Stupp, Roger and Mason, WP and van den Bent, MJ and Weller, M and Fisher, B and Taphoorn, MJB and Belanger, K and Brandes, AA and Marosi, C and Bogdahn, Ulrich and Curschmann, J and Janzer, RC and Ludwin, SK and Gorlia, T and Allgeier, A and Lacombe, D and Cairncross, JG and Eisenhauer, E and Mirimanoff, RO and Van Den Weyngaert, D and Kaendler, S and Krauseneck, P and Vinolas, N and Villa, S and Wurm, RE and Maillot, MHB and Spagnolli, F and Kantor, G and Malhaire, JP and Renard, L and De Witte, O and Scandolaro, L and Vecht, CJ and Maingon, P and Lutterbach, J and Kobierska, A and Bolla, M and Souchon, R and Mitine, C and Tzuk-Shina, T and Kuten, A and Haferkamp, G and de Greve, J and Priou, F and Menten, J and Rutten, I and Clavere, P and Malmstrom, A and Jancar, B and Newlands, E and Pigott, K and Twijnstra, A and Chinot, O and Reni, M and Boiardi, A and Fabbro, M and Campone, M and Bozzino, J and Frenay, M and Gijtenbeek, J and Brandes, AA and Delattre, JY and Bogdahn, Ulrich and De Paula, U and van den Bent, MJ and Hanzen, C and Pavanato, G and Schraub, S and Pfeffer, R and Soffietti, R and Weller, M and Kortmann, RD and Taphoorn, M and Torrecilla, JL and Marosi, C and Grisold, W and Huget, P and Forsyth, P and Fulton, D and Kirby, S and Wong, R and Fenton, D and Fisher, B and Cairncross, G and Whitlock, P and Belanger, K and Burdette-Radoux, S and Gertler, S and Saunders, S and Laing, K and Siddiqui, J and Martin, LA and Gulavita, S and Perry, J and Mason, W and Thiessen, B and Pai, H and Alam, ZY and Eisenstat, D and Mingrone, W and Hofer, S and Pesce, G and Curschmann, J and Dietrich, PY and Stupp, R and Mirimanoff, RO and Thum, P and Baumert, B and Ryan, G (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. NEW ENGLAND JOURNAL OF MEDICINE, 352 (10). pp. 987-996. ISSN 0028-4793, 1533-4406
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND: Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. The current standard of care for newly diagnosed glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus temozolomide, given concomitantly with and after radiotherapy, in terms of efficacy and safety. METHODS: Patients with newly diagnosed, histologically confirmed glioblastoma were randomly assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was overall survival. RESULTS: A total of 573 patients from 85 centers underwent randomization. The median age was 56 years, and 84 percent of patients had undergone debulking surgery. At a median follow-up of 28 months, the median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year survival rate was 26.5 percent with radiotherapy plus temozolomide and 10.4 percent with radiotherapy alone. Concomitant treatment with radiotherapy plus temozolomide resulted in grade 3 or 4 hematologic toxic effects in 7 percent of patients. CONCLUSIONS: The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma resulted in a clinically meaningful and statistically significant survival benefit with minimal additional toxicity.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | THERAPY-ONCOLOGY-GROUP; MALIGNANT GLIOMA; RADIATION-THERAPY; POSTOPERATIVE TREATMENT; PROGNOSTIC-FACTORS; RANDOMIZED-TRIAL; PHASE-II; CHEMOTHERAPY; MULTIFORME; CARMUSTINE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 May 2021 05:47 |
| Last Modified: | 21 May 2021 05:47 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36376 |
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