Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)

OBJECTIVE: We compared patients' preferences for intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration.; METHODS: Phase III, open-label, multicentre study in HER2-positive metastatic breast cancer. Patients were receiving IV-t for at least 4months without progression. Randomi...

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Autores: Ciruelos, Eva M, Montano, Alvaro, Rodriguez, Cesar A, Gonzalez-Flores, Encarnacion, Lluch, Ana, Garrigos, Laia, Quiroga, Vanesa, Anton, Antonio, Malon, Diego, Chacon, Jose I, Velasco, Montserrat, Gonzalez-Cortijo, Lucia, Jolis, Laura, Echarri, Maria J, Munoz, Montse, Pascual, Tomas, Amigo, Yolanda, Casas, Maribel, Carrasco, Eva, Casas, Ana
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p4560
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/4560
Access Level:acceso abierto
Palabra clave:healthcare professional preference
metastatic breast cancer
patients' preference
Subcutaneous trastuzumab
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spelling Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)Ciruelos, Eva MMontano, AlvaroRodriguez, Cesar AGonzalez-Flores, EncarnacionLluch, AnaGarrigos, LaiaQuiroga, VanesaAnton, AntonioMalon, DiegoChacon, Jose IVelasco, MontserratGonzalez-Cortijo, LuciaJolis, LauraEcharri, Maria JMunoz, MontsePascual, TomasAmigo, YolandaCasas, MaribelCarrasco, EvaCasas, Anahealthcare professional preferencemetastatic breast cancerpatients' preferenceSubcutaneous trastuzumabOBJECTIVE: We compared patients' preferences for intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration.; METHODS: Phase III, open-label, multicentre study in HER2-positive metastatic breast cancer. Patients were receiving IV-t for at least 4months without progression. Randomisation was 1:1 to administer 2 cycles of SC-t with vial followed by 2 cycles with single injection device (SID) or the reverse sequence (600mg SC-t every 3weeks for 4 cycles).; PRIMARY OBJECTIVE: patients' preference for IV-t versus SC-t; secondary objectives: patients' preference for vial versus SID, healthcare professional (HCP) preference and safety.; RESULTS: We randomised 166 patients in 26 sites. Median number of previous lines of chemotherapy and/or endocrine therapy was 1 (1-7). Median duration of prior IV-t was 1.8years (0.3-14). Of the159 patients completing the questionnaires, 86.2% preferred SC-t, 6.9% preferred IV-t, and 6.9% had no preference. Patients preferred SID (59.2%) over vial (26.3%). Most (87.2%) HCP preferred SC-t of whom 51.3% and 28.2% preferred SID and vial respectively. Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease.; CONCLUSIONS: SC-t is preferred with no safety impact. © 2020 John Wiley & Sons Ltd.WILEY2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/4560EUROPEAN JOURNAL OF CANCER CAREISSN: 09615423ISSNe: 13652354reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p45602026-06-07T16:35:31Z
dc.title.none.fl_str_mv Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
title Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
spellingShingle Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
Ciruelos, Eva M
healthcare professional preference
metastatic breast cancer
patients' preference
Subcutaneous trastuzumab
title_short Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
title_full Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
title_fullStr Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
title_full_unstemmed Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
title_sort Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)
dc.creator.none.fl_str_mv Ciruelos, Eva M
Montano, Alvaro
Rodriguez, Cesar A
Gonzalez-Flores, Encarnacion
Lluch, Ana
Garrigos, Laia
Quiroga, Vanesa
Anton, Antonio
Malon, Diego
Chacon, Jose I
Velasco, Montserrat
Gonzalez-Cortijo, Lucia
Jolis, Laura
Echarri, Maria J
Munoz, Montse
Pascual, Tomas
Amigo, Yolanda
Casas, Maribel
Carrasco, Eva
Casas, Ana
author Ciruelos, Eva M
author_facet Ciruelos, Eva M
Montano, Alvaro
Rodriguez, Cesar A
Gonzalez-Flores, Encarnacion
Lluch, Ana
Garrigos, Laia
Quiroga, Vanesa
Anton, Antonio
Malon, Diego
Chacon, Jose I
Velasco, Montserrat
Gonzalez-Cortijo, Lucia
Jolis, Laura
Echarri, Maria J
Munoz, Montse
Pascual, Tomas
Amigo, Yolanda
Casas, Maribel
Carrasco, Eva
Casas, Ana
author_role author
author2 Montano, Alvaro
Rodriguez, Cesar A
Gonzalez-Flores, Encarnacion
Lluch, Ana
Garrigos, Laia
Quiroga, Vanesa
Anton, Antonio
Malon, Diego
Chacon, Jose I
Velasco, Montserrat
Gonzalez-Cortijo, Lucia
Jolis, Laura
Echarri, Maria J
Munoz, Montse
Pascual, Tomas
Amigo, Yolanda
Casas, Maribel
Carrasco, Eva
Casas, Ana
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv healthcare professional preference
metastatic breast cancer
patients' preference
Subcutaneous trastuzumab
topic healthcare professional preference
metastatic breast cancer
patients' preference
Subcutaneous trastuzumab
description OBJECTIVE: We compared patients' preferences for intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration.; METHODS: Phase III, open-label, multicentre study in HER2-positive metastatic breast cancer. Patients were receiving IV-t for at least 4months without progression. Randomisation was 1:1 to administer 2 cycles of SC-t with vial followed by 2 cycles with single injection device (SID) or the reverse sequence (600mg SC-t every 3weeks for 4 cycles).; PRIMARY OBJECTIVE: patients' preference for IV-t versus SC-t; secondary objectives: patients' preference for vial versus SID, healthcare professional (HCP) preference and safety.; RESULTS: We randomised 166 patients in 26 sites. Median number of previous lines of chemotherapy and/or endocrine therapy was 1 (1-7). Median duration of prior IV-t was 1.8years (0.3-14). Of the159 patients completing the questionnaires, 86.2% preferred SC-t, 6.9% preferred IV-t, and 6.9% had no preference. Patients preferred SID (59.2%) over vial (26.3%). Most (87.2%) HCP preferred SC-t of whom 51.3% and 28.2% preferred SID and vial respectively. Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease.; CONCLUSIONS: SC-t is preferred with no safety impact. © 2020 John Wiley & Sons Ltd.
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://incliva.portalinvestigacion.com/publicaciones/4560
url https://incliva.portalinvestigacion.com/publicaciones/4560
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 WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv EUROPEAN JOURNAL OF CANCER CARE
ISSN: 09615423
ISSNe: 13652354
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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