Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial)

• DOI: 10.1093/neuonc/noad119
• Publication Date: 2023-07-05T21:21:14Z
• Authors: Anne Laprie; Georges Noel; Leonor Chaltiel; Gilles Truc; Marie-Pierre Sunyach; Marie Charissoux; Nicolas Magne; Pierre Auberdiac; Julian Biau; Soléakhéna Ken; Fatima Tensaouti; Jonathan Khalifa; Ingrid Sidibe; Franck-Emmanuel Roux; Laure Vieillevigne; Isabelle Catalaa; Sergio Boetto; Emmanuelle Uro-Coste; Stéphane Supiot; Valérie Bernier; Thomas Filleron; Muriel Mounier; Muriel Poublanc; Pascale Olivier; Jean-Pierre Delord; Elizabeth Cohen-J...
• Keywords: Temozolomide; Regimen

Abstract Background Glioblastoma (GBM) systematically recurs after a standard 60 Gy radio-chemotherapy regimen. Since magnetic resonance spectroscopic imaging (MRSI) has been shown to predict the site of relapse, we analyzed effect MRSI-guided dose escalation on overall survival (OS) patients with newly diagnosed GBM. Methods In this multicentric prospective phase III trial, who had undergone biopsy or surgery for GBM were randomly assigned (SD) high (HD) an additional simultaneous integrated boost totaling 72 MRSI metabolic abnormalities, tumor bed and residual contrast enhancements. Temozolomide was administered concomitantly maintained 6 months thereafter. Results One hundred eighty included in study between March 2011 2018. After median follow-up 43.9 (95% CI [42.5; 45.5]), OS 22.6 [18.9; 25.4]) versus 22.2 [18.3; 27.8]) HD, progression-free 8.6 [6.8; 10.8]) 7.8 [6.3; 8.6]), SD respectively. No increase toxicity rate observed arm. The pseudoprogression similar across (14.4%) HD (16.7%) groups. For O(6)-methylguanine-DNA methyltransferase (MGMT) methylated patients, 38 [23.2; NR]) 28.5 [21.1; 35.7]) patients. Conclusion irradiation well tolerated but did not improve Trial registration NCT01507506; date: December 20, 2011. https://clinicaltrials.gov/ct2/show/NCT01507506?cond=NCT01507506&rank=1