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Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial.
Weller, J; Schäfer, N; Schaub, C; Tzaridis, T; Zeyen, T; Schneider, M; Potthoff, A L; Giordano, F A; Steinbach, J P; Zeiner, P S; Kowalski, T; Sabel, M; Hau, P; Krex, D; Grauer, O; Goldbrunner, R; Schnell, O; Tabatabai, G; Ringel, F; Schmidt-Graf, F; Brehmer, S; Tonn, J C; Bullinger, L; Vajkoczy, P; Glas, M; Vatter, H; Herrlinger, U; Seidel, C.
Afiliación
  • Weller J; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany. johannes.weller@ukbonn.de.
  • Schäfer N; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Schaub C; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Tzaridis T; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Zeyen T; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Schneider M; Department of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.
  • Potthoff AL; Department of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.
  • Giordano FA; Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
  • Steinbach JP; Dr. Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
  • Zeiner PS; Dr. Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.
  • Kowalski T; Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.
  • Sabel M; Department of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany.
  • Hau P; Department of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Regensburg, Germany.
  • Krex D; Department of Neurosurgery, University of Dresden, Dresden, Germany.
  • Grauer O; Department of Neurology, University of Münster, Münster, Germany.
  • Goldbrunner R; Department of General Neurosurgery, Center of Neurosurgery, University of Cologne, Cologne, Germany.
  • Schnell O; Department of Neurosurgery, University of Freiburg, Freiburg, Germany.
  • Tabatabai G; Department of Neurology and Interdisciplinary Neurooncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research, Center for Neuro-Oncology, Comprehensive Cancer Center Tübingen-Stuttgart, German Cancer Consortium (DKTK), Partner site Tübingen, Eberhard Karls University, Tübin
  • Ringel F; Department of Neurosurgery, University of Mainz, Mainz, Germany.
  • Schmidt-Graf F; Department of Neurology, Technical University of Munich, Munich, Germany.
  • Brehmer S; Department of Neurosurgery, University of Mannheim, Mannheim, Germany.
  • Tonn JC; Department of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany.
  • Bullinger L; Department of Hematology, Oncology and Tumorimmunology, Charité University of Berlin, Berlin, Germany.
  • Vajkoczy P; Department of Neurosurgery, Charité University of Berlin, Berlin, Germany.
  • Glas M; Division of Clinical Neurooncology, Department of Neurology and West German Cancer Center (WTZ), German Cancer Consortium, Partner Site Essen, University Hospital Essen, Essen, Germany.
  • Vatter H; Department of Neurosurgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, Germany.
  • Herrlinger U; Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology (CIO), University Hospital Bonn, Venusberg-Campus 1, 53105, Bonn, Germany.
  • Seidel C; Department of Radiation Oncology, University of Leipzig, Leipzig, Germany.
J Neurooncol ; 161(1): 147-153, 2023 Jan.
Article en En | MEDLINE | ID: mdl-36609807
PURPOSE: In the randomized phase III trial CeTeG/NOA-09, temozolomide (TMZ)/lomustine (CCNU) combination therapy was superior to TMZ in newly diagnosed MGMT methylated glioblastoma, albeit reporting more frequent hematotoxicity. Here, we analyze high grade hematotoxicity and its prognostic relevance in the trial population. METHODS: Descriptive and comparative analysis of hematotoxicity adverse events ≥ grade 3 (HAE) according to the Common Terminology of Clinical Adverse Events, version 4.0 was performed. The association of HAE with survival was assessed in a landmark analysis. Logistic regression analysis was performed to predict HAE during the concomitant phase of chemotherapy. RESULTS: HAE occurred in 36.4% and 28.6% of patients under CCNU/TMZ and TMZ treatment, respectively. The median onset of the first HAE was during concomitant chemotherapy (i.e. first CCNU/TMZ course or daily TMZ therapy), and 42.9% of patients with HAE receiving further courses experienced repeat HAE. Median HAE duration was similar between treatment arms (CCNU/TMZ 11.5; TMZ 13 days). Chemotherapy was more often discontinued due to HAE in CCNU/TMZ than in TMZ (19.7 vs. 6.3%, p = 0.036). The occurrence of HAE was not associated with survival differences (p = 0.76). Regression analysis confirmed older age (OR 1.08) and female sex (OR 2.47), but not treatment arm, as predictors of HAE. CONCLUSION: Older age and female sex are associated with higher incidence of HAE. Although occurrence of HAE was not associated with shorter survival, reliable prediction of patients at risk might be beneficial to allow optimal management of therapy and allocation of supportive measures. TRIAL REGISTRATION: NCT01149109.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Encefálicas / Glioblastoma Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Female / Humans Idioma: En Revista: J Neurooncol Año: 2023 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Encefálicas / Glioblastoma Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Female / Humans Idioma: En Revista: J Neurooncol Año: 2023 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos