1. A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases
- Author
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May A. Shawki, Amr S Saad, Manal El-Hamamsy, and Hesham Elwakil
- Subjects
0301 basic medicine ,Male ,Quality of life ,Cancer Research ,medicine.medical_specialty ,Radiation-Sensitizing Agents ,Simvastatin ,medicine.medical_treatment ,Pilot Projects ,Disease-Free Survival ,Article ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,In patient ,Prospective Studies ,Brain metastases (BM) ,Not evaluated ,business.industry ,Brain Neoplasms ,Cancer ,Brain ,General Medicine ,Middle Aged ,medicine.disease ,Whole-brain radiation therapy (WBRT) ,Combined Modality Therapy ,Clinical trial ,Radiation therapy ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Female ,Whole brain radiation therapy ,business ,medicine.drug - 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.
- Published
- 2017