Kansarka qanjirka 'endocrine therapy' waa hab muhiim ah oo lagu daaweeyo hormoonka receptor togan kansarka naasaha.Sababta ugu weyn ee iska caabbinta daroogada ee bukaannada HR + ka dib markii la helo daawaynta safka hore (tamoxifen TAM ama aromatase inhibitor AI) waa isbeddellada ku jira hiddaha receptor estrogen α (ESR1).Bukaannada qaata hoos-u-dhaca soo-dhoweynta estrogen-ka ee xulashada ah (SERDs) ayaa ka faa'iideystey iyada oo aan loo eegin heerka isbeddelka ESR1.
Janaayo 27, 2023, FDA waxay ansixisay elacestrant (Orserdu) dumarka postmenopausal ama ragga qaangaarka ah ee qaba kansarka naasaha ee horumarsan ama metastatic leh ER+, HER2-, ESR1 isbeddellada iyo horumarka cudurka ka dib ugu yaraan hal xariiq oo daawaynta endocrine.bukaanka kansarka.FDA waxa ay sidoo kale ansixisay Guardant360 CDx assay sida qalab ogaanshaha iskudhaf ah si loo baadho bukaanka kansarka naasaha ee qaata elastran.
Oggolaanshahan wuxuu ku salaysan yahay EMERALD (NCT03778931), natiijooyinka ugu waaweyn ee lagu daabacay JCO.
Daraasada EMERALD (NCT03778931) waa xarun badan, randomized, calaamad furan, si firfircoon loo kantaroolo wajiga III tijaabo bukaan-socod kaas oo diiwaangeliyay wadarta guud ee 478 dumarka postmenopausal iyo ragga qaba ER +, HER2- horumarsan ama cudur metastatic, 228 kuwaas oo qabay ESR1 isbedel .Tijaabooyinku waxay u baahdeen bukaanada qaba horumarka cudurka ka dib daawaynta hore ee safka hore ama khadka labaad, oo ay ku jiraan inhibitors CDK4/6.Bukaannada xaqa u leh ayaa helay daawaynta ugu badan ee safka koowaad.Bukaan-socodka ayaa la kala soocay (1:1) si ay u helaan erastrol 345 mg afka hal mar maalintii (n=239) ama doorashada baaraha ee daaweynta endocrine (n=239), oo ay ku jiraan fulvestrant (n=239).166) ama aromatase inhibitors (n=73).Tijaabooyinku waa la habeeyey iyadoo loo eegayo heerka isku beddelka ESR1 (la ogaaday vs. lama ogaan), daawaynta buuxda ee hore (haa vs. Maya), iyo metastases visceral ah (haa vs. Maya).Heerka beddelka ESR1 waxaa go'aamiyay ctDNA iyadoo la adeegsanayo Guardant360 CDx assay waxaana lagu xaddiday ESR1 isbeddellada seeska ah ee qaybta isku xidhka ligand.
Meesha ugu dambaysa ee waxtarka leh waxay ahayd badbaadada-horumar la'aanta (PFS).Farqiga ugu muhiimsan ee tirakoobka ee PFS ayaa lagu arkay dadka loogu talagalay in lagu daweeyo (ITT) iyo kooxo-hoosaadyada bukaannada leh isbeddellada ESR1.
Bukaannada 228 ka mid ah (48%) oo leh isbeddel ESR1, dhexdhexaadiyaha PFS wuxuu ahaa 3.8 bilood kooxda elacestrant iyo bilaha 1.9 ee kooxda fulvestrant ama aromatase inhibitor (HR = 0.55, 95% CI: 0.39-0.77, p-qiimaha laba-dhinac ah = 0.0005).
Falanqaynta sahaminta ee PFS ee 250 (52%) bukaannada aan lahayn isbeddellada ESR1 waxay muujiyeen HR ee 0.86 (95% CI: 0.63-1.19), taas oo soo jeedinaysa in horumarinta dadka ITT ay inta badan u sabab tahay natiijooyinka isbeddelka ESR1.
Inta badan dhacdooyinka xun xun (≥10%) waxaa ka mid ah cillado shaybaarka aan caadi ahayn oo ay ku jiraan murqo xanuun, lallabbo, kolestaroolka kordhay, AST kordhay, triglycerides kordhay, daal, hoos u hemoglobin, matag, ALT kordhay, sodium hoos u dhacay, creatinine kordhay, rabitaanka cuntada oo yaraada, shuban, madax xanuun, calool-istaagga, calool-xanuun, kulayl kulul, iyo dheef-shiid kiimikaad.
Qiyaasta lagu taliyey ee elastrol waa 345 mg afka hal mar maalin kasta oo leh cunto ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.
Tani waa daawadii ugu horreysay ee afka laga qaato ee SERD si loo gaaro natiijooyin wanaagsan oo safka sare ah ee tijaabada caafimaad ee muhiimka ah ee bukaannada qaba ER+/HER2- horumarsan ama kansarka naasaha.Iyadoo aan loo eegin dadweynaha guud ama tirada dadka isku beddelka ESR1, Erasetran wuxuu keenay dhimis xisaabeed la taaban karo ee PFS iyo khatarta dhimashada, wuxuuna muujiyay badbaado iyo dulqaad wanaagsan.
Waqtiga boostada: Abriil-23-2023
