Prolonged Temozolomide Maintenance Therapy in Newly Diagnosed Glioblastoma

Author:

Skardelly Marco123,Dangel Elena12,Gohde Julia12,Noell Susan12,Behling Felix123,Lepski Guilherme12,Borchers Christian423,Koch Marilin423,Schittenhelm Jens1452,Bisdas Sotirios1462,Naumann Aline7,Paulsen Frank83,Zips Daniel83910,von Hehn Ulrike11,Ritz Rainer1,Tatagiba Marcos Soares1239,Tabatabai Ghazaleh14239

Affiliation:

1. Department of Neurosurgery, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

2. Department of Interdisciplinary Division of Neuro-Oncology, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

3. Department of Center for CNS Tumors, Comprehensive Cancer Center Tübingen Stuttgart, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

4. Department of Vascular Neurology, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

5. Department of Institute of Pathology and Neuropathology, Division of Neuropathology, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

6. Department of Neuroradiology, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

7. Department of Institute of Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

8. Department of Radiation Oncology, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany

9. German Cancer Consortium (DKTK), DKFZ partner site Tübingen, Tübingen, Germany

10. Center for Personalized Medicine, Eberhard Karls University of Tübingen, Tübingen, Germany

11. Medistat GmbH, Kiel, Germany

Abstract

Abstract Background The impact of prolonging temozolomide (TMZ) maintenance beyond six cycles in newly diagnosed glioblastoma (GBM) remains a topic of discussion. We investigated the effects of prolonged TMZ maintenance on progression-free survival (PFS) and overall survival (OS). Patients and Methods In this retrospective single-center cohort study, we included patients with GBM who were treated with radiation therapy with concomitant and adjuvant TMZ. For analysis, patients were considered who either completed six TMZ maintenance cycles (group B), continued with TMZ therapy beyond six cycles (group C), or stopped TMZ maintenance therapy within the first six cycles (group A). Patients with progression during the first six TMZ maintenance cycles were excluded. Results Clinical data from 107 patients were included for Kaplan-Meier analyses and 102 for Cox regressions. Median PFS times were 8.1 months (95% confidence interval [CI] 6.1–12.4) in group A, 13.7 months (95% CI 10.6–17.5) in group B, and 20.9 months (95% CI 15.2–43.5) in group C. At first progression, response rates of TMZ/lomustine rechallenge were 47% in group B and 13% in group C. Median OS times were 12.7 months (95% CI 10.3–16.8) in group A, 25.2 months (95% CI 17.7–55.5) in group B, and 28.6 months (95% CI 24.4–open) in group C. Nevertheless, multivariate Cox regression for patients in group C compared with group B that accounted for imbalances of other risk factors showed no different relative risk (RR) for OS (RR 0.77, p = .46). Conclusion Our data do not support a general extension of TMZ maintenance therapy beyond six cycles.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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