Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial

BACKGROUND: The SOLTI-1303-PATRICIA trial (NCT02448420) is a phase II study investigating palbociclib and trastuzumab, with or without endocrine therapy, in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This manuscript present...

ver descrição completa

Detalhes bibliográficos
Autores: Pascual, T, Villacampa, G, Oliveira, M, Escrivá-de-Romaní, S, Pernas, S, Paré, L, Adamo, B, Martínez, E, Cortés, J, Perelló-Martorell, Antonia, Galan, M, Melé, M, Villanueva, L, Gonzalez-Rodriguez, M, Tolosa, P, González-Farré, B, Galván, P, Canes, J, Nuciforo, P, Ferrero-Cafiero, J M, González-Farré, X, Villagrasa, P, Prat, A, Ciruelos, E
Formato: artículo
Fecha de publicación:2025
País:España
Recursos:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/25882
Acesso em linha:https://hdl.handle.net/20.500.13003/25882
Access Level:acceso abierto
Palavra-chave:Biomarkers
Gene Expression Profiling
Trastuzumab
Biomarcadores
Perfilación de la Expresión Génica
HR-positive/HER2-positive
biomarkers
gene expression profiling
metastatic breast cancer
palbociclib
trastuzumab
id ES_f17a5d5bee78f0a23ec44d91dd706a4e
oai_identifier_str oai:docusalut.com:20.500.13003/25882
network_acronym_str ES
network_name_str España
repository_id_str
spelling Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trialPascual, TVillacampa, GOliveira, MEscrivá-de-Romaní, SPernas, SParé, LAdamo, BMartínez, ECortés, JPerelló-Martorell, AntoniaGalan, MMelé, MVillanueva, LGonzalez-Rodriguez, MTolosa, PGonzález-Farré, BGalván, PCanes, JNuciforo, PFerrero-Cafiero, J MGonzález-Farré, XVillagrasa, PPrat, ACiruelos, EBiomarkersGene Expression ProfilingTrastuzumabBiomarcadoresPerfilación de la Expresión GénicaTrastuzumabHR-positive/HER2-positivebiomarkersgene expression profilingmetastatic breast cancerpalbociclibtrastuzumabBACKGROUND: The SOLTI-1303-PATRICIA trial (NCT02448420) is a phase II study investigating palbociclib and trastuzumab, with or without endocrine therapy, in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This manuscript presents final overall survival (OS) results and biomarker analyses. PATIENTS AND METHODS: Patients previously treated with trastuzumab and two to four regimens were eligible. For estrogen receptor (ER)-negative disease (cohort A), patients received palbociclib and trastuzumab. For ER-positive disease, patients were randomized 1 : 1 to cohort B1 (no additional therapy) or B2 (letrozole). OS and long-term progression-free survival (PFS) were pre-defined secondary endpoints. Kaplan-Meier curves and stratified Cox models were used. RESULTS: Among 71 patients, median OS was 29.8 months [95% confidence interval (CI) 20.9-38.0 months]; 4-year OS rates were 13.3% (A), 35.7% (B1), and 32.3% (B2). PAM50 luminal subtypes showed better OS than non-luminal subtypes (38.0 versus 26.6 months). Exploratory biomarker analyses found luminal-related genes associated with better long-term survival, while basal and proliferation-related genes were linked to resistance. Higher luminal A, luminal B, and previously reported chemo-endocrine scores correlated with favorable prognoses. CONCLUSIONS: These findings highlight the relevance of gene expression profiling in HER2-positive breast cancer and support biomarker-driven patient selection. Long-term PATRICIA results validate the potential of non-chemotherapy-based approaches in HR-positive/HER2-positive MBC.Elsevier20252025-09-0120252025-09-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/25882reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/258822026-06-22T12:44:07Z
dc.title.none.fl_str_mv Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
spellingShingle Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
Pascual, T
Biomarkers
Gene Expression Profiling
Trastuzumab
Biomarcadores
Perfilación de la Expresión Génica
Trastuzumab
HR-positive/HER2-positive
biomarkers
gene expression profiling
metastatic breast cancer
palbociclib
trastuzumab
title_short Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_full Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_fullStr Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_full_unstemmed Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_sort Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
dc.creator.none.fl_str_mv Pascual, T
Villacampa, G
Oliveira, M
Escrivá-de-Romaní, S
Pernas, S
Paré, L
Adamo, B
Martínez, E
Cortés, J
Perelló-Martorell, Antonia
Galan, M
Melé, M
Villanueva, L
Gonzalez-Rodriguez, M
Tolosa, P
González-Farré, B
Galván, P
Canes, J
Nuciforo, P
Ferrero-Cafiero, J M
González-Farré, X
Villagrasa, P
Prat, A
Ciruelos, E
author Pascual, T
author_facet Pascual, T
Villacampa, G
Oliveira, M
Escrivá-de-Romaní, S
Pernas, S
Paré, L
Adamo, B
Martínez, E
Cortés, J
Perelló-Martorell, Antonia
Galan, M
Melé, M
Villanueva, L
Gonzalez-Rodriguez, M
Tolosa, P
González-Farré, B
Galván, P
Canes, J
Nuciforo, P
Ferrero-Cafiero, J M
González-Farré, X
Villagrasa, P
Prat, A
Ciruelos, E
author_role author
author2 Villacampa, G
Oliveira, M
Escrivá-de-Romaní, S
Pernas, S
Paré, L
Adamo, B
Martínez, E
Cortés, J
Perelló-Martorell, Antonia
Galan, M
Melé, M
Villanueva, L
Gonzalez-Rodriguez, M
Tolosa, P
González-Farré, B
Galván, P
Canes, J
Nuciforo, P
Ferrero-Cafiero, J M
González-Farré, X
Villagrasa, P
Prat, A
Ciruelos, E
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Biomarkers
Gene Expression Profiling
Trastuzumab
Biomarcadores
Perfilación de la Expresión Génica
Trastuzumab
HR-positive/HER2-positive
biomarkers
gene expression profiling
metastatic breast cancer
palbociclib
trastuzumab
topic Biomarkers
Gene Expression Profiling
Trastuzumab
Biomarcadores
Perfilación de la Expresión Génica
Trastuzumab
HR-positive/HER2-positive
biomarkers
gene expression profiling
metastatic breast cancer
palbociclib
trastuzumab
description BACKGROUND: The SOLTI-1303-PATRICIA trial (NCT02448420) is a phase II study investigating palbociclib and trastuzumab, with or without endocrine therapy, in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This manuscript presents final overall survival (OS) results and biomarker analyses. PATIENTS AND METHODS: Patients previously treated with trastuzumab and two to four regimens were eligible. For estrogen receptor (ER)-negative disease (cohort A), patients received palbociclib and trastuzumab. For ER-positive disease, patients were randomized 1 : 1 to cohort B1 (no additional therapy) or B2 (letrozole). OS and long-term progression-free survival (PFS) were pre-defined secondary endpoints. Kaplan-Meier curves and stratified Cox models were used. RESULTS: Among 71 patients, median OS was 29.8 months [95% confidence interval (CI) 20.9-38.0 months]; 4-year OS rates were 13.3% (A), 35.7% (B1), and 32.3% (B2). PAM50 luminal subtypes showed better OS than non-luminal subtypes (38.0 versus 26.6 months). Exploratory biomarker analyses found luminal-related genes associated with better long-term survival, while basal and proliferation-related genes were linked to resistance. Higher luminal A, luminal B, and previously reported chemo-endocrine scores correlated with favorable prognoses. CONCLUSIONS: These findings highlight the relevance of gene expression profiling in HER2-positive breast cancer and support biomarker-driven patient selection. Long-term PATRICIA results validate the potential of non-chemotherapy-based approaches in HR-positive/HER2-positive MBC.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-09-01
2025
2025-09-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.13003/25882
url https://hdl.handle.net/20.500.13003/25882
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
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
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Docusalut
instname:Conselleria de Salut i Consum del Govern de les Illes Balears
instname_str Conselleria de Salut i Consum del Govern de les Illes Balears
reponame_str Docusalut
collection Docusalut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869424159223709696
score 15,812455

Registos relacionados