Gomarara remuzamu endocrine kurapa inzira yakakosha yekurapa kwehomoni receptor positive cancer cancer.Chikonzero chikuru chekusagadzikana kwezvinodhaka muHR + varwere mushure mekugamuchira mutsara wekutanga wekurapa (tamoxifen TAM kana aromatase inhibitor AI) kuchinja kweesrogen receptor gene α (ESR1).Varwere vanogamuchira sarudzo yeestrogen receptor degraders (SERDs) vakabatsirwa pasinei neESR1 mutation mamiriro.
Musi waNdira 27, 2023, iyo FDA yakabvumidza elacestrant (Orserdu) yevakadzi vepomenopausal kana varume vakuru vane kenza yepazamu yepamusoro kana metastatic ine ER+, HER2-, ESR1 shanduko uye kufambira mberi kwechirwere mushure memutsara mumwechete we endocrine therapy.varwere vegomarara.Iyo FDA yakabvumidzawo iyo Guardant360 CDx assay sechinhu chekuwedzera chekuongorora chekuongorora varwere vegomarara rezamu vanogamuchira elastran.
Mvumo iyi yakavakirwa pamuyedzo weEMERALD (NCT03778931), izvo zvakawanikwa zvakaburitswa muJCO.
Chidzidzo cheEMERALD (NCT03778931) chidzidzo chekiriniki chakawanda, chisingaverengeki, chakavhurika, chinoshanda-chinodzorwa chikamu III chakanyoresa vakadzi mazana mana nemakumi manomwe nesere nevarume vane ER+, HER2- advanced kana metastatic chirwere, mazana maviri nemakumi maviri nevasere vaive neESR1. mutations .Muedzo wacho waida varwere vane kufambira mberi kwechirwere mushure mekutanga-mutsara wekutanga kana wechipiri-mutsara endocrine therapy, kusanganisira CDK4/6 inhibitors.Varwere vanokodzera vaive vakagamuchira pakanyanya-mutsara chemotherapy.Varwere vaisarudzwa (1: 1) kuti vagamuchire erastrol 345 mg nemuromo kamwe chete pazuva (n = 239) kana kusarudzwa kwemuongorori we endocrine therapy (n = 239), kusanganisira fulvestrant (n = 239).166) kana aromatase inhibitors (n = 73).Miedzo yakarongwa maererano neESR1 mutation mamiriro (yakaonekwa vs. isina kuonekwa), isati yasvika fulvestrant therapy (hongu vs. kwete), uye visceral metastases (hongu vs. kwete).ESR1 mutation mamiriro akatemerwa ne ctDNA ichishandisa Guardant360 CDx assay uye yakaganhurirwa kuESR1 missense mutations mune ligand-binding domain.
Iyo yekutanga kushanda kwekupedzisira yaive kufambira mberi-isina kupona (PFS).Zvikamu zvakasiyana zvakasiyana muPFS zvakaonekwa muchinangwa-ku-kurapa (ITT) vanhu uye mapoka evarwere vane ESR1 mutations.
Pakati pevarwere ve228 (48%) vane ESR1 mutation, yepakati PFS yaive mwedzi 3.8 muboka re elacestrant rinopesana nemwedzi 1.9 muboka refulvestrant kana aromatase inhibitor (HR = 0.55, 95% CI: 0.39-0.77, maviri-sided p-value) = 0.0005).
Ongororo yekuongorora yePFS mu250 (52%) varwere vasina ESR1 mutations yakaratidza HR ye0.86 (95% CI: 0.63-1.19), zvichiratidza kuti kuvandudzwa kwehuwandu hweITT kwainyanya kukonzerwa nemhedzisiro muESR1 mutation vanhu.
Zviitiko zvinowanzoitika zvakashata (≥10%) zvinosanganisira kukanganisa kwerabhoritari zvinosanganisira marwadzo emusculoskeletal, kusvotwa, kuwedzera cholesterol, AST yakawedzera, triglycerides yakawedzera, kuneta, kuderera kwehemoglobin, kurutsa, ALT yakawedzera, sodium yakaderera, yakawedzera creatinine, kuderera kwechido, manyoka, musoro, kusvira, kurwadziwa mudumbu, kupisa kupenya, uye kusadya.
Nhamba yakakurudzirwa ye elastrol ndeye 345 mg nemuromo kamwe chete zuva nezuva nechikafu kusvikira kufambira mberi kwechirwere kana kusvibiswa kusingagamuchirwi.
Uyu ndiwo mushonga wekutanga wemuromo weSERD kuwana mhedzisiro yakanaka yepamusoro muyedzo yakakosha yekiriniki muvarwere vane ER+/HER2- advanced kana metastatic breast cancer.Uye zvisinei nehuwandu hwevanhu kana ESR1 mutation mutation, Erasetran yakaunza kuderedzwa kwakakosha muPFS uye njodzi yerufu, uye yakaratidza kuchengetedzwa kwakanaka uye kushivirira.
Nguva yekutumira: Kubvumbi-23-2023
