Lazaros Lazaridis1,2,3,4, Niklas Schäfer5, Sarah Teuber-Hanselmann6, Tobias Blau6, Teresa Schmidt1,2,3,4, Christoph Oster1,2,3,4, Johannes Weller5, Theophilos Tzaridis5, Daniela Pierscianek7,3,4, Kathy Keyvani6, Christoph Kleinschnitz8, Martin Stuschke9, Björn Scheffler2, Cornelius Deuschl10, Ulrich Sure7,3,4, Ulrich Herrlinger5, Sied Kebir1,2,3,4, Martin Glas11,12,13,14. 1. Division of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 2. DKFZ-Division Translational Neurooncology at the West German Cancer Centre (WTZ), German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany. 3. West German Cancer Centre (WTZ), University Hospital Essen, University Duisburg-Essen, Essen, Germany. 4. German Cancer Consortium, Partner Site University Hospital Essen, Essen, Germany. 5. Division of Clinical Neurooncology, Department of Neurology, University of Bonn Medical Centre, Bonn, Germany. 6. Department of Neuropathology, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 7. Department of Neurosurgery, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 8. Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 9. Department of Radiotherapy, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 10. Institute for Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 11. Division of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Martin.Glas@uk-essen.de. 12. DKFZ-Division Translational Neurooncology at the West German Cancer Centre (WTZ), German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany. Martin.Glas@uk-essen.de. 13. West German Cancer Centre (WTZ), University Hospital Essen, University Duisburg-Essen, Essen, Germany. Martin.Glas@uk-essen.de. 14. German Cancer Consortium, Partner Site University Hospital Essen, Essen, Germany. Martin.Glas@uk-essen.de.
Abstract
PURPOSE: In the EF-14 trial for newly diagnosed glioblastoma (ndGBM) patients addition of Tumour Treating Fields (TTFields) to temozolomide treatment resulted in a significantly improved overall survival (OS). In the NOA-09/CeTeG trial, combination of lomustine and temozolomide was superior to temozolomide monotherapy in patients with O6-methylguanine DNA methyltransferase (MGMT) promoter methylated (MGMTm) ndGBM. We evaluated combination of these two treatment modalities in patients with MGMTm ndGBM. There have been so far no data on the combination of these two efficient regimens. METHODS: This bicentric retrospective analysis investigated 16 patients. Parameters evaluated included safety outcome as measured by Common Toxicity Criteria for Adverse Events (CTCAE), clinical outcomes, and compliance to treatment. RESULTS: Hematologic adverse events CTCAE ≥ 3 were observed in seven, hepatotoxic adverse events of CTCAE ≥ 3 in four patients. Mild to moderate skin toxicity was detected in six patients. At data cutoff, patients demonstrated a median progression-free survival (PFS) of 20 months. The usage rate of TTFields showed a high median adherence (83%) to the therapy. CONCLUSIONS: This analysis provides first indication that the combination of TTFields/lomustine/temozolomide is safe and feasible. The observed survival outcomes might suggest potential beneficial effects.
PURPOSE: In the EF-14 trial for newly diagnosed glioblastoma (ndGBM) patients addition of Tumour Treating Fields (TTFields) to temozolomide treatment resulted in a significantly improved overall survival (OS). In the NOA-09/CeTeG trial, combination of lomustine and temozolomide was superior to temozolomide monotherapy in patients with O6-methylguanine DNA methyltransferase (MGMT) promoter methylated (MGMTm) ndGBM. We evaluated combination of these two treatment modalities in patients with MGMTm ndGBM. There have been so far no data on the combination of these two efficient regimens. METHODS: This bicentric retrospective analysis investigated 16 patients. Parameters evaluated included safety outcome as measured by Common Toxicity Criteria for Adverse Events (CTCAE), clinical outcomes, and compliance to treatment. RESULTS: Hematologic adverse events CTCAE ≥ 3 were observed in seven, hepatotoxic adverse events of CTCAE ≥ 3 in four patients. Mild to moderate skin toxicity was detected in six patients. At data cutoff, patients demonstrated a median progression-free survival (PFS) of 20 months. The usage rate of TTFields showed a high median adherence (83%) to the therapy. CONCLUSIONS: This analysis provides first indication that the combination of TTFields/lomustine/temozolomide is safe and feasible. The observed survival outcomes might suggest potential beneficial effects.
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