1. Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses: Final Results of the RAMSES-01 Trial.
- Author
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Rades, Dirk, Lomidze, Darejan, Jankarashvili, Natalia, Lopez Campos, Fernando, Navarro-Martin, Arturo, Segedin, Barbara, Groselj, Blaz, Staackmann, Christian, Kristiansen, Charlotte, Dennis, Kristopher, Schild, Steven E., and Cacicedo, Jon
- Subjects
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RADIOTHERAPY , *PSYCHOLOGICAL distress , *RESEARCH funding , *SPINAL cord compression , *SPINAL tumors , *METASTASIS , *LONGITUDINAL method , *RESEARCH , *PAIN , *RADIATION doses , *COMPARATIVE studies , *PROGRESSION-free survival , *OVERALL survival - Abstract
Simple Summary: Patients with MESCC and favorable survival prognoses assigned to radiotherapy alone may benefit from increased doses. In a multi-center phase 2 trial, patients receiving 15 × 2.633 Gy or 18 × 2.333 Gy were evaluated and subsequently compared to a historical control group receiving 10 × 3.0 Gy. The phase 2 cohort, including 50 (of 62 planned) evaluable patients, showed promising results regarding 12-month local progression-free survival (LPFS), 12-month overall survival (OS), improvement of motor and sensory functions, post-radiotherapy ambulatory status, and relief of pain and distress. Radiotherapy with 15 × 2.633 Gy or 18 × 2.333 Gy was well tolerated and appeared more effective than 10 × 3.0 Gy with respect to LPFS and improvement of motor function. 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 Gy10) or 18 × 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 × 3.0 Gy (32.5 Gy10). 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 (p = 0.039) and a trend for improved motor function (p = 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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