Promising survival for patients with newly diagnosed glioblastoma multiforme treated with concomitant radiation plus temozolomide followed by adjuvant temozolomide.

Details

Serval ID
serval:BIB_1EAD5E1C02D8
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Promising survival for patients with newly diagnosed glioblastoma multiforme treated with concomitant radiation plus temozolomide followed by adjuvant temozolomide.
Journal
Journal of Clinical Oncology
Author(s)
Stupp R., Dietrich P.Y., Ostermann Kraljevic S., Pica A., Maillard I., Maeder P., Meuli R., Janzer R., Pizzolato G., Miralbell R., Porchet F., Regli L., de Tribolet N., Mirimanoff R.O., Leyvraz S.
ISSN
0732-183X
Publication state
Published
Issued date
2002
Peer-reviewed
Oui
Volume
20
Number
5
Pages
1375-1382
Language
english
Abstract
PURPOSE: Temozolomide is a novel oral alkylating agent with demonstrated efficacy as second-line therapy for patients with recurrent anaplastic astrocytoma and glioblastoma multiforme (GBM). This phase II study was performed to determine the safety, tolerability, and efficacy of concomitant radiation plus temozolomide therapy followed by adjuvant temozolomide therapy in patients with newly diagnosed GBM. PATIENTS AND METHODS: Sixty-four patients were enrolled onto this open-label, phase II trial. Temozolomide (75 mg/m(2)/d x 7 d/wk for 6 weeks) was administered orally concomitant with fractionated radiotherapy (60 Gy total dose: 2 Gy x 5 d/wk for 6 weeks) followed by temozolomide monotherapy (200 mg/m(2)/d x 5 days, every 28 days for six cycles). The primary end points were safety and tolerability, and the secondary end point was overall survival. RESULTS: Concomitant radiation plus temozolomide therapy was safe and well tolerated. Nonhematologic toxicities were rare and mild to moderate in severity. During the concomitant treatment phase, grade 3 or 4 neutropenia, thrombocytopenia, or both were observed in 6% of patients, including two severe infections with Pneumocystis carinii. During adjuvant temozolomide, 2% and 6% of cycles were associated with grade 3 and 4 neutropenia or thrombocytopenia, respectively. Median survival was 16 months, and the 1- and 2-year survival rates were 58% and 31%, respectively. Patients younger than 50 years old and patients who underwent debulking surgery had the best survival outcome. CONCLUSION: Continuous daily temozolomide and concomitant radiation is safe. This regimen of concomitant chemoradiotherapy followed by adjuvant chemotherapy may prolong the survival of patients with glioblastoma. Further investigation is warranted, and a randomized trial is ongoing.
Keywords
Adult, Aged, Antineoplastic Agents, Alkylating, Brain Neoplasms, Chemotherapy, Adjuvant, Combined Modality Therapy, Dacarbazine, Drug Administration Schedule, Female, Glioblastoma, Humans, Male, Middle Aged, Pneumocystis Infections
Pubmed
Web of science
Create date
11/04/2008 8:23
Last modification date
20/08/2019 12:54
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