cutaneous toxicity. We didn’t observe any local or systemic toxicity of topical use of Reconval K1®. Conclusions. To our knowledge this is the first documented effect of topical use of K1 vitamin crème for reducing cetuximab induced cutaneous toxicity in patients with metastatic colorectal cancer. We conclude that Reconval K1® is useful in skin care in patients treated with cetuximab. Further studies are needed to evaluate the impact on response rate of cetuximab and quality of life.