8Gy single-dose radiotherapy is effective in metastatic spinal cord compression: results of a phase III randomized multicentre Italian trial.
OBJECTIVE
In a previous randomized trial we showed that the short-course radiotherapy (RT) regimen of 8 Gy x 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 x 2.


METHODS
Three hundred and twenty-seven patients with MSCC and short life expectancy were randomly assigned to a short-course of 8 Gy x 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.
Maranzano
Ernesto
E
Radiotherapy Centre, S. Maria Hospital, Terni, Italy. e.maranzano@aospterni.it
Trippa
Fabio
F
Casale
Michelina
M
Costantini
Sara
S
Lupattelli
Marco
M
Bellavita
Rita
R
Marafioti
Luigi
L
Pergolizzi
Stefano
S
Santacaterina
Anna
A
Mignogna
Marcello
M
Silvano
Giovanni
G
Fusco
Vincenzo
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D012008:Recurrence; D013117:Spinal Cord Compression / Q000532:radiotherapy*; D013120:Spinal Cord Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary*