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.
Correspondence
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(2008). Pseudoprogression in Glioblastoma. 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,
(2008). Phase I safety study of escalating doses of atrasentan in adults with recurrent malignant glioma. Neuro Oncol
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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.
(2008). A phase I trial of temozolomide and lomustine in newly diagnosed high-grade gliomas of childhood. Neuro Oncol
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Grossman, S. A., Carson, K. A., Phuphanich, S., Batchelor, T., Peereboom, D., Nabors, L. B., Lesser, G., Hausheer, F., Supko, J. G., for the New Approaches to Brain Tumor Therapy CNS,
(2008). Phase I and pharmacokinetic study of karenitecin in patients with recurrent malignant gliomas. Neuro Oncol
10: 608-616
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Milsom, M. D., Jerabek-Willemsen, M., Harris, C. E., Schambach, A., Broun, E., Bailey, J., Jansen, M., Schleimer, D., Nattamai, K., Wilhelm, J., Watson, A., Geiger, H., Margison, G. P., Moritz, T., Baum, C., Thomale, J., Williams, D. A.
(2008). Reciprocal Relationship between O6-Methylguanine-DNA Methyltransferase P140K Expression Level and Chemoprotection of Hematopoietic Stem Cells. Cancer Res.
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Wen, P. Y., Kesari, S.
(2008). Malignant Gliomas in Adults. NEJM
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Mason, W. P., Cairncross, J. G.
(2008). Invited Article: The expanding impact of molecular biology on the diagnosis and treatment of gliomas. Neurology
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Beier, D., Rohrl, S., Pillai, D. R., Schwarz, S., Kunz-Schughart, L. A., Leukel, P., Proescholdt, M., Brawanski, A., Bogdahn, U., Trampe-Kieslich, A., Giebel, B., Wischhusen, J., Reifenberger, G., Hau, P., Beier, C. P.
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Nandi, S., Ulasov, I. V., Tyler, M. A., Sugihara, A. Q., Molinero, L., Han, Y., Zhu, Z. B., Lesniak, M. S.
(2008). Low-Dose Radiation Enhances Survivin-Mediated Virotherapy against Malignant Glioma Stem Cells. Cancer Res.
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Colman, H., Aldape, K.
(2008). Molecular Predictors in Glioblastoma: Toward Personalized Therapy. Arch Neurol
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Liang, X.-J., Choi, Y., Sackett, D. L., Park, J. K.
(2008). Nitrosoureas Inhibit the Stathmin-Mediated Migration and Invasion of Malignant Glioma Cells. Cancer Res.
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Iafrate, A. J., Louis, D. N.
(2008). "MGMT for pt mgmt": Is Methylguanine-DNA Methyltransferase Testing Ready for Patient Management?. J. Mol. Diagn.
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Vlassenbroeck, I., Califice, S., Diserens, A.-C., Migliavacca, E., Straub, J., Di Stefano, I., Moreau, F., Hamou, M.-F., Renard, I., Delorenzi, M., Flamion, B., DiGuiseppi, J., Bierau, K., Hegi, M. E.
(2008). Validation of Real-Time Methylation-Specific PCR to Determine O6-Methylguanine-DNA Methyltransferase Gene Promoter Methylation in Glioma. J. Mol. Diagn.
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Murat, A., Migliavacca, E., Gorlia, T., Lambiv, W. L., Shay, T., Hamou, M.-F., de Tribolet, N., Regli, L., Wick, W., Kouwenhoven, M. C.M., Hainfellner, J. A., Heppner, F. L., Dietrich, P.-Y., Zimmer, Y., Cairncross, J. G., Janzer, R.-C., Domany, E., Delorenzi, M., Stupp, R., Hegi, M. E.
(2008). Stem Cell-Related "Self-Renewal" Signature and High Epidermal Growth Factor Receptor Expression Associated With Resistance to Concomitant Chemoradiotherapy in Glioblastoma. JCO
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Dirks, P. B.
(2008). Brain Tumor Stem Cells: Bringing Order to the Chaos of Brain Cancer. JCO
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De Vleeschouwer, S., Fieuws, S., Rutkowski, S., Van Calenbergh, F., Van Loon, J., Goffin, J., Sciot, R., Wilms, G., Demaerel, P., Warmuth-Metz, M., Soerensen, N., Wolff, J. E.A., Wagner, S., Kaempgen, E., Van Gool, S. W.
(2008). Postoperative Adjuvant Dendritic Cell-Based Immunotherapy in Patients with Relapsed Glioblastoma Multiforme. Clin. Cancer Res.
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Brandes, A. A., Franceschi, E., Tosoni, A., Blatt, V., Pession, A., Tallini, G., Bertorelle, R., Bartolini, S., Calbucci, F., Andreoli, A., Frezza, G., Leonardi, M., Spagnolli, F., Ermani, M.
(2008). MGMT Promoter Methylation Status Can Predict the Incidence and Outcome of Pseudoprogression After Concomitant Radiochemotherapy in Newly Diagnosed Glioblastoma Patients. JCO
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Kwon, C.-H., Zhao, D., Chen, J., Alcantara, S., Li, Y., Burns, D. K., Mason, R. P., Lee, E. Y.-H. P., Wu, H., Parada, L. F.
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(2008). Signal Transducer and Activator of Transcription-3: A Molecular Hub for Signaling Pathways in Gliomas. Mol Cancer Res
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Plummer, E. R., Calvert, H.
(2008). Targeting Poly(ADP-Ribose) Polymerase: A Two-Armed Strategy for Cancer Therapy. aacredbook
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Grossman, S. A., Olson, J., Batchelor, T., Peereboom, D., Lesser, G., Desideri, S., Ye, X., Hammour, T., Supko, J. G., for the New Approaches to Brain Tumor Therapy CNS,
(2008). Effect of phenytoin on celecoxib pharmacokinetics in patients with glioblastoma. Neuro Oncol
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Reardon, D. A., Zalutsky, M. R., Akabani, G., Coleman, R. E., Friedman, A. H., Herndon, J. E. II, McLendon, R. E., Pegram, C. N., Quinn, J. A., Rich, J. N., Vredenburgh, J. J., Desjardins, A., Guruangan, S., Boulton, S., Raynor, R. H., Dowell, J. M., Wong, T. Z., Zhao, X.-G., Friedman, H. S., Bigner, D. D.
(2008). A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost. Neuro Oncol
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Puduvalli, V. K., Giglio, P., Groves, M. D., Hess, K. R., Gilbert, M. R., Mahankali, S., Jackson, E. F., Levin, V. A., Conrad, C. A., Hsu, S. H., Colman, H., de Groot, J. F., Ritterhouse, M. G., Ictech, S. E., Yung, W. K. A.
(2008). Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme. Neuro Oncol
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Norden, A. D., Young, G. S., Setayesh, K., Muzikansky, A., Klufas, R., Ross, G. L., Ciampa, A. S., Ebbeling, L. G., Levy, B., Drappatz, J., Kesari, S., Wen, P. Y.
(2008). Bevacizumab for recurrent malignant gliomas: Efficacy, toxicity, and patterns of recurrence. Neurology
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Ozduman, K., Wollmann, G., Piepmeier, J. M., van den Pol, A. N.
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Fujita, M., Zhu, X., Sasaki, K., Ueda, R., Low, K. L., Pollack, I. F., Okada, H.
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Filippini, G., Falcone, C., Boiardi, A., Broggi, G., Bruzzone, M. G., Caldiroli, D., Farina, R., Farinotti, M., Fariselli, L., Finocchiaro, G., Giombini, S., Pollo, B., Savoiardo, M., Solero, C. L., Valsecchi, M. G., for the Brain Cancer Register of the Fondazione I.,
(2008). Prognostic factors for survival in 676 consecutive patients with newly diagnosed primary glioblastoma. Neuro Oncol
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Heimberger, A. B., Sun, W., Hussain, S. F., Dey, M., Crutcher, L., Aldape, K., Gilbert, M., Hassenbusch, S. J., Sawaya, R., Schmittling, B., Archer, G. E., Mitchell, D. A., Bigner, D. D., Sampson, J. H.
(2008). Immunological responses in a patient with glioblastoma multiforme treated with sequential courses of temozolomide and immunotherapy: Case study. Neuro Oncol
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Ziegler, D. S., Kung, A. L., Kieran, M. W.
(2008). Anti-Apoptosis Mechanisms in Malignant Gliomas. JCO
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Reardon, D. A., Desjardins, A., Vredenburgh, J. J., Sathornsumetee, S., Rich, J. N., Quinn, J. A., Lagattuta, T. F., Egorin, M. J., Gururangan, S., McLendon, R., Herndon, J. E. II, Friedman, A. H., Salvado, A. J., Friedman, H. S.
(2008). Safety and pharmacokinetics of dose-intensive imatinib mesylate plus temozolomide: Phase 1 trial in adults with malignant glioma. Neuro Oncol
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