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

Overview

Journal Cancers (Basel)

Publisher MDPI

Specialty Oncology

Date 2024 Mar 28

PMID 38539484

Authors

Dirk Rades

Darejan Lomidze

Natalia Jankarashvili

Fernando Lopez Campos

Arturo Navarro-Martin

Barbara Segedin

Blaz Groselj

Christian Staackmann

Charlotte Kristiansen

Kristopher Dennis

Steven E Schild

Jon Cacicedo

Affiliations

Soon will be listed here.

Abstract

Patients with metastatic epidural spinal cord compression (MESCC) and favorable survival prognoses may benefit from radiation doses exceeding 10 × 3.0 Gy. In a multi-center phase 2 trial, patients receiving 15 × 2.633 Gy (41.6 Gy) or 18 × 2.333 Gy (43.2 Gy) 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 × 3.0 Gy (32.5 Gy). In the phase 2 cohort, 50 (of 62 planned) patients were evaluated 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 ( = 0.039) and a trend for improved motor function ( = 0.057). Ambulatory and OS rates were not significantly different. Radiotherapy with 15 × 2.633 Gy or 18 × 2.333 Gy was well tolerated and appeared superior to 10 × 3.0 Gy.

Citing Articles

Radiotherapy with 15 × 2.633 Gy vs. 20 × 2.0 Gy in Patients with Malignant Spinal Cord Compression and Favorable Survival Prognoses: A Secondary Analysis of the RAMSES-01 Trial.

Rades D, Lomidze D, Jankarashvili N, Lopez Campos F, Navarro-Martin A, Segedin B Cancers (Basel). 2024; 16(20).

PMID: 39456531 PMC: 11506761. DOI: 10.3390/cancers16203436.

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