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Neurology. 2017 Apr 11;88(15):1422-1430. doi: 10.1212/WNL.0000000000003809. Epub 2017 Mar 15.

Limited role for extended maintenance temozolomide for newly diagnosed glioblastoma.

Author information

1
From the Department of Neurology and Brain Tumor Center (D.G., M.W.), University Hospital Zurich and University of Zurich, Switzerland; Department of Neuroradiology (P.K., M.B.), University Hospital of Heidelberg; Institute for Medical Informatics, Statistics and Epidemiology (B.H., M.L.), University of Leipzig; Departments of Neuropathology (J.F., G.R.) and Neurosurgery (M.S.), Heinrich-Heine University Düsseldorf; Division of Neurooncology (U.H.), Department of Neurology, University Medical Center Bonn; Department of Neurosurgery (G.S.), University of Dresden; Department of Neurosurgery (J.-C.T.), Ludwig Maximilians University Munich; Department of Neurosurgery (M.W.), University Medical Center Hamburg-Eppendorf, Hamburg; Department of Neurology (U.S.), Knappschaftskrankenhaus Bochum-Langendreer, Ruhr-University Bochum; Clinical Cooperation Unit Neurooncology (W.W.), German Cancer Consortium, German Cancer Research Center, and Neurology Clinic and National Center for Tumor Diseases, University Hospital Heidelberg; Department of Neuropathology (T.P.), DGNN Brain Tumor Reference Center, University of Bonn Medical School; and German Cancer Consortium (G.R.), German Cancer Research Center Heidelberg, Partner Site Essen/Düsseldorf, Düsseldorf, Germany. dorothee.gramatzki@usz.ch.
2
From the Department of Neurology and Brain Tumor Center (D.G., M.W.), University Hospital Zurich and University of Zurich, Switzerland; Department of Neuroradiology (P.K., M.B.), University Hospital of Heidelberg; Institute for Medical Informatics, Statistics and Epidemiology (B.H., M.L.), University of Leipzig; Departments of Neuropathology (J.F., G.R.) and Neurosurgery (M.S.), Heinrich-Heine University Düsseldorf; Division of Neurooncology (U.H.), Department of Neurology, University Medical Center Bonn; Department of Neurosurgery (G.S.), University of Dresden; Department of Neurosurgery (J.-C.T.), Ludwig Maximilians University Munich; Department of Neurosurgery (M.W.), University Medical Center Hamburg-Eppendorf, Hamburg; Department of Neurology (U.S.), Knappschaftskrankenhaus Bochum-Langendreer, Ruhr-University Bochum; Clinical Cooperation Unit Neurooncology (W.W.), German Cancer Consortium, German Cancer Research Center, and Neurology Clinic and National Center for Tumor Diseases, University Hospital Heidelberg; Department of Neuropathology (T.P.), DGNN Brain Tumor Reference Center, University of Bonn Medical School; and German Cancer Consortium (G.R.), German Cancer Research Center Heidelberg, Partner Site Essen/Düsseldorf, Düsseldorf, Germany.

Abstract

OBJECTIVE:

To explore an association with survival of modifying the current standard of care for patients with newly diagnosed glioblastoma of surgery followed by radiotherapy plus concurrent and 6 cycles of maintenance temozolomide chemotherapy (TMZ/RT → TMZ) by extending TMZ beyond 6 cycles.

METHODS:

The German Glioma Network cohort was screened for patients with newly diagnosed glioblastoma who received TMZ/RT → TMZ and completed ≥6 cycles of maintenance chemotherapy without progression. Associations of clinical patient characteristics, molecular markers, and residual tumor determined by magnetic resonance imaging after 6 cycles of TMZ with progression-free survival (PFS) and overall survival (OS) were analyzed with the log-rank test. Multivariate analyses using the Cox proportional hazards model were performed to assess associations of prolonged TMZ use with outcome.

RESULTS:

Sixty-one of 142 identified patients received at least 7 maintenance TMZ cycles (median 11, range 7-20). Patients with extended maintenance TMZ treatment had better PFS (20.5 months, 95% confidence interval [CI] 17.7-23.3, vs 17.2 months, 95% CI 10.2-24.2, p = 0.035) but not OS (32.6 months, 95% CI 28.9-36.4, vs 33.2 months, 95% CI 25.3-41.0, p = 0.126). However, there was no significant association of prolonged TMZ chemotherapy with PFS (hazard ratio [HR] = 0.8, 95% CI 0.4-1.6, p = 0.559) or OS (HR = 1.6, 95% CI 0.8-3.3, p = 0.218) adjusted for age, extent of resection, Karnofsky performance score, presence of residual tumor, O6-methylguanine DNA methyltransferase (MGMT) promoter methylation status, or isocitrate dehydrogenase (IDH) mutation status.

CONCLUSION:

These data may not support the practice of prolonging maintenance TMZ chemotherapy beyond 6 cycles.

CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that in patients with newly diagnosed glioblastoma, prolonged TMZ chemotherapy does not significantly increase PFS or OS.

PMID:
28298550
DOI:
10.1212/WNL.0000000000003809
[Indexed for MEDLINE]
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