Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

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 prim...

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Autores principales: Luis de la Cruz-Merino, María Gion, Josefina Cruz-Jurado, Vanesa Quiroga, Raquel Andrés, Fernando Moreno, Jose L. Alonso-Romero, Manuel Ramos, Esther Holgado, Javier Cortés, Elena López-Miranda, Fernando Henao-Carrasco, Natalia Palazón-Carrión, Luz M. Rodríguez, Isaac Ceballos, Maribel Casas, Sara Benito, Massimo Chiesa, Susana Bezares, Rosalia Caballero, Carlos Jiménez-Cortegana, Víctor Sánchez-Margalet, Federico Rojo
Formato: article
Lenguaje:EN
Publicado: MDPI AG 2021
Materias:
phase II
triple-negative
breast cancer
pembrolizumab
immunotherapy
biomarkers
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Acceso en línea:https://doaj.org/article/f493f8a297a3479694a4af97c2b66c7c
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Sumario: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.

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