Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial

HER2-positiu; Càncer de mama metastàsic; Trastuzumab emtansina

Detalles Bibliográficos
Autores: López-Miranda, Elena, Perez-Garcia, Jose Manuel, Brain, Etienne, Ravnik, Maja, Escriva de Romaní Muñoz, Santiago Ignacio, Cortés Castan, Javier, Di Cosimo, Serena
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/6248
Acceso en línea:https://hdl.handle.net/11351/6248
http://hdl.handle.net/11351/6248
Access Level:acceso abierto
Palabra clave:Mama - Càncer
Medicaments antineoplàstics - Efectes secundaris
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::Other subheadings::/adverse effects
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
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network_name_str España
repository_id_str
dc.title.none.fl_str_mv Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
title Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
spellingShingle Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
López-Miranda, Elena
Mama - Càncer
Medicaments antineoplàstics - Efectes secundaris
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::Other subheadings::/adverse effects
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
title_short Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
title_full Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
title_fullStr Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
title_full_unstemmed Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
title_sort Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial
dc.creator.none.fl_str_mv López-Miranda, Elena
Perez-Garcia, Jose Manuel
Brain, Etienne
Ravnik, Maja
Escriva de Romaní Muñoz, Santiago Ignacio
Cortés Castan, Javier
Di Cosimo, Serena
author López-Miranda, Elena
author_facet López-Miranda, Elena
Perez-Garcia, Jose Manuel
Brain, Etienne
Ravnik, Maja
Escriva de Romaní Muñoz, Santiago Ignacio
Cortés Castan, Javier
Di Cosimo, Serena
author_role author
author2 Perez-Garcia, Jose Manuel
Brain, Etienne
Ravnik, Maja
Escriva de Romaní Muñoz, Santiago Ignacio
Cortés Castan, Javier
Di Cosimo, Serena
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[López-Miranda E] Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. [Pérez-García JM] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. [Di Cosimo S] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), 08018 Barcelona, Spain. Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. [Brain E] Department of Medical Oncology, Institut Curie, St. Cloud, France. [Ravnik M] Department of Oncology, University Medical Centre Maribor, Maribor, Slovenia. [Escrivá-de-Romaní S] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cortés J] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Mama - Càncer
Medicaments antineoplàstics - Efectes secundaris
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::Other subheadings::/adverse effects
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
topic Mama - Càncer
Medicaments antineoplàstics - Efectes secundaris
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
Other subheadings::Other subheadings::Other subheadings::/adverse effects
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
description HER2-positiu; Càncer de mama metastàsic; Trastuzumab emtansina
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
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/11351/6248
http://hdl.handle.net/11351/6248
url https://hdl.handle.net/11351/6248
http://hdl.handle.net/11351/6248
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Cancers;12(12)
https://www.mdpi.com/2072-6694/12/12/3509
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869407549898358784
spelling Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib TrialLópez-Miranda, ElenaPerez-Garcia, Jose ManuelBrain, EtienneRavnik, MajaEscriva de Romaní Muñoz, Santiago IgnacioCortés Castan, JavierDi Cosimo, SerenaMama - CàncerMedicaments antineoplàstics - Efectes secundarisDISEASES::Neoplasms::Neoplasms by Site::Breast NeoplasmsANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy ProtocolsOther subheadings::Other subheadings::Other subheadings::/adverse effectsENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mamaTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinadaOtros calificadores::Otros calificadores::Otros calificadores::/efectos adversosHER2-positiu; Càncer de mama metastàsic; Trastuzumab emtansinaHER2 positivo; Cáncer de mama metastásico; Trastuzumab emtansinaHER2-positive; Metastatic breast cancer; Trastuzumab emtansineThe paper assesses the dose-limiting toxicities and the maximum tolerated dose (MTD) of trastuzumab emtansine (T-DM1) combined with non-pegylated liposomal doxorubicin (NPLD) in HER2-positive (HER2+) metastatic breast cancer (MBC). This single-arm, open-label, phase Ib trial (NCT02562378) enrolled anthracycline-naïve HER2+ MBC patients who had progressed on trastuzumab and taxanes. Patients received a maximum of 6 cycles of NPLD intravenously (IV) at various dose levels (45, 50, and 60 mg/m2) in the “3 plus 3” dose-escalation part. During expansion, they received 60 mg/m2 of NPLD every 3 weeks (Q3W) plus standard doses of T-DM1. The MTD was T-DM1 3.6 mg/kg plus NPLD 60 mg/m2 administered IV Q3W. No clinically relevant worsening of cardiac function was observed. Among all evaluable patients, the overall response rate was 40.0% (95%CI, 16.3–67.7) with a median duration of response of 6.9 months (95%CI, 4.8–9.1). Clinical benefit rate was 66.7% (95%CI, 38.4–88.2) and median progression-free survival was 7.2 months (95%CI, 4.5–9.6). No significant influence of NPLD on T-DM1 pharmacokinetics was observed. The addition of NPLD to T-DM1 is feasible but does not seem to improve the antitumor efficacy of T-DM1 in HER2+ MBC patients.Funding for this research was provided by F. Hoffmann-La Roche Ltd.MDPIInstitut Català de la Salut[López-Miranda E] Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. [Pérez-García JM] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. [Di Cosimo S] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), 08018 Barcelona, Spain. Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. [Brain E] Department of Medical Oncology, Institut Curie, St. Cloud, France. [Ravnik M] Department of Oncology, University Medical Centre Maribor, Maribor, Slovenia. [Escrivá-de-Romaní S] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cortés J] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202120212020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11351/6248http://hdl.handle.net/11351/6248Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésCancers;12(12)https://www.mdpi.com/2072-6694/12/12/3509Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/62482026-05-29T05:05:01Z
score 15,811543

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