Yuli 2023: Hukumar Abinci da Magunguna ta share talazoparib (Talzenna, Pfizer, Inc.) tare da enzalutamide don gyaran haɗe-haɗe (HRR) maye gurbi a cikin ciwon gurguwar ƙwayar cuta mai jurewa (mCRPC).
TALAPRO-2 (NCT03395197), bazuwar, makafi biyu, mai sarrafa wuribo, nazarin rukuni-rukuni tare da marasa lafiya 399 tare da HRR gene-mutated mCRPC, ya kalli yadda maganin yayi aiki sosai. An ba marasa lafiya ko dai enzalutamide 160 MG kowace rana tare da talazoparib 0.5 MG kowace rana ko dummy kowace rana. Dole ne majiyyata su fara samun orchiectomy, kuma idan hakan bai faru ba, an ba su analogues na gonadotropin-releasing hormone (GnRH). Marasa lafiya waɗanda suka karɓi tsarin tsarin tsarin mCRPC a da ba a ba su izini ba, amma marasa lafiya waɗanda suka karɓi inhibitors CYP17 ko docetaxel a baya don ƙaƙƙarfan castration-m. prostate ciwon daji (mCSPC) an yarda. Kafin jiyya tare da mai hana CYP17 ko docetaxel ya canza yadda aka yi bazuwar. Halittar HRR (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, ko RAD51C) an duba su ta amfani da gwaje-gwajen jeri na gaba-gaba dangane da ƙwayar ƙwayar cuta da / ko kewaya DNA ƙari (ctDNA) .
Rayuwa ba tare da ci gaban rediyo ba (rPFS) bisa ga sigar RECIST 1.1 don nama mai laushi da ƙa'idodin Rukunin Ciwon Ciwon Jiki na Prostate 3 na ƙashi shine mafi mahimmancin ma'auni na tasiri. An yi wannan ta hanyar makanta, bita ta tsakiya mai zaman kanta.
A cikin ƙungiyar masu maye gurbin HRR, talazoparib tare da enzalutamide sun nuna ingantaccen ƙididdiga a cikin rPFS idan aka kwatanta da placebo tare da enzalutamide, tare da tsaka-tsakin da ba a kai ba vs. 13.8 watanni (HR 0.45; 95% CI: 0.33, 0.61; p0.0001). A cikin binciken bincike ta matsayi na maye gurbi na BRCA, haɗarin haɗari ga rPFS a cikin marasa lafiya tare da BRCA-mutated mCRPC (n=155) shine 0.20 (95% CI: 0.11-0.36) kuma a cikin marasa lafiya da ba BRCAm HRR gene-mutated mCRPC, shi ne 0.72-0.49.
Abubuwan da suka faru na dakin gwaje-gwaje da abubuwan da suka faru fiye da 10% na lokaci sun kasance gajiya, raguwar platelets, rage calcium, tashin zuciya, rage cin abinci, rage sodium, rage phosphate, karaya, rage magnesium, dizziness, karuwar bilirubin, rage potassium, da dysgeusia. Duk marasa lafiya 511 da ke da mCRPC waɗanda aka yi wa talazoparib da enzalutamide akan TALAPRO-2 suna buƙatar ƙarin jini, tare da 22% na buƙatar fiye da ɗaya. An sami marasa lafiya guda biyu tare da ciwo na myelodysplastic / m myeloid leukemia (MDS / AML).
Adadin da aka ba da shawarar talazoparib shine 0.5 MG ana sha da baki sau ɗaya a rana tare da enzalutamide har sai cutar ta yi muni ko illolin sun yi muni sosai. Enzalutamide yakamata a sha ta baki sau ɗaya a rana a adadin 160 MG. Marasa lafiyar da suka ɗauki talazoparib da enzalutamide suma sun ɗauki analog ɗin GnRH ko kuma an cire su duka biyun.
Duba cikakken bayani na rubutawa na Talzenna
