12 After failure of initial therapy, subsequent lines of treatment have minimal effect, and rapidly progressive disease and short overall survival are seen. 11 Initial standard chemotherapy for BRAF V600E–mutated colorectal cancer results in poor outcomes, and attempts to intensify therapy have met with limited success. 1-10 This mutation identifies a distinct subtype of colorectal cancer that has a poor prognosis. The BRAF V600E mutation occurs in approximately 10% of patients with metastatic colorectal cancer, with recent estimates ranging from as low as 5% to as high as 21%. (Funded by Array BioPharma and others BEACON CRC number, NCT02928224 EudraCT number, 2015-005805-35.) Introduction ConclusionsĪ combination of encorafenib, cetuximab, and binimetinib resulted in significantly longer overall survival and a higher response rate than standard therapy in patients with metastatic colorectal cancer with the BRAF V600E mutation. Adverse events of grade 3 or higher occurred in 58% of patients in the triplet-therapy group, in 50% in the doublet-therapy group, and in 61% in the control group. The median overall survival in the doublet-therapy group was 8.4 months (hazard ratio for death vs. The confirmed response rate was 26% (95% CI, 18 to 35) in the triplet-therapy group and 2% (95% CI, 0 to 7) in the control group (P<0.001). The median overall survival was 9.0 months in the triplet-therapy group and 5.4 months in the control group (hazard ratio for death, 0.52 95% confidence interval, 0.39 to 0.70 P<0.001). We report here the results of a prespecified interim analysis. A secondary end point was overall survival in the doublet-therapy group as compared with the control group. The primary end points were overall survival and objective response rate in the triplet-therapy group as compared with the control group. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab (triplet-therapy group) encorafenib and cetuximab (doublet-therapy group) or the investigators’ choice of either cetuximab and irinotecan or cetuximab and FOLFIRI (folinic acid, fluorouracil, and irinotecan) (control group). In this open-label, phase 3 trial, we enrolled 665 patients with BRAF V600E–mutated metastatic colorectal cancer who had had disease progression after one or two previous regimens. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal growth factor receptor signaling. Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Original Article Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer List of authors. The most trusted, influential source of new medical knowledge and clinical best practices in the world. Information and tools for librarians about site license offerings. Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making.
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