Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.
作者信息
Fallon Marie, Hoskin Peter J, Colvin Lesley A, Fleetwood-Walker Susan M, Adamson Douglas, Byrne Anthony, Murray Gordon D, Laird Barry J A
机构信息
Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
出版信息
J Clin Oncol. 2016 Feb 20;34(6):550-6. doi: 10.1200/JCO.2015.63.8221. Epub 2015 Dec 7.
PURPOSE
Cancer-induced bone pain (CIBP) affects one third of patients with cancer. Radiotherapy remains the gold-standard treatment; however, laboratory and clinical work suggest that pregabalin may be useful in treating CIBP. The aim of this study was to examine pregabalin in patients with CIBP receiving radiotherapy.
PATIENTS AND METHODS
A multicenter, double-blind randomized trial of pregabalin versus placebo was conducted. Eligible patients were age ≥ 18 years, had radiologically proven bone metastases, were scheduled to receive radiotherapy, and had pain scores ≥ 4 of 10 (on 0-to-10 numeric rating scale). Before radiotherapy, baseline assessments were completed, followed by random assignment. Doses of pregabalin and placebo were increased over 4 weeks. The primary end point was treatment response, defined as a reduction of ≥ 2 points in worst pain by week 4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary end points assessed average pain, interference of pain with activity, breakthrough pain, mood, quality of life, and adverse events.
RESULTS
A total of 233 patients were randomly assigned: 117 to placebo and 116 to pregabalin. The most common cancers were prostate (n = 88; 38%), breast (n = 77; 33%), and lung (n = 42; 18%). In the pregabalin arm, 45 patients (38.8%) achieved the primary end point, compared with 47 (40.2%) in the placebo arm (adjusted odds ratio, 1.07; 95% CI, 0.63 to 1.81; P = .816). There were no statistically significant differences in average pain, pain interference, or quality of life between arms. There were differences in mood (P = .031) and breakthrough pain duration (P = .037) between arms. Outcomes were compared at 4 weeks.
CONCLUSION
Our findings do not support the role of pregabalin in patients with CIBP receiving radiotherapy. The role of pregabalin in CIBP with a clinical neuropathic pain component is unknown.
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