Agusta 2023: Haɗin ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙwayar niraparib da abiraterone acetate (Akeega, Janssen Biotech, Inc.), tare da prednisone, Cibiyar Abinci da Magunguna ta amince da ita don manya masu fama da cutar kansar prostate prostate (mCRPC) waɗanda aka tabbatar sun kasance. cutarwa ko ake zargin yana da illa saboda maye gurbi na BRCA.
Cohort 1 na MAGNITUDE (NCT03748641), bazuwar, makafi biyu, gwajin sarrafa wuribo wanda ya yi rajistar marasa lafiya 423 tare da gyaran gyare-gyare na homologous recombination (HRR) mCRPC, ya bincika tasirin maganin. Niraparib 200 MG da abiraterone acetate 1,000 MG da prednisone 10 MG kowace rana ko placebo da abiraterone acetate da prednisone kowace rana an ba marasa lafiya a cikin bazuwar 1: 1. Dole ne ko dai an yi wa marasa lafiya tiyata a baya ko kuma su kasance a kan analogues na GnRH. Abiraterone acetate da prednisone har zuwa watanni hudu a baya, tare da ci gaba da ADT, shine kawai tsarin tsarin tsarin da marasa lafiya tare da mCRPC suka cancanci. Wataƙila majiyyata sun riga sun karɓi maganin docetaxel ko androgen-receptor (AR) da aka yi niyya a cikin yanayin rashin lafiyar su. Kafin docetaxel, kafin maganin AR da aka yi niyya, kafin abiraterone acetate tare da prednisone, da matsayi na BRCA an yi la'akari da su lokacin da aka ƙaddamar da bazuwar. 225 (53%) na mutane 423 da aka yi rajista suna da maye gurbi na BRCA waɗanda aka gano daga baya (BRCAm). Marasa lafiya tare da mCRPC waɗanda ba su da maye gurbi na HRR (Cohort 2 na MAGNITUDE) ba su sami wani fa'ida ba tun lokacin da yanayin rashin amfani ya gamsu.
Rayukan ci gaban-kyauta na radiyo (rPFS), wanda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa kuma bisa ga Ciwon ƙwayar cuta Ma'auni na Rukuni na 3 na aiki don kashi, shine ma'aunin sakamako na farko. Wata manufa ita ce gaba ɗaya rayuwa (OS).
Tare da tsaka-tsaki na watanni 16.6 vs. 10.9 watanni, niraparib da abiraterone acetate da prednisone sun nuna ci gaba mai mahimmanci a cikin rPFS idan aka kwatanta da placebo da abiraterone acetate da prednisone (HR 0.53; 95% CI 0.36, 0.79; p0.0014 = 30.4). A cikin marasa lafiya na BRCAm, bincike na OS na bincike ya nuna matsakaicin matsakaici na 28.6 vs. 0.79 watanni (HR 95; 0.55% CI: 1.12, 1) don goyon bayan hannun gwaji. Yayin da aka sami ci gaba mai mahimmanci a cikin rPFS a cikin Ƙungiya 0.73 niyyar yin magani (ITT) yawan HRR (HR 95; 0.56% CI 0.96, 0.0217; p=198), ƙimar haɗari ga rPFS da OS a cikin rukunin 47 ( 0.99%) marasa lafiya tare da maye gurbin HRR ba na BRCA ba sune 1.13 da XNUMX, bi da bi, yana nuna cewa haɓakawa a cikin al'ummar ITT HRR da aka canza ta farko shine saboda
Rage haemoglobin, rage lymphocytes, rage farin jini, ciwon musculoskeletal, gajiya, rage platelet, ƙara alkaline phosphatase, maƙarƙashiya, hauhawar jini, tashin zuciya, rage neutrophils, ƙara creatinine, ƙara potassium, rage potassium, da kuma ƙara AST su ne mafi yawan m halayen. (20%), tare da rashin daidaituwa na dakin gwaje-gwaje. A cikin Cohort 1 na MAGNITUDE (n=423), 27% na marasa lafiya tare da mCRPC da aka yi musu magani tare da niraparib da abiraterone acetate tare da prednisone suna buƙatar ƙarin jini, tare da 11% na buƙatar ƙarin ƙarin jini.
Ana ba da shawarar kashi na yau da kullun na 200 MG na niraparib da 1,000 MG na abiraterone acetate tare da 10 MG na prednisone don Akeega har sai cutar ta ci gaba ko rashin haƙuri. Marasa lafiya da ke amfani da niraparib, abiraterone acetate, da prednisone yakamata su kasance suna ɗaukar analog na GnRH a lokaci guda, ko kuma yakamata a yi musu orchiectomy na biyu.
