Browsing by Subject "Phase II"

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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
    (MDPI, 2021-10-29) Cruz-Merino, Luis de la; Gion, María; Cruz-Jurado, Josefina; Quiroga, Vanesa; Andrés, Raquel; Moreno, Fernando; Alonso-Romero, José Luis; Ramos, Manuel; Holgado, Esther; Cortés, Javier; López-Miranda, Elena; Henao-Carrasco, Fernando; Palazón-Carrión, Natalia; Rodríguez, Luz M.; Ceballos, Isaac; Casas, Maribel; Benito, Sara; Chiesa, Massimo; Bezares, Susana; Caballero, Rosalia; Jiménez-Cortegana, Carlos; Sánchez-Margalet, Víctor; Rojo, Federico; Medicina
    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.