Titre
Promising survival for patients with newly diagnosed glioblastoma multiforme treated with concomitant radiation plus temozolomide followed by adjuvant temozolomide.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Stupp, R.
Auteure/Auteur
Dietrich, P.Y.
Auteure/Auteur
Ostermann Kraljevic, S.
Auteure/Auteur
Pica, A.
Auteure/Auteur
Maillard, I.
Auteure/Auteur
Maeder, P.
Auteure/Auteur
Meuli, R.
Auteure/Auteur
Janzer, R.
Auteure/Auteur
Pizzolato, G.
Auteure/Auteur
Miralbell, R.
Auteure/Auteur
Porchet, F.
Auteure/Auteur
Regli, L.
Auteure/Auteur
de Tribolet, N.
Auteure/Auteur
Mirimanoff, R.O.
Auteure/Auteur
Leyvraz, S.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
0732-183X
Statut éditorial
Publié
Date de publication
2002
Volume
20
Numéro
5
Première page
1375
Dernière page/numéro d’article
1382
Peer-reviewed
Oui
Langue
anglais
Résumé
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.
PID Serval
serval:BIB_1EAD5E1C02D8
PMID
Date de création
2008-04-11T07:23:41.293Z
Date de création dans IRIS
2025-05-20T17:42:02Z