UK Trial Shows Little Benefit of Pregabalin Combined With Palliative Radiotherapy for Cancer-Induced Bone Pain


Key Points

  • Pregabalin was not associated with better pain reduction vs placebo in patients with cancer-induced bone pain, according to the findings of a UK study.
  • Some benefit in mood and duration of breakthrough pain was observed with the investigational therapy.

In a UK study reported in the Journal of Clinical Oncology, Fallon et al found no improvement with pregabalin vs placebo combined with concurrent palliative radiotherapy in relieving cancer-induced bone pain.

Study Details

In the double-blind trial, 233 patients with bone metastases who were scheduled for radiotherapy and had pain scores of at least 4 of 10 (on 0–10 scale) from 5 UK sites were randomly assigned to receive pregabalin (n = 116) or placebo (n = 117). Patients received pregabalin (or placebo) at a starting dose of 75 mg twice daily, which could be increased to 300 mg twice daily on day 22 based on weekly assessment. Radiotherapy was to be given at 8 Gy in 1 fraction or 20 Gy in 5 fractions. The primary endpoint was treatment response defined as a reduction of at least 2 points in the worst pain by week 4 accompanied by a stable or reduced opioid dose compared with baseline.


Response was observed in 38.8% of the pregabalin group vs 40.2% in the placebo group (odds ratio = 1.07, P = .816, in analysis adjusting for fractionation regimen, cancer type, and site of bone metastasis). No significant differences between groups were observed in average pain, pain interference, or quality of life. However, patients in the pregabalin group had better mood on the Hospital Anxiety and Depression Scale (P = .031) and shorter breakthrough pain duration (P = .037) at 4 weeks.

The investigators concluded: “Our findings do not support the role of pregabalin in patients with [cancer-induced bone pain] receiving radiotherapy. The role of pregabalin in [cancer-induced bone pain] with a clinical neuropathic pain component is unknown.”

The study was supported by Cancer Research UK and Pfizer UK.

Marie Fallon, MD, of the Edinburgh Cancer Research Centre, University of Edinburgh, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.