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 principales:	Luis de la Cruz-Merino, María Gion, Josefina Cruz-Jurado, Vanesa Quiroga, Raquel Andrés, Fernando Moreno, Jose L. Alonso-Romero, Manuel Ramos, Esther Holgado, Javier Cortés, Elena López-Miranda, Fernando Henao-Carrasco, Natalia Palazón-Carrión, Luz M. Rodríguez, Isaac Ceballos, Maribel Casas, Sara Benito, Massimo Chiesa, Susana Bezares, Rosalia Caballero, Carlos Jiménez-Cortegana, Víctor Sánchez-Margalet, Federico Rojo
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	phase II triple-negative breast cancer pembrolizumab immunotherapy biomarkers Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/f493f8a297a3479694a4af97c2b66c7c
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spelling	oai:doaj.org-article:f493f8a297a3479694a4af97c2b66c7c2021-11-11T15:31:35ZPembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study10.3390/cancers132154322072-6694https://doaj.org/article/f493f8a297a3479694a4af97c2b66c7c2021-10-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/21/5432https://doaj.org/toc/2072-6694The 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.Luis de la Cruz-MerinoMaría GionJosefina Cruz-JuradoVanesa QuirogaRaquel AndrésFernando MorenoJose L. Alonso-RomeroManuel RamosEsther HolgadoJavier CortésElena López-MirandaFernando Henao-CarrascoNatalia Palazón-CarriónLuz M. RodríguezIsaac CeballosMaribel CasasSara BenitoMassimo ChiesaSusana BezaresRosalia CaballeroCarlos Jiménez-CorteganaVíctor Sánchez-MargaletFederico RojoMDPI AGarticlephase IItriple-negativebreast cancerpembrolizumabimmunotherapybiomarkersNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5432, p 5432 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	phase II triple-negative breast cancer pembrolizumab immunotherapy biomarkers Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	phase II triple-negative breast cancer pembrolizumab immunotherapy biomarkers Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Luis de la Cruz-Merino María Gion Josefina Cruz-Jurado Vanesa Quiroga Raquel Andrés Fernando Moreno Jose L. Alonso-Romero Manuel Ramos Esther Holgado Javier Cortés Elena López-Miranda Fernando Henao-Carrasco Natalia Palazón-Carrión Luz M. Rodríguez Isaac Ceballos Maribel Casas Sara Benito Massimo Chiesa Susana Bezares Rosalia Caballero Carlos Jiménez-Cortegana Víctor Sánchez-Margalet Federico Rojo Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
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.
format	article
author	Luis de la Cruz-Merino María Gion Josefina Cruz-Jurado Vanesa Quiroga Raquel Andrés Fernando Moreno Jose L. Alonso-Romero Manuel Ramos Esther Holgado Javier Cortés Elena López-Miranda Fernando Henao-Carrasco Natalia Palazón-Carrión Luz M. Rodríguez Isaac Ceballos Maribel Casas Sara Benito Massimo Chiesa Susana Bezares Rosalia Caballero Carlos Jiménez-Cortegana Víctor Sánchez-Margalet Federico Rojo
author_facet	Luis de la Cruz-Merino María Gion Josefina Cruz-Jurado Vanesa Quiroga Raquel Andrés Fernando Moreno Jose L. Alonso-Romero Manuel Ramos Esther Holgado Javier Cortés Elena López-Miranda Fernando Henao-Carrasco Natalia Palazón-Carrión Luz M. Rodríguez Isaac Ceballos Maribel Casas Sara Benito Massimo Chiesa Susana Bezares Rosalia Caballero Carlos Jiménez-Cortegana Víctor Sánchez-Margalet Federico Rojo
author_sort	Luis de la Cruz-Merino
title	Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study
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
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/f493f8a297a3479694a4af97c2b66c7c
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Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

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