Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses : Final Results of the RAMSES-01 Trial
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Cancers - 16(2024), 6 vom: 14. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rades, Dirk [VerfasserIn] |
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| Links: |
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| Themen: |
Highly conformal radiotherapy |
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| Anmerkungen: |
Date Revised 30.03.2024 published: Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3390/cancers16061149 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a 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 | ||
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| 700 | 1 | |a Lomidze, Darejan |e verfasserin |4 aut | |
| 700 | 1 | |a Jankarashvili, Natalia |e verfasserin |4 aut | |
| 700 | 1 | |a Lopez Campos, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Navarro-Martin, Arturo |e verfasserin |4 aut | |
| 700 | 1 | |a Segedin, Barbara |e verfasserin |4 aut | |
| 700 | 1 | |a Groselj, Blaz |e verfasserin |4 aut | |
| 700 | 1 | |a Staackmann, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Kristiansen, Charlotte |e verfasserin |4 aut | |
| 700 | 1 | |a Dennis, Kristopher |e verfasserin |4 aut | |
| 700 | 1 | |a Schild, Steven E |e verfasserin |4 aut | |
| 700 | 1 | |a Cacicedo, Jon |e verfasserin |4 aut | |
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