Efficacy
After a median follow-up of 27.6 months, PFS was significantly increased with bevacizumab compared with placebo when combined with oxaliplatin-based chemotherapy (HR=0.83; p=0.0023), the median PFS duration being 9.4 months with bevacizumab plus chemotherapy versus 8.0 months with placebo plus chemotherapy.
However, the overall survival differences did not reach statistical significance, and response rate was not improved by the addition of bevacizumab. The lack of continuation of either bevacizumab or flluoropyrimidine until disease progression may have blunted the contribution of bevacizumab, thereby diminishing its impact on OS and PFS.r
Efficacyr |
Placebo + FOLFOX4 or XELOX
(n=701) |
Bevacizumab + FOLFOX4 or XELOX
(n=699) |
p-value |
Median PFS |
8.0 months |
9.4 months |
0.0023 |
Median OS |
19.9 months |
21.3 months |
0.0769 |
Median duration of response |
7.4 months |
8.45 months |
0.0307 |
© J Clin Oncol 2008
In a planned subset analysis, the impact of bevacizumab addition on PFS was assessed for each chemotherapy regimen. Using the general PFS definition, statistical superiority of bevacizumab versus placebo was evident in the XELOX subgroup (HR=0.77; p=0.0026) but did not reach the significance level in FOLFOX 4 subgroup (HR=0.89; p=0.1871).
Kaplan-Meier graph of Progression-free survivalr
© J Clin Oncol 2008