Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma

Authors

  • David A. Reardon MD,

    Corresponding author
    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Department of Surgery, Duke University Medical Center, Durham, North Carolina
    3. Department of Pediatrics, Duke University Medical Center, Durham, North Carolina
    • Duke University Medical Center, Box 3624, Durham, NC 27710
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    • Fax: (919) 684-6674

  • Annick Desjardins MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Departent of Medicine, Duke University Medical Center, Durham, North Carolina
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  • James J. Vredenburgh MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Departent of Medicine, Duke University Medical Center, Durham, North Carolina
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  • James E. Herndon II PhD,

    1. Department of Biostatistics, Duke University Medical Center, Durham, North Carolina
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  • April Coan MS,

    1. Department of Biostatistics, Duke University Medical Center, Durham, North Carolina
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  • Sridharan Gururangan MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Department of Surgery, Duke University Medical Center, Durham, North Carolina
    3. Department of Pediatrics, Duke University Medical Center, Durham, North Carolina
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  • Katherine B. Peters MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Departent of Medicine, Duke University Medical Center, Durham, North Carolina
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  • Roger McLendon MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Department of Pathology, Duke University Medical Center, Durham, North Carolina
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  • Sith Sathornsumetee MD,

    1. Department of Medicine (Neurology), Faculty of Medicine at Siriraj Hospital, Mahidol University, Bangkok, Thailand
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  • Jeremy N. Rich MD,

    1. Department of Stem Cell Biology and Regenerative Medicine, Cleveland Clinic, Cleveland, Ohio
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  • Eric S. Lipp MD,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Department of Surgery, Duke University Medical Center, Durham, North Carolina
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  • Dorothea Janney RN,

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Departent of Medicine, Duke University Medical Center, Durham, North Carolina
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  • Henry S. Friedman MD

    1. The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
    2. Department of Surgery, Duke University Medical Center, Durham, North Carolina
    3. Department of Pediatrics, Duke University Medical Center, Durham, North Carolina
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  • In addition to the above investigators, we wish to thank Wendy Gentry for her assistance in the preparation of this manuscript.

Abstract

BACKGROUND:

We evaluated the efficacy of imatinib plus hydroxyurea in patients with progressive/recurrent low-grade glioma.

METHODS:

A total of 64 patients with recurrent/progressive low-grade glioma were enrolled in this single-center study that stratified patients into astrocytoma and oligodendroglioma cohorts. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg per day for patients not on enzyme-inducing antiepileptic drugs (EIAEDs) and at 500 mg twice a day if on EIAEDs. The primary endpoint was progression-free survival at 12 months (PFS-12) and secondary endpoints were safety, median progression-free survival, and radiographic response rate.

RESULTS:

Thirty-two patients were enrolled into each cohort. Eleven patients (17%) had before radiotherapy and 24 (38%) had received before chemotherapy. The median PFS and PFS-12 were 11 months and 39%, respectively. Outcome did not differ between the histologic cohorts. No patient achieved a radiographic response. The most common grade 3 or greater adverse events were neutropenia (11%), thrombocytopenia (3%), and diarrhea (3%).

CONCLUSIONS:

Imatinib plus hydroxyurea was well tolerated among recurrent/progressive LGG patients but this regimen demonstrated negligible antitumor activity. Cancer 2012. © 2012 American Cancer Society.

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