Mense Februarioret 2023Cibus et Drug Administration (FDA) elacestrant (Orserdu, Stemline Therapeutica, Inc.) pro feminis vel viris super 50 qui cancer pectus metastaticum progressi sunt et sunt ER-positivi, HER2-negative et mutationes ESR1 habent. Morbus profecit post unam saltem lineam endocrinam justo.
Custos CDx primordium etiam FDA approbavit ut socius instrumenti diagnostici ad elacestram curationem aegrorum cancri pectoris.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic pectus cancer in whom 228 patients had ESR1 mutations, investigated the effectiveness of the treatment. Patients had to have seen disease progression after receiving one or more lines of endocrine therapy in the past, including at least one line that contained a CDK4/6 inhibitor. Patients who were eligible could have had up to one prior line of chemotherapy for advanced or metastatic disease. Elacestrant 345 mg orally once daily was given to patients who were randomly assigned (1:1) to receive it or investigator’s choice of endocrine therapy, which included fulvestrant (n=166) or an aromatase inhibitor (n=73). ESR1 mutation status (found vs. not found), previous fulvestrant treatment (yes vs. no), and visceral metastasis were used to divide the patients into groups for randomization (yes vs. no). The Guardant360 CDx assay was used to identify ESR1 missense mutations in the ligand binding domain and was limited to blood circulating tumour deoxyribonucleic acid (ctDNA).
Praecipua exitus efficacia mensura erat progressionis liberorum superstes (PFS), quae aestimationem subiit per praecaecatum imaginum recognitionem. In populatione cum ITT et in subglobata aegrorum mutationum ESR1, peraeque notabilis differentia in PFS facta est.
Mediana PFS erat 3.8 mensium (95% CI: 2.2, 7.3) pro 228 (48%) patientibus mutationum ESR1 tractatorum elacestrantium et 1.9 mensium (95% CI: 1.9, 2.1) pro iis quae in fulvestrant vel inhibitore aromatasi tractantur. anceps ratio 0.55 [95% CI: 0.39, 0.77], 2 quadratum p-value=0.0005).
250 (52%) aegros sine ESR1 mutationibus in analysi exploratorii PFS habuerunt HR of 0.86 (95% CI: 0.63, 1.19) significans eventus qui in ESR1 mutant hominum eventus videntur praevalere responsabiles cohortis ITT emendationis. .
Dolor musculoskeletalis, nausea, cholesterolum elevatum, AST elevatum, triglycerides elevatum, lassitudo, haemoglobina minuitur, vomitus, ALT elevatus, sodium elevatum, creatinine elevatum, appetitus decrescentes, diarrhoea, capitis, constipatio, dolor abdominis, rubor calidus, et dyspepsia erant maxime. crebra adversa eventa (10%), etiam laboratorium abnormitates.
Monetur ut 345 medicamentum elacestrat semel in die cotidie cum cibo sumere, donec morbus procedat vel toxicitas intolerabilis fiat.
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