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8Gy single-dose radiotherapy is effective in metastatic spinal cord compression: Results of a phase III randomized multicentre Italian trial

2009; Elsevier BV; Volume: 93; Issue: 2 Linguagem: Inglês

10.1016/j.radonc.2009.05.012

1879-0887

Ernesto Maranzano, Fabio Trippa, Michelina Casale, Sara Costantini, Marco Lupattelli, Rita Bellavita, L. Marafioti, Stefano Pergolizzi, Anna Santacaterina, Marcello Mignogna, Giovanni Silvano, Vincenzo Fusco,

Spinal Fractures and Fixation Techniques

Background and purpose In a previous randomized trial we showed that the short-course radiotherapy (RT) regimen of 8 Gy × 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 8 Gy single-dose is as effective as 8 Gy × 2. Materials and methods Three hundred and twenty-seven patients with MSCC and short life expectancy were randomly assigned to a short-course of 8 Gy × 2 or to 8 Gy single-dose RT. Median follow-up was 31 months (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 4.5 months for short-course and single-dose RT (p = 0.4), respectively. The median overall survival was 4 months 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 8 Gy.