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Annals of Oncology Advance Access originally published online on April 27, 2005
Annals of Oncology 2005 16(7):1177-1184; doi:10.1093/annonc/mdi225
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© 2005 European Society for Medical Oncology

Temozolomide in combination with BCNU before and after radiotherapy in patients with inoperable newly diagnosed glioblastoma multiforme

M. Barrié1, C. Couprie2, H. Dufour1, D. Figarella-Branger3, X. Muracciole4, K. Hoang-Xuan5, D. Braguer2, P. M. Martin6, J. C. Peragut1, F. Grisoli1 and O. Chinot1,6,*

1 Unité de Neuro-Oncologie, Service de Neurochirurgie, CHU Timone, Assistance Publique—Hôpitaux de Marseille, 2 Service de Pharmacie, CHU Timone, 3 Laboratoire d'Anatomie Pathologie, CHU Timone, 4 Service de Radiothérapie, CHU Timone, 5 Département de Neurologie, CHU Pitié Salpêtrière, Paris; 6 Laboratoire de Cancérologie Expérimentale, INSERM EMI 0359, Université de la Méditerranée, Faculté de Médecine de Marseille, Marseille, France

* Correspondence to: Dr O. Chinot, Unité de Neuro-Oncologie, Service de Neurochirurgie, Hôpital de la Timone, 264 rue Saint Pierre, 13385 Marseille cedex 05, France. Tel: +33-4-91-38-65-69; Fax: +33-4-91-38-73-48; Email: olivier.chinot{at}mail.ap-hm.fr

Background:: The aim of this study was to evaluate the efficacy and safety of carmustine (BCNU) in combination with temozolomide as first-line chemotherapy before and after radiotherapy (RT) in patients with inoperable, newly diagnosed glioblastoma multiforme (GBM).

Patients and methods:: Forty patients were treated with BCNU (150 mg/m2) on day 1 and temozolomide (110 mg/m2/day) on days 1 through 5 of each 42-day cycle for up to four cycles prior to conventional RT (2 Gy fractions to a total of 60 Gy). After RT, BCNU + temozolomide was administered for four additional cycles or until progression. The primary end point was response rate; secondary end points included progression-free survival (PFS); overall survival (OS) and safety.

Results:: Sixty per cent of patients completed four cycles of neo-adjuvant BCNU + temozolomide. Objective response rate (intention-to-treat) was 42.5% (95% confidence interval 27% to 58%), including two (5%) complete and 15 (37.5%) partial responses. In the eligible population (n=37) the objective response rate was 46%. Nine (24%) patients had stable disease and 14 (35%) had progressive disease. Median PFS and OS were 7.4 and 12.7 months, respectively. Age was the only significant prognostic factor and tumor location (lobar versus multifocal versus corpus callosum) showed a trend. Grade 3–4 toxicities included thrombocytopenia (n=11) and neutropenia (n=7) for both pre- and post-RT chemotherapy. Four patients required platelet transfusions. No patient discontinued treatment because of toxicity.

Conclusions:: The combination of BCNU plus temozolomide as neo-adjuvant therapy in inoperable GBM exhibited promising activity with a good safety profile and warrants further evaluation.

Key words: 3-bis(2-chloroethyl)-1-nitrosourea (BCNU), chemotherapy neo-adjuvant strategy, glioblastoma, inoperable brain tumor, temozolomide


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