The clinical trial phase 3 ‘Breakwater’ has shown that first-line treatment with the combination of encorafenib and cetuximab with chemotherapy improves overall survival and progression-free survival in patients with metastatic colorectal cancer with a mutation in the Braf V600E gene who have not been previously treated.
Oncologist Elena Élez from the Vall d’Hebron Hospital in Barcelona and head of the Colorectal Cancer Group at the Vall d’Hebron Institute of Oncology (Vhio) presented the results at the American Society of Clinical Oncology (Asco) Congress, taking place until June 4 in Chicago, United States. The results were also published simultaneously in ‘The New England Journal of Medicine’, as reported by Vhio in a statement on Friday.
The results indicate that the median overall survival was 30.3 months in patients treated with the experimental combination in the first line compared to 15.1 months in patients who received standard treatment.
Colorectal cancer is the third most diagnosed type of tumor in the world and the second leading cause of cancer death in Europe. Between 20 and 30% of colon cancer patients already have metastases at the time of diagnosis, and 50% end up developing metastases during the course of the disease.
Between 8 and 12% of metastatic colorectal cancers have mutations in the Braf V600E gene, which are associated with a poor prognosis. In 2019, a study led by Josep Tabernero, head of the Medical Oncology Service at the Vall d’Hebron Hospital and director of Vhio, identified a therapy that achieved significantly longer overall survival and a higher response rate in patients with metastatic colorectal cancer with mutations in Braf V600E who had been previously treated.
«Thanks to these results, the combination became an approved treatment option in second and third lines for patients with metastatic colorectal cancer with BRAFV600 mutations in most countries. However, first-line therapeutic strategies for these patients have shown limited efficacy,» Tabernero explains.
In ‘Breakwater’, 637 patients participated who were randomly assigned to receive the combination of encorafenib and cetuximab or standard treatment for metastatic colorectal cancer with Braf V600E mutations that had not been previously treated.
Applying the experimental combination showed a statistically and clinically significant benefit in overall survival compared to standard treatment, doubling it. The median overall survival was 30.3 months in patients treated with encorafenib and cetuximab with chemotherapy compared to 15.1 months in patients treated with standard therapy.
Improvements were also observed in progression-free survival, the time it takes for the tumor to progress after starting treatment, which was a median of 12.8 months in patients treated with encorafenib and cetuximab compared to 7.1 months in those treated with standard therapy.
Elena Élez pointed out that the results of this therapeutic strategy will represent a «radical change» in the prognosis of patients.
FUENTE