Pilot Clinical Trial on the Efficacy of Prophylactic Use of Vitamin K1–Based Cream (Vigorskin) to Prevent Cetuximab-Induced Skin Rash in Patients With Metastatic Colorectal Cancer

Pinta, Francesco; Ponzetti, Agostino; Spadi, Rosella; Fanchini, Laura; Zanini, M.; Mecca, C.; Sonetto, Cristina; Ciuffreda, Libero; Racca, Patrizia

doi:10.1016/j.clcc.2013.10.001

Cited by 37 publications

(27 citation statements)

References 36 publications

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“…Their use is based on clinical experience and expert opinion . Other topical agents such as retinoids and vitamin K1 cream have potential roles for the management of ERSEs . However, their efficacies have not been fully investigated through prospective studies.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities

Kim

et al. 2019

The Oncologist

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Background The efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non‐small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor‐related skin adverse events (ERSEs). Materials and Methods This placebo‐controlled, double‐blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily. Results Efficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex‐16 after treatment were significantly different among arms (mean ± SD: −5.2 ± 8.6 for arm 1, −11.7 ± 14.2 for arm 2, and − 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm. Conclusion EGF ointment is effective for managing ERSEs. It can also improve patients’ QoL compared with placebo. Clinical trial identification number. NCT02284139 Implications for Practice Patients with non‐small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor‐related skin adverse events.

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Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities

Kim

et al. 2019

The Oncologist

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“…Among them, vitamin K1 is used to prevent disruption of the balance between proliferation and differentiation, thinning of the epidermis, immune reactions and inflammatory reactions leading to folliculitis. Currently, there is no major rationale for using vitamin K1 as a pre‐emptive measure, as it provided only a minimal or insignificant benefit in reducing skin rash due to anti‐EGFR agents …”

Section: Discussionmentioning

confidence: 99%

Antibiotic prophylaxis for skin toxicity induced by antiepidermal growth factor receptor agents: a systematic review and meta-analysis

et al. 2016

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Topical and systemic prophylactic measures, which are administered before the development of epidermal growth factor receptor (EGFR)-related acneiform rash, are appropriate interventions to mitigate the intensity of skin toxicity. We have performed a systematic review and meta-analysis to evaluate whether prophylactic antibiotics may reduce the occurrence and severity of anti-EGFR drug-related skin rashes. A systematic review was performed by searching Medline, Scopus, Embase, CINAHL, LILACS, Web of Science and the Cochrane Library from inception until March 2016 for publications regarding the pre-emptive role of antibiotics for EGFR-induced skin rashes. Fixed- or random-effects meta-analyses, according to heterogeneity, were used to summarize odds ratios of skin toxicity with antibiotic use. Of the 827 citations found in the search, 13 studies comprising 1073 patients were included in the analysis. In 12 studies, patients in the prophylactic antibiotic arms had a lower risk of developing a skin rash (odds ratio 0·53, 95% confidence interval 0·39-0·72, P < 0·01) than patients without antibiotic prophylaxis. In particular, moderate-to-severe toxicities (grades 2-4) were reduced by nearly two-thirds (odds ratio 0·36, 95% confidence interval 0·22-0·60, P < 0·01) in 13 studies. This translated to a 26% absolute difference of high-grade skin rash compared with the control arms (from 50% to 24%). The results of this meta-analysis show that the risk of skin rash after treatment with anti-EGFR agents for solid tumours was significantly lower in patients taking prophylaxis with antibiotics than in those who were not. Therefore, taking pre-emptive tetracyclines for several weeks at the start of anti-EGFR treatment can significantly reduce the incidence and severity of cutaneous acneiform rash.

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“…These include vitamin K, and in particular vitamin K1 (fillochinone) and K3 (menadione). [27][28][29][30][31][32][33][34][35]52,53 Early data on antibiotic prophylaxis also indicate a positive role of tetracyclines. [37][38][39][40][41] The updated Expert Opinion detailed in this article represents the second Italian consensus positions derived from best clinical practices and from the available scientific literature on the treatment of anti-EGFR skin reactions.…”

Section: Antibioticsmentioning

confidence: 99%

Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy

Pinto¹,

Barone

Girolomoni

et al. 2016

American Journal of Clinical Oncology

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Pilot Clinical Trial on the Efficacy of Prophylactic Use of Vitamin K1–Based Cream (Vigorskin) to Prevent Cetuximab-Induced Skin Rash in Patients With Metastatic Colorectal Cancer

Abstract: This experience confirms available data in a homogeneous population, suggesting a possible benefit of topical vitamin K1 as prophylaxis for cetuximab-induced skin rash in patients with metastatic colorectal cancer.

Cited by 37 publications

References 36 publications

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities

Antibiotic prophylaxis for skin toxicity induced by antiepidermal growth factor receptor agents: a systematic review and meta-analysis

Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy

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