Precision Radiation Therapy for Metastatic Spinal Cord Compression: Final results of the PRE-MODE Trial

Dirk Rades, Jon Cacicedo, Antonio J Conde-Moreno, Barbara Segedin, Jasna But-Hadzic, Blaz Groselj, Gvantsa Kevlishvili, Darejan Lomidze, Raquel Ciervide Jurio, Carmen Rubio, Luis A Perez-Romasanta, Ana Alvarez-Gracia, Denise Olbrich, Claudia Doemer, Steven E Schild, Niels H Hollaender

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Abstrakt

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.

OriginalsprogEngelsk
Sider (fra-til)780-789
Antal sider10
TidsskriftInternational Journal of Radiation Oncology Biology Physics
Vol/bind106
Udgave nummer4
Tidlig onlinedato5 dec. 2019
DOI
StatusUdgivet - 15 mar. 2020

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