Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses: Final Results of the RAMSES-01 Trial

Dirk Rades
* ,
Darejan Lomidze
,
Natalia Jankarashvili
,
Fernando Lopez Campos
ORCID logo ,
Arturo Navarro-Martin
,
Barbara Segedin
ORCID logo ,
Blaz Groselj
,
Christian Staackmann
,
Charlotte Kristiansen
ORCID logo ,
Kristopher Dennis
,
Steven E. Schild
ORCID logo ,
Jon Cacicedo
Version 1 : Received: 1 March 2024 / Approved: 4 March 2024 / Online: 4 March 2024 (06:01:20 CET)

A peer-reviewed article of this Preprint also exists.

Rades, D.; Lomidze, D.; Jankarashvili, N.; Lopez Campos, F.; Navarro-Martin, A.; Segedin, B.; Groselj, B.; Staackmann, C.; Kristiansen, C.; Dennis, K.; Schild, S.E.; Cacicedo, J. Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses: Final Results of the RAMSES-01 Trial. Cancers 2024, 16, 1149. Rades, D.; Lomidze, D.; Jankarashvili, N.; Lopez Campos, F.; Navarro-Martin, A.; Segedin, B.; Groselj, B.; Staackmann, C.; Kristiansen, C.; Dennis, K.; Schild, S.E.; Cacicedo, J. Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses: Final Results of the RAMSES-01 Trial. Cancers 2024, 16, 1149.

Abstract

Patients with metastatic epidural spinal cord compression (MESCC) and favorable survival prognoses may benefit from radiation doses exceeding 10 x 3.0 Gy. In a multi-center phase 2 trial, patients receiving 15 x 2.633 Gy (41.6 Gy10) or 18 x 2.333 Gy (43.2 Gy10) were evaluated for local progression-free survival (LPFS), motor/sensory functions, ambulatory status, pain, distress, toxicity, and overall survival (OS). They were compared (propensity score adjusted Cox regression) to a historical control group (N=266) receiving 10 x 3.0 Gy (32.5 Gy10). In the phase 2-cohort, 50 (of 62 planned) patients were evaluable for LPFS. Twelve-month rates of LPFS and OS were 96.8% and 69.9%, respectively. Motor and sensory functions improved in 56% and 57.1% of patients, and 94.0% were ambulatory following radiotherapy. Pain and distress decreased in 84.4% and 78.0% of patients. Ten and two patients experienced grade 2 and 3 toxicities, respectively. Phase 2 patients showed significantly better LPFS than the control group (p = 0.039) and a trend for improved motor function (p = 0.057). Ambulatory and OS rates were not significantly different. Radiotherapy with 15 x 2.633 Gy or 18 x 2.333 Gy was well tolerated and appeared superior to 10 x 3.0 Gy.

Keywords

metastatic epidural spinal cord compression; highly-conformal radiotherapy; increased doses; phase 2 trial; historical control group; local progression-free survival

Subject

Medicine and Pharmacology, Oncology and Oncogenics

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download PDF

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0
Get PDF Cite Share 0
Bookmark BibSonomy Mendeley Reddit Delicious
×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.