Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial

Capecitabina; Neoplàsies del sistema nerviós central; Neratinib

Bibliographic Details
Authors: Antunes de Melo Oliveira, Ana Mafalda, Trudeau, Maureen E., Moy, Beverly, Saura Manich, Cristina, Delaloge, Suzette, Hurvitz, Sara
Format: article
Status:Published version
Publication Date:2021
Country:España
Institution:Departament de Salut de la Generalitat de Catalunya (DS)
Repository:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/7052
Online Access:https://hdl.handle.net/11351/7052
Access Level:Open access
Keyword:Mama - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::/uso terapéutico
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oai_identifier_str oai:scientiasalut.gencat.cat:11351/7052
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
title Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
spellingShingle Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
Antunes de Melo Oliveira, Ana Mafalda
Mama - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::/uso terapéutico
title_short Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
title_full Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
title_fullStr Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
title_full_unstemmed Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
title_sort Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial
dc.creator.none.fl_str_mv Antunes de Melo Oliveira, Ana Mafalda
Trudeau, Maureen E.
Moy, Beverly
Saura Manich, Cristina
Delaloge, Suzette
Hurvitz, Sara
author Antunes de Melo Oliveira, Ana Mafalda
author_facet Antunes de Melo Oliveira, Ana Mafalda
Trudeau, Maureen E.
Moy, Beverly
Saura Manich, Cristina
Delaloge, Suzette
Hurvitz, Sara
author_role author
author2 Trudeau, Maureen E.
Moy, Beverly
Saura Manich, Cristina
Delaloge, Suzette
Hurvitz, Sara
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Hurvitz SA] University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, California, USA. [Saura C, Oliveira M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. SOLTI Breast Cancer Cooperative Group, Barcelona, Spain. [Trudeau ME] Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. [Moy B] Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA. [Delaloge S] Gustave Roussy, Villejuif, France
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Mama - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::/uso terapéutico
topic Mama - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::/uso terapéutico
description Capecitabina; Neoplàsies del sistema nerviós central; Neratinib
publishDate 2021
dc.date.none.fl_str_mv 2021
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/7052
url https://hdl.handle.net/11351/7052
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv The Oncologist;26(8)
https://doi.org/10.1002/onco.13830
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869403344097771520
spelling Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA TrialAntunes de Melo Oliveira, Ana MafaldaTrudeau, Maureen E.Moy, BeverlySaura Manich, CristinaDelaloge, SuzetteHurvitz, SaraMama - Càncer - TractamentQuimioteràpia combinadaAvaluació de resultats (Assistència sanitària)DISEASES::Neoplasms::Neoplasms by Site::Breast NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy ProtocolsOther subheadings::Other subheadings::/therapeutic useENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mamaOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinadaOtros calificadores::Otros calificadores::/uso terapéuticoCapecitabina; Neoplàsies del sistema nerviós central; Neratinibcapecitabina; Neoplasias del sistema nervioso central; NeratinibCapecitabine; Central nervous system neoplasms; NeratinibBackground Neratinib has efficacy in central nervous system (CNS) metastases from HER2-positive metastatic breast cancer (MBC). We report outcomes among patients with CNS metastases at baseline from the phase III NALA trial of neratinib plus capecitabine (N + C) versus lapatinib plus capecitabine (L + C). Materials and Methods NALA was a randomized, active-controlled trial in patients who received two or more previous HER2-directed regimens for HER2-positive MBC. Patients with asymptomatic/stable brain metastases (treated or untreated) were eligible. Patients were assigned to N + C (neratinib 240 mg per day, capecitabine 750 mg/m2 twice daily) or L + C (lapatinib 1,250 mg per day, capecitabine 1,000 mg/m2 twice daily) orally. Independently adjudicated progression-free survival (PFS), overall survival (OS), and CNS endpoints were considered. Results Of 621 patients enrolled, 101 (16.3%) had known CNS metastases at baseline (N + C, n = 51; L + C, n = 50); 81 had received prior CNS-directed radiotherapy and/or surgery. In the CNS subgroup, mean PFS through 24 months was 7.8 months with N + C versus 5.5 months with L + C (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.41–1.05), and mean OS through 48 months was 16.4 versus 15.4 months (HR, 0.90; 95% CI, 0.59–1.38). At 12 months, cumulative incidence of interventions for CNS disease was 25.5% for N + C versus 36.0% for L + C, and cumulative incidence of progressive CNS disease was 26.2% versus 41.6%, respectively. In patients with target CNS lesions at baseline (n = 32), confirmed intracranial objective response rates were 26.3% and 15.4%, respectively. No new safety signals were observed. Conclusion These analyses suggest improved PFS and CNS outcomes with N + C versus L + C in patients with CNS metastases from HER2-positive MBC.Funded by Puma Biotechnology, Inc. Medical writing support was also funded by Puma Biotechnology Inc. and provided by Miller Medical Communications.WileyInstitut Català de la Salut[Hurvitz SA] University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, California, USA. [Saura C, Oliveira M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. SOLTI Breast Cancer Cooperative Group, Barcelona, Spain. [Trudeau ME] Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. [Moy B] Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA. [Delaloge S] Gustave Roussy, Villejuif, FranceVall d'Hebron Barcelona Hospital Campus202220222021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfapplication/pdfhttps://hdl.handle.net/11351/7052Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésThe Oncologist;26(8)https://doi.org/10.1002/onco.13830Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/70522026-06-12T09:38:37Z
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