Publication: Pembrolizumab plus gemcitabine in the subset of triple-negative advanced breast cancer patients in the GEICAM/2015-04 (PANGEA-Breast) study
Authors
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
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Publisher
MDPI
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DOI
https://doi.org/10.3390/cancers13215432
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info:eu-repo/semantics/article
Description
© 2021 by the authors. Licensee MDPI, Basel, Switzerlan. This manuscript version is made available under the CC-BY 4.0 license http://creativecommons.org/licenses/by/4.0/. This document is the Published version of a Published Work that appeared in final form in Cancers. To access the final edited and published work see https://doi.org/10.3390/cancers13215432
Abstract
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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Phase II , Triple-negative , Breast cancer , Pembrolizumab , Immunotherapy , Biomarkers , PD-L1 , TILs , MDSCs
Citation
Cancers 2021, 13, 5432
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