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Topical Use of a Silymarin-Based Preparation to Prevent Radiodermatitis

Results of a Prospective Study in Breast Cancer Patients

Prophylaxe und Therapie der Radiodermatitis mit einer silymarinhaltigen Cremeformulierung: Ergebnisse einer prospektiven Untersuchung von Mammakarzinom-Patientinnen

Abstract

Purpose:

More than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade 3 lesions. Side effects may reduce the patient’s 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 9–16 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50 patients 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. 29 days (SOC), p < 0.0001). Only 9.8% of patients using silymarin-based cream showed grade 2 toxicity in week 5 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 grade 3 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.

Zusammenfassung

Hintergrund:

Im Rahmen einer Strahlentherapie (RT) nach brusterhaltender Operation von Mammakarzinom-Patientinnen stehen die Hautreaktionen im Vordergrund der akuten Nebenwirkungen. Dies kann die Lebensqualität erheblich beeinträchtigen und den Therapieerfolg gefährden. In dieser Untersuchung sollte daher geprüft werden, inwieweit eine prophylaktische Anwendung mit einer silymarinhaltigen Cremeformulierung (Leviaderm®), Hautreaktionen im Vergleich zur Standardpflege reduzieren kann.

Material und Methode:

Ausgewertet wurden insgesamt 101 Mammakarzinom-Patientinnen, die nach einer brusterhaltenden OP mit einer ZVD von 50,4 Gy + Boost 9–16 Gy bestrahlt wurden. Bei 51 Patientinnen wurde eine silymarinhaltige Cremeformulierung prophylaktisch angewendet. Zusätzlich wurden 50 Patientinnen dokumentiert, die gemäß der Standardpflege nur bei Auftreten von Hautreaktionen eine panthenolhaltige Salbe erhielten. Die akuten Hautreaktionen wurden entsprechend den RTOG- und VAS (Visual Analogue Scale) Kriterien klassifiziert.

Ergebnisse:

Unter der silymarinhaltigen Pflegeformulierung kam es signifikant seltener zu Hautnebenwirkungen (mittlere Zeitdauer bis zum Auftreten einer Toxizität 45 Tage vs. 29 Tage im Standardarm, p < 0,0001). In Woche 5 der RT zeigte sich eine G2-Toxizität nur bei 9.8% der Leviaderm®-Patienten (vs 52% im Kontrollarm). 23,5% der Patientinnen, die prophylaktisch eine silymarinhaltige Pflege anwendeten, zeigten bei RT-Ende keine Hautreaktionen gegenüber 2% im Standardarm; G3-Toxizitäten kamen im Verlauf nur in 2% der Fälle unter silymarinhaltiger Lokal-Pflege vor (vs 28% im Kontrollarm).

Schlussfolgerung:

Unsere Daten dieser prospektiven, nicht-randomisierten Untersuchung zeigen, dass die prophylaktische Anwendung einer antioxidativen silymarinhaltigen Cremeformulierung wie Leviaderm® signifikant Schweregrad und Häufigkeit einer Radiodermatitis bei Mammakarzinom-Patientinnen reduzieren kann.

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Correspondence to Martina Becker-Schiebe.

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Becker-Schiebe, M., Mengs, U., Schaefer, M. et al. Topical Use of a Silymarin-Based Preparation to Prevent Radiodermatitis. Strahlenther Onkol 187, 485 (2011). https://doi.org/10.1007/s00066-011-2204-z

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Key Words

  • Breast cancer
  • Radiodermatitis
  • Silymarin
  • Leviaderm®
  • Panthenol

Schlüsselwörter

  • Mammakarzinom
  • Strahlendermatitis
  • Silymarin
  • Leviaderm®
  • Panthenol