Phase II study of border zone stereotactic radiosurgery with bevacizumab in patients with recurrent or progressive glioblastoma multiforme

J Neurooncol. 2023 Aug;164(1):179-190. doi: 10.1007/s11060-023-04398-0. Epub 2023 Jul 29.

Abstract

Purpose: Recurrent glioblastoma is universally fatal with limited effective treatment options. The aim of this phase 2 study of Border Zone SRS plus bevacizumab was to evaluate OS in patients with recurrent GBM.

Methods: Patients with histologically confirmed GBM with recurrent disease who had received prior first-line treatment with fractionated radiotherapy and chemotherapy and eligible for SRS were enrolled. Bevacizumab 10 mg/kg was given day -1, day 14, and then every 14 days until disease progression. 1-14 days before BZ-SRS procedure, patients underwent brain MRI /MRS. MRS with measurement of choline-to-N-acetyl aspartate index (CNI) area ≥ 3 was targeted for SRS.

Results: From 2015-2017, sixteen of planned 40 patients were enrolled. The median age was 62 (range, 48-74Y). 3/16 (0.188) participants experienced grade 2 toxicity. No AREs were reported. The mOS was 11.73 months compared to 8.74 months (P = 0.324) from date of SRS for the BZ-SRS and institutional historical controls, respectively. PFS-6 and OS-6 were 31.2% (p = 0.00294) and 81.2%(p = 0.058), respectively. Of 13 evaluable for best response: 1 CR (p = 0.077), 4 PR (p = 0.308), 7 SD (p = 0.538), and 1 PD (p = 0.077). 11/16 participants had MRS scans with an estimated probability that MRS changes a treatment plan of 0 (0, 0.285).

Conclusion: BZ-SRS with bevacizumab was feasible and well tolerated. There is no significant survival benefit using BZ-SRS with bevacizumab compared to institutional historical controls. Secondary analysis revealed a trend toward improved PFS-6, but not OS-6 after BZ-SRS. MRS scans did not result in changes to SRS treatment plans.

Keywords: Bevacizumab; Glioblastoma; High-grade Glioma; Spectroscopy; Stereotactic Radiosurgery.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Bevacizumab / therapeutic use
  • Brain Neoplasms* / drug therapy
  • Brain Neoplasms* / pathology
  • Glioblastoma* / diagnostic imaging
  • Glioblastoma* / drug therapy
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Radiosurgery* / methods

Substances

  • Bevacizumab