First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A...

Area of Science:

• Oncology
• Medical Research
• Clinical Trials

Background:

• Fluoropyrimidine monotherapy is a treatment option for inoperable metastatic colorectal cancer.
• The anti-angiogenic agent aflibercept's efficacy and safety in combination with fluoropyrimidine monotherapy for this patient group remain unevaluated.

Purpose of the Study:

• To assess if adding aflibercept to fluoropyrimidine monotherapy improves efficacy in patients with metastatic colorectal cancer.
• To determine if aflibercept increases toxicity when combined with fluoropyrimidine monotherapy in this patient population.

Main Methods:

• A multicenter, phase II, non-comparative trial.
• Evaluated aflibercept plus infusional 5-fluorouracil/folinic acid (LV5FU2) versus LV5FU2 alone as first-line treatment.
• Included 117 elderly patients unfit for doublet chemotherapy; primary endpoint was 6-month progression-free survival (PFS).

Main Results:

• Six-month PFS was 54.7% in both the aflibercept (arm A) and control (arm B) groups.
• Median overall survival was 21.8 months (arm A) vs. 25.1 months (arm B).
• Grade ≥3 toxicity was significantly higher in the aflibercept arm (82% vs. 58.2%).

Conclusions:

• While the study met its primary endpoint for PFS, the addition of aflibercept led to substantially increased toxicity.
• The high toxicity profile of aflibercept in this elderly population suggests it is not a viable option.
• Continuation to phase III trials is not recommended due to the unfavorable risk-benefit profile.