Long-Term Survival Outcomes of Modified-FOLFOXIRI Plus Cetuximab Versus Bevacizumab in RAS / BRAF Wild-Type Metastatic Colorectal Cancer: Final Analysis of the DEEPER Trial.
Yu Sunakawa, Manabu Shiozawa, Takanori Watanabe et al.
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In 30 seconds
The randomized phase II DEEPER trial compared m-FOLFOXIRI plus cetuximab with m-FOLFOXIRI plus bevacizumab in patients with RAS wild-type metastatic colorectal cancer, reporting final survival outcomes and exploratory subgroup analyses. Overall, progression-free and overall survival did not differ in the per-protocol population. Among patients with RAS/BRAF wild-type, left-sided tumors, median progression-free survival was 14.8 months with cetuximab versus 11.9 months with bevacizumab (HR, 0.71; 95% CI, 0.52 to 0.97; P = .029). Overall survival in this subgroup numerically favored cetuximab but was not statistically conclusive.
Key findings
- In the per-protocol population, progression-free and overall survival did not differ between treatment groups.
- For RAS/BRAF wild-type, left-sided tumors, median progression-free survival was 14.8 v 11.9 months (HR, 0.71 [95% CI, 0.52 to 0.97]; P = .029) with cetuximab versus bevacizumab.
- In the same subgroup, median overall survival was 50.2 months with cetuximab and 40.2 months with bevacizumab (HR, 0.74 [95% CI, 0.53 to 1.05]).
- Exploratory analyses associated cetuximab-based therapy with longer overall survival in male patients (HR, 0.59; P = .016) and patients with extrahepatic disease (HR, 0.60; P = .014).
Why it matters
The overall survival analysis did not show a difference across the per-protocol population, while the left-sided RAS/BRAF wild-type subgroup had longer progression-free survival with cetuximab. These results help frame the potential relevance of tumor molecular and sidedness characteristics when interpreting first-line regimen comparisons, while the exploratory subgroup signals require cautious interpretation.
What to keep in mind
The reported subgroup analyses were exploratory, and the overall survival estimate in the RAS/BRAF wild-type, left-sided subgroup was imprecise, with a 95% CI crossing 1.