August 2022: Darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) mapiritsi akasanganiswa nedocetaxel akabvumirwa neFood and Drug Administration kune varwere vakuru vane metastatic hormone-sensitive prostate cancer (mHSPC).
ARASENS (NCT02799602), a randomised, multicenter, double-blind, placebo-controlled controlled clinical trial inosanganisira 1306 varwere vane mHSPC, yakashanda senheyo yekubudirira. Varwere vakagoverwa kuti vagamuchire docetaxel pamwe ne placebo kana darolutamide 600 mg nemuromo kaviri zuva nezuva kuwedzera kune docetaxel 75 mg/m2 inopinzwa mutsinga mavhiki matatu ega ega kusvika kumatanho matanhatu. Vese varwere vaive nebilateral orchiectomy kana kutonga panguva imwe chete yegonadotropin-inoburitsa mahormone analogue.
Huwandu hwekupona hwese hwaive hwakanyanya hwekuita metric (OS). Imwe metric yekubudirira yaive nguva kusvika kurwadziwa kwatanga kufambira mberi. Mune darolutamide pamwe nedocetaxel ruoko, iyo yepakati OS haina kuwanikwa (NR) (95% CI: NR, NR), nepo mudocetaxel pamwe ne placebo ruoko, yepakati OS yaive mwedzi 48.9 (95% CI: 44.4, NR) ( HR 0.68; 95% CI: 0.57, 0.80; p0.0001). Nguva yekufambira mberi kwemarwadzo yakaverengerwa zvakanyanya kunonoka nekurapa nedarolutamide pamwe nedocetaxel (HR 0.79; 95% CI: 0.66, 0.95; 1-sided p = 0.006).
Avhareji yezera revarwere kubva pa41 kusvika pa89, uye 17% yavo vaive 75 kana kupfuura. Rondedzero inotevera yenhamba dzakasarudzwa dzakapihwa: 36% Asia, 4% Mutema kana African American, 52% White, 7% Hispanic/Latino. Varwere vaiva nechirwere cheM1a (3%) chakapararira kune lymph nodes kure, 83% yakanga ine chirwere cheM1b (83%), uye 14% yakanga ine chirwere cheM1c (yakapararira kune nhengo).
Kudzimbirwa, kuderera kwechido, kuputika, kubuda ropa, kukwira kwehuremu, uye hypertension ndiyo yaiwanzogara yakashata yakataurwa nevarwere (chiitiko 10% ne2% kuwedzera pamusoro pe placebo ne docetaxel). Anemia, hyperglycemia, yakaderera lymphocyte count, yakadzikira neutrophil count, yakawedzera AST, yakakwira ALT, uye hypocalcemia ndiyo yainyanya kushata inoonekwa muongororo dzamarabhoritari (30%).
Kune mHSPC, muyero we600 mg (mbiri 300 mg mapiritsi) e darolutamide kaviri zuva nezuva nechikafu unorairwa kusvika muchetura usingashiviriki kana kukura kwechirwere. Kwematanho matanhatu, docetaxel 6 mg/m75 inobaiwa mutsinga mavhiki matatu ega ega. Mumavhiki matanhatu mushure mekutanga kurapwa kwe darolutamide, muyero wekutanga wedocetaxel unofanirwa kupihwa.
View full prescribing information for Nubeqa.
