title: Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients.
abstract: OBJECTIVE
  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.
authors.affiliation: Klinik für Radioonkologie und Strahlentherapie, Klinikum Braunschweig, Braunschweig, Germany. m.schiebe@klinikum-braunschweig.de
authors.forename: Martina
authors.initials: M
authors.lastname: Becker-Schiebe
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mengs
authors.forename: Margitta
authors.initials: M
authors.lastname: Schaefer
authors.forename: Michael
authors.initials: M
authors.lastname: Bulitta
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hoffmann
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009367:Neoplasm Staging; D009824:Ointments; D010205:Pantothenic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011292:Premedication; D011446:Prospective Studies; D011837:Radiation-Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011855:Radiodermatitis / Q000517:prevention & control*; D011880:Radiotherapy Planning, Computer-Assisted; D018714:Radiotherapy, Adjuvant; D012838:Silymarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009824:Ointments; D010936:Plant Extracts; D011837:Radiation-Protective Agents; D012838:Silymarin; D010205:Pantothenic Acid; C007288:dexpanthenol