201. Local and sustained delivery of 5-fluorouracil from biodegradable microspheres for the radiosensitization of malignant glioma: a randomized phase II trial.
- Author
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Menei P, Capelle L, Guyotat J, Fuentes S, Assaker R, Bataille B, François P, Dorwling-Carter D, Paquis P, Bauchet L, Parker F, Sabatier J, Faisant N, and Benoit JP
- Subjects
- Biodegradation, Environmental, Combined Modality Therapy, Delayed-Action Preparations, Female, Humans, Male, Middle Aged, Radiation-Sensitizing Agents, Antimetabolites, Antineoplastic therapeutic use, Fluorouracil administration & dosage, Glioma drug therapy, Glioma radiotherapy, Microspheres, Supratentorial Neoplasms drug therapy, Supratentorial Neoplasms radiotherapy
- Abstract
Objective: This 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., Methods: Patients 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., Results: A 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., Conclusion: It 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.
- Published
- 2005
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