Abstract: Background: FOLFIRI-Aflibercept (A) is one of the 2nd-line standard treatments for mCRC. We evaluated the efficacy and safety of induction with FOLFIRI-A (6 cycles) followed by maintenance with 5FU/LV-A or FOLFIRI-A until progression in older pts with mCRC. Methods: This was a multicenter, randomized, open-label, non-inferiority phase II trial. Pts aged ?70 years who failed a prior oxaliplatin-based regimen, were randomly assigned (1:1) to induction with 6 cycles FOLFIRI-A followed by maintenance with 5FU/LV-A until progression (arm A, experimental) or FOLFIRI-A until progression (arm B, control). Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate (ORR), and safety. To claim non Results: Between November 2017 and February 2022, 170 pts were randomized to arm A (n=85) or arm B (n=85). Both arms were comparable at baseline (median age 74 years). Over a median follow-up time of 12.2 months (m) in arm A vs 10.9 m in arm B, most pts had died (arm A 83.5%, arm B 88.2%) mainly from disease progression. Arm A was non inferior to arm B in terms of PFS (HR=0.781 [95% CI 0.566-1.076]). There were also no significant differences in OS and ORR between arms (Table). Grade ?3 adverse events Conclusions: Primary endpoint was met: induction with 6 cycles FOLIRI-A followed by maintenance with 5FU/LV-A was non-inferior to FOLFIRI-A until progression, in terms of PFS. OS and ORR did not either differ between arms. In older pts, severe asthenia was significantly reduced with 5FU/LV-A maintenance.

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