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Hypofractionated-intensity modulated radiotherapy (hypo-IMRT) and temozolomide (TMZ) with or without bevacizumab (BEV) for newly diagnosed glioblastoma multiforme (GBM): a comparison of two prospective phase II trials

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Abstract

To compare progression-free (PFS) and overall survival (OS) in patients treated in two consecutive phase II trials of hypofractionated-intensity modulated radiotherapy (hypo-IMRT) and temozolomide (TMZ) with or without bevacizumab (BEV). Patients with newly diagnosed glioblastoma multiforme (GBM) after biopsy or resection were enrolled on a clinical trial with hypo-IMRT and TMZ (hypo-IMRT/TMZ alone) from 2008 to 2010, or in the second protocol with the same hypo-IMRT and TMZ plus BEV (hypo-IMRT/TMZ/BEV) from 2010 to 2013. All patients received postoperative hypo-IMRT to the surgical cavity and residual tumor plus margin to a total dose of 60 Gy and to the T2 abnormality with margin to 30 Gy, both in ten fractions. Concurrent TMZ (75 mg/m2/day) was given to all patients for 28 consecutive days followed by adjuvant TMZ (150–200 mg/m2/day). Patients enrolled on the hypo-IMRT/TMZ/BEV trial received concurrent and adjuvant BEV (10 mg/kg) on days 1 and 15 of each 28-day cycle. Hazard ratios of PFS and OS were compared between trials in a Cox proportional hazards model. Twenty-six patients were enrolled on the hypo-IMRT/TMZ alone trial and 30 patients on the hypo-IMRT/TMZ/BEV trial. Median follow-up was 13.9 and 14.7 months, respectively. Median PFS was 3.4 months longer with hypo-IMRT/TMZ/BEV but the difference was not statistically significant (12.8 vs. 9.4 months, p = 0.58). Median (OS) was 16.3 months for both trials. The addition of BEV to TMZ and hypo-IMRT did not improve OS for patients with GBM in two phase II trials with small patient numbers; PFS was longer with BEV, but the difference was not statistically significant.

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The authors report no conflict of interest.

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Authors and Affiliations

  1. Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, USA

    Julie A. Carlson, Laurie E. Gaspar & Brian D. Kavanagh

  2. Department of Radiation Oncology, University of Toledo College of Medicine and Life Sciences, Aurora, USA

    Krishna Reddy & Changhu Chen

  3. Department of Neurology, University of Colorado School of Medicine, Aurora, USA

    Douglas Ney & Denise Damek

  4. Department of Neurosurgery, University of Colorado School of Medicine, Aurora, USA

    Kevin Lillehei

  5. 1665 Aurora Court, Suite 1032, Aurora, CO, 80045, USA

    Julie A. Carlson

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  1. Julie A. Carlson
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  2. Krishna Reddy
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  3. Laurie E. Gaspar
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  4. Douglas Ney
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  5. Brian D. Kavanagh
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  6. Denise Damek
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  7. Kevin Lillehei
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  8. Changhu Chen
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Correspondence to Julie A. Carlson.

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Carlson, J.A., Reddy, K., Gaspar, L.E. et al. Hypofractionated-intensity modulated radiotherapy (hypo-IMRT) and temozolomide (TMZ) with or without bevacizumab (BEV) for newly diagnosed glioblastoma multiforme (GBM): a comparison of two prospective phase II trials. J Neurooncol 123, 251–257 (2015). https://doi.org/10.1007/s11060-015-1791-4

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  • DOI: https://doi.org/10.1007/s11060-015-1791-4

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