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Oncology. 2020;98(1):16-22. doi: 10.1159/000502483. Epub 2019 Sep 12.

Open-Label Phase II Evaluation of Imatinib in Primary Inoperable or Incompletely Resected and Recurrent Glioblastoma.

Author information

1
Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
2
Day Treatment Center (TTZ), Interdisciplinary Tumor Center Mannheim (ITM) and 3rd Medical Clinic, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
3
Department of Neurosurgery, Klinikum Idar-Oberstein, Idar-Oberstein, Germany.
4
Department of Neurosurgery, Charité University Hospital, Humboldt University Berlin, Berlin, Germany.
5
Department of Neuroradiology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany.
6
Department of Neurosurgery, Ruhr-University Bochum, Bochum, Germany.
7
Department of Internal Medicine II, University Hospital Jena, Jena, Germany.
8
University Medical Center Freiburg, Freiburg, Germany.
9
Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany, frank.giordano@umm.de.

Abstract

PURPOSE:

Preclinical studies indicated that imatinib may have single-agent activity in glioblastoma through inhibition of tyrosine kinase activity and also that it might enhance the efficacy of radiotherapy. We therefore sought to investigate clinical efficacy in patients with newly diagnosed and recurrent glioblastoma in combination with radiotherapy.

METHODS:

We conducted a nonrandomized, 2-arm, open-label phase II trial including patients aged 18 years or older with an ECOG performance status of 0-2 that were either newly diagnosed (arm A) with a measurable tumor (i.e., after incomplete resection or biopsy) or that were diagnosed with progression of a glioblastoma after initial therapy (arm B). Patients in arm A received 600 mg/day imatinib in combination with hypofractionated radiotherapy (2.5 Gy per fraction, 22 fractions). Patients in arm B received 600 mg/day imatinib alone or in combination with re-irradiation at various doses. In case tumor progression occurred, CCNU was added (2 cycles, 100 mg/m2) to imatinib. The primary end point was progression-free survival (PFS). The secondary end point was safety, defined as per Common Terminology Criteria for Adverse Events (version 2.0). Overall survival (OS) was analyzed as an exploratory end point.

RESULTS:

Fifty-one patients were enrolled, of which 19 were included in arm A and 32 in arm B. The median follow-up was 4 (0.5-30) months in arm A and 6.5 (0.3-51.5) months in arm B. The median PFS was 2.8 months (95% CI 0-8.7) in arm A and 2.1 months (95% CI 0-11.8) in arm B. The median OS was 5.0 (0.8-30) months (95% CI 0-24.1) in arm A and 6.5 (0.3-51.5) months (95% CI 0-32.5) in arm B. The major grade 3 events were seizure (present in 17 patients), pneumonia (11 patients), and vigilance decrease (7 patients).

CONCLUSIONS:

Imatinib showed no measurable activity in patients with newly diagnosed or recurrent glioblastoma.

KEYWORDS:

Gleevec; Glioblastoma; Glioma; Imatinib

PMID:
31514200
DOI:
10.1159/000502483
[Indexed for MEDLINE]

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