Bevacizumab improves the overall and progression-free survival of patients with metastatic colorectal cancer treated with 5-fluorouracil-based regimens irrespective of baseline risk.

Kohne et al. [Ann Oncol 2002;13:308-317] showed that four prognostic variables can be used to classify patients with metastatic colorectal cancer (CRC) treated with 5-fluorouracil (5-FU)/leucovorin (LV) into three risk groups with different overall survival (OS). This model was applied to data from phase II/III trials of first-line bevacizumab plus 5-FU/LV with/without irinotecan (IFL).Data on tumor sites, Eastern Cooperative Oncology Group performance status, alkaline phosphatase levels and white blood cell counts were used to classify patients into Kohne prognostic high-, intermediate- and low-risk groups. Median OS and progression-free survival (PFS) were calculated for patients receiving 5-FU/LV plus bevacizumab or placebo (n = 489) and IFL plus bevacizumab or placebo (n = 812).Median OS was longer in 5-FU/LV/bevacizumab (11.2-22.6 months) than in the 5-FU/LV/placebo (5.7-17.5 months), and in the IFL/bevacizumab arm (14.3-22.5 months) than in the IFL/placebo arm (8.4-17.9 months) across the Kohne high-, intermediate- and low-risk groups. The addition of bevacizumab also extended median PFS across the Kohne risk groups compared with placebo.Bevacizumab improves OS and PFS across the Kohne risk classification in patients with metastatic CRC. The Kohne model can be extended to patients treated with 5-FU/LV/bevacizumab, IFL and IFL/bevacizumab and to PFS data.