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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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dc.contributor.authorCruz-Merino, Luis de la
dc.contributor.authorGion, María
dc.contributor.authorCruz-Jurado, Josefina
dc.contributor.authorQuiroga, Vanesa
dc.contributor.authorAndrés, Raquel
dc.contributor.authorMoreno, Fernando
dc.contributor.authorAlonso-Romero, José Luis
dc.contributor.authorRamos, Manuel
dc.contributor.authorHolgado, Esther
dc.contributor.authorCortés, Javier
dc.contributor.authorLópez-Miranda, Elena
dc.contributor.authorHenao-Carrasco, Fernando
dc.contributor.authorPalazón-Carrión, Natalia
dc.contributor.authorRodríguez, Luz M.
dc.contributor.authorCeballos, Isaac
dc.contributor.authorCasas, Maribel
dc.contributor.authorBenito, Sara
dc.contributor.authorChiesa, Massimo
dc.contributor.authorBezares, Susana
dc.contributor.authorCaballero, Rosalia
dc.contributor.authorJiménez-Cortegana, Carlos
dc.contributor.authorSánchez-Margalet, Víctor
dc.contributor.authorRojo, Federico
dc.contributor.departmentMedicina
dc.date.accessioned2024-11-05T12:16:56Z
dc.date.available2024-11-05T12:16:56Z
dc.date.issued2021-10-29
dc.description© 2021 by the authors. Licensee MDPI, Basel, Switzerlan. This manuscript version is made available under the CC-BY 4.0 license http://creativecommons.org/licenses/by/4.0/. This document is the Published version of a Published Work that appeared in final form in Cancers. To access the final edited and published work see https://doi.org/10.3390/cancers13215432
dc.description.abstractThe 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.es
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dc.format.extent14es
dc.identifier.citationCancers 2021, 13, 5432
dc.identifier.doihttps://doi.org/10.3390/cancers13215432
dc.identifier.issnElectronic: 2072-6694
dc.identifier.urihttp://hdl.handle.net/10201/146021
dc.languageenges
dc.publisherMDPI
dc.relationThe study was partially supported by a research grant from Merck’s (MSD in Europe) Investigator Initiated Studies Program, which also supplied the pembrolizumab.es
dc.relation.publisherversionhttps://www.mdpi.com/2072-6694/13/21/5432
dc.rightsinfo:eu-repo/semantics/openAccesses
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectPhase IIes
dc.subjectTriple-negativees
dc.subjectBreast canceres
dc.subjectPembrolizumabes
dc.subjectImmunotherapyes
dc.subjectBiomarkerses
dc.subjectPD-L1es
dc.subjectTILses
dc.subjectMDSCses
dc.titlePembrolizumab plus gemcitabine in the subset of triple-negative advanced breast cancer patients in the GEICAM/2015-04 (PANGEA-Breast) studyes
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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