A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases
El-Hamamsy, M; Elwakil H.; Saad, AS; May Ahmed Shawki;
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 (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 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.
Other data
Title | A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases | Authors | El-Hamamsy, M; Elwakil H. ; Saad, AS; May Ahmed Shawki | Keywords | Brain metastases (BM);Quality of life;Simvastatin;Whole-brain radiation therapy (WBRT);CLINICAL-TRIALS;STATINS;RADIOTHERAPY;ONCOLOGY;RATINGS | Issue Date | 2016 | Publisher | COGNIZANT COMMUNICATION CORP | Journal | ONCOLOGY RESEARCH | Volume | 24 | Issue | 6 | Start page | 521 | End page | 528 | ISSN | 0965-0407 | DOI | 10.3727/096504016X14719078133528 | PubMed ID | 28281972 | Scopus ID | 2-s2.0-84992593362 | Web of science ID | WOS:000386594000014 |
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