Topical atorvastatin 1% for prevention of skin toxicity in patients receiving radiation therapy for breast cancer: a randomized, double-blind, placebo-controlled trial

Eur J Clin Pharmacol. 2019 Feb;75(2):171-178. doi: 10.1007/s00228-018-2570-x. Epub 2018 Oct 6.

Abstract

Background and purpose: The purpose of this randomized, placebo-controlled, double-blind study was to investigate the preventive effect of topical administration of atorvastatin (ATV) on the acute radiation-induced skin toxicity in patients with breast cancer.

Patients and methods: Seventy breast cancer patients were randomly assigned to use topical ATV 1% or placebo gels during radiotherapy twice daily. Radiation-induced dermatitis was classified according to the radiation therapy oncology group (RTOG) criteria, as well as pain and itching were scored according to VAS (visual analogue scale) for 6 weeks of treatment.

Results: Topical administration of ATV gel during radiotherapy reduced significantly radiation-induced breast swelling, itching, and pain in breast cancer patients by factors of 1.8, 1.7, and 1.5, respectively. ATV reduced the redness caused by radiotherapy in patients as compared with placebo; however, this difference was statistically not significant.

Conclusion: ATV was able to reduce significantly itching, breast edema, and pain in patients during radiotherapy.

Keywords: Atorvastatin; Radioprotective; Radiotherapy; Skin toxicity.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Atorvastatin / administration & dosage*
  • Atorvastatin / adverse effects*
  • Breast Neoplasms / radiotherapy*
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Radiodermatitis / drug therapy*
  • Skin / drug effects*
  • Skin / radiation effects*

Substances

  • Atorvastatin