Safety and activity of ziv-aflibercept in combination with irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) in patients with colorectal cancer previously treated with irinotecan: Results from a phase 1 study

e14510 Background: In a phase 1 study investigating ziv-aflibercept (Z, known as aflibercept outside the United States) with FOLFIRI, an analysis was performed to evaluate safety and activity in colorectal cancer (CRC) patients previously treated with irinotecan (I). Methods: The first part of the study was an open-label, dose-escalation stage in which patients with advanced solid tumors received Z at doses of 2, 4, 5, or 6 mg/kg on day 1, followed by FOLFIRI q2wks. The second part of the study was an expansion stage at the recommended dose of Z (4 mg/kg). This analysis is limited to CRC patients previously treated with I and receiving a dose of Z ≥4 mg/kg in either part of the study. Results: Of the 61 patients in the overall study with a planned dose of Z ≥4 mg/kg, 37 CRC patients previously treated with I received an actual dose of Z ≥4 mg/kg (56.8% men; mean age 57.6 years; 94.6% with ECOG performance status 0-1). Table shows response rates for the prior I efficacy population (n=36) and overall study ...