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One week on/one week off regimen of temozolomide for recurrent glioblastoma: A phase II study.



Website: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-00510,00.asp

Posted on: 06/08/2004

One week on/one week off regimen of temozolomide for recurrent glioblastoma: A phase II study.

Meeting: 2004 ASCO Annual Meeting
Category: Central Nervous System Tumors
SubCategory: CNS Tumors

Abstract No: 1536
Author(s): W. Wick, J. P. Steinbach, J. Schuth, J. Dichgans, M. Bamberg, M. Weller; University of Tübingen, Tübingen, Germany; ESSEX Oncology Research, München, Germany

Abstract:
Background:Median survival for patients with glioblastoma is 12 months. Patients progressing after cytoreductive surgery, radiotherapy and nitrosourea-based adjuvant chemotherapy experience a median survival of 4-6 months. There is no standard treatment for recurrent malignant glioma. Temozolomide has shown activity in phase II studies of malignant gliomas and a phase III study of metastatic malignant melanoma. It is generally administered orally at 200 mg/m2 body surface area in a five-day every 28 days schedule. Methods:Twentyone patients with recurrent or progressive glioblastoma were enrolled in a prospective, unicenter trial to determine whether a one week on/one week off regimen of temozolomide is feasible and effective as a salvage therapy. Chemotherapy consisted of temozolomide at 150 mg/m2 on days 1 to 7 and days 15 to 21 of 28 days treatment cycles. Results:There was no specific treatment-related neurotoxicity, but 3 of 21 patients (14%) had to discontinue chemotherapy because of WHO IV hematological toxicity. There were two partial responses (10%), 17 patients (81%) had stable disease according to MacDonald criteria. The median progression-free survival is 5 months, and the progression-free survival rate at 6 months is 43%. The median overall survival from diagnosis has not yet been reached, but will be more than 16 months. Conclusions:The schedule used in the present study is a feasible and effective treatment of recurrent glioblastoma.


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