Treatment > Radiation-Enhancing Agents  

Meeting Abstract

A randomized phase II trial of early radiotherapy (RT) with or without local fluorouracil-releasing microspheres (FU-M) in patients (pts) with complete surgical resection of high grade glioma (HGG): preliminary results

P Menei, L Capelle, R Assaker, J Guyotat, P Francois, B Bataille, T Dufour, D Dorwling-Carter, J Sabatier, F Parker, P Paquis, O Chinot, L Bauchet, A Yovine, B Lhote

CHU d'Angers, Angers, France; Hopital Pitie Salpetriere, Paris, France; CHU de Lille, Lille, France; Hospices de Lyon, Lyon, France; CHU de Tours, Tours, France; CHU de Poitiers, Poitiers, France; CHR d'Orleans, Orleans, France; CHU de Toulouse, Toulouse, France; CHU de Kremlin Bicetre, Kremlin Bicetre, France; CHU de Nice, Nice, France; CHU la Timone, Marseille, France; CHU de Montpellier, Montpellier, France; CAC, Kremlin-Bicetre, France; Ethypharm, Saint Cloud, France

Median survival of HGG pts after surgery followed by RT is 36 weeks. 
PLAGA-FU-M are biodegradable. 
FU is slowly released from tissue-implanted microspheres and used as radiosensitization. 
In vivo preclinical studies show that FU-M/RT combination is more effective than either treatment alone. 
We report preliminary results of a randomized phase II trial comparing surgery followed by local implantation of FU-M plus early RT (A) and surgery plus early RT alone (B) in HGG pts. 
The principal objectives were to assess local progression free survival and safety. 
Treatment: FU-M were injected around the walls of the resection cavity every cm² and RT (59.4 Gy over 6.5 wks) was begun within 7 days of surgery. 
Tumor assessment was made by MRI every 3 months. 

Results. As of November 2001, 70 pts were randomized. 
Results are presented for the first 58 pts: 37 pts treated (HGG not histologically confirmed: 21 pts), A: 18 and B: 19. 
Median age A: 55 years (range 35-69), B: 58 (29-67). 
Sex (M/F) A: 12/6, B: 11/9. 
Complete/incomplete (radiological) resection: A: 13/5, B: 11/8. 
Radiotherapy was completed in all pts. 
Efficacy: 37 pts evaluable (A: 18, B: 19); median follow up A: 15 months (3.5 - 21.5), B: 14.2 months (4.6-25). 
Local progression A: 7 pts (2.6-10.5 months), B: 12 pts (1.6-12.7 months). 
Distant progression only A: 5; B: 1. 
No relapse: A: 6 pts (5.3+ to 9.2+ months), B: 6 pts (2.3+ to 15+ months). 
Safety: 11 pts experienced neurological adverse events in A (grade 3-4 in 7 pts) and 12 pts in B (grade 3-4 in 2 pts), most being reversible. 
No local healing complications were observed. 

Conclusions. This technique is feasible and well tolerated. 
These preliminary results suggest FU-M may delay local relapse.

© Copyright 2002 American Society of Clinical Oncology