BACKGROUND: Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. The current standard of care for newly diagnosed glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus temozolomide, given concomitantly with and after radiotherapy, in terms of efficacy and safety. METHODS:Patients with newly diagnosed, histologically confirmed glioblastoma were randomly assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was overall survival. RESULTS: A total of 573 patients from 85 centers underwent randomization. The median age was 56 years, and 84 percent of patients had undergone debulking surgery. At a median follow-up of 28 months, the median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year survival rate was 26.5 percent with radiotherapy plus temozolomide and 10.4 percent with radiotherapy alone. Concomitant treatment with radiotherapy plus temozolomide resulted in grade 3 or 4 hematologic toxic effects in 7 percent of patients. CONCLUSIONS: The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma resulted in a clinically meaningful and statistically significant survival benefit with minimal additional toxicity. Copyright 2005 Massachusetts Medical Society.
RCT Entities:
BACKGROUND:Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. The current standard of care for newly diagnosed glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus temozolomide, given concomitantly with and after radiotherapy, in terms of efficacy and safety. METHODS:Patients with newly diagnosed, histologically confirmed glioblastoma were randomly assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was overall survival. RESULTS: A total of 573 patients from 85 centers underwent randomization. The median age was 56 years, and 84 percent of patients had undergone debulking surgery. At a median follow-up of 28 months, the median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year survival rate was 26.5 percent with radiotherapy plus temozolomide and 10.4 percent with radiotherapy alone. Concomitant treatment with radiotherapy plus temozolomide resulted in grade 3 or 4 hematologic toxic effects in 7 percent of patients. CONCLUSIONS: The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma resulted in a clinically meaningful and statistically significant survival benefit with minimal additional toxicity. Copyright 2005 Massachusetts Medical Society.
Authors: Monika E Hegi; Els Genbrugge; Thierry Gorlia; Roger Stupp; Mark R Gilbert; Olivier L Chinot; L Burt Nabors; Greg Jones; Wim Van Criekinge; Josef Straub; Michael Weller Journal: Clin Cancer Res Date: 2018-12-04 Impact factor: 12.531
Authors: Katherine S Panageas; Fabio M Iwamoto; Timothy F Cloughesy; Kenneth D Aldape; Andreana L Rivera; April F Eichler; David N Louis; Nina A Paleologos; Barbara J Fisher; Lynn S Ashby; J Gregory Cairncross; Gloria B Roldán Urgoiti; Patrick Y Wen; Keith L Ligon; David Schiff; H Ian Robins; Brandon G Rocque; Marc C Chamberlain; Warren P Mason; Susan A Weaver; Richard M Green; Francois G Kamar; Lauren E Abrey; Lisa M Deangelis; Suresh C Jhanwar; Marc K Rosenblum; Andrew B Lassman Journal: Neuro Oncol Date: 2012-05-31 Impact factor: 12.300
Authors: Georges Noel; Aymeri Huchet; Loic Feuvret; Jean Philippe Maire; Pierre Verrelle; Emilie Le Rhun; Maud Aumont; François Thillays; Marie Pierre Sunyach; Chantal Henzen; Fernand Missohou; Renaud de Crevoisier; Pierre Yves Bondiau; Philippe Collin; Xavier Durando; Gilles Truc; Christine Kerr; Valérie Bernier; Jean-Baptiste Clavier; David Atlani; Anne D'Hombres; Sandrine Vinchon-Petit; Jean Léon Lagrange; Luc Taillandier Journal: J Neurooncol Date: 2012-06-02 Impact factor: 4.130
Authors: Mekhail Anwar; Annette M Molinaro; Olivier Morin; Susan M Chang; Daphne A Haas-Kogan; Sarah J Nelson; Janine M Lupo Journal: Radiat Res Date: 2017-07-19 Impact factor: 2.841
Authors: Donald M O'Rourke; MacLean P Nasrallah; Arati Desai; Jan J Melenhorst; Keith Mansfield; Jennifer J D Morrissette; Maria Martinez-Lage; Steven Brem; Eileen Maloney; Angela Shen; Randi Isaacs; Suyash Mohan; Gabriela Plesa; Simon F Lacey; Jean-Marc Navenot; Zhaohui Zheng; Bruce L Levine; Hideho Okada; Carl H June; Jennifer L Brogdon; Marcela V Maus Journal: Sci Transl Med Date: 2017-07-19 Impact factor: 17.956