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 presents...

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Autores: Pascual, Tomás, Villacampa, Guillermo, Oliveira, Mafalda, Escrivá de Romaní, Santiago, Pernas, Sònia, Paré Brunet, Laia, Adamo, Barbara, Martínez Fraiz, Elena, Cortés, Javier, Perelló Martorell, Antonia, Galán, M., Melé, M., Villanueva, Lorea, González Rodríguez, Marta, Tolosa, Pablo, González Farré, Blanca, Galván, Patricia, Canes, Jordi, Nuciforo, Paolo, Ferrero Cafiero, Juan Manuel, González Farré, Xavier, Villagrasa, Patricia, Prat Aparicio, Aleix, Ciruelos, Eva
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
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:2445/223564
Acceso en línea:https://hdl.handle.net/2445/223564
Access Level:acceso abierto
Palabra clave:Tractament adjuvant del càncer
Medicaments antineoplàstics
Càncer de mama
Metàstasi
Adjuvant treatment of cancer
Antineoplastic agents
Breast cancer
Metastasis
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spelling Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trialPascual, TomásVillacampa, GuillermoOliveira, MafaldaEscrivá de Romaní, SantiagoPernas, SòniaParé Brunet, LaiaAdamo, BarbaraMartínez Fraiz, ElenaCortés, JavierPerelló Martorell, AntoniaGalán, M.Melé, M.Villanueva, LoreaGonzález Rodríguez, MartaTolosa, PabloGonzález Farré, BlancaGalván, PatriciaCanes, JordiNuciforo, PaoloFerrero Cafiero, Juan ManuelGonzález Farré, XavierVillagrasa, PatriciaPrat Aparicio, AleixCiruelos, EvaTractament adjuvant del càncerMedicaments antineoplàsticsCàncer de mamaMetàstasiAdjuvant treatment of cancerAntineoplastic agentsBreast cancerMetastasisBackground 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.Elsevier2025202520252025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion7 p.application/pdfhttps://hdl.handle.net/2445/223564Articles publicats en revistes (Medicina)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2025.105572ESMO Open, 2025, vol. 10, num.9https://doi.org/10.1016/j.esmoop.2025.105572cc-by-nc-nd (c) Pascual, Tomás et al., 2025http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2235642026-05-29T05:05:01Z
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, Tomás
Tractament adjuvant del càncer
Medicaments antineoplàstics
Càncer de mama
Metàstasi
Adjuvant treatment of cancer
Antineoplastic agents
Breast cancer
Metastasis
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, Tomás
Villacampa, Guillermo
Oliveira, Mafalda
Escrivá de Romaní, Santiago
Pernas, Sònia
Paré Brunet, Laia
Adamo, Barbara
Martínez Fraiz, Elena
Cortés, Javier
Perelló Martorell, Antonia
Galán, M.
Melé, M.
Villanueva, Lorea
González Rodríguez, Marta
Tolosa, Pablo
González Farré, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero Cafiero, Juan Manuel
González Farré, Xavier
Villagrasa, Patricia
Prat Aparicio, Aleix
Ciruelos, Eva
author Pascual, Tomás
author_facet Pascual, Tomás
Villacampa, Guillermo
Oliveira, Mafalda
Escrivá de Romaní, Santiago
Pernas, Sònia
Paré Brunet, Laia
Adamo, Barbara
Martínez Fraiz, Elena
Cortés, Javier
Perelló Martorell, Antonia
Galán, M.
Melé, M.
Villanueva, Lorea
González Rodríguez, Marta
Tolosa, Pablo
González Farré, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero Cafiero, Juan Manuel
González Farré, Xavier
Villagrasa, Patricia
Prat Aparicio, Aleix
Ciruelos, Eva
author_role author
author2 Villacampa, Guillermo
Oliveira, Mafalda
Escrivá de Romaní, Santiago
Pernas, Sònia
Paré Brunet, Laia
Adamo, Barbara
Martínez Fraiz, Elena
Cortés, Javier
Perelló Martorell, Antonia
Galán, M.
Melé, M.
Villanueva, Lorea
González Rodríguez, Marta
Tolosa, Pablo
González Farré, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero Cafiero, Juan Manuel
González Farré, Xavier
Villagrasa, Patricia
Prat Aparicio, Aleix
Ciruelos, Eva
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.subject.none.fl_str_mv Tractament adjuvant del càncer
Medicaments antineoplàstics
Càncer de mama
Metàstasi
Adjuvant treatment of cancer
Antineoplastic agents
Breast cancer
Metastasis
topic Tractament adjuvant del càncer
Medicaments antineoplàstics
Càncer de mama
Metàstasi
Adjuvant treatment of cancer
Antineoplastic agents
Breast cancer
Metastasis
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
2025
2025
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/2445/223564
url https://hdl.handle.net/2445/223564
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2025.105572
ESMO Open, 2025, vol. 10, num.9
https://doi.org/10.1016/j.esmoop.2025.105572
dc.rights.none.fl_str_mv cc-by-nc-nd (c) Pascual, Tomás et al., 2025
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc-nd (c) Pascual, Tomás et al., 2025
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 7 p.
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
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
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score 15,811543

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