Kev kho mob cancer mis endocrine yog ib qho tseem ceeb ntawm kev kho mob ntawm cov tshuaj hormone receptor zoo mob cancer mis.Qhov laj thawj tseem ceeb ntawm cov tshuaj tiv thaiv hauv HR + cov neeg mob tom qab tau txais kev kho thawj kab (tamoxifen TAM lossis aromatase inhibitor AI) yog kev hloov pauv hauv cov tshuaj estrogen receptor gene α (ESR1).Cov neeg mob tau txais cov tshuaj estrogen receptor degraders (SERDs) tau txais txiaj ntsig tsis hais txog ESR1 kev hloov pauv.
Thaum Lub Ib Hlis 27, 2023, FDA pom zoo elacestrant (Orserdu) rau cov poj niam postmenopausal lossis cov txiv neej laus uas muaj mob qog noj ntshav lossis mob qog noj ntshav nrog ER +, HER2-, ESR1 kev hloov pauv thiab kab mob kev loj hlob tom qab tsawg kawg ib kab ntawm kev kho mob endocrine.cov neeg mob qog noj ntshav.FDA kuj tau pom zoo rau Guardant360 CDx assay ua ib qho kev kuaj mob ntxiv los tshuaj xyuas cov neeg mob qog noj ntshav uas tau txais elastran.
Qhov kev pom zoo no yog ua raws li EMERALD (NCT03778931), qhov kev tshawb pom tseem ceeb uas tau tshaj tawm hauv JCO.
EMERALD txoj kev tshawb fawb (NCT03778931) yog ntau lub chaw, randomized, qhib-label, nquag tswj theem III kev soj ntsuam kuaj mob uas tau tso npe rau tag nrho 478 tus poj niam postmenopausal thiab cov txiv neej nrog ER +, HER2- mob siab lossis mob metastatic, 228 ntawm cov neeg muaj ESR1. kev hloov pauv.Qhov kev sim xav tau cov neeg mob uas muaj kab mob kev loj hlob tom qab thawj kab lossis thib ob kab mob endocrine kho, suav nrog CDK4/6 inhibitors.Cov neeg mob tsim nyog tau txais kev kho mob thawj zaug feem ntau.Cov neeg mob tau randomized (1: 1) kom tau txais erastrol 345 mg ntawm qhov ncauj ib hnub ib zaug (n = 239) lossis tus kws tshawb nrhiav xaiv kev kho mob endocrine (n = 239), suav nrog fulvestrant (n = 239).166) los yog aromatase inhibitors (n=73).Cov kev sim tau stratified raws li ESR1 kev hloov pauv (ntaus vs. tsis kuaj), ua ntej fulvestrant therapy (yog vs. tsis), thiab visceral metastases (yog vs. tsis).ESR1 kev hloov pauv tau raug txiav txim siab los ntawm ctDNA siv Guardant360 CDx kev soj ntsuam thiab raug txwv rau ESR1 kev hloov pauv tsis zoo nyob rau hauv ligand-binding domain.
Thawj qhov ua tau zoo kawg nkaus yog kev muaj sia nyob tsis muaj sia nyob (PFS).Kev txheeb xyuas qhov sib txawv tseem ceeb hauv PFS tau pom nyob rau hauv lub hom phiaj-rau-kho (ITT) cov pej xeem thiab pab pawg ntawm cov neeg mob uas muaj ESR1 kev hloov pauv.
Ntawm 228 tus neeg mob (48%) nrog kev hloov pauv ESR1, nruab nrab PFS yog 3.8 lub hlis hauv pawg elacestrant piv rau 1.9 lub hlis hauv pawg fulvestrant lossis aromatase inhibitor pawg (HR = 0.55, 95% CI: 0.39-0.77, ob sab p-tus nqi = 0.0005).
Kev tshawb xyuas ntawm PFS hauv 250 (52%) cov neeg mob uas tsis muaj ESR1 kev hloov pauv tau pom HR ntawm 0.86 (95% CI: 0.63-1.19), qhia tias kev txhim kho hauv ITT cov pej xeem feem ntau tshwm sim los ntawm ESR1 cov neeg hloov pauv.
Feem ntau cov xwm txheej tsis zoo (≥10%) suav nrog kev kuaj mob xws li mob musculoskeletal, xeev siab, nce cov roj cholesterol, AST nce, triglycerides nce, qaug zog, txo hemoglobin, ntuav, ALT nce, sodium txo, nce creatinine, txo qab los noj mov, raws plab, mob taub hau, cem quav, mob plab, kub flashes, thiab indigestion.
Qhov pom zoo koob tshuaj elastrol yog 345 mg ntawm qhov ncauj ib zaug ib hnub nrog zaub mov kom txog thaum muaj kab mob kis los yog tsis muaj tshuaj lom.
Qhov no yog thawj cov tshuaj SERD hauv qhov ncauj kom ua tiav cov txiaj ntsig zoo tshaj plaws hauv kev sim tshuaj ntsuam xyuas tseem ceeb hauv cov neeg mob ER + / HER2- qib siab lossis mob qog noj ntshav hauv lub mis.Thiab tsis hais txog ntawm cov pej xeem lossis cov neeg hloov pauv ESR1, Erasetran tau coj cov txiaj ntsig tseem ceeb hauv PFS thiab kev pheej hmoo tuag, thiab pom tias muaj kev nyab xeeb zoo thiab kev zam.
Post lub sij hawm: Apr-23-2023
