Agasti 2022: Amaphilisi e-Darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) ahlanganiswe ne-docetaxel agunyazwe i-Food and Drug Administration ezigulini ezikhulile ezinomdlavuza we-prostate we-metastatic-sensitive hormone (mHSPC).
I-ARASENS (NCT02799602), isilingo somtholampilo esilawulwa ngokungahleliwe, esimaphakathi, esingaboni kabili, esilawulwa yi-placebo esibandakanya iziguli ze-1306 ezine-mHSPC, sasebenza njengesisekelo sokusebenza ngempumelelo. Iziguli zabelwa ngokungahleliwe ukuthi zithole i-docetaxel kanye ne-placebo noma i-darolutamide 600 mg ngomlomo kabili ngosuku ngaphezu kwe-docetaxel 75 mg/m2 enikezwa ngomthambo njalo emavikini amathathu kuze kube imijikelezo eyisithupha. Zonke iziguli zine-orchiectomy yamazwe amabili noma ukuphathwa kanyekanye kwe-analogue ye-hormone ekhulula i-gonadotropin.
Isilinganiso sokusinda sisonke bekuyi-metric eyinhloko yokusebenza kahle (OS). Enye i-metric yokusebenza kahle kwakuyisikhathi kuze kube yilapho ubuhlungu buqala ukuqhubeka. Engalweni ye-darolutamide kanye ne-docetaxel, i-median OS ayizange ifinyelelwe (NR) (95% CI: NR, NR), kuyilapho ingalo ye-docetaxel kanye ne-placebo, i-OS emaphakathi yayiyizinyanga ezingu-48.9 (95% CI: 44.4, NR) ( HR 0.68; 95% CI: 0.57, 0.80; p0.0001). Isikhathi sokuqhubekela phambili kobuhlungu sibambezeleke ngokwezibalo ngokuphawulekayo ngokwelashwa nge-darolutamide kanye ne-docetaxel (HR 0.79; 95% CI: 0.66, 0.95; 1-sided p = 0.006).
Isilinganiso seminyaka yeziguli sisukela ku-41 kuya ku-89, kanti u-17% wazo ubeneminyaka engama-75 noma ngaphezulu. Uhlu olulandelayo lwezibalo zabantu ezikhethiwe lunikeziwe: 36% Asian, 4% Black noma African American, 52% White, 7% Hispanic/Latino. Iziguli ezazinesifo i-M1a (3%) zasakazwa kuma-lymph nodes akude, i-83% yayinesifo se-M1b (83%), kanti i-14% yayinesifo se-M1c (esatshalaliswa ezithweni).
Ukuqunjelwa, ukuncipha kwesifiso sokudla, ukuqubuka, ukopha, ukwenyuka kwesisindo, nomfutho wegazi ophakeme kwakuyimiphumela emibi evame ukubikwa yiziguli (isigameko esingu-10% ngokunyuka ngo-2% ngaphezu kwe-placebo nge-docetaxel). I-anemia, i-hyperglycemia, ukwehla kwesibalo se-lymphocyte, ukwehla kwenani lama-neutrophil, ukwanda kwe-AST, i-ALT ephakeme, kanye ne-hypocalcemia kwakuyizinto ezingavamile ezibonakala ekuhlolweni kwaselabhorethri (30%).
Ku-mHSPC, umthamo wama-600 mg (amaphilisi amabili angu-300 mg) we-darolutamide kabili ngosuku ngokudla uyalulekwa kuze kube yilapho ubuthi obungabekezeleleki noma ukukhula kwesifo. Kuze kufike emijikelezweni engu-6, i-docetaxel 75 mg/m2 ijova ngomjovo njalo emavikini angu-3. Emavikini ayisithupha ngemva kokuqaliswa kokwelashwa kwe-darolutamide, umthamo wokuqala we-docetaxel kufanele unikezwe.
View full prescribing information for Nubeqa.
