2026-04-17T03:50:53Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/130382025-05-07T03:34:08Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Eng, Cathy
author
Kim, Tae Won
author
Wasan, Harpreet
author
Kopetz, Scott
author
Yoshino, Takayuki
author
Van Cutsem, Eric
author
Tabernero, Josep
2025-05-07T03:34:08Z
2025-05-07T03:34:08Z
2025-05-06T10:19:39Z2025-05-06T10:19:39Z2025-03
http://hdl.handle.net/11351/13038
Chemotherapy; Colorectal cancer; BRAF-mutantQuimioterapia; Cáncer colorrectal; Mutación BRAFQuimioteràpia; Càncer colorectal; Mutació BRAFEncorafenib + 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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
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
Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion