Herrlinger, Ulrich and Schaefer, Niklas and Steinbach, Joachim P. and Weyerbrock, Astrid and Hau, Peter and Goldbrunner, Roland and Friedrich, Franziska and Rohde, Veit and Ringel, Florian and Schlegel, Uwe and Sabel, Michael and Ronellenfitsch, Michael W. and Uhl, Martin and Maciaczyk, Jaroslaw and Grau, Stefan and Schnell, Oliver and Haenel, Mathias and Krex, Dietmar and Vajkoczy, Peter and Gerlach, Ruediger and Kortmann, Rolf-Dieter and Mehdorn, Maximilian and Tuettenberg, Jochen and Mayer-Steinacker, Regine and Fietkau, Rainer and Brehmer, Stefanie and Mack, Frederic and Stuplich, Moritz and Kebir, Sied and Kohnen, Ralf and Dunkl, Elmar and Leutgeb, Barbara and Proescholdt, Martin and Pietsch, Torsten and Urbach, Horst and Belka, Claus and Stummer, Walter and Glas, Martin (2016) Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O-6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial. JOURNAL OF CLINICAL ONCOLOGY, 34 (14). 1611-U134. ISSN 0732-183X, 1527-7755
Full text not available from this repository. (Request a copy)Abstract
Purpose In patients with newly diagnosed glioblastoma that harbors a nonmethylated O-6-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 (10mg/kg every 2 weeks) during radiotherapy (RT) followed by maintenance BEV (10mg/kg every 2 weeks) plus IRI(125 mg/m(2) every 2 weeks) or to daily TMZ (75 mg/m(2)) during RT followed by six courses of TMZ (150-200 mg/m(2)/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. (C) 2016 by American Society of Clinical Oncology
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ENDOTHELIAL GROWTH-FACTOR; PHASE-II; RECURRENT GLIOBLASTOMA; ADJUVANT TEMOZOLOMIDE; STANDARD TREATMENT; MALIGNANT GLIOMA; OPEN-LABEL; GENE; RADIOTHERAPY; CONCOMITANT; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Mar 2019 10:11 |
| Last Modified: | 22 Mar 2019 10:11 |
| URI: | https://pred.uni-regensburg.de/id/eprint/2940 |
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