Bishii Febraayoriyo 2023, Maamulka Cuntada iyo Dawooyinka (FDA) waxay ansixiyeen elacestranti (Orserdu, Stemline Therapeutics, Inc.) ee haweenka ama ragga ka weyn 50 ee uu ku dhacay kansarka naasaha oo horumaray ama metastatic ah oo ER-positive ah, HER2-negative, oo leh ESR1 beddelaad. Cudurku wuu hormaray ka dib ugu yaraan hal xariiq oo daawaynta endocrine ah.
Baaritaanka Guardant360 CDx assay ayaa sidoo kale la siiyay oggolaanshaha FDA sida qalab ogaanshaha saaxiibka ah ee daaweynta aadka u wanaagsan ee bukaanka qaba kansarka naasaha.
EMERALD (NCT03778931), calaamad aan kala sooc lahayn, calaamad furan, la xakameeyey firfircooni, tijaabin xarumo badan leh oo ay ku jiraan 478 haween postmenopausal ah iyo rag leh heer sare ama metastatic kansarka naasaha kuwaas oo 228 bukaan ay ku sameeyeen isbeddellada ESR1, waxay baareen waxtarka daaweynta. Bukaan-socodka waa inay arkaan horumarka cudurka ka dib markii ay heleen hal ama dhowr xariiq oo daawaynta endocrine ah ee la soo dhaafay, oo ay ku jiraan ugu yaraan hal xariiq oo ka kooban CDK4/6 inhibitor. Bukaannada xaqa u lahaa waxay lahaan karaan ilaa hal xariiq oo kiimiko ah oo hore oo loogu talagalay cudur horumarsan ama metastatic. Elacestrant 345 mg afka hal mar maalin kasta ayaa la siiyay bukaanada si aan kala sooc lahayn loo qoondeeyay (1: 1) si ay u helaan ama doorashada baaraha ee daaweynta endocrine, oo ay ku jiraan fulvestrant (n=166) ama aromatase inhibitor (n=73). Xaaladda beddelka ESR1 (la helay vs. lama helin), daawaynta hore ee buuxda (haa vs. Maya), iyo metastasis visceral ah ayaa loo isticmaalay si loogu qaybiyo bukaannada kooxo si aan kala sooc lahayn (haa vs. Maya). Guardant360 CDx assay waxaa loo isticmaalay in lagu aqoonsado isu-bedelka khaldan ee ESR1 ee ku jira ligand-ka xidhitaanka waxayna ku koobnayd dhiiga wareegaya buro deoxyribonucleic acid (ctDNA).
Qiyaasta natiijada waxtarka ugu weyn waxay ahayd badbaadada-horumar la'aanta (PFS), kaas oo ay qiimayn ku sameeyeen guddi indho la'aan ah oo dib-u-eegis sawireed. Dadka qaba ITT iyo koox-hoosaadka bukaannada qaba isbeddellada ESR1, waxaa jiray farqi weyn oo xagga PFS ah.
Dhexdhexaadiyaha PFS wuxuu ahaa bilaha 3.8 (95% CI: 2.2, 7.3) ee 228 (48%) bukaanada leh ESR1 isbeddellada lagu daaweeyay bilaha 1.9 (95% CI: 1.9, 2.1) kuwa lagu daaweeyay fulvestrant ama aromatase inhibitor (Samiga khatarta [HR] ee 0.55 [95% CI: 0.39, 0.77], 2-dhinac p-qiimaha = 0.0005).
Bukaannada 250 (52%) ee aan lahayn isbeddellada ESR1 ee falanqaynta sahaminta ee PFS waxay lahaayeen HR ee 0.86 (95% CI: 0.63, 1.19) taas oo muujinaysa in natiijooyinka lagu arkay dadka mutant ESR1 ay inta badan mas'uul ka yihiin horumarinta kooxda ITT .
Xanuunka murqaha, lallabbo, kolesteroolka oo sarreeya, AST oo sarreeya, triglycerides oo sarreeya, daal, hoos u dhaca haemoglobin, matag, ALT oo sarreeya, sodium-ka sarreeya, creatinine oo sarreeya, rabitaanka cuntada oo yaraada, shuban, madax-xanuun, calool-istaag, calool xanuun, qulqulo kulul, iyo dyspepsia ayaa ugu badan. Dhacdooyinka xun xun ee soo noqnoqda (10%), oo ay ku jiraan cilladaha shaybaadhka.
Waxaa lagu talinayaa in la qaato 345 mg oo elacester maalintii hal mar cunto ilaa inta uu cudurku ka sii socdo ama ay suntu noqoto mid aan loo dulqaadan karin.
U fiirso xogta buuxda ee Orserdu.
