Post-progression therapy (PPT) effect on survival in AVF2107, a phase III trial of bevacizumab in first-line treatment of metastatic colorectal cancer (mCRC)

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Abstract
3517 Background: Bevacizumab [Avastin (BV)], a recombinant humanized monoclonal antibody against VEGF, significantly prolongs overall survival (OS) when added to 1st-line chemotherapy for mCRC. BV joins 5-Fluorouracil/ leucovorin (5-FU/LV), irinotecan,(I) and oxaliplatin (Ox) as agents with demonstrated survival benefit in the treatment of mCRC. A recent analysis of phase III trials in mCRC, where treatment with 5-FU/LV, I, and Ox was available, demonstrates a correlation between the percentage of patients receiving all 3 active agents and OS (Grothey, J Clin Oncol, in press). We analyzed the effect of use of active agents over the treatment course on OS in AVF2107. Methods: The findings of AVF2107 have been reported. In AVF2107, use and composition of PPT (Ox-containing vs non-Ox-containing) was at the discretion of the investigator. OS was determined in the two randomized treatment arms [IFL/ placebo (Arm 1, n=412) and IFL/ BV (Arm 2, n=402)] according to PPT use and composition. Baseline characteristics were compared between these subgroups. Results: 231 (56.2%) and 222 (55.2%) patients received PPT in Arms 1 and 2, respectively. Table 1 summarizes OS by PPT composition. For Arm 1 patients who received PPT, the group receiving Ox PPT was younger (median age 57 vs 64 yrs), had better performance status (ECOG 0, 64 vs 52%) and a longer 1st-line PFS (7.4 vs 5.8 months) compared to those receiving non-Ox PPT. For Arm 2, differences between Ox and non-Ox PPT subgroups were not observed. Conclusion: BV prolongs survival in patients with mCRC when added to first-line chemotherapy. In addition, this subset analysis suggests that a treatment strategy incorporating all active agents over the course of disease optimizes OS. These results are consistent with an analysis of other recent phase III trials in mCRC.

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