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...

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Autores: Cruz Merino, Luis de la, Gion, María, Cruz Jurado, Josefina, Quiroga, Vanesa, Andrés, Raquel, Moreno, Fernando, Jiménez Cortegana, Carlos, Sánchez Margalet, Víctor, Rojo, Federico
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/139262
Acceso en línea:https://hdl.handle.net/11441/139262
https://doi.org/10.3390/cancers13215432
Access Level:acceso abierto
Palabra clave:Phase II
Triple-negative
Breast cancer
Pembrolizumab
Immunotherapy
Biomarkers
PD-L1
TILs
MDSCs
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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, RaquelMoreno, FernandoJiménez Cortegana, CarlosSánchez Margalet, VíctorRojo, FedericoPhase IITriple-negativeBreast cancerPembrolizumabImmunotherapyBiomarkersPD-L1TILsMDSCsThe 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.MDPIMedicinaBioquímica Médica y Biología Molecular e Inmunología2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/139262https://doi.org/10.3390/cancers13215432reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésCancers, 13 (21), 5432.https://www.mdpi.com/2072-6694/13/21/5432/htminfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1392622026-06-17T12:51:07Z
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
Phase II
Triple-negative
Breast cancer
Pembrolizumab
Immunotherapy
Biomarkers
PD-L1
TILs
MDSCs
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, Raquel
Moreno, Fernando
Jiménez Cortegana, Carlos
Sánchez Margalet, Víctor
Rojo, Federico
author Cruz Merino, Luis de la
author_facet Cruz Merino, Luis de la
Gion, María
Cruz Jurado, Josefina
Quiroga, Vanesa
Andrés, Raquel
Moreno, Fernando
Jiménez Cortegana, Carlos
Sánchez Margalet, Víctor
Rojo, Federico
author_role author
author2 Gion, María
Cruz Jurado, Josefina
Quiroga, Vanesa
Andrés, Raquel
Moreno, Fernando
Jiménez Cortegana, Carlos
Sánchez Margalet, Víctor
Rojo, Federico
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
Bioquímica Médica y Biología Molecular e Inmunología
dc.subject.none.fl_str_mv Phase II
Triple-negative
Breast cancer
Pembrolizumab
Immunotherapy
Biomarkers
PD-L1
TILs
MDSCs
topic Phase II
Triple-negative
Breast cancer
Pembrolizumab
Immunotherapy
Biomarkers
PD-L1
TILs
MDSCs
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
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/11441/139262
https://doi.org/10.3390/cancers13215432
url https://hdl.handle.net/11441/139262
https://doi.org/10.3390/cancers13215432
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Cancers, 13 (21), 5432.
https://www.mdpi.com/2072-6694/13/21/5432/htm
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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