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

The 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 a...

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Autores: Lopez-Miranda, E, Perez-Garcia, JM, Di Cosimo, S, Brain, E, Ravnik, M, Escriva-de-Romani, S, Vidal, M, Gligorov, J, Borstnar, S, Calabuig, L, Sampayo-Cordero, M, Malfettone, A, Llombart-Cussac, A, Suter, TM, Cortes, J
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2020
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositório:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p10888
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/10888
Access Level:Acceso aberto
Palavra-chave:HER2-positive
T-DM1
metastatic breast cancer
non-pegylated liposomal doxorubicin
trastuzumab emtansine
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spelling Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial.Lopez-Miranda, EPerez-Garcia, JMDi Cosimo, SBrain, ERavnik, MEscriva-de-Romani, SVidal, MGligorov, JBorstnar, SCalabuig, LSampayo-Cordero, MMalfettone, ALlombart-Cussac, ASuter, TMCortes, JHER2-positiveT-DM1metastatic breast cancernon-pegylated liposomal doxorubicintrastuzumab 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/m(2)) in the "3 plus 3" dose-escalation part. During expansion, they received 60 mg/m(2) 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/m(2) 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.MDPI2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/10888CancersISSN: 20726694reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p108882026-06-11T12:45:17Z
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.
Lopez-Miranda, E
HER2-positive
T-DM1
metastatic breast cancer
non-pegylated liposomal doxorubicin
trastuzumab emtansine
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 Lopez-Miranda, E
Perez-Garcia, JM
Di Cosimo, S
Brain, E
Ravnik, M
Escriva-de-Romani, S
Vidal, M
Gligorov, J
Borstnar, S
Calabuig, L
Sampayo-Cordero, M
Malfettone, A
Llombart-Cussac, A
Suter, TM
Cortes, J
author Lopez-Miranda, E
author_facet Lopez-Miranda, E
Perez-Garcia, JM
Di Cosimo, S
Brain, E
Ravnik, M
Escriva-de-Romani, S
Vidal, M
Gligorov, J
Borstnar, S
Calabuig, L
Sampayo-Cordero, M
Malfettone, A
Llombart-Cussac, A
Suter, TM
Cortes, J
author_role author
author2 Perez-Garcia, JM
Di Cosimo, S
Brain, E
Ravnik, M
Escriva-de-Romani, S
Vidal, M
Gligorov, J
Borstnar, S
Calabuig, L
Sampayo-Cordero, M
Malfettone, A
Llombart-Cussac, A
Suter, TM
Cortes, J
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv HER2-positive
T-DM1
metastatic breast cancer
non-pegylated liposomal doxorubicin
trastuzumab emtansine
topic HER2-positive
T-DM1
metastatic breast cancer
non-pegylated liposomal doxorubicin
trastuzumab emtansine
description The 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/m(2)) in the "3 plus 3" dose-escalation part. During expansion, they received 60 mg/m(2) 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/m(2) 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.
publishDate 2020
dc.date.none.fl_str_mv 2020
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://fisabio.portalinvestigacion.com/publicaciones/10888
url https://fisabio.portalinvestigacion.com/publicaciones/10888
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Cancers
ISSN: 20726694
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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