Randomized clinical trial with two palliative radiotherapy regimens in painful bone metastases: 30 Gy in 10 fractions compared with 8 Gy in single fraction.

BACKGROUND AND PURPOSE The aim was to demonstrate similar pain relief with two schedules of radiotherapy for painful bone metastases. MATERIALS AND METHODS A total of 160 patients were assigned to receive a single 8-Gy fraction or 30 Gy in 10 fractions. Pain intensity was measured on an ordinal pain scale of 0-10. Partial response was defined as a pain reduction of two points or more and complete response as a pain score of zero at the treated area. Response follow-up was at 3, 12, 24 and 48 weeks. RESULTS The overall response was 75% in the 8-Gy arm and 86% in the 30-Gy arm. Complete response and partial response rates were 15% and 60% in the 8-Gy arm, 13% and 73% in the 30-Gy arm. Acute toxicity was of 18% in the 30-Gy arm and of 12% in the 8-Gy arm. These differences were not statistically significant. The re-treatment rate was 28% vs 2% in the 8-Gy and 30-Gy arms, respectively, these were statistically significant. CONCLUSIONS A single-fraction regimen of 8 Gy was as safe and effective as a multifraction regimen of 30 Gy for painful bone metastases in terms of pain relief.