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

Abstract 

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 30Gy 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 8Gy was as safe and effective as a multifraction regimen of 30Gy for painful bone metastases in terms of pain relief.

Keywords: Bone metastases, Radiotherapy, Fractionation