Efficacy of radiotherapy for painful bone metastases during the last 12 weeks of life: results from the Dutch Bone Metastasis Study.

BACKGROUND: Radiotherapy is an effective treatment for painful bone metastases. Whether this applies also in patients with limited survival remains to be investigated. This study analyzed the effect of radiotherapy for painful bone metastases in patients with a survival < or =12 weeks. METHODS: In the Dutch Bone Metastasis Study, 1157 patients with painful bone metastases were randomized to single fraction (1 x 8 grays [Gy]) or multiple fraction (6 x 4 Gy) radiotherapy. Patients who died within 12 weeks after randomization were included in this analysis. Patients were classified as responders or nonresponders, based on their pain response to radiotherapy. This response was calculated considering changes in pain intensity (measured with an 11-point numeric rating scale) and analgesic usage. Cox proportional hazards models were used to analyze pain response and survival. RESULTS: Two hundred seventy-4 patients were included in this analysis. At randomization, the mean pain intensity score (+/-standard deviation) was 7 (+/-2). The proportion showing a pain response did not differ between the single fraction and multiple fraction groups. Toward death, pain intensity score decreased to 5 (+/-3) in responders (45%), whereas in nonresponders (55%) no change was observed. Despite the benefit in responders, in 60% of all patients pain intensity remained 5 after randomization. CONCLUSIONS: Pain responded in about half of the patients who survived < or =12 weeks after randomization into the Dutch Bone Metastasis Study. When considering radiotherapy, single fraction should be preferred. Additional palliative measures remain essential for adequate pain control