Agusta 2022: Darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) allunan haɗe tare da docetaxel an amince da su ta Cibiyar Abinci da Magunguna don manya marasa lafiya tare da ciwon gurguwar ƙwayar cuta (mHSPC).
ARASENS (NCT02799602), bazuwar, cibiyar sadarwa da yawa, makafi biyu, gwajin gwaji na asibiti da aka sarrafa wanda ya ƙunshi marasa lafiya 1306 tare da mHSPC, sun yi aiki a matsayin tushe don tasiri. An ba marasa lafiya bazuwar don karɓar ko dai docetaxel da placebo ko darolutamide 600 MG da baki sau biyu a kowace rana ban da docetaxel 75 mg / m2 a cikin intravenously da aka ba kowane mako uku har zuwa zagaye shida. Duk marasa lafiya suna da orchiectomy na gefe biyu ko gudanarwa na lokaci guda na analog na hormone mai sakin gonadotropin.
Adadin rayuwa gabaɗaya shine babban ma'aunin inganci (OS). Wani ma'auni don inganci shine lokacin har sai zafi ya fara ci gaba. A cikin darolutamide da docetaxel hannu, OS na tsakiya bai samu ba (NR) (95% CI: NR, NR), yayin da a cikin docetaxel da placebo hannu, OS na tsakiya ya kasance watanni 48.9 (95% CI: 44.4, NR) ( HR 0.68; 95% CI: 0.57, 0.80; p0.0001). Lokaci zuwa ci gaba da jin zafi an jinkirta jinkiri ta hanyar jiyya tare da darolutamide da docetaxel (HR 0.79; 95% CI: 0.66, 0.95; 1-sided p=0.006).
Matsakaicin shekarun marasa lafiya sun kasance daga 41 zuwa 89, kuma 17% daga cikinsu sun kasance 75 ko fiye. An bayar da jerin abubuwan da aka zaɓa masu zuwa: 36% Asiya, 4% Baƙar fata ko Ba'amurke, 52% Fari, 7% Hispanic/Latino. Marasa lafiya da ke da cutar M1a (3%) sun yada shi zuwa ƙwayoyin lymph masu nisa, 83% suna da cutar M1b (83%), kuma 14% suna da cutar M1c (ya yadu zuwa gabobin jiki).
Maƙarƙashiya, raguwar ci, kurji, zub da jini, hauhawar nauyi, da hauhawar jini sune mafi yawan tasirin da marasa lafiya suka ruwaito (haɗuwar 10% tare da karuwar 2% sama da placebo tare da docetaxel). Anemia, hyperglycemia, raguwar ƙididdiga na lymphocyte, rage yawan neutrophils, ƙara yawan AST, haɓakar ALT, da hypocalcemia sune mafi yawan abubuwan da ba a saba gani ba a gwaje-gwajen dakin gwaje-gwaje (30%).
Don mHSPC, kashi na 600 MG (biyu 300 MG na allunan) na darolutamide sau biyu kowace rana tare da abinci ana ba da shawarar har sai daɗaɗɗen ƙwayar cuta ko ci gaban cuta. Har zuwa hawan keke 6, ana yin allurar docetaxel 75 mg/m2 a cikin jini kowane mako 3. A cikin makonni shida bayan ƙaddamar da maganin darolutamide, ya kamata a ba da kashi na farko na docetaxel.
View full prescribing information for Nubeqa.
