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Topical Use of a Silymarin-Based Preparation to Prevent Radiodermatitis
Results of a Prospective Study in Breast Cancer Patients
Martina Becker-Schiebe1, Ulrich Mengs2, Margitta Schaefer2, Michael Bulitta3, Wolfgang Hoffmann1
Purpose: More than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade3 lesions. Side effects may reduce the patients compliance and can be limiting factors to follow RT protocols. Therefore, there is a high need for more effective prophylactic treatments. In this study, a silymarin-based cream (Leviaderm) was tested in comparison to our standard of care (SOC) at the involved site.
Methods: A total of 101 patients were evaluated after breast-conserving surgery followed by RT with 50.4 Gy plus boost 916 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50patients were documented receiving a panthenol-containing cream interventionally, if local skin lesions occurred. The acute skin reactions were classified according to the RTOG and VAS (Visual Analogue Scale) scores.
Results: The median time to toxicity was prolonged significantly with silymarin-based cream (45 vs. 29days (SOC), p<0.0001). Only 9.8% of patients using silymarin-based cream showed grade2 toxicity in week5 of RT in comparison to 52% with SOC. At the end of RT, 23.5% of patients in the silymarin-based study group developed no skin reactions vs. 2% with SOC, while grade3 toxicity occurred only in 2% in the silymarin-based arm compared to 28% (SOC).
Conclusions: Silymarin-based cream Leviaderm may be a promising and effective treatment for the prevention of acute skin lesions caused by RT of breast cancer patients. To confirm the results of this nonrandomized, observational trial, this component should be tested in larger multicenter studies in this setting.
Key Words: Breast cancer Radiodermatitis Silymarin Leviaderm Panthenol
Strahlenther Onkol 2011;187:48591
DOI 10.1007/s00066-011-2204-z
Prophylaxe und Therapie der Radiodermatitis mit einer silymarinhaltigen Cremeformulierung: Ergebnisse einer prospektiven Untersuchung von Mammakarzinom-Patientinnen
Hintergrund: Im Rahmen einer Strahlentherapie (RT) nach brusterhaltender Operation von Mammakarzinom-Patientinnen stehen die Hautreaktionen im Vordergrund der akuten Nebenwirkungen. Dies kann die Lebensqualitt erheblich beeintrchtigen und den Therapieerfolg gefhrden. In dieser Untersuchung sollte daher geprft werden, inwieweit eine prophylaktische An wendung mit einer silymarinhaltigen Cremeformulierung (Leviaderm), Hautreaktionen im Vergleich zur Standardpflege reduzieren kann.
Material und Methode: Ausgewertet wurden insgesamt 101 Mammakarzinom-Patientinnen, die...