dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Gion, María | es |
dc.creator | Cruz Jurado, Josefina | es |
dc.creator | Quiroga, Vanesa | es |
dc.creator | Andrés, Raquel | es |
dc.creator | Moreno, Fernando | es |
dc.creator | Jiménez Cortegana, Carlos | es |
dc.creator | Sánchez Margalet, Víctor | es |
dc.creator | Rojo, Federico | es |
dc.date.accessioned | 2022-11-10T15:34:00Z | |
dc.date.available | 2022-11-10T15:34:00Z | |
dc.date.issued | 2021-10-29 | |
dc.identifier.citation | Cruz Merino, L.d.l., Gion, M., Cruz Jurado, J., Quiroga, V., Andrés, R., Moreno, F.,...,Rojo, F. (2021). Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study. Cancers, 13 (21), 5432. https://doi.org/10.3390/cancers13215432. | |
dc.identifier.issn | 2072-6694 | es |
dc.identifier.uri | https://hdl.handle.net/11441/139262 | |
dc.description.abstract | 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. | es |
dc.format | application/pdf | es |
dc.format.extent | 14 p. | es |
dc.language.iso | eng | es |
dc.publisher | MDPI | es |
dc.relation.ispartof | Cancers, 13 (21), 5432. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Phase II | es |
dc.subject | Triple-negative | es |
dc.subject | Breast cancer | es |
dc.subject | Pembrolizumab | es |
dc.subject | Immunotherapy | es |
dc.subject | Biomarkers | es |
dc.subject | PD-L1 | es |
dc.subject | TILs | es |
dc.subject | MDSCs | es |
dc.title | Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Bioquímica Médica y Biología Molecular e Inmunología | es |
dc.relation.publisherversion | https://www.mdpi.com/2072-6694/13/21/5432/htm | es |
dc.identifier.doi | 10.3390/cancers13215432 | es |
dc.journaltitle | Cancers | es |
dc.publication.volumen | 13 | es |
dc.publication.issue | 21 | es |
dc.publication.initialPage | 5432 | es |