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Radiotherapy for Metastatic Epidural Spinal Cord Compression with Increased Doses: Final Results of the RAMSES-01 Trial.
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; Cacicedo, Jon.
Afiliación
  • Rades D; Department of Radiation Oncology, University of Lubeck, 23562 Lubeck, Germany.
  • Lomidze D; Radiation Oncology Department, Tbilisi State Medical University, 0186 Tbilisi, Georgia.
  • Jankarashvili N; Ingorokva High Medical Technology University Clinic, 0144 Tbilisi, Georgia.
  • Lopez Campos F; Department of Radiation Oncology, Acad. F. Todua Medical Center-Research Institute of Clinical Medicine, 0112 Tbilisi, Georgia.
  • Navarro-Martin A; Department of Radiation Oncology, University Hospital Ramón y Cajal, 28034 Madrid, Spain.
  • Segedin B; Department of Radiation Oncology, Instituto Catalán de Oncología, 08908 l'Hospitalet de Llobregat, Spain.
  • Groselj B; Department of Radiotherapy, Institute of Oncology Ljubljana and Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
  • Staackmann C; Department of Radiotherapy, Institute of Oncology Ljubljana and Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
  • Kristiansen C; Department of Radiation Oncology, University of Lubeck, 23562 Lubeck, Germany.
  • Dennis K; Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.
  • Schild SE; Division of Radiation Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
  • Cacicedo J; Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA.
Cancers (Basel) ; 16(6)2024 Mar 14.
Article en En | MEDLINE | ID: mdl-38539484
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 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cancers (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cancers (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza