TY - JOUR
T1 - AVAREG
T2 - A phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma
AU - Brandes, A.
AU - Finocchiaro, Gaetano
AU - Zagonel, Vittorina
AU - Reni, Michele
AU - Caserta, Claudia
AU - Fabi, Alessandra
AU - Clavarezza, Matteo
AU - Maiello, Evaristo
AU - Eoli, Marica
AU - Lombardi, Giuseppe
AU - Monteforte, Marta
AU - Proietti, Emanuela
AU - Agati, Raffaele
AU - Eusebi, V.
AU - Franceschi, Enrico
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
KW - AVAREG
KW - bevacizumab
KW - fotemustine
KW - glioblastoma
KW - overall survival
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U2 - 10.1093/neuonc/now035
DO - 10.1093/neuonc/now035
M3 - Article
SN - 1522-8517
VL - 18
SP - 1304
EP - 1312
JO - Neuro-Oncology
JF - Neuro-Oncology
IS - 9
ER -