Evaluation of the Impact of Cetuximab Plus FOLFIRI on Progression-Free Survival in Patients with Newly Diagnosed Metastatic Colorectal Cancer

Background: Metastatic colorectal cancer (mCRC) remains a leading cause of cancer-related morbidity and mortality worldwide. Standard first-line therapy commonly involves combination chemotherapy such as FOLFIRI. The addition of targeted biological agents has been shown to improve clinical outcomes in selected patients.Objectives: This study aimed to assess the progression-free survival of FOLFIRI chemotherapy with or without cetuximab.Patients and Methods: A prospective study was conducted at Ain Shams University Hospitals between December 2016 and December 2019, including 40 patients with newly diagnosed EGFR-expressing, K-RAS/N-RAS wild-type mCRC. Patients were randomized into two groups: Protocol 1 (cetuximab + FOLFIRI, n = 20) and Protocol 2 (FOLFIRI alone, n = 20). Patients were evaluated clinically, biochemically, and radiologically every 3 months for one year. Progression-free survival (PFS) was analyzed by Kaplan–Meier method.Results: Radiological response at first evaluation favored Protocol 1 (95% vs. 60%, p = 0.02). Subsequent assessments and tumor markers showed no significant differences. Median PFS was significantly longer with Protocol 1 (9 vs. 6 months, p = 0.004).Conclusion: The addition of cetuximab to FOLFIRI significantly improved progression-free survival and radiological response in EGFR-expressing mCRC patients.