Radiation therapy for the management of painful bone metastases: Results from a randomized trial.

Aim: The aim of this study was to compare the effectiveness of two radiotherapy schedules in patients with bone metastases.

Background: We analyzed the need for re-irradiation, rates of pain control, pathological fractures, and functionality in patients randomized to single-fraction (8 Gy 1×) or multiple-fraction radiotherapy (3 Gy 10×) with at least 12 months follow-up, during five years. The hypothesis was that the two radiotherapy schedules are equally effective.

Materials And Methods: Ninety patients with painful skeletal metastases were randomized to receive single fraction (8 Gy) or multiple fraction (3 Gy 10×) radiotherapy.

Results: In the single-fraction group, seven pathological fractures occurred (15.5%) versus two (4.4%) in the multiple-fraction group. There was no statistically significant difference between the time it took to suffer a pathological fracture in both groups (p = 0.099). Patients in the single-fraction group received twelve re-irradiations (26.6%), four in the multiple-fraction group (8.8%), with no significant difference between time elapsed before the first re-irradiation (p = 0.438).

Conclusion: This study shows no difference between the two groups for the majority of patients with painful bone metastases. Patients were followed up during five years, and the trial showed no disadvantage for 8 Gy 1× compared to 3 Gy 10×. Despite the fact that the pathological fracture rate is 3.75 times higher in the single-fraction group, this schedule is considered more convenient for patients and more cost-effective for radiotherapy departments.