Recalcification and pain relief following radiotherapy for bone metastases. A randomized trial of 2 different fractionation schedules (10 x 3 Gy vs 1x 8 Gy) - A prospective trial

Background: In a prospective randomized trial we examined pain relief and r ecalcification following radiotherapy for bone metastases. Patients and Method: One hundred and seven patients with histologically pro ven breast, lung, prostate or kidney cancer and radiologically confirmed bo ne metastases were included in this trial. They were stratified to primary tumor sites and randomized in 2 different fractionation schedules: 1 x 8 Gy vs 10 x 3 Gy. Pain relief was registered using of pain score, analgesic us age and subjective perception of pain. The recalcification was measured at the computertomograph. Pain status and recalcification were assessed before , day after, 6 weeks, 3 and 6 months after radiotherapy. Results: There was no significant difference in overall (81% vs 78%) and co mplete (33% vs 31%) pain response. In the single dose group (1 x 8 Gy) the pain response was measured a little rarer. The recalcification showed a sig nificant difference between patients in the fractionated group (173%) and t he single dose group (120%, p < 0.0001). In the fractionated group there wa s a significant difference between patients with breast and lung cancer (p = 0.015). There was a slight trend favoring 10 x 3 Gy in recalcification fo r all primary tumor sites but only a significant difference in breast cance r (p < 0.001). Conclusion: The basis of pain response and recalcification is different. In mere consideration of pain a short-course fractionation is recommendable. This fractionation schedule is effective, well tolerable and short. In cons ideration of recalcification a more fractionated schedule is recommendable because the biological efficacy is higher and this leads to better stabilis ation.