TY - JOUR
T1 - Precision Radiation Therapy for Metastatic Spinal Cord Compression: Final Results of the PRE-MODE Trial
AU - Rades, Dirk
AU - Cacicedo, Jon
AU - Conde-Moreno, Antonio J.
AU - Segedin, Barbara
AU - But-Hadzic, Jasna
AU - Groselj, Blaz
AU - Kevlishvili, Gvantsa
AU - Lomidze, Darejan
AU - Raquel, Ciervide Jurio
AU - Rubio, Carmen
AU - Perez-Romasanta, Luis A.
AU - Alvarez-Gracia, Ana
AU - Olbrich, Denise
AU - Doemer, Claudia
AU - Schild, Steven E.
AU - Hollaender, Niels H.
N1 - Funding Information:
As part of the project InnoCan, the PRE-MODE trial was funded by the European Regional Development Fund (Interreg program), reference: Innoc 11-1.0-15.
Publisher Copyright:
© 2019 Elsevier Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/3/15
Y1 - 2020/3/15
N2 - Objective: To investigate precision radiation therapy for metastatic spinal cord compression and compare it to conventional radiation therapy. Methods and Materials: In a multicenter phase 2 study, 40 patients received 5 Gy × 5 fractions of precision radiation therapy (38 volume modulated arc therapy, 2 intensity modulated radiation therapy) for metastatic spinal cord compression and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS), and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk, <0.03%) of the prescription dose. Patients were compared with a historical control group conventionally irradiated with 4 Gy × 5 fractions (propensity score analysis). The equivalent dose in 2 Gy-fractions of 5 Gy × 5 fractions is similar to 3 Gy × 10 fractions, which results in better LPFS than 4 Gy × 5 fractions. It was assumed that 5 Gy × 5 fractions is also superior to 4 Gy × 5 fractions for LPFS. (ClinicalTrials.gov-identifier: NCT03070431) Results: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory after radiation therapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients 1 month after radiation therapy. Grade 3 toxicities occurred in 1 patient and grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity score analysis; 5 Gy × 5 fractions was significantly superior to 4 Gy × 5 fractions with regard to LPFS (P =.026) but not motor function (P =.51) or OS (P =.82). Conclusions: Precision radiation therapy with 5 Gy × 5 fractions was well tolerated and effective and appeared superior to 4 Gy × 5 fractions in terms of LPFS. The retrospective nature of the historic control group, which might have led to a hidden selection bias, needs to be considered when interpreting the results.
AB - Objective: To investigate precision radiation therapy for metastatic spinal cord compression and compare it to conventional radiation therapy. Methods and Materials: In a multicenter phase 2 study, 40 patients received 5 Gy × 5 fractions of precision radiation therapy (38 volume modulated arc therapy, 2 intensity modulated radiation therapy) for metastatic spinal cord compression and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS), and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk, <0.03%) of the prescription dose. Patients were compared with a historical control group conventionally irradiated with 4 Gy × 5 fractions (propensity score analysis). The equivalent dose in 2 Gy-fractions of 5 Gy × 5 fractions is similar to 3 Gy × 10 fractions, which results in better LPFS than 4 Gy × 5 fractions. It was assumed that 5 Gy × 5 fractions is also superior to 4 Gy × 5 fractions for LPFS. (ClinicalTrials.gov-identifier: NCT03070431) Results: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory after radiation therapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients 1 month after radiation therapy. Grade 3 toxicities occurred in 1 patient and grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity score analysis; 5 Gy × 5 fractions was significantly superior to 4 Gy × 5 fractions with regard to LPFS (P =.026) but not motor function (P =.51) or OS (P =.82). Conclusions: Precision radiation therapy with 5 Gy × 5 fractions was well tolerated and effective and appeared superior to 4 Gy × 5 fractions in terms of LPFS. The retrospective nature of the historic control group, which might have led to a hidden selection bias, needs to be considered when interpreting the results.
UR - http://www.scopus.com/inward/record.url?scp=85079905039&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2019.11.401
DO - 10.1016/j.ijrobp.2019.11.401
M3 - Journal articles
C2 - 31812719
AN - SCOPUS:85079905039
SN - 0360-3016
VL - 106
SP - 780
EP - 789
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 4
ER -
