689 Background: InVELOUR trial the addition of aflibercept to FOLFIRI regimen, demonstrated a statistically significant overall survival improvement in mCRC patients (pts) who progressed on or after a prior oxaliplatin based regimen with or without biologic agents. Our goal is to assess in the real-life setting the activity and safety profile of Afli+F in mCRC. Methods: Retrospective data collection (baseline characteristics, progression free survival [PFS], objective response rate [ORR], salvage surgeries, and safety profile) of pts who received Afli+F as a 2nd line treatment on a compassionate use program in Spain. GERCOR prognostic model has been applied to evaluate PFS. These are the final results of the analysis (Cut-off date June 2015). Results: The retrospective study population comprised 71 pts (34 hospitals); 60.6% men and 39.4% women, median age 64 years (19.7% > 70) and 98.6% had ECOG scores = 0-1. 63.4% (n = 45) had ≥ 2 metastatic sites (liver [81.7%], lung [38.0%]) and 67.7% (46/68) patients were K-RAS mutated. 60.6% (n = 43) had received prior bevacizumab (BVZ) treatment, 16.9% (n = 12) had received prior cetuximab and 5.6% (n = 4) panitumumab. Patients received a median of 6 cycles (range: 1-30) of Afli+F. Median PFS with Afli+F was 5.3 months (CI 95%: 3.7-8.6); which was not significantly modified by the presence of K-RAS mutation (HR: 1.1663; 95%CI: 0.6676-2.0373; p = 0.5867), by prior BVZ treatment (HR: 1.2424; 95%CI: 0.7238-2.1327; p = 0.4283) or by anti-EGFRs treatment (HR: 0.5681; 95%CI: 0.3117-1.0356; p = 0.0604). ORR was 19.7% (CI 95%: 11.2-30.9) and 8.5% (n = 6) of salvage surgeries. The most frequent adverse events grade ≥ 3 related with treatment were asthenia (n = 8), neutropenia (n = 7) and diarrhea (n = 6). The characteristic anti-angiogenic events were hypertension (n = 8), proteinuria (n = 1), vascular events (n = 1), and one intestinal perforation resulting in death. GERCOR prognostic model: Median PFS = 8.30 months [1.28-18.71] low risk, 5.29 [4.08-9.93] intermediate risk and 2.56 [1.94-4.57] high risk. Conclusions: In spite of the differences in sample size, in the real-life setting, Afli+F achieve a PFS comparable to VELOUR, regardless of K-RAS status or prior BVZ and anti-EGFR’s treatment, with an appropriate safety profile. Funding: Sanofi.
Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study
