Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882).

Details

Serval ID
serval:BIB_D1F0737F890F
Type
Article: article from journal or magazin.
Collection
Publications
Title
Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882).
Journal
European Journal of Cancer
Author(s)
Hildebrand J., Gorlia T., Kros J.M., Afra D., Frenay M., Omuro A., Stupp R., Lacombe D., Allgeier A., van den Bent M.J.
Working group(s)
EORTC Brain Tumour Group investigators
Contributor(s)
Afra D., Maat B., Hildebrand J., de Wit O., Frenay F., Chatel M., Rivier I., Taphoorn M., Delattre JY., de Tribolet N., Stupp R., Punt J., Garfield J., Chinot O., van den Bent M., Lahrmann H., Cristo C., Mouchamps M., Haferkamp G., Bravo Marques J.
ISSN
0959-8049 (Print)
ISSN-L
0959-8049
Publication state
Published
Issued date
2008
Peer-reviewed
Oui
Volume
44
Number
9
Pages
1210-1216
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
BACKGROUND: In a previous randomised EORTC study on adjuvant dibromodulcitol (DBD) and bichloroethylnitrosourea (BCNU) in adults with glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), a clinically significant trend towards a longer overall survival (OS) and a progression-free survival (PFS) was observed in the subgroup of AA. The aim of the present study was to test this adjuvant regimen in a larger number of AA patients.
METHODS: Continuation of the previous phase III trial for newly diagnosed AA according to the local pathologist. Patients were randomised to either radiotherapy only or to radiotherapy in combination with BCNU on day 2 and weekly DBD, followed by adjuvant DBD and BCNU in cycles of six weeks for a maximum total treatment duration of one year. OS was the primary end-point.
RESULTS: Patients (193 ) with newly diagnosed AA according to local pathological assessment were randomised to radiotherapy (RT) alone (n=99), or to RT plus DBD/BCNU (n=94); 12 patients were considered not eligible. At central pathology review, over half (53%) of the locally diagnosed AA cases could not be confirmed. On intent-to-treat analysis, no statistically significant differences in OS (p=0.111) and PFS (p=0.087) were observed, median OS after RT was only 23.9 months 95% confidence interval (CI), [18.4-34.0] after RT plus DBD/BCNU 27.3 months 95% CI [21.4-46.8].
CONCLUSION: No statistically significant improvement in survival was observed after BCNU/DBD adjuvant chemotherapy in AA patients. The trend towards improved survival is consistent with previous reports. Central pathology review of grade 3 tumours remains crucial.
Keywords
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Astrocytoma/drug therapy, Astrocytoma/radiotherapy, Carmustine/administration & dosage, Carmustine/adverse effects, Chemotherapy, Adjuvant, Female, Hematologic Diseases/chemically induced, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mitolactol/administration & dosage, Mitolactol/adverse effects, Treatment Failure
Pubmed
Web of science
Create date
12/03/2009 14:35
Last modification date
20/08/2019 16:52
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