Abstract
grades: nausea 82%, diarrhea 68%, vomiting 61%, decreased appetite 52%, fatigue 57%, mucositis 46%, hypertension 36%, hand-foot syndrome 30%). A higher than expected rate of bleeding events was observed ((n = 45) grade 1:38%, grade 3/ 4:7%, grade 5:2%). An interim analysis did not show higher than expected TREs (n = 3/45, 1 arterial), which was consistent with data from other brivanib studies. Therefore, the protocol was amended and aspirin treatment was stopped. Discontinuations were mostly due to progression (61%) followed by related AEs (13%). Conclusion: The safety profile of brivanib in GI-malignancy patients is manageable and consistent with monotherapy toxicities; there does not seem to be an increase in TREs, however, with aspirin co-treatment, the bleeding rate was higher than expected. The MTD is 800mg with 5FU/LV and 600mg with FOLFIRI.
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