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Radiotherapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

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Radiotherapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma The new england journal of medicine original article 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., and 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* abstract background Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. From the Centre Hospitalier Universitaire The current standard of care for newly diagnosed glioblastoma is surgical resection to Vaudois, Lausanne, Switzerland (R.S., R-C.J., R.O.M.); Princess Margaret Hospital, the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radio- Toronto (W.P.M.); Daniel den Hoed Oncol- therapy alone with radiotherapy plus temozolomide, given concomitantly with and after ogy Center–Erasmus University Medical radiotherapy, in terms of efficacy and safety. Center Rotterdam, Rotterdam, the Neth- erlands (M.J.B.); the University of Tübin- methods gen Medical School, Tübingen, Germany (M.W.); the University of Western Ontario, Patients with newly diagnosed, histologically confirmed glioblastoma were randomly London, Ont., Canada (B.F.); the Universi- assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of ty Medical Center, Utrecht, the Netherlands 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus contin- (M.J.B.T.); Hôpital Notre Dame du Centre Hospitalier Universitaire, Montreal (K.B.); uous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days Azienda-Ospedale Università, Padova, Italy per week from the first to the last day of radiotherapy), followed by six cycles of adju- (A.A.B.); Medical University of Vienna, Vi- vant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day enna (C.M.); Universitätskliniken, Regens- burg, Germany (U.B.); Inselspital, Bern, cycle). The primary end point was overall survival. Switzerland (J.C.); Queen’s University, results Kingston, Ont., Canada (S.K.L.); the Euro- pean Organisation for Research and Treat- A total of 573 patients from 85 centers underwent randomization. The median age was ment of Cancer Data Center, Brussels (T.G., 56 years, and 84 percent of patients had undergone debulking surgery. At a median fol- A.A., D.L.); the University of Calgary, Cal- gary, Alta., Canada (J.G.C.); and the Nation- low-up of 28 months, the median survival was 14.6 months with radiotherapy plus al Cancer Institute of Canada Clinical Trials temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio Group, Kingston, Ont., Canada (E.E.). Ad- for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence dress reprint requests to Dr. Stupp at the Multidisciplinary Oncology Center, Centre interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year survival rate was Hospitalier Universitaire Vaudois, 46, rue 26.5 percent with radiotherapy plus temozolomide and 10.4 percent with radiotherapy du Bugnon, CH-1011 Lausanne, Switzer- alone. Concomitant treatment with radiotherapy plus temozolomide resulted in grade 3 land, or at [email protected]. or 4 hematologic toxic effects in 7 percent of patients. *Participating institutions and investiga- conclusions tors are listed in the Appendix. The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma result- N Engl J Med 2005;352:987-96. ed in a clinically meaningful and statistically significant survival benefit with minimal Copyright © 2005 Massachusetts Medical Society. additional toxicity. n engl j med 352;10 www.nejm.org march 10, 2005 987 The New England Journal of Medicine Downloaded from nejm.org at UAMS Library on January 30, 2012. For personal use only. No other uses without permission. Copyright © 2005 Massachusetts Medical Society. All rights reserved. The new england journal of medicine lioblastoma is the most frequent methods primary malignant brain tumor in adults. g patients Median survival is generally less than one year from the time of diagnosis, and even in the Patients 18 to 70 years of age with newly diagnosed most favorable situations, most patients die within and histologically confirmed glioblastoma (World two years.1-3 Standard therapy consists of surgical Health Organization [WHO] grade IV astrocytoma) resection to the extent that is safely feasible, fol- were eligible for the study. Eligible patients had a lowed by radiotherapy; in the United States, adju- WHO performance status of 2 or less and adequate vant carmustine, a nitrosourea drug, is commonly hematologic, renal, and hepatic function (absolute prescribed.4,5 Cooperative-group trials have inves- neutrophil count, ≥1500 per cubic millimeter; plate- tigated the addition of various chemotherapeutic let count, ≥100,000 per cubic millimeter; serum cre- regimens to radiotherapy,6-9 but no randomized atinine level, ≤1.5 times the upper limit of normal phase 3 trial of nitrosourea-based adjuvant chemo- in the laboratory where it was measured; total se- therapy has demonstrated a significant survival ben- rum bilirubin level, ≤1.5 times the upper limit of efit as compared with radiotherapy alone, although normal; and liver-function values, <3 times the up- there were more long-term survivors in the chemo- per limit of normal for the laboratory). Patients who therapy groups in some studies.10 A meta-analysis were receiving corticosteroids had to receive a stable based on 12 randomized trials suggested a small or decreasing dose for at least 14 days before ran- survival benefit of chemotherapy, as compared domization. All patients provided written informed with radiotherapy alone (a 5 percent increase in consent, and the study was approved by the ethics survival at two years, from 15 percent to 20 per- committees of the participating centers. cent).11 The meta-analysis included 37 percent of patients with prognostically more favorable, lower- study design and treatment grade gliomas. Within six weeks after the histologic diagnosis of Temozolomide, an oral alkylating agent, has glioblastoma, we randomly assigned eligible pa- demonstrated antitumor activity as a single agent tients to receive standard focal radiotherapy alone in the treatment of recurrent glioma.12-14 The ap- (the control group) or standard radiotherapy plus proved conventional schedule is a daily dose of 150 concomitant daily temozolomide, followed by adju- to 200 mg per square meter of body-surface area for vant temozolomide. Randomization was performed 5 days of every 28-day cycle. Daily therapy at a dose at the EORTC Data Center, and patients were strat- of 75 mg per square meter for up to seven weeks is ified according to WHO performance status, wheth- safe; this level of exposure to temozolomide15 de- er or not they had previously undergone debulking pletes the DNA-repair enzyme O6-methylguanine- surgery, and the treatment center.20 The assigned DNA methyltransferase (MGMT).16 This effect may treatment had to begin within one week after ran- be important because low levels of MGMT in tumor domization. tissue are associated with longer survival among pa- Radiotherapy consisted of fractionated focal ir- tients with glioblastoma who are receiving nitroso- radiation at a dose of 2 Gy per fraction given once urea-based adjuvant chemotherapy.17,18 daily five days per week (Monday through Friday) A pilot phase 2 trial demonstrated the feasibility over a period of six weeks, for a total dose of 60 Gy. of the concomitant administration of temozolo- Radiotherapy was delivered to the gross tumor vol- mide with fractionated radiotherapy, followed by up ume with a 2-to-3-cm margin for the clinical target to six cycles of adjuvant temozolomide, and suggest- volume. Radiotherapy was planned with dedicated ed that this treatment had promising clinical activ- computed tomography (CT) and three-dimensional ity (two-year survival rate, 31 percent).19 The Euro- planning systems; conformal radiotherapy was de- pean Organisation for Research and Treatment of livered with linear accelerators with nominal energy Cancer (EORTC) Brain Tumor and Radiotherapy of 6 MV or more, and quality assurance was per- Groups and the National Cancer Institute of Canada formed by means of individual case reviews.21 (NCIC) Clinical Trials Group therefore initiated a Concomitant chemotherapy consisted of tem- randomized, multicenter, phase 3 trial to compare ozolomide (marketed as Temodal in Europe and this regimen with radiotherapy alone in patients Canada and Temodar in the United States; Scher- with newly diagnosed glioblastoma. ing-Plough) at a dose of 75 mg per square meter per 988 n engl j med 352;10 www.nejm.org march 10, 2005 The New England Journal of Medicine Downloaded from nejm.org at UAMS Library on January 30, 2012. For personal use only. No other uses without permission. Copyright © 2005 Massachusetts Medical Society. All rights reserved. radiotherapy with or without temozolomide for glioblastoma day, given 7 days per week from the first day of ra- statistical analysis diotherapy until the last day of radiotherapy, but for The primary end point was overall survival; second- no longer than 49 days. After a 4-week break, pa- ary end points were progression-free survival, safety, tients were then to receive up to six cycles of adju- and the quality of life. Overall survival and pro- vant temozolomide according to the standard 5-day gression-free survival were analyzed by the Kaplan– schedule every 28 days.
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