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Effect of CYP3A-inducing anti-epileptics on sorafenib exposure: results of a phase II study of sorafenib plus daily temozolomide in adults with recurrent glioblastoma

  • Clinical Study – Patient Study
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Abstract

Sorafenib, an oral VEGFR-2, Raf, PDGFR, c-KIT and Flt-3 inhibitor, is active against renal cell and hepatocellular carcinomas, and has recently demonstrated promising activity for lung and breast cancers. In addition, various protracted temozolomide dosing schedules have been evaluated as a strategy to further enhance its anti-tumor activity. We reasoned that sorafenib and protracted, daily temozolomide may provide complementary therapeutic benefit, and therefore performed a phase 2 trial among recurrent glioblastoma patients. Adult glioblastoma patients at any recurrence after standard temozolomide chemoradiotherapy received sorafenib (400 mg twice daily) and continuous daily temozolomide (50 mg/m2/day). Assessments were performed every eight weeks. The primary endpoint was progression-free survival at 6 months (PFS-6) and secondary end points were radiographic response, overall survival (OS), safety and sorafenib pharmacokinetics. Of 32 enrolled patients, 12 (38%) were on CYP3-A inducing anti-epileptics (EIAEDs), 17 (53%) had 2 or more prior progressions, 15 had progressed while receiving 5-day temozolomide, and 12 (38%) had failed either prior bevacizumab or VEGFR inhibitor therapy. The most common grade ≥ 3 toxicities were palmer-planter erythrodysesthesia (19%) and elevated amylase/lipase (13%). Sorafenib pharmacokinetic exposures were comparable on day 1 regardless of EIAED status, but significantly lower on day 28 for patients on EIAEDs (P = 0.0431). With a median follow-up of 93 weeks, PFS-6 was 9.4%. Only one patient (3%) achieved a partial response. In conclusion, sorafenib can be safely administered with daily temozolomide, but this regimen has limited activity for recurrent GBM. Co-administration of EIAEDs can lower sorafenib exposures in this population.

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Abbreviations

CR:

Complete response

EIAEDs:

Enzyme-inducing antieptileptic drugs

GBM:

Glioblastoma multiforme

ITT:

Intent-to treat

KPS:

Karnofsky performance status

MAPK:

Mitogen-activated protein kinase

OS:

Overall survival

PD:

Progressive disease

PFS:

Progression-free survival

PR:

Partial response

SD:

Stable disease

VEGF:

Vascular endothelial growth factor

VEGFR:

Vascular endothelial growth factor receptor

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Acknowledgments

This work was supported by NIH Grants NS20023 and CA11898; NIH Grant MO1 RR 30, GCRC Program, NCRR; and NCI SPORE 1 P20 CA096890.

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Authors and Affiliations

  1. Department of Surgery, Duke University Medical Center, Durham, NC, 27710, USA

    David A. Reardon, Sridharan Gururangan, John H. Sampson, Dorothea Janney, Allan H. Friedman & Henry S. Friedman

  2. Department of Neurology, Duke University Medical Center, Durham, NC, 27710, USA

    Annick Desjardins & Katherine Peters

  3. Department of Pediatrics, Duke University Medical Center, Durham, NC, 27710, USA

    David A. Reardon, Sridharan Gururangan & Henry S. Friedman

  4. Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA

    James J. Vredenburgh

  5. Department of Cancer Center Biostatistics, Duke University Medical Center, Durham, NC, 27710, USA

    Jennifer Marcello & James E. Herndon II

  6. Department of Pathology, Duke University Medical Center, Durham, NC, 27710, USA

    Roger E. McLendon & Darell D. Bigner

  7. The Brain Tumor Center at Duke, Duke University Medical Center, Box 3624, Durham, NC, 27710, USA

    David A. Reardon

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Reardon, D.A., Vredenburgh, J.J., Desjardins, A. et al. Effect of CYP3A-inducing anti-epileptics on sorafenib exposure: results of a phase II study of sorafenib plus daily temozolomide in adults with recurrent glioblastoma. J Neurooncol 101, 57–66 (2011). https://doi.org/10.1007/s11060-010-0217-6

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