Sistema de Salut de Catalunya
Institut Català de la Salut
[Bidard FC] Institut Curie, Paris and Saint Cloud, France. Versailles Saint Quentin/Paris-Saclay University, Saint Cloud, France. [Kaklamani VG] University of Texas Health Sciences Center, San Antonio, TX. [Neven P] Universitaire Ziekenhuizen (UZ)—Leuven Cancer Institute, Leuven, Belgium. [Streich G] Centro Médico Austral, Buenos Aires, Argentina. [Montero AJ] University Hospitals Seidman Cancer Center-Case Western Reserve University, Cleveland, OH. [Forget F] Centre Hospitalier de l’Ardenne—Site de Libramont, Libramont-Chevigny, Belgium. [Cortés J] International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain. Scientific Department, Medica Scientia Innovation Research, Valencia, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
2022-11-04T08:45:50Z
2022-11-04T08:45:50Z
2022-10-01
Elacestrant; Càncer de mama
Elacestrant; Cáncer de mama
Elacestrant; Breast cancer
PURPOSE Patients with pretreated estrogen receptor (ER)–positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer have poor prognosis. Elacestrant is a novel, oral selective ER degrader that demonstrated activity in early studies. METHODS This randomized, open-label, phase III trial enrolled patients with ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy. Patients were randomly assigned to elacestrant 400 mg orally once daily or standard-of-care (SOC) endocrine monotherapy. Primary end points were progression-free survival (PFS) by blinded independent central review in all patients and patients with detectable ESR1 mutations. RESULTS Patients were randomly assigned to elacestrant (n = 239) or SOC (n = 238). ESR1 mutation was detected in 47.8% of patients, and 43.4% received two prior endocrine therapies. PFS was prolonged in all patients (hazard ratio = 0.70; 95% CI, 0.55 to 0.88; P = .002) and patients with ESR1 mutation (hazard ratio = 0.55; 95% CI, 0.39 to 0.77; P = .0005). Treatment-related grade 3/4 adverse events occurred in 7.2% receiving elacestrant and 3.1% receiving SOC. Treatment-related adverse events leading to treatment discontinuations were 3.4% in the elacestrant arm versus 0.9% in SOC. Nausea of any grade occurred in 35.0% receiving elacestrant and 18.8% receiving SOC (grade 3/4, 2.5% and 0.9%, respectively). CONCLUSION Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer.
Article
Published version
English
Mama - Càncer - Tractament; Medicaments antineoplàstics - Ús terapèutic; Avaluació de resultats (Assistència sanitària); 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; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; 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; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
American Society of Clinical Oncology
Journal of Clinical Oncology;40(28)
https://doi.org/10.1200/JCO.22.00338
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
