1520P - Placebo-controlled randomised phase II study of topical vitamin K3 for treatment of cetuximab induced folliculitis

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Complications of Treatment
Supportive Care
Presenter Inger Kaalund
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors I. Kaalund1, O. Clemmensen2, P. Pfeiffer1, J.G. Eriksen1
  • 1Dept. Of Oncology, Odense Universityhospital, 5000 - Odense C/DK
  • 2Dept. Of Pathology, Odense Universityhospital, 5000 - Odense C/DK

Abstract

Aim

Cetuximab produce a range of commonly occurring side effects like cutaneous folliculitis. The physical and psychosocial discomfort might lead to interruption of treatment, dose modification or poor compliance. It is therefore important to effectively reduce these side effects as much as possible. Vitamin K3 (menadione) has preclinically shown to be a potential activator of the Epidermal Growth Factor Receptor (EGFR) by phosphorylating the receptor. The present study investigated the effect of a vitamin K3 lotion on cetuximab induced folliculitis.

Methods

From May 2010 to May 2012 30 patients (pts) was included in a double-blinded randomised placebo controlled phase II trial. Pts receiving biweekly cetuximab 500 mg/m2 in combination with chemotherapy for metastatic cancer were included. Treatment with vitamin K3 lasted up to two months and was followed up 14 days after end of treatment. On each patient two areas (truncus or face) of 10x10 cm was selected. Each area was applied with either placebo or vitamin K3 lotion twice daily. Folliculitis was monitored by clinical photos every second week, registered according to CTCAE 4.0 and assessed by the patient. Systemic tetracycline but not topical prednisolone was allowed. Ten pts volunteered to have skin biopsies taken before and after one month of treatment from each treatment area. Biopsies were stained for p27, EGFR and p-EGFR.

Results

Mean number of inflamed follicles was 4.9 (placebo) vs. 5.1 (K3) at baseline (p = 0.9), increasing to 11.1 (placebo) vs. 14.1 (K3) at two weeks (p = 0.5), and declining to 8.9 (placebo) vs. 7.3 (K3) at 4 weeks (p = 0.7). In fact, at any time point during the study there was no significant difference between placebo and vitamin K3 areas within 18 evaluable pts. No severe toxicity was observed. For skin biopsies, no difference in staining pattern or intensity of proliferation marker p27, EGFR or p-EGFR expression was observed. Furthermore, no subjective difference in skin toxicity between placebo and vitamin K3 areas was reported.

Conclusions

We found no clinical objective or subjective benefit and no histologic difference after 4 weeks application of vitamin K3 or placebo lotion. Our results do not support the use of topical vitamin K3 for cetuximab-induced folliculitis.

Disclosure

All authors have declared no conflicts of interest.