Biodegradable carmustine wafers (Gliadel) alone or in combination with chemoradiotherapy: the French experience.
BACKGROUND
Carmustine-releasing wafers (Gliadel have been available and reimbursed in France since 2005.


METHODS
A retrospective multicenter study was conducted in 26 French Departments of Neurosurgery to analyze practices of French neurosurgeons using Gliadel, compare the adverse effects and survival with those of previous phase III trials, and assess survival in patients with newly diagnosed malignant gliomas (MG) receiving Gliadel plus radiochemotherapy with temozolomide (TMZ). A total of 163 patients who received Gliadel for MG were included in this study: 83 (51%) with newly diagnosed MG and 80 (49%) with recurrent MG. In the newly diagnosed group, 51.8% of patients received radiochemotherapy with TMZ.


RESULTS
Adverse events (AEs) emerged in 44.6% of the population, including 6% with septic abscess. The AE rate was not statistically correlated with adjuvant use of TMZ. For the newly diagnosed group, median survival was 17 months. Total or subtotal resection appeared to have a great impact on survival (P = 0.016), as did treatment with adjuvant radiotherapy (P = 0.004). For the group with recurrent MG, median survival was 7 months. Total or subtotal resection excision appeared to have a great impact on survival (P = 0.002), as did preoperative Karnowsky Scale (PO-KPS) (P = 0.012).


CONCLUSIONS
Survival rates for newly diagnosed patients were better than those reported in previous phase III trials. The combination of Gliadel and radiochemotherapy with TMZ was well tolerated and appeared to increase survival without increasing AEs.
Menei
Philippe
P
Département de Neurochirurgie, INSERM U646, CHU d'Angers, Angers, France. phmenei@chu-angers.fr
Metellus
Philippe
P
Parot-Schinkel
Elsa
E
Loiseau
Hugues
H
Capelle
Laurent
L
Jacquet
Guy
G
Guyotat
Jacques
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001672:Biocompatible Materials; D001932:Brain Neoplasms / Q000473:pathology / Q000628:therapy*; D002330:Carmustine / Q000008:administration & dosage; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003652:Decanoic Acids / Q000008:administration & dosage*; D004337:Drug Carriers; D005260:Female; D005602:France; D005910:Glioma / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011091:Polyesters / Q000008:administration & dosage*; D011879:Radiotherapy Dosage; D012189:Retrospective Studies; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome; D055815:Young Adult
D001672:Biocompatible Materials; D003652:Decanoic Acids; D004337:Drug Carriers; D011091:Polyesters; D003606:Dacarbazine; C055401:decanedioic acid-4,4'-(1,3-propanediylbis(oxy))bis(benzoic acid) copolymer; D002330:Carmustine; D000077204:Temozolomide