Unyango lwe-endocrine lomhlaza webele yindlela ebalulekileyo yonyango lwe-hormone receptor positive umhlaza wamabele.Oyena nobangela wokunganyangeki kweziyobisi kwizigulane ze-HR + emva kokufumana unyango lokuqala (i-tamoxifen TAM okanye i-aromatase inhibitor AI) lutshintsho kwi-estrogen receptor gene α (ESR1).Izigulane ezifumana i-estrogen receptor degraders (SERDs) ezikhethiweyo zixhamle kungakhathaliseki ukuba i-ESR1 yokuguqula isimo.
NgoJanuwari 27, 2023, i-FDA ivume i-elacestrant (i-Orserdu) kubasetyhini be-postmenopausal okanye amadoda amadala anomdlavuza webele ophezulu okanye we-metastatic kunye ne-ER +, HER2-, ukuguqulwa kwe-ESR1 kunye nokuqhubela phambili kwesifo emva komgca omnye wonyango lwe-endocrine.izigulane zomhlaza.I-FDA ikwaphumeze uvavanyo lwe-Guardant360 CDx njengesixhobo soxilongo esongezelelweyo sokuhlola izigulane ezinomhlaza wamabele ezifumana i-elastran.
Le mvume isekelwe kulingo lwe-EMERALD (NCT03778931), iziphumo eziphambili ezipapashwe kwi-JCO.
Uphononongo lwe-EMERALD (i-NCT03778931) luvavanyo lwekliniki oluphakathi, olungenamkhethe, oluvulekileyo, olusebenzayo olulawulwayo lwesigaba sesi-III esibhalisa inani elipheleleyo lama-478 abasetyhini be-postmenopausal kunye namadoda ane-ER +, i-HER2-i-advanced okanye isifo se-metastatic, i-228 kubo ene-ESR1. iinguqulelo zemfuza .Ulingo lwalufuna izigulane ezinenkqubela phambili yesifo emva konyango lwangaphambili lomgca wokuqala okanye wesibini we-endocrine, kuquka i-CDK4/6 inhibitors.Abaguli abafanelekileyo babefumene uninzi lwechemotherapy yodidi lokuqala.Izigulane zazingahleliwe (1: 1) ukufumana i-erastrol 345 mg ngomlomo kanye ngosuku (n = 239) okanye ukhetho lomphandi wonyango lwe-endocrine (n = 239), kuquka i-fulvestrant (n = 239).166) okanye i-aromatase inhibitors (n = 73).Iimvavanyo zahlulwe ngokwesimo se-ESR1 soguqulo (ifunyenwe vs. ayibonwa), unyango lwangaphambili lwe-fulvestrant (ewe vs. no), kunye ne-visceral metastases (ewe vs. no).Isimo soguqulo se-ESR1 sigqitywe yi-ctDNA isebenzisa i-Guardant360 CDx assay kwaye yayithintelwe kwi-ESR1 yokuguqulwa kwe-missense kwi-domain ebopha i-ligand.
Eyona nto iphambili yokuphumelela yayiyi-progression-free survival (PFS).Ukwahluka kwezibalo kwi-PFS kubonwe kwiinjongo-to-treat (ITT) yabemi kunye namaqela angaphantsi kwezigulane ezine-ESR1.
Phakathi kwezigulane ezingama-228 (48%) ezinenguquko ye-ESR1, i-PFS ephakathi yayiziinyanga ze-3.8 kwiqela le-elacestrant ngokuchasene neenyanga ze-1.9 kwiqela le-fulvestrant okanye i-aromatase inhibitor (HR = 0.55, 95% CI: 0.39-0.77, i-p-value yamacala amabini e-p-value). = 0.0005).
Uhlalutyo lokuhlola lwe-PFS kwi-250 (52%) izigulane ezingenazo ukuguqulwa kwe-ESR1 zibonise i-HR ye-0.86 (95% CI: 0.63-1.19), ebonisa ukuba ukuphuculwa kwenani labantu be-ITT kubangelwa kakhulu kwiziphumo kwi-ESR1 yokuguqulwa kwabantu.
Uninzi lweziganeko ezimbi ezixhaphakileyo (≥10%) ziquka ukungahambi kakuhle kwebhubhoratri kubandakanya intlungu ye-musculoskeletal, isicaphucaphu, ukwanda kwe-cholesterol, i-AST yanda, i-triglycerides yanda, ukudinwa, ukwehla kwe-hemoglobin, ukuhlanza, ukunyuka kwe-ALT, ukwehla kwe-sodium, ukunyuka kwe-creatinine, ukuncipha kokutya, isifo sohudo, intloko ebuhlungu, ukuqhinwa, iintlungu zesisu, ukuvutha kobushushu, kunye nokungatyi.
I-dose ephakanyisiweyo ye-elastrol yi-345 mg ngomlomo kanye ngosuku kunye nokutya kuze kube yinkqubela yesifo okanye ubuthi obungamkelekanga.
Eli lichiza lokuqala lomlomo le-SERD lokufumana iziphumo ezilungileyo zomgca ophezulu kulingo olubalulekileyo lwekliniki kwizigulana ezinomhlaza webele we-ER+/HER2-obuqhubela phambili okanye we-metastatic.Kwaye kungakhathaliseki ukuba inani labantu ngokubanzi okanye i-ESR1 yokuguqulwa kwabantu, i-Erasetran yazisa ukunciphisa okuphawulekayo kwi-PFS kunye nomngcipheko wokufa, kwaye yabonisa ukhuseleko oluhle kunye nokunyamezela.
Ixesha lokuposa: Apr-23-2023
