Kanseri y'ibere ivura endocrine ni uburyo bw'ingenzi bwo kuvura imisemburo ya kanseri nziza y'ibere.Impamvu nyamukuru itera kurwanya imiti mu barwayi ba HR + nyuma yo guhabwa umurongo wa mbere (tamoxifen TAM cyangwa aromatase inhibitor AI) ni ihinduka ry’imiterere ya estrogene yakira α (ESR1).Abarwayi bahabwa imiti igabanya ubukana bwa estrogene (SERDs) bungukiwe batitaye kuri ESR1 ihinduka.
Ku ya 27 Mutarama 2023, FDA yemeje elacestrant (Orserdu) ku bagore nyuma yo gucura cyangwa abagabo bakuze bafite kanseri y'ibere yateye imbere cyangwa metastatike hamwe na ER +, HER2-, ESR1 ihindagurika ndetse n'indwara nyuma yo nibura umurongo umwe wo kuvura endocrine.abarwayi ba kanseri.FDA yemeje kandi CDx ya Guardant360 nk'igikoresho cyo gusuzuma cyo gusuzuma abarwayi ba kanseri y'ibere bakira elastran.
Iki cyemezo gishingiye ku rubanza rwa EMERALD (NCT03778931), imyanzuro nyamukuru yabyo yatangajwe muri JCO.
Ubushakashatsi bwa EMERALD (NCT03778931) ni ikigo kinini, giteganijwe, gifunguye-kirango, kigenzurwa cyane n’icyiciro cya gatatu cy’amavuriro cyanditswemo abagore n’abagabo 478 nyuma yo gucura bafite ER +, HER2- indwara zateye imbere cyangwa metastatike, 228 muri bo bakaba barwaye ESR1 ihinduka.Ikigeragezo cyasabye abarwayi bafite uburwayi nyuma yo kuvura umurongo wa mbere cyangwa umurongo wa kabiri wa endocrine ivura, harimo na CDK4 / 6 inhibitor.Abarwayi bujuje ibisabwa bari barahawe imiti myinshi ya chimiotherapie.Abarwayi batoranijwe (1: 1) kugirango bakire erastrol 345 mg kumunwa rimwe kumunsi (n = 239) cyangwa abashakashatsi bahisemo kuvura endocrine ivura (n = 239), harimo na fulvestrant (n = 239).166) cyangwa inhibitori ya aromatase (n = 73).Ibigeragezo byashyizwe mu byiciro hakurikijwe ihinduka ry’imihindagurikire ya ESR1 (byagaragaye ko bitamenyekanye), mbere yo kuvura neza (yego na oya), hamwe na metastase ya visceral (yego na oya).Imiterere ya mutation ya ESR1 yagenwe na ctDNA ikoresheje CDx ya Guardant360 kandi yagarukiye gusa kuri ESR1 ihindagurika ryimiterere muri ligand-binding.
Iherezo ryibanze ryibanze kwari ukutabaho kwiterambere (PFS).Itandukaniro rishingiye ku mibare muri PFS ryagaragaye mu bushake bwo kuvura (ITT) no mu matsinda y’abarwayi bafite ihinduka rya ESR1.
Mu barwayi 228 (48%) bafite ihinduka rya ESR1, PFS yo hagati yari amezi 3.8 mu itsinda rya elacestrant ugereranije n’amezi 1.9 mu itsinda ryangiza cyangwa ryuzuye (HR = 0.55, 95% CI: 0.39-0.77, p-agaciro k'impande zombi = 0.0005).
Isesengura ryakozwe kuri PFS ku barwayi 250 (52%) badafite ihinduka rya ESR1 ryerekanye HR ya 0.86 (95% CI: 0.63-1.19), byerekana ko iterambere ry’abaturage ba ITT ryatewe ahanini n’ibisubizo byaturutse ku muturage wa ESR1.
Ibintu byinshi byakunze kugaragara (≥10%) harimo laboratoire idasanzwe harimo ububabare bwa musculoskeletal, isesemi, kwiyongera kwa cholesterol, AST yiyongereye, triglyceride yiyongera, umunaniro, kugabanuka kwa hemoglobine, kuruka, ALT yiyongereye, sodium yagabanutse, kwiyongera kwa creinine, kugabanuka kwa appetit, impiswi, kubabara umutwe, kuribwa mu nda, kubabara mu nda, gushyuha, no kutarya.
Igipimo gisabwa cya elastrol ni 345 mg kumunwa rimwe kumunsi hamwe nibiryo kugeza igihe indwara igenda itera cyangwa uburozi butemewe.
Uyu niwo muti wa mbere wo mu kanwa SERD wageze ku ntera nziza yo mu rwego rwo hejuru mu isuzuma rikomeye ry’amavuriro ku barwayi bafite kanseri y'ibere ya ER + / HER2- yateye imbere cyangwa metastatike.Hatitawe ku baturage basanzwe cyangwa abaturage ba mutation ya ESR1, Erasetran yazanye igabanuka rikomeye ry’imibare muri PFS n’impanuka z’urupfu, kandi yerekanaga umutekano n’ubworoherane.
Igihe cyo kohereza: Apr-23-2023
