Cruz Merino, Luis de laGion, MaríaCruz Jurado, JosefinaQuiroga, VanesaAndrés Conejero, RaquelMoreno Antón, FernandoAlonso Romero, José LuisRamos Vázquez, ManuelCortés Castán, JavierRojo Todo, FedericoEt al.2023-06-192023-06-192021Cruz-Merino, L., Gion, M., Cruz-Jurado, J., Quiroga, V., Andrés, R., Moreno, F., Alonso-Romero, J., Ramos, M., Holgado, E., Cortés, J., López-Miranda, E., Henao-Carrasco, F., Palazón-Carrión, N., Rodríguez, L., Ceballos, I., Casas, M., Benito, S., Chiesa, M., Bezares, S., … 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/cancers132154322072-6694http://hdl.handle.net/11268/12149The 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.engAtribución 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/Neoplasias de la mamaQuimioterapiaAnticuerpos monoclonalesjournal article10.3390/cancers13215432open accessCáncerMujerTratamiento médico