Abstract
528 Background: In the VELOUR study, adding ziv-aflibercept (Z) (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in metastatic colorectal cancer (mCRC) patients (pts) who had received prior oxaliplatin. Prior treatment with bevacizumab (B) did not appear to impact safety profile of Z. The global ASQoP/AFEQT studies are 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) designed to capture QoL and safety data from a population similar to VELOUR but treated in a real-life setting. We report safety data from the 4th interim analysis in B-pretreated pts. Methods: ASQoP/AFEQT are single-arm, open-label trials of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2w on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses of FOLFIRI and subsequent modifications are at treating physician’s discretion. % of pts with grade (G) 3 or 4 AEs in the combined B-pretreated safety population of ASQoP/AFEQT is compared with B-pretreated pts in the Z + FOLFIRI arm of VELOUR. Results: At data cutoff, overall safety population comprised 688 pts with ≥1 completed treatment cycle; 343 (49.9%) were B-pretreated. Currently, median number of cycles administered to ASQoP/AFEQT pts is 6; in VELOUR, pts in Z + FOLFIRI arm had a median of 9. Table shows summary of TEAEs in B-pretreated pts. Conclusions: Thisinterim safety analysis of ASQoP/AFEQT in B-pretreated pts identified no new safety signals for Z and a trend toward decreased G3/4 events. The analysis provides additional safety data suggesting an acceptable toxicity profile in a real-life setting. Clinical trial information: NCT01571284. [Table: see text]
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