The most common grade 3 or higher adverse events in the ABRAXANE arm (following addendum) were neutropenia (43%), leukopenia (26%), thrombocytopenia (17%) and anemia (17%). In the temozolomide arm, the most common grade 3 or higher adverse events were vomiting (12%), fatigue (10%), leukopenia (10%) and neutropenia (10%).

In the second, single-arm study, patients received ABRAXANE (150 mg/m2) on days 1, 8 and 15, and bevacizumab (10mg/m2) on days 1 and 15 of a 28-day cycle.

The PFS rate at 4 months, which was the primary endpoint of the study, was 73%. The median PFS for patients in the study was 7.63 months (95% CI: 5.56 to 9.93 months). The median overall survival was 16.8 months (95% CI: 11.3 to 20.7 months). The 12-month survival rate was 62% and the 2-year survival rate was 30%. The response rate was 36.0%.

In the study, the most common grade 3 or higher adverse events related to study drug were neutropenia (20%), neuropathy (14%), mucositis (8%) and fatigue (6%).

Source: Celgene International S? rl