RT Journal Article
T1 Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study.
A1 de la Cruz-Merino, Luis
A1 Gion, María
A1 Cruz-Jurado, Josefina
A1 Quiroga, Vanesa
A1 Andrés, Raquel
A1 Moreno, Fernando
A1 Alonso-Romero, Jose L
A1 Ramos, Manuel
A1 Holgado, Esther
A1 Cortés, Javier
A1 López-Miranda, Elena
A1 Henao-Carrasco, Fernando
A1 Palazón-Carrión, Natalia
A1 Rodríguez, Luz M
A1 Ceballos, Isaac
A1 Casas, Maribel
A1 Benito, Sara
A1 Chiesa, Massimo
A1 Bezares, Susana
A1 Caballero, Rosalia
A1 Jiménez-Cortegana, Carlos
A1 Sánchez-Margalet, Víctor
A1 Rojo, Federico
K1 MDSCs
K1 PD-L1
K1 TILs
K1 biomarkers
K1 breast cancer
K1 immunotherapy
K1 pembrolizumab
K1 phase II
K1 triple-negative
AB 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.
SN 2072-6694
YR 2021
FD 2021-10-29
LK https://hdl.handle.net/10668/24740
UL https://hdl.handle.net/10668/24740
LA en
DS RISalud
RD Apr 5, 2025