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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(2009). Efficacy of the HSP90 inhibitor 17-AAG in human glioma cell lines and tumorigenic glioma stem cells. Neuro Oncol Duke
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Jahnke, K., Muldoon, L. L., Varallyay, C. G., Lewin, S. J., Kraemer, D. F., Neuwelt, E. A.
(2009). Bevacizumab and carboplatin increase survival and asymptomatic tumor volume in a glioma model. Neuro Oncol Duke
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Vogelbaum, M. A., Berkey, B., Peereboom, D., Macdonald, D., Giannini, C., Suh, J. H., Jenkins, R., Herman, J., Brown, P., Blumenthal, D. T., Biggs, C., Schultz, C., Mehta, M.
(2009). Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol Duke
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Kozak, K. R., Mahadevan, A., Moody, J. S.
(2009). Adult gliosarcoma: epidemiology, natural history, and factors associated with outcome. Neuro Oncol Duke
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Kitange, G. J., Carlson, B. L., Schroeder, M. A., Grogan, P. T., Lamont, J. D., Decker, P. A., Wu, W., James, C. D., Sarkaria, J. N.
(2009). Induction of MGMT expression is associated with temozolomide resistance in glioblastoma xenografts. Neuro Oncol Duke
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Schomas, D. A., Laack, N. N. I., Rao, R. D., Meyer, F. B., Shaw, E. G., O'Neill, B. P., Giannini, C., Brown, P. D.
(2009). Intracranial low-grade gliomas in adults: 30-year experience with long-term follow-up at Mayo Clinic. Neuro Oncol Duke
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Bryant, N. L., Suarez-Cuervo, C., Gillespie, G. Y., Markert, J. M., Nabors, L. B., Meleth, S., Lopez, R. D., Lamb, L. S. Jr.
(2009). Characterization and immunotherapeutic potential of {gamma}{delta} T-cells in patients with glioblastoma. Neuro Oncol Duke
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Miyatake, S.-I., Kawabata, S., Nonoguchi, N., Yokoyama, K., Kuroiwa, T., Matsui, H., Ono, K.
(2009). Pseudoprogression in boron neutron capture therapy for malignant gliomas and meningiomas. Neuro Oncol Duke
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Maes, W., Rosas, G. G., Verbinnen, B., Boon, L., De Vleeschouwer, S., Ceuppens, J. L., Van Gool, S. W.
(2009). DC vaccination with anti-CD25 treatment leads to long-term immunity against experimental glioma. Neuro Oncol Duke
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Schaich, M., Kestel, L., Pfirrmann, M., Robel, K., Illmer, T., Kramer, M., Dill, C., Ehninger, G., Schackert, G., Krex, D.
(2009). A MDR1 (ABCB1) gene single nucleotide polymorphism predicts outcome of temozolomide treatment in glioblastoma patients. Ann Oncol
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Sigmond, J., Honeywell, R. J., Postma, T. J., Dirven, C. M. F., de Lange, S. M., van der Born, K., Laan, A. C., Baayen, J. C. A., Van Groeningen, C. J., Bergman, A. M., Giaccone, G., Peters, G. J.
(2009). Gemcitabine uptake in glioblastoma multiforme: potential as a radiosensitizer. Ann Oncol
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Liu, T. F., Cai, J., Gibo, D. M., Debinski, W.
(2009). Reoxygenation of Hypoxic Glioblastoma Multiforme Cells Potentiates the Killing Effect of an Interleukin-13-Based Cytotoxin. Clin. Cancer Res.
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Kulke, M. H., Hornick, J. L., Frauenhoffer, C., Hooshmand, S., Ryan, D. P., Enzinger, P. C., Meyerhardt, J. A., Clark, J. W., Stuart, K., Fuchs, C. S., Redston, M. S.
(2009). O6-Methylguanine DNA Methyltransferase Deficiency and Response to Temozolomide-Based Therapy in Patients with Neuroendocrine Tumors. Clin. Cancer Res.
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Lassman, A. B.
(2009). Management of Newly Diagnosed Anaplastic Oligodendrogliomas. Am Soc Clin Oncol Ed Book
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(2009). Antiangiogenic Therapies for Malignant Gliomas. Am Soc Clin Oncol Ed Book
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Rodero, M., Marie, Y., Coudert, M., Blondet, E., Mokhtari, K., Rousseau, A., Raoul, W., Carpentier, C., Sennlaub, F., Deterre, P., Delattre, J.-Y., Debre, P., Sanson, M., Combadiere, C.
(2008). Polymorphism in the Microglial Cell-Mobilizing CX3CR1 Gene Is Associated With Survival in Patients With Glioblastoma. JCO
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Pallini, R., Ricci-Vitiani, L., Banna, G. L., Signore, M., Lombardi, D., Todaro, M., Stassi, G., Martini, M., Maira, G., Larocca, L. M., De Maria, R.
(2008). Cancer Stem Cell Analysis and Clinical Outcome in Patients with Glioblastoma Multiforme. Clin. Cancer Res.
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Brown, P. D., Krishnan, S., Sarkaria, J. N., Wu, W., Jaeckle, K. A., Uhm, J. H., Geoffroy, F. J., Arusell, R., Kitange, G., Jenkins, R. B., Kugler, J. W., Morton, R. F., Rowland, K. M. Jr, Mischel, P., Yong, W. H., Scheithauer, B. W., Schiff, D., Giannini, C., Buckner, J. C.
(2008). Phase I/II Trial of Erlotinib and Temozolomide With Radiation Therapy in the Treatment of Newly Diagnosed Glioblastoma Multiforme: North Central Cancer Treatment Group Study N0177. JCO
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Reardon, D. A., Fink, K. L., Mikkelsen, T., Cloughesy, T. F., O'Neill, A., Plotkin, S., Glantz, M., Ravin, P., Raizer, J. J., Rich, K. M., Schiff, D., Shapiro, W. R., Burdette-Radoux, S., Dropcho, E. J., Wittemer, S. M., Nippgen, J., Picard, M., Nabors, L. B.
(2008). Randomized Phase II Study of Cilengitide, an Integrin-Targeting Arginine-Glycine-Aspartic Acid Peptide, in Recurrent Glioblastoma Multiforme. JCO
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Llaguno, S. A., Chen, J., Kwon, C.-H., Parada, L.F.
(2008). Neural and Cancer Stem Cells in Tumor Suppressor Mouse Models of Malignant Astrocytoma. Cold Spring Harb Symp Quant Biol
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(2008). Chemotherapy for Malignant Brain Tumors of Childhood. J Child Neurol
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(2008). Diagnostic and Therapeutic Stratification of Childhood Brain Tumors: Implications for Translational Research. J Child Neurol
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Wakabayashi, T., Kayama, T., Nishikawa, R., Takahashi, H., Yoshimine, T., Hashimoto, N., Aoki, T., Kurisu, K., Natsume, A., Ogura, M., Yoshida, J.
(2008). A Multicenter Phase I Trial of Interferon-{beta} and Temozolomide Combination Therapy for High-grade Gliomas (INTEGRA Study). Jpn J Clin Oncol
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Buie, L. W, Valgus, J.
(2008). Bevacizumab: A Treatment Option for Recurrent Glioblastoma Multiforme. The Annals of Pharmacotherapy
42: 1486-1490
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Parsons, D. W., Jones, S., Zhang, X., Lin, J. C.-H., Leary, R. J., Angenendt, P., Mankoo, P., Carter, H., Siu, I-M., Gallia, G. L., Olivi, A., McLendon, R., Rasheed, B. A., Keir, S., Nikolskaya, T., Nikolsky, Y., Busam, D. A., Tekleab, H., Diaz, L. A. Jr., Hartigan, J., Smith, D. R., Strausberg, R. L., Marie, S. K. N., Shinjo, S. M. O., Yan, H., Riggins, G. J., Bigner, D. D., Karchin, R., Papadopoulos, N., Parmigiani, G., Vogelstein, B., Velculescu, V. E., Kinzler, K. W.
(2008). An Integrated Genomic Analysis of Human Glioblastoma Multiforme. Science
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Neyns, B., Cordera, S., Joosens, E., Nader, P.
(2008). Non-Hodgkin's Lymphoma in Patients With Glioma Treated With Temozolomide. JCO
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Hegi, M. E., Liu, L., Herman, J. G., Stupp, R., Wick, W., Weller, M., Mehta, M. P., Gilbert, M. R.
(2008). Correlation of O6-Methylguanine Methyltransferase (MGMT) Promoter Methylation With Clinical Outcomes in Glioblastoma and Clinical Strategies to Modulate MGMT Activity. JCO
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Idbaih, A., Ducray, F., Sierra Del Rio, M., Hoang-Xuan, K., Delattre, J.-Y.
(2008). Therapeutic Application of Noncytotoxic Molecular Targeted Therapy in Gliomas: Growth Factor Receptors and Angiogenesis Inhibitors. The Oncologist
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Phuphanich, S., Carson, K. A., Grossman, S. A., Lesser, G., Olson, J., Mikkelsen, T., Desideri, S., Fisher, J. D., for the New Approaches to Brain Tumor Therapy (NAB,
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Jakacki, R. I., Yates, A., Blaney, S. M., Zhou, T., Timmerman, R., Ingle, A. M., Flom, L., Prados, M. D., Adamson, P. C., Pollack, I. F.
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