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Publications

Journal Article Epublish 1 citation

PubMed: 39592624 DOI: 10.1038/s41523-024-00710-x

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

NPJ Breast Cancer 10(1):101

Authors: 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

Affiliations

  • SOLTI Cancer Research Group, Barcelona, Spain.
  • Institut Catala d'Oncologia-IDIBELL; L'Hospitalet, Barcelona, Spain.
  • SOLTI Cancer Research Group, Barcelona, Spain.
  • August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
  • Pathology Department Hospital Clinic de Barcelona, Barcelona, Spain.
  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
  • Hospital Universitario Virgen del Rocio, Sevilla, Spain.
  • Hospital Son Espases, Palma, Illes Balears, Spain.
  • Institut Oncològic Dr. Rosell, Barcelona, Spain.
  • Hospital General de Catalunya, Sant Cugat del Vallès, Spain.
  • Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
  • Hospitales Regional y Universitario Virgen de la Victoria, Málaga, Spain.
  • Hospital Universitario Infanta Sofía, Madrid, Spain.
  • Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.
  • Hospital Clínico Universitario Virgen de la Victoria, Málaga. Instituto de Investigación Biomédica de Málaga, IBIMA, Málaga, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain.
  • Hospital Clínic de Barcelona, Barcelona, Spain.
  • Medicine Department, University of Barcelona, Barcelona, Spain.
  • SOLTI Cancer Research Group, Barcelona, Spain.
  • Hospital 12 de Octubre, Madrid, Spain.

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.

MeSH

Genes, Breast Neoplasms, Neoplasms, Letrozole, Drug Therapy, Biomarkers, Hormones, Breast, Chemotherapy

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