AVAREG: A phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma

A. Brandes, Gaetano Finocchiaro, Vittorina Zagonel, Michele Reni, Claudia Caserta, Alessandra Fabi, Matteo Clavarezza, Evaristo Maiello, Marica Eoli, Giuseppe Lombardi, Marta Monteforte, Emanuela Proietti, Raffaele Agati, V. Eusebi, Enrico Franceschi

Research output: Contribution to journalArticle

Abstract

Background Few prospective studies have assessed the role of bevacizumab and included a control arm with standard treatments for recurrent glioblastoma. We conducted a noncomparative phase II trial (AVAREG) to examine the efficacy of bevacizumab or fotemustine in this setting. Methods Eligible patients were randomized 2:1 to receive bevacizumab (10 mg/kg every 2 weeks) or fotemustine (75 mg/m2 on days 1, 8, and 15, then 100 mg/m2 every 3 weeks after a 35-day interval). The primary endpoint was 6-month overall survival (OS) rate (OS-6). No formal efficacy comparison was made between the treatment arms. Results Ninety-one patients were enrolled (bevacizumab n = 59; fotemustine n = 32). Median age was 57 years (range, 28-78 y), and patients had Eastern Cooperative Oncology Group performance status of 0 (n = 42), 1 (n = 35), or 2 (n = 14). OS-6 rate was 62.1% (95% confidence interval [CI], 48.4-74.5) with bevacizumab and 73.3% (95% CI, 54.1-87.7) with fotemustine. OS-6 rates were lower in bevacizumab-treated patients with MGMT promoter methylated tumors than in those with unmethylated tumors (50% and 85%, respectively), but higher in fotemustine-treated patients (87.5% and 50%, respectively). OS rates at 9 months were 37.9% (95% CI, 25.5-51.6) and 46.7% (95% CI, 28.3-65.7) with bevacizumab and fotemustine, respectively, and median OS was 7.3 months (95% CI, 5.8-9.2) and 8.7 months (95% CI, 6.3-15.4), respectively. Toxicity was as expected with the 2 agents. Conclusion Single-agent bevacizumab may have a role in patients with recurrent glioblastoma.

Original languageEnglish
Pages (from-to)1304-1312
Number of pages9
JournalNeuro-Oncology
Volume18
Issue number9
DOIs
Publication statusPublished - Sep 1 2016

Keywords

  • AVAREG
  • bevacizumab
  • fotemustine
  • glioblastoma
  • overall survival

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Clinical Neurology
  • Cancer Research

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    Brandes, A., Finocchiaro, G., Zagonel, V., Reni, M., Caserta, C., Fabi, A., Clavarezza, M., Maiello, E., Eoli, M., Lombardi, G., Monteforte, M., Proietti, E., Agati, R., Eusebi, V., & Franceschi, E. (2016). AVAREG: A phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma. Neuro-Oncology, 18(9), 1304-1312. https://doi.org/10.1093/neuonc/now035