Publication: Encorafenib and binimetinib followed by radiotherapy for patients with BRAF<SUP>V600</SUP>-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study)
dc.contributor.author | Marquez-Rodas, Ivan | |
dc.contributor.author | Alvarez, Ana | |
dc.contributor.author | Arance, Ana | |
dc.contributor.author | Valduvieco, Izaskun | |
dc.contributor.author | Berciano-Guerrero, Miguel-angel | |
dc.contributor.author | Delgado, Raquel | |
dc.contributor.author | Soria, Ainara | |
dc.contributor.author | Lopez-Campos, Fernando | |
dc.contributor.author | Sanchez, Pedro | |
dc.contributor.author | Romero, Jose Luis | |
dc.contributor.author | Martin-Liberal, Juan | |
dc.contributor.author | Lucas, Anna | |
dc.contributor.author | Diaz-Beveridge, Roberto | |
dc.contributor.author | Conde-Moreno, Antonio-Jose | |
dc.contributor.author | Alamo-de-la-Gala, Maria del Carmen | |
dc.contributor.author | Garcia-Castano, Almudena | |
dc.contributor.author | Prada, Pedro Jose | |
dc.contributor.author | Gonzalez-Cao, Maria | |
dc.contributor.author | Puertas, Enrique | |
dc.contributor.author | Vidal, Joana | |
dc.contributor.author | Foro, Palmira | |
dc.contributor.author | Aguado-de-la-Rosa, Carlos | |
dc.contributor.author | Corona, Juan Antonio | |
dc.contributor.author | Cerezuela-Fuentes, Pablo | |
dc.contributor.author | Lopez, Paco | |
dc.contributor.author | Luna, Pablo | |
dc.contributor.author | Aymar, Neus | |
dc.contributor.author | Puertolas, Teresa | |
dc.contributor.author | Sanagustin, Pilar | |
dc.contributor.author | Berrocal, Alfonso | |
dc.contributor.funder | Spanish Multidisciplinary Melanoma Group (GEM) | |
dc.date.accessioned | 2025-05-28T17:59:17Z | |
dc.date.available | 2025-05-28T17:59:17Z | |
dc.date.issued | 2024-07-01 | |
dc.description.abstract | Background. Encorafenib plus binimetinib (EB) is a standard-of-care treatment for advanced BRAF(V600)-mutant melanoma. We assessed the efficacy and safety of encorafenib plus binimetinib in patients with BRAF(V600)-mutant melanoma and brain metastasis (BM) and explored if radiotherapy improves the duration of response. Methods. E-BRAIN/GEM1802 was a prospective, multicenter, single-arm, phase II trial that enrolled patients with melanoma BRAF(V600)-mutant and BM. Patients received encorafenib 450 mg once daily plus binimetinib 45 mg BID, and those who achieved a partial response or stable disease at first tumor assessment were offered radiotherapy. Treatment continued until progression. Primary endpoint was intracranial response rate (icRR) after 2 months of EB, establishing a futility threshold of 60%. Results. The study included 25 patients with no BM symptoms and 23 patients with BM symptoms regardless of using corticosteroids. Among them, 31 patients (64.6%) received sequential radiotherapy. After 2 months, icRR was 70.8% (95% CI: 55.9-83.1); 10.4% complete response. Median intracranial progression-free survival (PFS) and OS were 8.5 (95% CI: 6.4-11.8) and 15.9 (95% CI: 10.7-21.4) months, respectively (8.3 months for icPFS and 13.9 months OS for patients receiving RDT). Most common grades 3-4 treatment-related adverse event was alanine aminotransferase (ALT) increased (10.4%). Conclusions. Encorafenib plus binimetinib showed promising clinical benefit in terms of icRR, and tolerable safety profile with low frequency of high-grade TRAEs, in patients with BRAFV600-mutant melanoma and BM, including those with symptoms and need for steroids. Sequential radiotherapy is feasible but it does not seem to prolong response. | |
dc.description.version | Yes | |
dc.identifier.citation | Márquez-Rodas I, Álvarez A, Arance A, Valduvieco I, Berciano-Guerrero MÁ, Delgado R, et al. Encorafenib and binimetinib followed by radiotherapy for patients with BRAFV600-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study). Neuro Oncol. 2024 Nov 4;26(11):2074-2083 | |
dc.identifier.doi | 10.1093/neuonc/noae116 | |
dc.identifier.issn | 1522-8517 | |
dc.identifier.uri | https://hdl.handle.net/10668/28507 | |
dc.identifier.wosID | WOS:001270732200001 | |
dc.issue.number | 11 | |
dc.journal.title | Neuro-Oncology | |
dc.language.iso | en | |
dc.page.number | 10 | |
dc.publisher | Oxford University Press | |
dc.relation.publisherversion | https://academic.oup.com/neuro-oncology/article-lookup/doi/10.1093/neuonc/noae116 | |
dc.rights | Attribution 4.0 International | en |
dc.rights.accessRights | open access | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Brain metastasis | |
dc.subject | Encorafenib and binimetinib | |
dc.subject | Melanoma | |
dc.subject | Radiotherapy | |
dc.subject | Targeted therapy | |
dc.subject.decs | Radioterapia | |
dc.subject.decs | Encéfalo | |
dc.subject.decs | Supervivencia sin progresión | |
dc.subject.decs | Inutilidad médica | |
dc.subject.decs | Metástasis de la neoplasia | |
dc.subject.decs | Corticoesteroides | |
dc.subject.mesh | Proto-Oncogene Proteins B-raf | |
dc.subject.mesh | Alanine Transaminase | |
dc.subject.mesh | Progression-Free Survival | |
dc.subject.mesh | Medical Futility | |
dc.subject.mesh | Brain Neoplasms | |
dc.subject.mesh | Steroids | |
dc.subject.mesh | Adrenal Cortex Hormones | |
dc.title | Encorafenib and binimetinib followed by radiotherapy for patients with BRAF<SUP>V600</SUP>-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study) | |
dc.type | research article | |
dc.type.hasVersion | VoR | |
dc.volume.number | 26 | |
dspace.entity.type | Publication |