%0 Journal Article
%A de la Cruz-Merino, Luis
%A Gion, María
%A Cruz-Jurado, Josefina
%A Quiroga, Vanesa
%A Andrés, Raquel
%A Moreno, Fernando
%A Alonso-Romero, Jose L
%A Ramos, Manuel
%A Holgado, Esther
%A Cortés, Javier
%A López-Miranda, Elena
%A Henao-Carrasco, Fernando
%A Palazón-Carrión, Natalia
%A Rodríguez, Luz M
%A Ceballos, Isaac
%A Casas, Maribel
%A Benito, Sara
%A Chiesa, Massimo
%A Bezares, Susana
%A Caballero, Rosalia
%A Jiménez-Cortegana, Carlos
%A Sánchez-Margalet, Víctor
%A Rojo, Federico
%T Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study.
%D 2021
%@ 2072-6694
%U https://hdl.handle.net/10668/24740
%X 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.
%K MDSCs
%K PD-L1
%K TILs
%K biomarkers
%K breast cancer
%K immunotherapy
%K pembrolizumab
%K phase II
%K triple-negative
%~