Ukwelashwa kwe-endocrine yomdlavuza webele kuyindlela ebalulekile yokwelapha umdlavuza webele we-hormone receptor positive.Imbangela eyinhloko yokumelana nezidakamizwa ezigulini ze-HR+ ngemva kokuthola ukwelashwa komugqa wokuqala (i-tamoxifen TAM noma i-aromatase inhibitor AI) ukuguqulwa kwezakhi zofuzo ze-estrogen receptor α (ESR1).Iziguli ezithola izinciphisi ze-estrogen receptor ezikhethiwe (ama-SERD) zizuze kungakhathaliseki ukuthi i-ESR1 ishintshe isimo.
Ngomhla zingama-27 kuJanuwari 2023, i-FDA igunyaze i-elacestrant (i-Orserdu) yabesifazane abadlule kokuya esikhathini noma amadoda amadala anomdlavuza webele othuthukisiwe noma we-metastatic one-ER+, HER2-, ESR1 nokuqhubeka kwesifo ngemva okungenani komugqa owodwa wokwelashwa kwe-endocrine.iziguli ezinomdlavuza.I-FDA iphinde yagunyaza ukuhlolwa kwe-Guardant360 CDx njengethuluzi lokuxilonga elihambisanayo lokuhlola iziguli ezinomdlavuza webele ezithola i-elastran.
Lokhu kugunyazwa kusekelwe ocwaningweni lwe-EMERALD (NCT03778931), okutholakele okuyinhloko okushicilelwe ku-JCO.
Ucwaningo lwe-EMERALD (NCT03778931) luyisivivinyo somtholampilo esigxile ezindaweni eziningi, esingahleliwe, esivulekile, esilawulwa ngokusebenzayo esinesigaba sesi-III esibhalise inani eliphelele lama-478 abesifazane nabesilisa abangemva kokuya esikhathini abane-ER+, HER2- isifo esithuthukile noma esimetastatic, abangama-228 kubo abaneESR1. ukuguqulwa kwezakhi zofuzo .Uhlolo lwaludinga iziguli ezinokuqhubeka kwesifo ngemva kokwelashwa kwangaphambili komugqa wokuqala noma wesibili we-endocrine, okuhlanganisa nama-CDK4/6 inhibitors.Iziguli ezifanelekile zazithole ukwelashwa ngamakhemikhali komugqa wokuqala.Iziguli zazingahleliwe (1:1) ukuze zithole i-erastrol 345 mg ngomlomo kanye ngosuku (n=239) noma ukukhetha komphenyi we-endocrine therapy (n=239), okuhlanganisa i-fulvestrant (n=239).166) noma ama-aromatase inhibitors (n=73).Izivivinyo zahlukaniswa ngokuya ngesimo sokuguqulwa kwe-ESR1 (kutholwe uma kuqhathaniswa.Isimo sokuguqulwa kwe-ESR1 sanqunywa i-ctDNA isebenzisa i-Guardant360 CDx assay futhi yakhawulelwa ekuguquleni okuyiphutha kwe-ESR1 kusizinda esibopha i-ligand.
Isiphetho esiyinhloko sokusebenza kwakungu-progression-free survival (PFS).Umehluko ophawulekayo wezibalo ku-PFS ubonwe emphakathini wenhloso yokwelapha (ITT) kanye namaqeqebana eziguli ezinezinguquko ze-ESR1.
Phakathi kweziguli ezingama-228 (48%) ezinokuguqulwa kwe-ESR1, i-PFS emaphakathi yayiyizinyanga ezingu-3.8 eqenjini le-elacestrant uma iqhathaniswa nezinyanga ezingu-1.9 eqenjini le-fulvestrant noma i-aromatase inhibitor (HR=0.55, 95% CI: 0.39-0.77, inani le-p elizinhlangothi ezimbili = 0.0005).
Ukuhlaziywa kokuhlola kwe-PFS ezigulini ezingama-250 (52%) ngaphandle kokuguqulwa kwe-ESR1 kubonise i-HR ye-0.86 (95% CI: 0.63-1.19), ephakamisa ukuthi ukuthuthukiswa kwesibalo se-ITT kwakubangelwa kakhulu imiphumela ye-ESR1 yabantu abaguqukayo.
Izehlakalo ezimbi ezivame kakhulu (≥10%) zihlanganisa ukungahambi kahle kwaselabhorethri okuhlanganisa ubuhlungu bemisipha namathambo, isicanucanu, ukwanda kwe-cholesterol, ukwanda kwe-AST, ukwanda kwe-triglycerides, ukukhathala, ukwehla kwe-hemoglobin, ukuhlanza, ukwanda kwe-ALT, ukwehla kwe-sodium, ukwanda kwe-creatinine, ukuncipha kwesifiso sokudla, isifo sohudo, ikhanda, ukuqunjelwa, ubuhlungu besisu, ukushisa, nokungagayeki kahle kokudla.
Umthamo onconyiwe we-elastrol ngu-345 mg ngomlomo kanye ngosuku ngokudla kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
Lona umuthi wokuqala womlomo we-SERD othola imiphumela emihle ephezulu ekuhlolweni komtholampilo okubalulekile ezigulini ezinomdlavuza webele we-ER+/HER2- advanced noma metastatic.Futhi kungakhathaliseki inani labantu elivamile noma inani labantu abaguquguqukayo be-ESR1, i-Erasetran ilethe ukuncipha okuphawulekayo kwezibalo ku-PFS nobungozi bokufa, futhi yabonisa ukuphepha okuhle nokubekezeleleka.
Isikhathi sokuthumela: Apr-23-2023
