Journal of Clinical Oncology, Vol 20, Issue 5
(March), 2002: 1375-1382
© 2002 American Society for Clinical Oncology
Promising Survival for Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concomitant Radiation Plus Temozolomide Followed by Adjuvant Temozolomide
By Roger Stupp,
Pierre-Yves Dietrich,
Sandrine Ostermann Kraljevic,
Alessia Pica,
Ivan Maillard,
Phillipe Maeder,
Reto Meuli,
Robert Janzer,
Gianpaolo Pizzolato,
Raymond Miralbell,
François Porchet,
Luca Regli,
Nicolas de Tribolet,
René O. Mirimanoff,
Serge Leyvraz
From the Departments of Medical Oncology, Radiation Therapy, Neurosurgery, Pathology, and Radiology, Centre Hospitalier Universitaire Vaudois, Lausanne, and Hôpital Universitaire Genevois, Geneva, Switzerland.
Address reprint requests to Roger Stupp, MD, Centre Hospitalier Universitaire Vaudois, Multidisciplinary Center for Oncology, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland; email: roger.stupp{at}chuv .hospvd.ch.
PURPOSE: Temozolomide is a novel oral alkylating agent with demonstrated efficacy as second-line therapy for patients with recurrent anaplastic astrocytoma and glioblastoma multiforme (GBM). This phase II study was performed to determine the safety, tolerability, and efficacy of concomitant radiation plus temozolomide therapy followed by adjuvant temozolomide therapy in patients with newly diagnosed GBM.
PATIENTS AND METHODS: Sixty-four patients were enrolled onto this open-label, phase II trial. Temozolomide (75 mg/m2/d x 7 d/wk for 6 weeks) was administered orally concomitant with fractionated radiotherapy (60 Gy total dose: 2 Gy x 5 d/wk for 6 weeks) followed by temozolomide monotherapy (200 mg/m2/d x 5 days, every 28 days for six cycles). The primary end points were safety and tolerability, and the secondary end point was overall survival.
RESULTS: Concomitant radiation plus temozolomide therapy was safe and well tolerated. Nonhematologic toxicities were rare and mild to moderate in severity. During the concomitant treatment phase, grade 3 or 4 neutropenia, thrombocytopenia, or both were observed in 6% of patients, including two severe infections with Pneumocystis carinii. During adjuvant temozolomide, 2% and 6% of cycles were associated with grade 3 and 4 neutropenia or thrombocytopenia, respectively. Median survival was 16 months, and the 1- and 2-year survival rates were 58% and 31%, respectively. Patients younger than 50 years old and patients who underwent debulking surgery had the best survival outcome.
CONCLUSION: Continuous daily temozolomide and concomitant radiation is safe. This regimen of concomitant chemoradiotherapy followed by adjuvant chemotherapy may prolong the survival of patients with glioblastoma. Further investigation is warranted, and a randomized trial is ongoing.
P.Y.D. and S.O.K. contributed equally to this study.
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[Abstract]
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D. Rajesh, R. A. Stenzel, and S. P. Howard
Perillyl Alcohol as a Radio-/Chemosensitizer in Malignant Glioma
J. Biol. Chem.,
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[Abstract]
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The Neuro-Oncology Working Group of the German Can
Neuro-Oncology Working Group 01 Trial of Nimustine Plus Teniposide Versus Nimustine Plus Cytarabine Chemotherapy in Addition to Involved-Field Radiotherapy in the First-Line Treatment of Malignant Glioma
J. Clin. Oncol.,
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[Abstract]
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T. Calzascia, W. Di Berardino-Besson, R. Wilmotte, F. Masson, N. d. Tribolet, P.-Y. Dietrich, and P. R. Walker
Cutting Edge: Cross-Presentation as a Mechanism for Efficient Recruitment of Tumor-Specific CTL to the Brain
J. Immunol.,
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[Abstract]
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M. R. Gilbert, H. S. Friedman, J. F. Kuttesch, M. D. Prados, J. J. Olson, G. H. Reaman, and S. L. Zaknoen
A phase II study of temozolomide in patients with newly diagnosed supratentorial malignant glioma before radiation therapy
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C. Nieder
Treatment of Newly Diagnosed Glioblastoma Multiforme
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P. Beauchesne, R. Stupp, S. Ostermann-Kraljevic, P.-Y. Dietrich, R. O. Mirimanoff, D. Reardon, and D. D. Bigner
Promising Survival and Concomitant Radiation Plus Temozolomide Followed by Adjuvant Temozolomide
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