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Preradiation combination of temozolomide (TMZ) and BCNU as primary treatment before radiotherapy (RT) in inoperable newly diagnosed glioblastoma multiforme (GBM)

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 06/14/2003

39th ASCO Annual Meeting • Chicago, IL • May 31-June 3, 2003 (Abstract No. 431)

Preradiation combination of temozolomide (TMZ) and BCNU as primary treatment before radiotherapy (RT) in inoperable newly diagnosed glioblastoma multiforme (GBM)

O. Chinot, M. Barrie, C. Couprie, H. Dufour, D. Figarella, X. Muracciole, D. Braguer, K. Hoang-Huan, J.-C. Peragut, F. Grisoli

Chu Timone, Marseille, France; CHU Pitie-Salpetriere, Paris, France

Purpose: To evaluate the efficacy and safety of a combination of BCNU and TMZ as first line chemotherapy before RT in patients with inoperable newly diagnosed GBM.

Patients and Methods: Patients with newly diagnosed GBM, presenting a measurable disease after biopsy, were enrolled in this prospective study. Treatment consisted of BCNU 150 mg/m2 at day 1 and TMZ 110 mg/m2/day from day 1-day 5 in a 42-day cycle, and was administered for up to 4 cycles before RT, and then after RT up to 8 cycles or until progression. Assessment of response was performed after each cycle. Primary endpoint was response rate (MacDonald criterias, with response confirmed 1 month apart); secondary endpoints included progression free survival (PFS); overall survival (OS) and toxicity. Independent review of all histologies and of MRI responses were performed.

Results: Of the 40 patients included (median age: 61 years; median KPS: 70 ), 37 patients were considered eligible. Location was lobar (23), multifocal (10), and of the corpus callosum (7). 60%, 15%, and 10% of pts completed 4, 3, and 2 cycles. 75% of patients completed radiotherapy. As the ITT analysis, response included, CR: 2 (5%), PR: 15 (37.5%), SD: 9 (24%), and PD: 12 (33%) (objective response rate: 42.5% (ITT) and 46% in the eligible population, 95% exact CI (29.9-62)). With a median follow-up of 18.8 months (ITT analysis), median PFS and OS were 7.4 and 12.7 months respectively. Survival rate at 6, 12, and 18 months were 77%, 54%, and 20% respectively. The associated OS per response was 16.6, 14.5, and 4.4 months respectively in case of PR, SD PD (p < 0.0001). Age (< 50y), and location (lobar), exhibit positive prognostic value. Toxicity (NCI) evaluated during 204 cycles included grade 3-4 toxicities per patient: thrombocytopenia (n=11), neutropenia (n=7) platelets transfusion (n=4); emesis, constipation, asthenia were moderate. No pulmonary toxicity was observed.

Conclusion: Combination of TMZ/BCNU in GBM is feasible and exhibit significant efficacy with a good safety profile and warrant further evaluation.

© Copyright 2003 American Society of Clinical Oncology All rights reserved worldwide

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