Palbociclib and letrozole for hormone receptor-positive HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy

Autor: Sonia Pernas, Esther Sanfeliu, Guillermo Villacampa, Javier Salvador, Antonia Perelló, Xavier González, Begoña Jiménez, María Merino, Patricia Palacios, Tomás Pascual, Emilio Alba, Lorea Villanueva, Samyukta Chillara, Juan Manuel Ferrero-Cafiero, Patricia Galvan, Aleix Prat, Eva Ciruelos
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: npj Breast Cancer, Vol 10, Iss 1, Pp 1-8 (2024)
Druh dokumentu: article
ISSN: 2374-4677
DOI: 10.1038/s41523-024-00710-x
Popis: Abstract With the incorporation of cyclin-dependent kinase inhibitors in early breast cancer (BC), a better identification of biomarkers is needed. The PROMETEO II trial aimed to evaluate the antitumor activity of palbociclib plus letrozole and to identify response biomarkers in patients with operable HR+/HER2- BC and residual disease after neoadjuvant chemotherapy (NAC). The primary endpoint was the rate of complete cell cycle arrest (CCCA), centrally determined by Ki67 ≤ 2.7% at surgery. A comprehensive translational analysis was conducted. At surgery, the CCCA rate was 59.1%, with a 44.2% decrease in Ki67 from the end of NAC. Changes in intrinsic subtypes occurred in 48% of patients, with proliferation genes suppressed, and immune genes more upregulated in tumors with CCCA. Overall, 14% of tumors were classified as PD-L1+ after palbociclib. Nine patients experienced grade 3 adverse events (AEs). Palbociclib showed an anti-proliferative effect, with increased immune infiltration in residual tumors with CCCA. Trial registration: Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy (PROMETEO II) ClinicalTrial.gov number NCT04130152. Study registration; October 17, 2019.
Databáze: Directory of Open Access Journals