Sistema de Salut de Catalunya
Institut Català de la Salut
[de la Cruz-Merino L] Medical Oncology Department, Virgen Macarena University Hospital, Medicine Department University of Seville, Seville, Spain. GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. [Gion M] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Cruz-Jurado J] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. [Quiroga V] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Badalona Applied Research Group in Oncology (B-ARGO Group), Catalan Institute of Oncology, Badalona, Spain. [Andrés R] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. [Moreno F] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain. [Cortés J] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. International Breast Cancer Center (IBCC), Quirón Teknon Hospital (Quironsalud Group), Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
2022-06-03T06:54:25Z
2022-06-03T06:54:25Z
2021-10-29
Bomarkers; Breast cancer; Pembrolizumab
Biomarcadores; Cáncer de mama; Pembrolizumab
Biomarcadors; Càncer de mama; Pembrolizumab
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.
The study was partially supported by a research grant from Merck’s (MSD in Europe) Investigator Initiated Studies Program, which also supplied the pembrolizumab.
Article
Published version
English
Càncer - Immunoteràpia; Mama - Càncer - Tractament; DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms::Triple Negative Breast Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama::neoplasias de mama triple negativos; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación::inmunoterapia
MDPI
Cancers;13(21)
https://doi.org/10.3390/cancers13215432
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
