title: Randomized trial of pentoxifylline and vitamin E vs standard follow-up after breast irradiation to prevent breast fibrosis, evaluated by tissue compliance meter.
abstract: OBJECTIVE
  To conduct a randomized clinical trial to determine whether the combination of pentoxifylline (PTX) and vitamin E given for 6 months after breast/chest wall irradiation effectively prevents radiation-induced fibrosis (RIF).
  
  
  METHODS
  Fifty-three breast cancer patients with localized disease were enrolled and randomized to treatment with oral PTX 400 mg 3 times daily and oral vitamin E 400 IU daily for 6 months after radiation (n=26), or standard follow up (n=27). Tissue compliance meter (TCM) measurements were obtained at 18 months to compare tissue compliance in the irradiated and untreated breast/chest wall in treated subjects and controls. Measurements were obtained at 2 mirror image sites on each breast/chest wall, and the average difference in tissue compliance was scored. Differences in TCM measurements were compared using a t test. Subjects were followed a minimum of 2 years for local recurrence, disease-free survival, and overall survival.
  
  
  RESULTS
  The mean difference in TCM measurements in the 2 groups was 0.88 mm, median of 1.00 mm (treated) and 2.10 mm, median of 2.4 mm (untreated). The difference between the 2 groups was significant (P=.0478). Overall survival (100% treated, 90.6% controls at 5 years) and disease-free survival (96.2% treated, 86.8% controls at 5 years) were not significantly different in the 2 groups.
  
  
  CONCLUSIONS
  This study of postirradiation breast cancer patients treated with PTX/vitamin E or standard follow-up indicated a significant difference in radiation-induced fibrosis as measured by TCM. There was no observed impact on local control or survival within the first 2 years of follow-up. The treatment was safe and well tolerated. Pentoxifylline/vitamin E may be clinically useful in preventing fibrosis after radiation in high-risk patients.
authors: Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA. geraldine-jacobson@uiowa.edu
authors: Geraldine
authors: G
authors: Jacobson
authors: Sudershan
authors: S
authors: Bhatia
authors: Brian J
authors: BJ
authors: Smith
authors: Anna M
authors: AM
authors: Button
authors: Kellie
authors: K
authors: Bodeker
authors: John
authors: J
authors: Buatti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001940:Breast / Q000473:pathology* / Q000528:radiation effects*; D001943:Breast Neoplasms / Q000532:radiotherapy*; D003187:Compliance / Q000502:physiology / Q000528:radiation effects; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005355:Fibrosis / Q000175:diagnosis / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D010431:Pentoxifylline / Q000627:therapeutic use*; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D014810:Vitamin E / Q000627:therapeutic use*
chemical_list: D011837:Radiation-Protective Agents; D014810:Vitamin E; D010431:Pentoxifylline