TY - JOUR
T1 - Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression
AU - Thirion, Pierre G.
AU - Dunne, Mary T.
AU - Kelly, Paul J.
AU - Flavin, Aileen
AU - O’Sullivan, Joe M.
AU - Hacking, Dayle
AU - Sasiadek, Wojciech
AU - Small, Cormac
AU - Pomeroy, Maeve M.
AU - Martin, Joseph
AU - McArdle, Orla
AU - Parker, Imelda
AU - O’Sullivan, Lydia S.
AU - Shannon, Aoife M.
AU - Clayton-Lea, Angela
AU - Collins, Conor D.
AU - Stevenson, Michael R.
AU - Alvarez-Iglesias, Alberto
AU - Armstrong, John G.
AU - Moriarty, Michael
N1 - Publisher Copyright:
© 2020, The Author(s), under exclusive licence to Cancer Research UK.
PY - 2020/4/28
Y1 - 2020/4/28
N2 - Background: The optimal EBRT schedule for MSCC is undetermined. Our aim was to determine whether a single fraction (SF) was non-inferior to five daily fractions (5Fx), for functional motor outcome. Methods: Patients not proceeding with surgical decompression in this multicentre non-inferiority, Phase 3 trial were randomised to 10 Gy/SF or 20 Gy/5Fx. A change in mobility from baseline to 5 weeks for each patient, was evaluated by a Modified Tomita score: 1 = ‘Walk unaided’, 2 = ‘With walking aid’ and 3 = ‘Bed-bound’. The margin used to establish non-inferiority was a detrimental change of −0.4 in the mean difference between arms. Results: One-hundred and twelve eligible patients were enrolled. Seventy-three patients aged 30–87 were evaluated for the primary analysis. The 95% CI for the difference in the mean change in mobility scores between arms was −0.12 to 0.6. Since −0.4 is not included in the interval, there is evidence that 10 Gy/SF is non-inferior to 20 Gy/5Fx. One grade 3 AE was reported in the 5Fx arm. Twelve (26%) patients in the 5Fx arm had a Grade 2–3 AE compared with six (11%) patients in the SF arm (p = 0.093). Conclusion: For mobility preservation, one 10-Gy fraction is non-inferior to 20 Gy in five fractions, in patients with MSCC not proceeding with surgical decompression. Clinical Trial Registration: Cancer Trials Ireland ICORG 05-03; NCT00968643; EU-20952.
AB - Background: The optimal EBRT schedule for MSCC is undetermined. Our aim was to determine whether a single fraction (SF) was non-inferior to five daily fractions (5Fx), for functional motor outcome. Methods: Patients not proceeding with surgical decompression in this multicentre non-inferiority, Phase 3 trial were randomised to 10 Gy/SF or 20 Gy/5Fx. A change in mobility from baseline to 5 weeks for each patient, was evaluated by a Modified Tomita score: 1 = ‘Walk unaided’, 2 = ‘With walking aid’ and 3 = ‘Bed-bound’. The margin used to establish non-inferiority was a detrimental change of −0.4 in the mean difference between arms. Results: One-hundred and twelve eligible patients were enrolled. Seventy-three patients aged 30–87 were evaluated for the primary analysis. The 95% CI for the difference in the mean change in mobility scores between arms was −0.12 to 0.6. Since −0.4 is not included in the interval, there is evidence that 10 Gy/SF is non-inferior to 20 Gy/5Fx. One grade 3 AE was reported in the 5Fx arm. Twelve (26%) patients in the 5Fx arm had a Grade 2–3 AE compared with six (11%) patients in the SF arm (p = 0.093). Conclusion: For mobility preservation, one 10-Gy fraction is non-inferior to 20 Gy in five fractions, in patients with MSCC not proceeding with surgical decompression. Clinical Trial Registration: Cancer Trials Ireland ICORG 05-03; NCT00968643; EU-20952.
UR - https://www.scopus.com/pages/publications/85081694595
U2 - 10.1038/s41416-020-0768-z
DO - 10.1038/s41416-020-0768-z
M3 - Article
C2 - 32157242
AN - SCOPUS:85081694595
SN - 0007-0920
VL - 122
SP - 1315
EP - 1323
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 9
ER -
