• Philippe Menei, Laurent Capelle, Jacques Guyotat, Stéphane Fuentes, Richard Assaker, Benoit Bataille, Patrick François, Didier Dorwling-Carter, Philippe Paquis, Luc Bauchet, Fabrice Parker, Jean Sabatier, Nathalie Faisant, and Jean-Pierre Benoit.
• Department of Neurosurgery, Institut National de la Santé et de la Recherche Médicale, Unite 646, University Hospital, Angers, France. phmenei@chu-angers.fr
• Neurosurgery. 2005 Feb 1; 56 (2): 242-8; discussion 242-8.

ObjectiveThis study was a randomized, multicenter Phase II trial comparing the effect of perioperative implantation of 5-fluorouracil-releasing microspheres followed by early radiotherapy (Arm A) and early radiotherapy alone (Arm B) in patients with gross total resection of high-grade glioma.MethodsPatients were randomized on clinical and radiological assumption of supratentorial high-grade glioma. All patients underwent surgery, and after resection and histological confirmation, patients randomized to Arm A received multiple injections of microsphere suspension (130 mg of 5-fluorouracil). Conventional fractionated radiotherapy (59.4 Gy) was initiated between the second and the seventh day after surgery for both arms.ResultsA total of 95 patients were randomized. Seventy-seven patients were treated and analyzed in intention to treat for efficacy and safety. Overall survival was 15.2 months in Arm A and 13.5 months in Arm B. In the subpopulation of patients with complete resection, overall survival was 15.2 months in Arm A versus 12.3 months in Arm B. However, these differences were not significant. Safety was acceptable with prophylactic high doses of corticosteroids.ConclusionIt may be hypothesized that the implantation of 5-fluorouracil-loaded microspheres in the wall of the cavity resection did increase the overall survival, but the present study was not designed and sufficiently powered to demonstrate this.

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