@Article{096504016X14719078133528,
AUTHOR = {Manal El-Hamamsy, Hesham Elwakil, Amr S. Saad, May A. Shawki},
TITLE = {A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to  Whole-Brain Radiation Therapy in Patients With Brain Metastases},
JOURNAL = {Oncology Research},
VOLUME = {24},
YEAR = {2016},
NUMBER = {6},
PAGES = {521--528},
URL = {http://www.techscience.com/or/v24n6/57009},
ISSN = {1555-3906},
ABSTRACT = {Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical 
trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain 
radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, 
open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to 
receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT+ simvastatin 80 mg/day for the WBRT 
period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after 
WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and 
health-related quality of life (HRQL) that was assessed using the European Organization for the Research and 
Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), 
at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one 
patients were not evaluated for radiological response because of death (<i>n</i> = 16), noncompliance to follow-up 
(<i>n</i> = 4), and clinical deterioration (<i>n</i> = 1). Response rates were 60% and 78.6% (<i>p</i> = 0.427), 1-year PFS rates 
were 5.2% and 17.7% (<i>p</i> = 0.392), and 1-year OS rates were 12% and 8% (<i>p</i> = 0.880) for the control group 
and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding 
HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with 
BM receiving WBRT.},
DOI = {10.3727/096504016X14719078133528}
}