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Original Article
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Volume 352:987-996 March 10, 2005 Number 10
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Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma
Roger Stupp, M.D., Warren P. Mason, M.D., Martin J. van den Bent, M.D., Michael Weller, M.D., Barbara Fisher, M.D., Martin J.B. Taphoorn, M.D., Karl Belanger, M.D., Alba A. Brandes, M.D., Christine Marosi, M.D., Ulrich Bogdahn, M.D., Jürgen Curschmann, M.D., Robert C. Janzer, M.D., Samuel K. Ludwin, M.D., Thierry Gorlia, M.Sc., Anouk Allgeier, Ph.D., Denis Lacombe, M.D., J. Gregory Cairncross, M.D., Elizabeth Eisenhauer, M.D., René O. Mirimanoff, M.D., for the European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups and the National Cancer Institute of Canada Clinical Trials Group

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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.


Source Information

From the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (R.S., R-C.J., R.O.M.); Princess Margaret Hospital, Toronto (W.P.M.); Daniel den Hoed Oncology Center–Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands (M.J.B.); the University of Tübingen Medical School, Tübingen, Germany (M.W.); the University of Western Ontario, London, Ont., Canada (B.F.); the University Medical Center, Utrecht, the Netherlands (M.J.B.T.); Hôpital Notre Dame du Centre Hospitalier Universitaire, Montreal (K.B.); Azienda-Ospedale Università, Padova, Italy (A.A.B.); Medical University of Vienna, Vienna (C.M.); Universitätskliniken, Regensburg, Germany (U.B.); Inselspital, Bern, Switzerland (J.C.); Queen's University, Kingston, Ont., Canada (S.K.L.); the European Organisation for Research and Treatment of Cancer Data Center, Brussels (T.G., A.A., D.L.); the University of Calgary, Calgary, Alta., Canada (J.G.C.); and the National Cancer Institute of Canada Clinical Trials Group, Kingston, Ont., Canada (E.E.).

Address reprint requests to Dr. Stupp at the Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois, 46, rue du Bugnon, CH-1011 Lausanne, Switzerland, or at roger.stupp{at}chuv.hospvd.ch.

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Related Letters:

Treatment of Brain Tumors
Paulino A. C., Teh B. S., Sadeh M., Seiter K., Ashby L., LaRocca R., Ryken T., Aiken R. D., Rutkowski S., Ottensmeier H., Pietsch T., Stupp R., Hegi M. E., DeAngelis L. M.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:2350-2353, Jun 2, 2005. Correspondence

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