Vitamin K1 cream in the management of skin rash during anti-EGFR monoclonal antibody (mAb) treatment in patients with metastatic cancer: First analysis of an observational Italian study.

Abstract

594 Background: Cutaneous toxicity, and especially skin rash, is a predictable side- effect of anti-EGFR mAb therapy. Preclinical studies have shown that vitamin K1 reactivated EGFR-mediated signal transduction after inhibition via EGFR receptor antagonists. The aim of this study was to evaluate the impact of vitamin K1 cream in skin rash management. Methods: In two Italian Oncology Centers sequential pts at the first therapy with cetuximab/panitumumab for metastatic cancer were treated with vitamin K1 cream at the first onset of grade ≥2 skin rash. Topical treatment with vitamin K1 (phytomenadione 0.1%) cream twice/die was administered continuously until the end of anti-EGFR treatment. Skin toxicity, according to NCI-CTC v3.0 grading system, was clinically evaluated every week and in a standardized way, taking pictures of 5 different body areas. Treatment benefit was evaluated according to symptom reduction and compliance to therapy. Results: From February to September 2010, 33 pts, 22M (66.6%) and 11F (33.4%), median age 63 years (range 27-79), were evaluated. The primary tumor site was 3 (9.1%) esophagus/stomach, 28 (84.8%) colon-rectum, 2 (6.1%) head-neck. Eighteen (54.5%) pts were treated as first-line and 15 (45.5%) were pretreated. The regimen contained cetuximab in 26 (78.7%) pts and panitumumab in 7 (21.3%). The combination regimens were platinum compounds-based in 23 (69.6%) pts, and irinotecan-based in 6 (18.2%); panitumumab was administered in monotherapy in 4 (12.2%) pts. The median time of vitamin K1 cream treatment was 24 weeks (range 6-28); the oral tetracyclines therapy was associated in 13 (39.4%) pts. The decrease in skin rash to grade 1-0 was observed in 12 (36.4%) pts, and 13 (39.4%) pts showed unchanged grade 2. The increase to grade 3 in skin rash was observed in 8 (24.2%) pts. Good skin rash symptom control was obtained in 69.2% of pts. Cetuximab/panitumumab dose reduction and treatment delays was required in 9 (27.3%) pts. Conclusions: These preliminary results suggest a favorable impact of vitamin K1 cream in skin rash management, which should be considered in a future clinical trial. No significant financial relationships to disclose.