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Bevacizumab with, without irinotecan improved response, survival in recurrent glioblastoma

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Bevacizumab alone or in combination with irinotecan improved response rates, PFS and OS compared with that typically seen in patients with recurrent glioblastoma, according to the results of a phase-2 study.

Researchers conducted a multicenter, open-label study of 167 patients randomly assigned bevacizumab (Avastin, Genentech) 10 mg/kg alone (n=85) or in combination with irinotecan 340 mg/m² or 125 mg/m² (n=82) once every two weeks. Patients who received the 340 mg/m² dose of irinotecan (36.6%) also received enzyme-inducing antiepileptic drugs.

The data, originally presented at the 2008 ASCO Annual Meeting, were published in The Journal of Clinical Oncology this week.

In the bevacizumab alone group, six-month PFS was 42.6%, objective response rate was 28.2%, and median OS was 9.2 months. In the group receiving both bevacizumab and irinotecan, six-month PFS was 50.3%, objective response rate was 37.8%, and median OS was 8.7 months.

These numbers exceeded those assumed for traditional treatments. The researchers assumed a 15% rate for six-month PFS with salvage chemotherapy and irinotecan alone (P<.0001). The objective response rate was assumed to be 5% for salvage chemotherapy compared with the bevacizumab group, and 10% for irinotecan alone compared with the bevacizumab and irinotecan group (P<.0001). The researchers also noted a trend for patients receiving corticosteroids at baseline to take stable or decreasing doses over time.

Grade-3 or higher adverse events occurred in 46.4% of patients receiving bevacizumab alone and in 65.8% of patients receiving bevacizumab and irinotecan. The most common events included hypertension (8.3%) and convulsion (6%) in the bevacizumab alone group; and convulsion (13.9%), neutropenia (8.9%) and fatigue (8.9%) with bevacizumab plus irinotecan.

Researchers reported intracranial hemorrhage in 2.4% of patients in the bevacizumab alone group and in 3.8% of patients in the bevacizumab and irinotecan group.

Friedman HS. J Clin Oncol. 2009;doi:10.1200/JCO.2008.19.8721.

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