A randomized controlled trial of a digital lifestyle intervention involving postoperative patients with colorectal cancer
FOLFIRI plus bevacizumab is non-inferior to mFOLFOX6 plus bevacizumab for progression-free survival as first-line therapy in metastatic colorectal cancer.
Background: FOLFIRI and mFOLFOX6 have shown equivalent efficacy for metastatic colorectal cancer, but their comparative effectiveness when combined with bevacizumab is unknown. Methods: In the WJOG4407G phase III trial, 395 previously untreated metastatic colorectal cancer patients were randomized 1:1 to receive either FOLFIRI plus bevacizumab (FOLFIRI+Bev) or mFOLFOX6 plus bevacizumab (mFOLFOX6+Bev). The primary endpoint was non‑inferiority of FOLFIRI+Bev to mFOLFOX6+Bev in progression‑free survival (PFS) with a margin of 1.25. Secondary endpoints included overall survival (OS), response rate, safety, and quality of life. Results: Median PFS was 12.1 months for FOLFIRI+Bev versus 10.7 months for mFOLFOX6+Bev (Hazard Ratio 0.905; 95% CI 0.723–1.133; P = 0.003 for non‑inferiority). Median OS was 31.4 months vs 30.1 months (HR 0.990; 95% CI 0.785–1.249). Response rates were 64% vs 62%. Grade ≥3 adverse events were comparable, with neutropenia (46% vs 35%) and peripheral neuropathy (0% vs 22%) most common. Conclusion: FOLFIRI plus bevacizumab is non‑inferior to mFOLFOX6 plus bevacizumab for PFS as first‑line systemic therapy in metastatic colorectal cancer.
Determining the optimal first‑line regimen is critical for balancing efficacy and toxicity in metastatic colorectal cancer. This study demonstrates that FOLFIRI+Bev provides similar progression‑free survival to mFOLFOX6+Bev, offering clinicians an alternative choice that may be tailored to patient comorbidities, toxicity profiles, and preferences.
Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.
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