Ciwon daji na endocrin farfesa wata hanya ce mai mahimmanci don kula da mai karɓar hormone tabbataccen ciwon nono.Babban abin da ke haifar da juriya na miyagun ƙwayoyi a cikin marasa lafiya na HR + bayan karbar maganin farko na farko (tamoxifen TAM ko aromatase inhibitor AI) shine maye gurbi a cikin kwayar halittar estrogen α (ESR1).Marasa lafiya da ke karɓar zaɓaɓɓun masu karɓar masu karɓar isrogen (SERDs) sun amfana ba tare da la’akari da matsayin maye gurbin ESR1 ba.
A ranar 27 ga Janairu, 2023, FDA ta amince da elacestrant (Orserdu) don matan da suka shude ko kuma mazan manya masu ci gaba ko ciwon nono tare da ER +, HER2-, ESR1 maye gurbi da ci gaban cuta bayan aƙalla layi ɗaya na maganin endocrine.masu ciwon daji.FDA ta kuma amince da Guardant360 CDx assay a matsayin na'urar bincike na gaba don tantance masu cutar kansar nono da ke karɓar elastran.
Wannan amincewa ya dogara ne akan gwajin EMERALD (NCT03778931), babban binciken da aka buga a cikin JCO.
Nazarin EMERALD (NCT03778931) shine cibiyar da yawa, bazuwar, alamar buɗewa, gwajin gwaji na lokaci na III mai sarrafa aiki wanda ya sanya jimlar 478 mata da maza da mata da maza tare da ER +, HER2-ci gaba ko cututtukan metastatic, 228 daga cikinsu suna da ESR1 maye gurbi .Gwajin ya buƙaci marasa lafiya da ci gaba da cututtuka bayan layin farko na farko ko na biyu na maganin endocrin, ciki har da masu hana CDK4 / 6.Marasa lafiyan da suka cancanta sun karɓi a mafi yawan maganin chemotherapy na farko.An ba da izini ga marasa lafiya (1: 1) don karɓar erastrol 345 MG da baki sau ɗaya a rana (n = 239) ko zaɓin mai bincike na maganin endocrin (n = 239), gami da fulvestrant (n=239).166) ko masu hana aromatase (n=73).An tsara gwaje-gwaje bisa ga matsayin maye gurbin ESR1 (wanda aka gano vs. ba a gano shi ba), kafin maganin fulvestrant (ee vs. a'a), da metastases na visceral (ee vs. a'a).Matsayin maye gurbin ESR1 an ƙaddara ta ctDNA ta amfani da Guardant360 CDx assay kuma an iyakance shi ga maye gurbin ESR1 a cikin yanki mai ɗaure ligand.
Babban maƙasudin ingantaccen inganci shine rayuwa marar ci gaba (PFS).An lura da bambance-bambance masu mahimmanci a cikin PFS a cikin yawan niyya don magance (ITT) da ƙungiyoyin marasa lafiya tare da maye gurbin ESR1.
Daga cikin marasa lafiya na 228 (48%) tare da maye gurbin ESR1, PFS na tsakiya shine watanni 3.8 a cikin ƙungiyar masu haɓakawa tare da watanni 1.9 a cikin fulvestrant ko aromatase inhibitor group (HR = 0.55, 95% CI: 0.39-0.77, p-darajar gefe biyu). = 0.0005).
Binciken bincike na PFS a cikin 250 (52%) marasa lafiya ba tare da maye gurbin ESR1 ba ya nuna HR na 0.86 (95% CI: 0.63-1.19), yana nuna cewa haɓakawa a cikin yawan jama'ar ITT ya fi dacewa da sakamakon a cikin yawan maye gurbin ESR1.
Yawancin abubuwan da ba su da kyau (≥10%) sun haɗa da rashin daidaituwa na dakin gwaje-gwaje ciki har da ciwon musculoskeletal, tashin zuciya, ƙara yawan cholesterol, AST ya karu, triglycerides ya karu, gajiya, rage haemoglobin, amai, ƙara ALT, sodium rage , ƙara creatinine, rage ci, zawo, ciwon kai, maƙarƙashiya, ciwon ciki, zafi mai zafi, da rashin narkewar abinci.
Adadin da aka ba da shawarar na elastrol shine 345 MG na baki sau ɗaya kowace rana tare da abinci har sai cutar ta ci gaba ko rashin yarda da guba.
Wannan shine maganin SERD na baka na farko don cimma kyakkyawan sakamako na saman layi a cikin gwaji na asibiti mai mahimmanci a cikin marasa lafiya tare da ER +/HER2-ci-gaba ko ciwon nono mai tsauri.Kuma ba tare da la'akari da yawan jama'a ko yawan maye gurbin ESR1 ba, Erasetran ya kawo raguwar ƙididdiga masu mahimmanci a cikin PFS da haɗarin mutuwa, kuma ya nuna kyakkyawan aminci da haƙuri.
Lokacin aikawa: Afrilu-23-2023
