Aflibercept and 5-FU vs. FOLFOX as 1st line treatment for older adults or frail elderly patients with metastatic colorectal cancer - The randomized phase 2 AIO / IKF ELDERLY trial (AIO-KRK-0117 / IKF
9 hours ago
- #Elderly mCRC treatment
- #Aflibercept vs. FOLFOX
- #Frail patient oncology
- The AIO/IKF ELDERLY trial was a randomized phase 2 study comparing dose-reduced mFOLFOX7 (Arm A) with aflibercept plus dose-reduced mLV5FU2 (Arm B) as first-line treatment for older or frail elderly patients with metastatic colorectal cancer (mCRC) ineligible for full-dose combinations.
- Primary endpoint results showed a 6-month progression-free survival (PFS) rate of 68% in Arm A and 46% in Arm B, with median PFS of 7.9 vs. 5.5 months, median overall survival of 20.4 vs. 19.0 months, and overall response rates of 47% vs. 22%, respectively.
- Safety data indicated higher toxicity in Arm B, with frequent grade ≥3 adverse events including hypertension (41%) and proteinuria (10%), and more treatment-related serious adverse events (17% vs. 5% in Arm A).
- Both regimens were feasible, with dose-reduced mFOLFOX7 showing better efficacy and tolerability, though promising survival outcomes were noted likely due to subsequent treatments in this frail elderly population.