8Gy single-dose radiotherapy is effective in metastatic spinal cord compression: Results of a phase III randomized multicentre Italian trial
Received 2 February 2009; received in revised form 27 April 2009; accepted 10 May 2009. published online 11 June 2009.
Abstract
Background and purpose
In a previous randomized trial we showed that the short-course radiotherapy (RT) regimen of 8Gy×2 was feasible in patients with metastatic spinal cord compression (MSCC) and short life expectancy. This phase III trial was planned to determine whether in the same category of patients 8Gy single-dose is as effective as 8Gy×2.
Materials and methods
Three hundred and twenty-seven patients with MSCC and short life expectancy were randomly assigned to a short-course of 8Gy×2 or to 8Gy single-dose RT. Median follow-up was 31months (range, 4–58).
Results
A total of 303 (93%) patients are assessable, 150 treated with the short-course and 153 with the single-dose RT. No difference in response was found between the two RT schedules adopted. Median duration of response was 5 and 4.5months for short-course and single-dose RT (p=0.4), respectively. The median overall survival was 4months for all cases. Light acute toxicity was registered in a minority of cases. Late toxicity was never recorded.
Conclusions
Both RT schedules adopted were effective. As already shown in several trials evaluating RT regimens in uncomplicated painful bone metastases, also MSCC patients may achieve palliation with minimal toxicity and inconvenience with a single-dose of 8Gy.
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