2026-04-17T20:02:41Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/84972025-10-24T10:26:07Zcom_2072_378070com_2072_378040col_2072_378092

Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer Cortés Castan, Javier Loirat, Delphine Gómez Pardo, Patricia Schmid, Peter Rugo, Hope Marmé, Frederik Bardia, Aditya Institut Català de la Salut [Rugo HS] Department of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. [Bardia A] Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA. [Marmé F] Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Heidelberg, Germany. [Cortes J] Medical Oncology Department, International Breast Cancer Center, Pangaea Oncology, Quironsalud Group, Madrid and Barcelona, Spain. Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain. [Schmid P] Barts Cancer Institute, Queen Mary University of London, London, United Kingdom. [Loirat D] Medical Oncology Department and D3i, Institut Curie, Paris, France. [Gomez Pardo P] Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Mama - Càncer - Tractament Medicaments antineoplàstics - Ús terapèutic Anticossos monoclonals - Ús terapèutic DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados Sacituzumab govitecán; Cáncer de mama metastásico Sacituzumab govitecan; Càncer de mama metastàtic Sacituzumab govitecan; Metastatic breast cancer PURPOSE Hormone receptor–positive (HR+) human epidermal growth factor receptor 2–negative (HER2–) endocrine-resistant metastatic breast cancer is treated with sequential single-agent chemotherapy with poor outcomes. Sacituzumab govitecan (SG) is a first-in-class antibody-drug conjugate with an SN-38 payload targeting trophoblast cell-surface antigen 2, an epithelial antigen expressed in breast cancer. METHODS In this global, randomized, phase III study, SG was compared with physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in endocrine-resistant, chemotherapy-treated HR+/HER2– locally recurrent inoperable or metastatic breast cancer. The primary end point was progression-free survival (PFS) by blinded independent central review. RESULTS Patients were randomly assigned to receive SG (n = 272) or chemotherapy (n = 271). The median age was 56 years, 95% had visceral metastases, and 99% had a prior cyclin-dependent kinase 4/6 inhibitor, with three median lines of chemotherapy for advanced disease. Primary end point was met with a 34% reduction in risk of progression or death (hazard ratio, 0.66 [95% CI, 0.53 to 0.83; P = .0003]). The median PFS was 5.5 months (95% CI, 4.2 to 7.0) with SG and 4.0 months (95% CI, 3.1 to 4.4) with chemotherapy; the PFS at 6 and 12 months was 46% (95% CI, 39 to 53) v 30% (95% CI, 24 to 37) and 21% (95% CI, 15 to 28) v 7% (95% CI, 3 to 14), respectively. Median overall survival (first planned interim analysis) was not yet mature (hazard ratio, 0.84; P = .14). Key grade ≥ 3 treatment-related adverse events (SG v chemotherapy) were neutropenia (51% v 38%) and diarrhea (9% v 1%). CONCLUSION SG demonstrated statistically significant PFS benefit over chemotherapy, with a manageable safety profile in patients with heavily pretreated, endocrine-resistant HR+/HER2– advanced breast cancer and limited treatment options. 2022-11-18T08:11:05Z 2022-11-18T08:11:05Z 2022-10-10 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Rugo HS, Bardia A, Marmé F, Cortes J, Schmid P, Loirat D, et al. Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365–76. 1527-7755 https://hdl.handle.net/11351/8497 10.1200/JCO.22.01002 36027558 000864709100004 http://hdl.handle.net/11351/8497 eng Journal of Clinical Oncology;40(29) http://dx.doi.org/10.1200/JCO.22.01002 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf American Society of Clinical Oncology Scientia