Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial

Stupp, Roger ; Hegi, Monika E. ; Mason, Warren P. ; van den Bent, Martin J. ; Taphoorn, Martin J. B. ; Janzer, Robert C. ; Ludwin, Samuel K. ; Allgeier, Anouk ; Fisher, Barbara ; Belanger, Karl ; Hau, Peter ; Brandes, Alba A. ; Gijtenbeek, Johanna ; Marosi, Christine ; Vecht, Charles J. ; Mokhtari, Karima ; Wesseling, Pieter ; Villa, Salvador ; Eisenhauer, Elizabeth ; Gorlia, Thierry ; Weller, Michael ; Lacombe, Denis ; Cairncross, J. Gregory ; Mirimanoff, René-Olivier

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Details

Item type:	Article
Journal or Publication Title:	The lancet oncology
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
Volume:	10
Number of Issue or Book Chapter:	5
Page Range:	pp. 459-466
Date:	2009
Additional Information (public):	European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group
Institutions:	Medicine > Lehrstuhl für Neurologie
Identification Number:	Value Type 19410186 PubMed ID 10.1016/S1470-2045(09)70025-7 DOI
Classification:	Notation Type Antineoplastic Agents, Alkylating/therapeutic use MESH Brain Neoplasms/radiotherapy MESH Combined Modality Therapy MESH DNA Methylation MESH DNA Modification Methylases/genetics MESH DNA Repair Enzymes/genetics MESH Dacarbazine/therapeutic use MESH Disease Progression MESH Female MESH Follow-Up Studies MESH Glioblastoma/radiotherapy MESH Humans MESH Male MESH Middle Aged MESH Prognosis MESH Promoter Regions, Genetic MESH Survival Analysis MESH Survival Rate MESH Tumor Suppressor Proteins/genetics MESH
Keywords:	NEWLY-DIAGNOSED GLIOBLASTOMA; RECURSIVE PARTITIONING ANALYSIS; MGMT PROMOTER METHYLATION; CONTROLLED CLINICAL-TRIAL; ASPARTIC ACID PEPTIDE; MALIGNANT GLIOMA; PROGNOSTIC-FACTORS; ACCELERATED RADIOTHERAPY; ONCOLOGY-GROUP; MULTIFORME;
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Unknown
Item ID:	29262

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Abstract

Background In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adjuvant temozolomide and radiotherapy. We report the final results with a median follow-up of more ...

Abstract

Background In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adjuvant temozolomide and radiotherapy. We report the final results with a median follow-up of more than 5 years. Methods Adult patients with newly diagnosed glioblastoma were randomly assigned to receive either standard radiotherapy or identical radiotherapy with concomitant temozolomide followed by up to six cycles of adjuvant temozolomide. The methylation status of the methyl-guanine methyl transferase gene, MGMT was determined retrospectively from the tumour tissue of 206 patients. The primary endpoint was overall survival. Analyses were by intention to treat. This trial is registered with Clinicaltrials.gov, number NCT00006353. Findings Between Aug 17, 2000, and March 22, 2002, 573 patients were assigned to treatment. 278 (97%) of 286 patients in the radiotherapy alone group and 254 (89%) of 287 in the combined-treatment group died during 5 years of follow-up. Overall survival was 27.2% (95% CI 22.2-32.5) at 2 years, 16.0% (12.0-20.6) at 3 years, 12.1% (8.5-16.4) at 4 years, and 9.8% (6.4-14.0) at 5 years with temozolomide, versus 10.9% (7.6-14.8), 4.4% (2.4-7.2), 3.0% (1.4-5.7), and 1.9% (0.6-4.4) with radiotherapy alone (hazard ratio 0.6, 95% CI 0.5-0.7; p<0.0001). A benefit of combined therapy was recorded in all clinical prognostic subgroups, including patients aged 60-70 years. Methylation of the MGMT promoter was the strongest predictor for outcome and benefit from temozolomide chemotherapy. Interpretation Benefits of adjuvant temozolomide with radiotherapy lasted throughout 5 years of follow-up. A few patients in favourable prognostic categories survive longer than 5 years. MGMT methylation status identifies patients most likely to benefit from the addition of temozolomide.

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