medwireNews: Adding bevacizumab to lomustine does not prolong overall survival (OS) compared with lomustine alone in patients with progressive glioblastoma, but may delay disease progression, show phase III study data.
The EORTC 26101 trial was therefore “unable to confirm the conclusion of phase 2 trials that the addition of bevacizumab to lomustine improves survival in patients with progressive glioblastoma,” Wolfgang Wick (University of Heidelberg, Germany) and co-authors remark.
They report in The New England Journal of Medicine that median OS was 9.1 months among the 288 patients with glioblastoma progression after chemoradiation who were randomly assigned to receive lomustine 90 mg/m2 (maximum 160 mg) every 6 weeks plus bevacizumab 10 mg/kg every 2 weeks.
This was not significantly longer than the median 8.6-month median OS period recorded among the 149 patients randomly assigned to receive lomustine 110 mg/m2 (maximum 200 mg) every 6 weeks alone.
The study, which was carried out at 38 institutions in eight countries, did however show a significant 51% reduced risk for disease progression with combination therapy versus monotherapy; progression-free survival was 4.2 and 1.5 months, respectively.
Nearly two-thirds (63.6%) of patients in the combination group experienced grade 3 to 5 adverse events compared with just over one-third (38.1%) of patients in the monotherapy group.
But Wick and team note that the longer treatment period in the combination therapy group (median three cycles versus one cycle with monotherapy) should be taken into account when assessing these data.
Quality of life did not change significantly from baseline to week 24 in either treatment group, but by week 36 scores for global health status and social functioning were lower in the combination group than in the monotherapy group.
By contrast, the addition of bevacizumab to lomustine had no significant effect on neurocognitive function.
When the researchers grouped the patients according to O6-methylguanine–DNA methyltransferase (MGMT) promoter methylation status, they observed similar results to the overall data, indicating that “MGMT status was not predictive of benefit from the combined therapy.”
By Laura Cowen
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