2026-04-13T14:19:27Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/128482025-05-03T03:19:50Zcom_2072_378070com_2072_378040col_2072_378092

Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial Salgado, Roberto Romero Díaz, Roberto Iván Rojas, Carlos Loi, Sherene Curigliano, Giuseppe Delaloge, Suzette Saura Manich, Cristina Institut Català de la Salut [Loi S] Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. University of Melbourne, Parkville, Victoria, Australia. [Salgado R] Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. Department of Pathology, ZAS Hospitals, Antwerp, Belgium. [Curigliano G] European Institute of Oncology, IRCCS, Milan, Italy. University of Milan, Milan, Italy. [Romero Díaz RI] Consultorio de Oncólogo Médico, Oaxaca, Mexico. [Delaloge S] Gustave Roussy Cancer Campus, Villejuif, France. [Rojas García CI] Bradford Hill Investigación Clinica, Región Metropolitana, Santiago, Chile. [Saura C] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Mama - Càncer - Tractament Quimioteràpia combinada Anticossos monoclonals - Ús terapèutic Estrògens - Receptors ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal Other subheadings::Other subheadings::/therapeutic use CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales Otros calificadores::Otros calificadores::/uso terapéutico COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenos Neoadjuvant nivolumab; Breast cancer; Estrogen receptor Nivolumab neoadyuvante; Cáncer de mama; Receptor de estrógeno Nivolumab neoadjuvant; Càncer de mama; Receptors d'estrògen Patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) primary breast cancer (BC) have low pathological complete response (pCR) rates with neoadjuvant chemotherapy. A subset of ER+/HER2− BC contains dense lymphocytic infiltration. We hypothesized that addition of an anti-programmed death 1 agent may increase pCR rates in this BC subtype. We conducted a randomized, multicenter, double-blind phase 3 trial to investigate the benefit of adding nivolumab to neoadjuvant chemotherapy in patients with newly diagnosed, high-risk, grade 3 or 2 (ER 1 to ≤10%) ER+/HER2− primary BC. In total, 510 patients were randomized to receive anthracycline and taxane-based chemotherapy with either intravenous nivolumab or placebo. The primary endpoint of pCR was significantly higher in the nivolumab arm compared with placebo (24.5% versus 13.8%; P = 0.0021), with greater benefit observed in patients with programmed death ligand 1-positive tumors (VENTANA SP142 ≥1%: 44.3% versus 20.2% respectively). There were no new safety signals identified. Of the five deaths that occurred in the nivolumab arm, two were related to study drug toxicity; no deaths occurred in the placebo arm. Adding nivolumab to neoadjuvant chemotherapy significantly increased pCR rates in high-risk, early-stage ER+/HER2− BC, particularly among patients with higher stromal tumor-infiltrating lymphocyte levels or programmed death ligand 1 expression, suggesting a new treatment paradigm that emphasizes the role of immunotherapy and T cell immunosurveillance in luminal disease. Clinical trials.gov identifier: NCT04109066 2025-03-31T10:18:14Z 2025-03-31T10:18:14Z 2025-02 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Loi S, Salgado R, Curigliano G, Romero Díaz RI, Delaloge S, Rojas García CI, et al. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31:433-41. 1546-170X http://hdl.handle.net/11351/12848 10.1038/s41591-024-03414-8 39838118 001401147900001 http://hdl.handle.net/11351/12848 eng Nature Medicine;31 https://doi.org/10.1038/s41591-024-03414-8 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Nature Portfolio Scientia