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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorLin, Nancy U.
dc.contributor.authorBorges, Virginia
dc.contributor.authorMurthy, Rashmi K.
dc.contributor.authorPaplomata, Elisavet
dc.contributor.authorHamilton, Erika
dc.contributor.authorAntunes de Melo Oliveira, Ana Mafalda
dc.contributor.authorAnders, Carey
dc.date.accessioned2021-08-23T09:56:40Z
dc.date.available2021-08-23T09:56:40Z
dc.date.issued2020-08-10
dc.identifier.citationLin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, et al. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020 Aug 10;38(23):2610–2619.
dc.identifier.issn1527-7755
dc.identifier.urihttps://hdl.handle.net/11351/6230
dc.descriptionBreast cancer; Survival; Tucatinib
dc.description.abstractPURPOSE In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs. PATIENTS AND METHODS Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease. RESULTS There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48; P < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85; P = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03). CONCLUSION In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;38(23)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectMama - Càncer
dc.subjectMedicaments antineoplàstics - Ús terapèutic - Eficàcia
dc.subject.meshBreast Neoplasms
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.mesh/therapeutic use
dc.titleIntracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.20.00775
dc.subject.decsneoplasias de la mama
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.subject.decs/uso terapéutico
dc.relation.publishversionhttps://ascopubs.org/doi/10.1200/JCO.20.00775
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Lin NU] Dana-Farber Cancer Institute, Boston, MA, USA. [Borges V] University of Colorado Cancer Center, Aurora, CO, USA. [Anders C] Duke Cancer Institute, Durham, NC, USA. [Murthy RK] MD Anderson Cancer Center, Houston, TX, USA. [Paplomata E] Carbone Cancer Center/University of Wisconsin, Madison, WI, USA. [Hamilton E] Sarah Cannon Research Institute/Tennessee Oncology–Nashville, Nashville, TN, USA. [Oliveira M] Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid32468955
dc.identifier.wos000559991300004
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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