Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

The PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The prim...

Full description

Bibliographic Details
Authors: Cruz Merino, Luis de la, Gion, María, Cruz Jurado, Josefina, Quiroga, Vanesa, Andrés Conejero, Raquel, Moreno Antón, Fernando, Alonso Romero, José Luis, Ramos Vázquez, Manuel, Cortés Castán, Javier, Rojo Todo, Federico, Et al.
Format: article
Publication Date:2021
Country:España
Institution:Universidad Europea (UEM)
Repository:ABACUS. Repositorio de Producción Científica
Language:English
OAI Identifier:oai:abacus.universidadeuropea.com:11268/12149
Online Access:http://hdl.handle.net/11268/12149
Access Level:Open access
Keyword:Neoplasias de la mama
Quimioterapia
Anticuerpos monoclonales
Cáncer
Mujer
Tratamiento médico
id ES_6c00a9e0ed647f655f1f22f059d886d8
oai_identifier_str oai:abacus.universidadeuropea.com:11268/12149
network_acronym_str ES
network_name_str España
repository_id_str
spelling Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) StudyCruz Merino, Luis de laGion, MaríaCruz Jurado, JosefinaQuiroga, VanesaAndrés Conejero, RaquelMoreno Antón, FernandoAlonso Romero, José LuisRamos Vázquez, ManuelCortés Castán, JavierRojo Todo, FedericoEt al.Neoplasias de la mamaQuimioterapiaAnticuerpos monoclonalesCáncerMujerTratamiento médicoThe PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The primary objective was the objective response rate (ORR). The tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumor, and the myeloid-derived suppressor cells (MDSCs) level in peripheral blood, were analyzed to explore associations with treatment efficacy. Considering a two-stage Simon's design, the study recruitment was stopped after its first stage as statistical assumptions were not met. A subset of 21 triple-negative breast cancer (TNBC) patients was enrolled. Their median age was 49 years; 15 patients had visceral involvement, and 16 had ≤3 metastatic locations. Treatment discontinuation due to progressive disease (PD) was reported in 16 patients. ORR was 15% (95% CI 3.2-37.9). Four patients were on treatment >6 months before PD. Grade ≥3 treatment-related adverse events were observed in 8 patients, where neutropenia was the most common. No association was found between TILs density, PD-L1 expression or MDSCs levels and treatment efficacy. ORR in TNBC patients also did not meet the assumptions, but 20% were on treatment >6 months.20232023-06-1920212021-01-0120212021-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/11268/12149reponame:ABACUS. Repositorio de Producción Científicainstname:Universidad Europea (UEM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Atribución 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:abacus.universidadeuropea.com:11268/121492026-06-11T12:41:27Z
dc.title.none.fl_str_mv Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
title Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
spellingShingle Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
Cruz Merino, Luis de la
Neoplasias de la mama
Quimioterapia
Anticuerpos monoclonales
Cáncer
Mujer
Tratamiento médico
title_short Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
title_full Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
title_fullStr Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
title_full_unstemmed Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
title_sort Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
dc.creator.none.fl_str_mv Cruz Merino, Luis de la
Gion, María
Cruz Jurado, Josefina
Quiroga, Vanesa
Andrés Conejero, Raquel
Moreno Antón, Fernando
Alonso Romero, José Luis
Ramos Vázquez, Manuel
Cortés Castán, Javier
Rojo Todo, Federico
Et al.
author Cruz Merino, Luis de la
author_facet Cruz Merino, Luis de la
Gion, María
Cruz Jurado, Josefina
Quiroga, Vanesa
Andrés Conejero, Raquel
Moreno Antón, Fernando
Alonso Romero, José Luis
Ramos Vázquez, Manuel
Cortés Castán, Javier
Rojo Todo, Federico
Et al.
author_role author
author2 Gion, María
Cruz Jurado, Josefina
Quiroga, Vanesa
Andrés Conejero, Raquel
Moreno Antón, Fernando
Alonso Romero, José Luis
Ramos Vázquez, Manuel
Cortés Castán, Javier
Rojo Todo, Federico
Et al.
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Neoplasias de la mama
Quimioterapia
Anticuerpos monoclonales
Cáncer
Mujer
Tratamiento médico
topic Neoplasias de la mama
Quimioterapia
Anticuerpos monoclonales
Cáncer
Mujer
Tratamiento médico
description The PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The primary objective was the objective response rate (ORR). The tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumor, and the myeloid-derived suppressor cells (MDSCs) level in peripheral blood, were analyzed to explore associations with treatment efficacy. Considering a two-stage Simon's design, the study recruitment was stopped after its first stage as statistical assumptions were not met. A subset of 21 triple-negative breast cancer (TNBC) patients was enrolled. Their median age was 49 years; 15 patients had visceral involvement, and 16 had ≤3 metastatic locations. Treatment discontinuation due to progressive disease (PD) was reported in 16 patients. ORR was 15% (95% CI 3.2-37.9). Four patients were on treatment >6 months before PD. Grade ≥3 treatment-related adverse events were observed in 8 patients, where neutropenia was the most common. No association was found between TILs density, PD-L1 expression or MDSCs levels and treatment efficacy. ORR in TNBC patients also did not meet the assumptions, but 20% were on treatment >6 months.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-01-01
2021
2021-01-01
2023
2023-06-19
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/11268/12149
url http://hdl.handle.net/11268/12149
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
Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/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
Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:ABACUS. Repositorio de Producción Científica
instname:Universidad Europea (UEM)
instname_str Universidad Europea (UEM)
reponame_str ABACUS. Repositorio de Producción Científica
collection ABACUS. Repositorio de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869410237447929856
score 15,300719

Similar Items