Patients with a favourable prognosis are equally palliated with single and multiple fraction radiotherapy: results on survival in the Dutch Bone Metastasis Study.

BACKGROUND AND PURPOSE: In the prospectively, randomized Dutch Bone Metastasis Study on the effect of a single fraction of 8 Gy versus 24 Gy in six fractions on painful bone metastases, 28% of the patients survived for more than 1 year. Purpose of the present study was to analyze the palliative effect of radiotherapy in long-term surviving patients, and to identify prognostic factors for survival. MATERIAL AND METHODS: Response rates were compared in all patients surviving>52 weeks. The Cox proportional hazards model stratified by primary tumour was used for multivariate (MV) analyses of prognostic factors for survival. RESULTS: In 320 patients surviving>52 weeks, responses were 87% after 8 Gy and 85% after 24 Gy (P=0.54). Duration of response and progression rates were similar. For all primary tumours, prognostic factors for survival were a good Karnofsky Performance Score, no visceral metastases, and non-opioid analgesics intake (all factors, MV P<0.001). CONCLUSIONS: Single fraction radiotherapy should be the standard dose schedule for all patients with painful bone metastases, including patients with an expected favourable survival. General prognosticators as the Karnofsky Performance Score and metastatic tumour load are useful in predicting survival.

Single- versus multiple-fraction radiotherapy in patients with painful bone metastases: cost-utility analysis based on a randomized trial.

BACKGROUND: Radiotherapy is an effective palliative treatment for cancer patients with painful bone metastases. Although single- and multiple-fraction radiotherapy are thought to provide equal palliation, which treatment schedule provides better value for the money is unknown. We compared quality-adjusted life expectancy (the overall valuation of the health of the patients) and societal costs for patients receiving either single- or multiple-fraction radiotherapy. METHODS: A societal cost-utility analysis was performed on a Dutch randomized, controlled trial of 1157 patients with painful bone metastases that compared pain responses and quality of life from a single-fraction treatment schedule of 8 Gy with a treatment schedule of six fractions of 4 Gy each. The societal values of life expectancies were assessed with the EuroQol classification system (EQ-5D) questionnaire. A subset of 166 patients also answered additional questionnaires to estimate nonradiotherapy and nonmedical costs. Statistical tests were two-sided. RESULTS: Comparing the single- and multiple-fraction radiotherapy schedules, no differences were found in life expectancy (43.0 versus 40.4 weeks, P =.20) or quality-adjusted life expectancy (17.7 versus 16.0 weeks, P =.21). The estimated cost of radiotherapy, including retreatments and nonmedical costs, was statistically significantly lower for the single-fraction schedule than for the multiple-fraction schedule ($2438 versus $3311, difference = $873, 95% confidence interval [CI] on the difference = $449 to $1297; P<.001). The estimated difference in total societal costs was larger, also in favor of the single-fraction schedule, but it was not statistically significant ($4700 versus $6453, difference = $1753, 95% CI on the difference = -$99 to $3604; P =.06). For willingness-to-pay between $5000 and $40 000 per quality-adjusted life year, the single-fraction schedule was statistically significantly more cost-effective than the multiple-fraction schedule (P< or =.05). CONCLUSIONS: Compared with multiple-fraction radiotherapy, single-fraction radiotherapy provides equal palliation and quality of life and has lower medical and societal costs, at least in The Netherlands. Therefore, single-fraction radiotherapy should be considered as the palliative treatment of choice for cancer patients with painful bone metastases.

Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment.

PURPOSE: The Dutch Bone Metastasis Study on the effect on painful bone metastases of 8 Gy single fraction (SF) vs. 24 Gy in multiple fractions (MF) showed 24% retreatment after SF vs. 6% after MF (p < 0.001). The purpose of the present study was to evaluate factors influencing retreatment and its effect on response. METHODS AND MATERIALS: The database on all randomized patients was reanalyzed with separately calculated responses to initial treatment and retreatment. RESULTS: Response to initial treatment was 71% after SF vs. 73% after MF (p = 0.84). Retreatment raised response to 75% for SF; MF remained unaltered (p = 0.54). The response status after initial treatment did not predict occurrence of retreatment: 35% SF vs. 8% MF nonresponders and 22% SF vs. 10% MF patients with progressive pain were retreated. Logistic regression analyses showed the randomization arm and the pain score before retreatment to significantly predict retreatment (p < 0.001). Retreatment for nonresponders was successful in 66% SF vs. 33% MF patients (p = 0.13). Retreatment for progression was successful in 70% SF vs. 57% MF patients (p = 0.24). CONCLUSIONS: With or without the effect of retreatment, SF and MF radiotherapy provided equal palliation for painful bone metastases. Irrespective of response to initial treatment, physicians were more willing to retreat after a single fraction. Overall, retreatment was effective in 63% of retreated patients.