1. This phase 2 randomized clinical trial found that patients with metastatic colorectal cancer who were treated with cetuximab maintenance therapy had improved progression-free survival and median overall survival compared to those undergoing observation alone in the maintenance phase.
2. There was no statistical difference in adverse events when comparing the control to patients taking Cetuximab.
Evidence Rating Level: 1 (Excellent)
Metastatic colorectal cancer (mCRC), particularly in patients with RAS wild-type tumours, presents a significant clinical challenge. While initial treatments like FOLFIRI (a chemotherapy regimen) combined with cetuximab have shown promise, the question of how to sustain these positive outcomes over the long term remains unanswered. This recent Phase 2 randomized clinical trial investigated the use of cetuximab as maintenance therapy after an initial response to FOLFIRI plus cetuximab in patients with RAS wild-type mCRC. After first-line induction therapy, 214 patients without disease progression were randomized to biweekly maintenance with cetuximab or observation. The 6-month progression-free rate from randomization was significantly higher in the cetuximab group (38.8%; 95% CI, 27.1%-51.5%) compared to the observation group (5.6%; 95% CI, 1.5%-13.6%). At follow-up (median 40.5 months), median progression-free survival was 5.3 months in the cetuximab group and 2 months in the observation group, whereas medial overall survival was 24.8 months for cetuximab-treated patients (95% CL, 18.7-30.4) and 19.7 months for those who underwent observation only (95% CI, 13.3-24.4). These results suggest that cetuximab may be a valuable tool in prolonging disease control after an initial positive response. Biomolecular exploratory analyses also demonstrated that any tumorigenic mutation in the MAPK pathway was associated with worse progression-free survival rates (HR, 1.63 [95% CI, 1.01-2.62]; P = .04). With respect to its safety profile, maintenance with cetuximab was generally well-tolerated with manageable side effects. There was no significant difference found in adverse events with this compared to the control group. This Phase 2 trial shows promise, but further research is required to confirm these findings. Additionally, investigations into cetuximab maintenance therapy’s optimal duration and timing will be essential in refining its clinical applications.
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