vitamin-k-1 and Acneiform-Eruptions

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.. 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.. 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.. 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.

Topics: Acneiform Eruptions; Antineoplastic Agents; Cetuximab; Double-Blind Method; Humans; Ointments; Panitumumab; Vitamin K 1

Acne-like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double-blind randomized phase II trial (EVITA) in patients with metastatic colorectal cancer receiving cetuximab. EVITA demonstrated a trend towards less severe skin rash in Reconval K1-treated patients using the tripartite WoMo skin reaction grading score as a thorough tool for quantification of drug related skin reactions. This gender-specific analysis of the EVITA trial evaluated the application of the WoMo score for assessment of epidermal growth factor receptor (EGFR)-related skin toxicities according to treatment arm and gender. To show the robustness of results parametric and non-parametric statistical analyses were conducted. All three parts of the WoMo score independently demonstrated the superiority of the treatment arm (Reconval K1) regarding a significant reduction in acneiform skin reactions in women. Men did not benefit from Reconval K1 cream at any time point in none of the WoMo score analyses. The treatment effect in women was confirmed by the use of skin rash categories based on the final WoMo overall score and mixed effect longitudinal multiple linear regression analysis. The WoMo score represents a sensitive tool for studies exploiting treatments against EGFR mediated acne-like skin rash. Part C of the WoMo score seems to be sufficient for quantification of drug related skin toxicities in further studies. Standard WoMo skin reaction score values for future studies are provided.

Topics: Acneiform Eruptions; Adult; Aged; Aged, 80 and over; Cetuximab; Colorectal Neoplasms; Double-Blind Method; ErbB Receptors; Female; Humans; Male; Middle Aged; Neoplasm Metastasis; Protein Kinase Inhibitors; Sex Characteristics; Skin Cream; Treatment Outcome; Vitamin K 1

Topics: Acneiform Eruptions; Administration, Cutaneous; Antineoplastic Agents, Immunological; Cetuximab; Colorectal Neoplasms; Drug Eruptions; ErbB Receptors; Female; Humans; Incidence; Male; Severity of Illness Index; Skin Cream; Treatment Outcome; Vitamin K 1

A double-blind, placebo-controlled study evaluating the efficacy and safety of vitamin K1 ointment for the treatment of patients with cetuximab-induced acneiform eruption has started. Vitamin K1 ointment and placebo are applied twice daily for 8 consecutive weeks after the development of acneiform eruptions. Vitamin K1 ointment is applied in the middle of one side (face, neck or chest) and placebo is applied to the other side. The primary endpoint is the regression rate of acneiform eruptions on right- and left-side lesions in the same patient, compared with baseline at the final evaluation in the 10-week trial. The secondary endpoints include adverse events of acneiform eruption and other adverse events.

Topics: Acneiform Eruptions; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Cetuximab; Clinical Protocols; Double-Blind Method; Follow-Up Studies; Humans; Ointments; Prognosis; Vitamin K 1; Vitamins