1. In this randomized phase 2 clinical trial, patients with metastatic colorectal cancer who received cetuximab maintenance therapy had median progression-free and overall survival compared with patients who received observation only during the maintenance phase. The values were found to be improving.
2. There were no statistical differences in adverse events when comparing controls and patients taking cetuximab.
Evidence evaluation level: 1 (great)
Metastatic colorectal cancer (mCRC), especially in patients with RAS wild-type tumors, poses a significant clinical challenge. Initial treatments such as FOLFIRI (chemotherapy regimen) in combination with cetuximab have shown promise, but the question of how to maintain these positive results 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 his FOLFIRI and cetuximab in patients with RAS wild-type mCRC. After first-line induction therapy, 214 patients without disease progression were randomly assigned to biweekly maintenance therapy with cetuximab or observation. The 6-month progression-free rate by randomization was 38.8%, 95% CI, 27.1% to 51.5% in the cetuximab group compared with the observation group (5.6%, 95% CI, 1.5% to 13.6%). It was significantly higher. . Median progression-free survival at follow-up (median 40.5 months) was 5.3 months in the cetuximab group and 2 months in the observation group, whereas median overall survival for cetuximab-treated patients was 24.8 months (95 %CL, 18.7 to 30.4 months). ), and in patients who received observation only he was 19.7 months (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. Exploratory biomolecular analysis also demonstrated that oncogenic mutations in the MAPK pathway were associated with decreased progression-free survival (HR, 1.63 [95% CI, 1.01-2.62]; P = .04). Regarding the safety profile, maintenance therapy with cetuximab was generally well tolerated and side effects were manageable. There were no significant differences in adverse events compared to the control group. Although this phase 2 trial shows promise, further studies are needed to confirm these results. Furthermore, research on the optimal duration and timing of cetuximab maintenance therapy is essential to improve its clinical application.
Click to read the study on JAMA Network Open
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