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Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial.

Al's Comment:

Impressive gain in progression free survival. These trials should NOT even try to report on overall survival. They say 83% of patients in the control group took Avastin at the time of recurrence.  So they are comparing patients who took Avastin to patients who took Avastin and found no difference in overall survival. Duh.

 


Posted on: 03/17/2016

  J Clin Oncol. 2016 Mar 14. pii: JCO634691. [Epub ahead of print]
Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial.
Herrlinger U1, Schäfer N2, Steinbach JP2, Weyerbrock A2, Hau P2, Goldbrunner R2, Friedrich F2, Rohde V2, Ringel F2, Schlegel U2, Sabel M2, Ronellenfitsch MW2, Uhl M2, Maciaczyk J2, Grau S2, Schnell O2, Hänel M2, Krex D2, Vajkoczy P2, Gerlach R2, Kortmann RD2, Mehdorn M2, Tüttenberg J2, Mayer-Steinacker R2, Fietkau R2, Brehmer S2, Mack F2, Stuplich M2, Kebir S2, Kohnen R2, Dunkl E2, Leutgeb B2, Proescholdt M2, Pietsch T2, Urbach H2, Belka C2, Stummer W2, Glas M2.
 
Author information:
1Ulrich Herrlinger, Niklas Schäfer, Frederic Mack, Moritz Stuplich, Sied Kebir, Torsten Pietsch, and Martin Glas, University of Bonn, Bonn; Joachim P. Steinbach and Michael W. Ronellenfitsch, University of Frankfurt, Frankfurt; Astrid Weyerbrock and Horst Urbach, University of Freiburg, Freiburg; Peter Hau and Martin Uhl, University Hospital Regensburg, Regensburg; Roland Goldbrunner and Stefan Grau, University of Cologne, Cologne; Franziska Friedrich and Rolf-Dieter Kortmann, University of Leipzig, Leipzig; Veit Rohde, University of Goettingen, Goettingen; Florian Ringel, Klinikum rechts der Isar Technical University of Munich; Oliver Schnell and Claus Belka, Ludwig Maximillian University of Munich, Munich; Uwe Schlegel, Ruhr-Universität Bochum, Bochum; Michael Sabel and Jaroslaw Maciaczyk, University of Düsseldorf, Düsseldorf; Mathias Hänel, Klinikum Chemnitz, Chemnitz; Dietmar Krex, University of Dresden, Dresden; Peter Vajkoczy, Charité, Humboldt University of Berlin, Berlin; Rüdiger Gerlach, Helios Klinikum Erfurt, Erfurt; Maximilian Mehdorn, University of Kiel, Kiel; Jochen Tüttenberg, Klinikum Idar-Oberstein, Idar-Oberstein; Regine Mayer-Steinacker, University of Ulm, Ulm; Rainer Fietkau, University of Erlangen, Erlangen; Stefanie Brehmer, University of Mannheim, Mannheim; Ralf Kohnen and Elmar Dunkl, RPS Research Germany, Nürnberg; Barbara Leutgeb and Martin Proescholdt, Roche Pharma AG, Grenzach-Wyhlen; and Walter Stummer, University of Münster, Münster, Germany ulrich.herrlinger@ukb.uni-bonn.de.
2Ulrich Herrlinger, Niklas Schäfer, Frederic Mack, Moritz Stuplich, Sied Kebir, Torsten Pietsch, and Martin Glas, University of Bonn, Bonn; Joachim P. Steinbach and Michael W. Ronellenfitsch, University of Frankfurt, Frankfurt; Astrid Weyerbrock and Horst Urbach, University of Freiburg, Freiburg; Peter Hau and Martin Uhl, University Hospital Regensburg, Regensburg; Roland Goldbrunner and Stefan Grau, University of Cologne, Cologne; Franziska Friedrich and Rolf-Dieter Kortmann, University of Leipzig, Leipzig; Veit Rohde, University of Goettingen, Goettingen; Florian Ringel, Klinikum rechts der Isar Technical University of Munich; Oliver Schnell and Claus Belka, Ludwig Maximillian University of Munich, Munich; Uwe Schlegel, Ruhr-Universität Bochum, Bochum; Michael Sabel and Jaroslaw Maciaczyk, University of Düsseldorf, Düsseldorf; Mathias Hänel, Klinikum Chemnitz, Chemnitz; Dietmar Krex, University of Dresden, Dresden; Peter Vajkoczy, Charité, Humboldt University of Berlin, Berlin; Rüdiger Gerlach, Helios Klinikum Erfurt, Erfurt; Maximilian Mehdorn, University of Kiel, Kiel; Jochen Tüttenberg, Klinikum Idar-Oberstein, Idar-Oberstein; Regine Mayer-Steinacker, University of Ulm, Ulm; Rainer Fietkau, University of Erlangen, Erlangen; Stefanie Brehmer, University of Mannheim, Mannheim; Ralf Kohnen and Elmar Dunkl, RPS Research Germany, Nürnberg; Barbara Leutgeb and Martin Proescholdt, Roche Pharma AG, Grenzach-Wyhlen; and Walter Stummer, University of Münster, Münster, Germany.
 
Abstract
PURPOSE:
 
In patients with newly diagnosed glioblastoma that harbors a nonmethylated O6-methylguanine-DNA methyltransferase promotor, standard temozolomide (TMZ) has, at best, limited efficacy. The GLARIUS trial thus explored bevacizumab plus irinotecan (BEV+IRI) as an alternative to TMZ.
PATIENTS AND METHODS:
 
In this phase II, unblinded trial 182 patients in 22 centers were randomly assigned 2:1 to BEV (10 mg/kg every 2 weeks) during radiotherapy (RT) followed by maintenance BEV (10 mg/kg every 2 weeks) plus IRI(125 mg/m2 every 2 weeks) or to daily TMZ (75 mg/m2) during RT followed by six courses of TMZ (150-200 mg/m2/d for 5 days every 4 weeks). The primary end point was the progression-free survival rate after 6 months (PFS-6).
RESULTS:
 
In the modified intention-to-treat (ITT) population, PFS-6 was increased from 42.6% with TMZ (95% CI, 29.4% to 55.8%) to 79.3% with BEV+IRI (95% CI, 71.9% to 86.7%; P <.001). PFS was prolonged from a median of 5.99 months (95% CI, 2.7 to 7.3 months) to 9.7 months (95% CI, 8.7 to 10.8 months; P < .001). At progression, crossover BEV therapy was given to 81.8% of all patients who received any sort of second-line therapy in the TMZ arm. Overall survival (OS) was not different in the two arms: the median OS was 16.6 months (95% CI, 15.4 to 18.4 months) with BEV+IRI and was 17.5 months (95% CI, 15.1 to 20.5 months) with TMZ. The time course of quality of life (QOL) in six selected domains of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (QLQ) -C30 and QLQ-BN20 (which included cognitive functioning), of the Karnofsky performance score, and of the Mini Mental State Examination score was not different between the treatment arms.
CONCLUSION:
 
BEV+IRI resulted in a superior PFS-6 rate and median PFS compared with TMZ. However, BEV+IRI did not improve OS, potentially because of the high crossover rate. BEV+IRI did not alter QOL compared with TMZ.
 
© 2016 by American Society of Clinical Oncology.

 


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