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
Background Glioblastoma, the most common primary brain tumorin adults, is usually rapidly fatal. The current standard ofcare for newly diagnosed glioblastoma is surgical resectionto the extent feasible, followed by adjuvant radiotherapy. Inthis trial we compared radiotherapy alone with radiotherapyplus temozolomide, given concomitantly with and after radiotherapy,in terms of efficacy and safety.
Methods Patients with newly diagnosed, histologically confirmedglioblastoma were randomly assigned to receive radiotherapyalone (fractionated focal irradiation in daily fractions of2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy)or radiotherapy plus continuous daily temozolomide (75 mg persquare meter of body-surface area per day, 7 days per week fromthe first to the last day of radiotherapy), followed by sixcycles of adjuvant temozolomide (150 to 200 mg per square meterfor 5 days during each 28-day cycle). The primary end pointwas overall survival.
Results A total of 573 patients from 85 centers underwent randomization.The median age was 56 years, and 84 percent of patients hadundergone debulking surgery. At a median follow-up of 28 months,the median survival was 14.6 months with radiotherapy plus temozolomideand 12.1 months with radiotherapy alone. The unadjusted hazardratio for death in the radiotherapy-plus-temozolomide groupwas 0.63 (95 percent confidence interval, 0.52 to 0.75; P<0.001by the log-rank test). The two-year survival rate was 26.5 percentwith radiotherapy plus temozolomide and 10.4 percent with radiotherapyalone. Concomitant treatment with radiotherapy plus temozolomideresulted in grade 3 or 4 hematologic toxic effects in 7 percentof patients.
Conclusions The addition of temozolomide to radiotherapy fornewly diagnosed glioblastoma resulted in a clinically meaningfuland statistically significant survival benefit with minimaladditional 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.
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.
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N Engl J Med 2005;
352:2350-2353, Jun 2, 2005.
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Grewal, J., Dellinger, C. A., Yung, W.K.A.
(2007). Fatal Reactivation of Hepatitis B with Temozolomide. NEJM
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Simanek, R., Vormittag, R., Hassler, M., Roessler, K., Schwarz, M., Zielinski, C., Pabinger, I., Marosi, C.
(2007). Venous thromboembolism and survival in patients with high-grade glioma. Neuro Oncol
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Cahill, D. P., Levine, K. K., Betensky, R. A., Codd, P. J., Romany, C. A., Reavie, L. B., Batchelor, T. T., Futreal, P. A., Stratton, M. R., Curry, W. T., Iafrate, A. J., Louis, D. N.
(2007). Loss of the Mismatch Repair Protein MSH6 in Human Glioblastomas Is Associated with Tumor Progression during Temozolomide Treatment. Clin. Cancer Res.
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Demuth, T., Reavie, L. B., Rennert, J. L., Nakada, M., Nakada, S., Hoelzinger, D. B., Beaudry, C. E., Henrichs, A. N., Anderson, E. M., Berens, M. E.
(2007). MAP-ing glioma invasion: Mitogen-activated protein kinase kinase 3 and p38 drive glioma invasion and progression and predict patient survival. Molecular Cancer Therapeutics
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Hart, L. S., Ornelles, D., Koumenis, C.
(2007). The Adenoviral E4orf6 Protein Induces Atypical Apoptosis in Response to DNA Damage. J. Biol. Chem.
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Kunwar, S., Prados, M. D., Chang, S. M., Berger, M. S., Lang, F. F., Piepmeier, J. M., Sampson, J. H., Ram, Z., Gutin, P. H., Gibbons, R. D., Aldape, K. D., Croteau, D. J., Sherman, J. W., Puri, R. K.
(2007). Direct Intracerebral Delivery of Cintredekin Besudotox (IL13-PE38QQR) in Recurrent Malignant Glioma: A Report by the Cintredekin Besudotox Intraparenchymal Study Group. JCO
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Hau, P., Koch, D., Hundsberger, T., Marg, E., Bauer, B., Rudolph, R., Rauch, M., Brenner, A., Rieckmann, P., Schuth, J., Jauch, T., Koch, H., Bogdahn, U.
(2007). Safety and feasibility of long-term temozolomide treatment in patients with high-grade glioma. Neurology
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Vredenburgh, J. J., Desjardins, A., Herndon, J. E. II, Dowell, J. M., Reardon, D. A., Quinn, J. A., Rich, J. N., Sathornsumetee, S., Gururangan, S., Wagner, M., Bigner, D. D., Friedman, A. H., Friedman, H. S.
(2007). Phase II Trial of Bevacizumab and Irinotecan in Recurrent Malignant Glioma. Clin. Cancer Res.
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Narin, O., Drappatz, J., Doherty, L. M., Wen, P. Y., Kesari, S.
(2007). Cerebrospinal Fluid Spread of Anaplastic Glioma. JCO
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Weingart, J., Grossman, S. A., Carson, K. A., Fisher, J. D., Delaney, S. M., Rosenblum, M. L., Olivi, A., Judy, K., Tatter, S. B., Dolan, M. E.
(2007). Phase I Trial of Polifeprosan 20 With Carmustine Implant Plus Continuous Infusion of Intravenous O6-Benzylguanine in Adults With Recurrent Malignant Glioma: New Approaches to Brain Tumor Therapy CNS Consortium Trial. JCO
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Samuels, M. A.
(2007). Update in Neurology. ANN INTERN MED
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Zhang, J. G., Eguchi, J., Kruse, C. A., Gomez, G. G., Fakhrai, H., Schroter, S., Ma, W., Hoa, N., Minev, B., Delgado, C., Wepsic, H. T., Okada, H., Jadus, M. R.
(2007). Antigenic Profiling of Glioma Cells to Generate Allogeneic Vaccines or Dendritic Cell-Based Therapeutics. Clin. Cancer Res.
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Bosma, I., Vos, M. J., Heimans, J. J., Taphoorn, M. J.B., Aaronson, N. K., Postma, T. J., van der Ploeg, H. M., Muller, M., Vandertop, W. P., Slotman, Ben. J., Klein, M.
(2007). The course of neurocognitive functioning in high-grade glioma patients. Neuro Oncol
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Gerber, D. E., Grossman, S. A., Zeltzman, M., Parisi, M. A., Kleinberg, L.
(2007). The impact of thrombocytopenia from temozolomide and radiation in newly diagnosed adults with high-grade gliomas. Neuro Oncol
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Brown, P. D., Jensen, A. W., Felten, S. J., Ballman, K. V., Schaefer, P. L., Jaeckle, K. A., Cerhan, J. H., Buckner, J. C.
(2006). Detrimental Effects of Tumor Progression on Cognitive Function of Patients With High-Grade Glioma. JCO
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Chaichana, K., Zamora-Berridi, G., Camara-Quintana, J., Quinones-Hinojosa, A.
(2006). Neurosphere Assays: Growth Factors and Hormone Differences in Tumor and Nontumor Studies. Stem Cells
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Rubie, H., Chisholm, J., Defachelles, A. S., Morland, B., Munzer, C., Valteau-Couanet, D., Mosseri, V., Bergeron, C., Weston, C., Coze, C., Auvrignon, A., Djafari, L., Hobson, R., Baunin, C., Dickinson, F., Brisse, H., McHugh, K., Biassoni, L., Giammarile, F., Vassal, G.
(2006). Phase II Study of Temozolomide in Relapsed or Refractory High-Risk Neuroblastoma: A Joint Societe Francaise des Cancers de l'Enfant and United Kingdom Children Cancer Study Group New Agents Group Study. JCO
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Kushner, B. H., Kramer, K., Modak, S., Cheung, N.-K. V.
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Liu, F., Park, P. J., Lai, W., Maher, E., Chakravarti, A., Durso, L., Jiang, X., Yu, Y., Brosius, A., Thomas, M., Chin, L., Brennan, C., DePinho, R. A., Kohane, I., Carroll, R. S., Black, P. M., Johnson, M. D.
(2006). A Genome-Wide Screen Reveals Functional Gene Clusters in the Cancer Genome and Identifies EphA2 as a Mitogen in Glioblastoma. Cancer Res.
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Lun, X., Senger, D. L., Alain, T., Oprea, A., Parato, K., Stojdl, D., Lichty, B., Power, A., Johnston, R. N., Hamilton, M., Parney, I., Bell, J. C., Forsyth, P. A.
(2006). Effects of Intravenously Administered Recombinant Vesicular Stomatitis Virus (VSV{Delta}M51) on Multifocal and Invasive Gliomas.. JNCI J Natl Cancer Inst
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Grommes, C., Landreth, G. E., Sastre, M., Beck, M., Feinstein, D. L., Jacobs, A. H., Schlegel, U., Heneka, M. T.
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Schadendorf, D, Hauschild, A, Ugurel, S, Thoelke, A, Egberts, F, Kreissig, M, Linse, R, Trefzer, U, Vogt, T, Tilgen, W, Mohr, P, Garbe, C
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Maxwell, J. A., Johnson, S. P., Quinn, J. A., McLendon, R. E., Ali-Osman, F., Friedman, A. H., Herndon, J. E. II, Bierau, K., Bigley, J., Bigner, D. D., Friedman, H. S.
(2006). Quantitative analysis of O6-alkylguanine-DNA alkyltransferase in malignant glioma.. Molecular Cancer Therapeutics
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Herrlinger, U., Rieger, J., Koch, D., Loeser, S., Blaschke, B., Kortmann, R.-D., Steinbach, J. P., Hundsberger, T., Wick, W., Meyermann, R., Tan, T.-C., Sommer, C., Bamberg, M., Reifenberger, G., Weller, M.
(2006). Phase II Trial of Lomustine Plus Temozolomide Chemotherapy in Addition to Radiotherapy in Newly Diagnosed Glioblastoma: UKT-03. JCO
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Tabatabai, G., Frank, B., Mohle, R., Weller, M., Wick, W.
(2006). Irradiation and hypoxia promote homing of haematopoietic progenitor cells towards gliomas by TGF-{beta}-dependent HIF-1{alpha}-mediated induction of CXCL12. Brain
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Grossman, S. A., Carson, K. A., Batchelor, T. T., Lesser, G., Mikkelsen, T., Alavi, J. B., Phuphanich, S., Hammour, T., Fisher, J. D., Supko, J. G.
(2006). The Effect of Enzyme-Inducing Antiseizure Drugs on the Pharmacokinetics and Tolerability of Procarbazine Hydrochloride. Clin. Cancer Res.
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Buckner, J. C., Ballman, K. V., Michalak, J. C., Burton, G. V., Cascino, T. L., Schomberg, P. J., Hawkins, R. B., Scheithauer, B. W., Sandler, H. M., Marks, R. S., O'Fallon, J. R.
(2006). Phase III Trial of Carmustine and Cisplatin Compared With Carmustine Alone and Standard Radiation Therapy or Accelerated Radiation Therapy in Patients With Glioblastoma Multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 Trials. JCO
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Wong, E. T., Brandes, A. A., Tosoni, A.
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