Sistema de Salut de Catalunya
Institut Català de la Salut
[Kopetz S] University of Texas MD Anderson Cancer Center, Houston, TX, USA. [Yoshino T] National Cancer Center Hospital East, Kashiwa, Japan. [Van Cutsem E] University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium. [Eng C] Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. [Kim TW] Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. [Wasan HS] Hammersmith Hospital, Division of Cancer, Imperial College London, London, UK. [Tabernero J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat de Vic - Universitat Central de Catalunya, Vic, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-05-06T10:19:39Z
2025-05-06T10:19:39Z
2025-03
Chemotherapy; Colorectal cancer; BRAF-mutant
Quimioterapia; Cáncer colorrectal; Mutación BRAF
Quimioteràpia; Càncer colorectal; Mutació BRAF
Encorafenib + cetuximab (EC) is approved for previously treated BRAF V600E-mutant metastatic colorectal cancer (mCRC) based on the BEACON phase 3 study. Historically, first-line treatment of BRAF V600E-mutant mCRC with chemotherapy regimens has had limited efficacy. The phase 3 BREAKWATER study investigated EC+mFOLFOX6 versus standard of care (SOC) in patients with previously untreated BRAF V600E mCRC. The dual primary endpoint of progression-free survival is event driven; data were not mature at data cutoff. BREAKWATER met the other dual primary endpoint of objective response rate, demonstrating significant and clinically relevant improvement in objective response rate (EC+mFOLFOX6: 60.9%; SOC: 40.0%; odds ratio, 2.443; 95% confidence interval (CI): 1.403–4.253; 99.8% CI: 1.019–5.855; one-sided P = 0.0008). Median duration of response was 13.9 versus 11.1 months. At this first interim analysis of overall survival, the hazard ratio was 0.47 (95% CI: 0.318–0.691; repeated CI: 0.166–1.322). Serious adverse event rates were 37.7% versus 34.6%. The safety profiles were consistent with those known for each agent. BREAKWATER demonstrated a significantly improved response rate that was durable for first-line EC+mFOLFOX6 versus SOC in patients with BRAF V600E mCRC. ClinicalTrials.gov identifier: NCT04607421.
Article
Published version
English
Anomalies cromosòmiques; Quimioteràpia combinada; Avaluació de resultats (Assistència sanitària); Recte - Càncer - Tractament; Còlon - Càncer - Tractament; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols; DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; PHENOMENA AND PROCESSES::Genetic Phenomena::Genetic Variation::Mutation; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome::Progression-Free Survival; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; FENÓMENOS Y PROCESOS::fenómenos genéticos::variación genética::mutación; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento::supervivencia libre de progresión
Nature Portfolio
Nature Medicine;31
https://doi.org/10.1038/s41591-024-03443-3
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3436]
