Iyul: 2023: Oziq-ovqat va farmatsevtika idorasi metastatik kastratsiyaga chidamli prostata saratonida (mCRPC) gomologik rekombinatsiyani tiklash (HRR) gen mutatsiyalari uchun talazoparibni (Talzenna, Pfizer, Inc.) enzalutamid bilan tozaladi.
TALAPRO-2 (NCT03395197), a randomised, double-blind, placebo-controlled, multi-cohort study with 399 patients with HRR gene-mutated mCRPC, looked at how well the drug worked. The patients were given either enzalutamide 160 mg daily plus talazoparib 0.5 mg daily or a dummy every day. Patients had to get an orchiectomy first, and if that didn’t happen, they were given gonadotropin-releasing hormone (GnRH) analogues. Patients who had received systemic treatment for mCRPC before were not allowed, but patients who had received CYP17 inhibitors or docetaxel before for metastatic castration-sensitive Prostata saratoni (mCSPC) were allowed. Prior treatment with a CYP17 inhibitor or docetaxel changed how the randomization was done. HRR genes (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) were looked at using next-generation sequencing tests based on tumour tissue and/or circulating tumour DNA (ctDNA).
Yumshoq to'qimalar uchun RECIST 1.1 versiyasiga va suyak uchun prostata saratoni ishchi guruhi 3 standartlariga muvofiq rentgenografik progressiyasiz omon qolish (rPFS) samaradorlikning eng muhim ko'rsatkichi bo'ldi. Bu ko'r-ko'rona, mustaqil markaziy tekshiruv tomonidan amalga oshirildi.
HRR gen mutatsiyasiga uchragan guruhda enzalutamid bilan talazoparib enzalutamid bilan platsebo bilan solishtirganda rPFSda statistik jihatdan sezilarli yaxshilanishni ko'rsatdi, mediana 13.8 oyga nisbatan erishilmagan (HR 0.45; 95% CI: 0.33, 0.61; p0.0001). . BRCA mutatsiyasining holati bo'yicha o'tkazilgan tadqiqotda BRCA mutatsiyaga uchragan mCRPC (n = 155) bo'lgan bemorlarda rPFS uchun xavf darajasi 0.20 (95% CI: 0.11-0.36) va BRCAm bo'lmagan HRR gen mutatsiyasiga uchragan mCRPC bo'lgan bemorlarda, 0.72 (0.49-1.07) ni tashkil etdi.
Vaqtning 10% dan ko'prog'ida sodir bo'lgan laboratoriya anormalliklari va nojo'ya ta'sirlar charchoq, trombotsitlar kamayishi, kaltsiyning pasayishi, ko'ngil aynishi, ishtahaning pasayishi, natriyning kamayishi, fosfatning kamayishi, yoriqlar, magniyning kamayishi, bosh aylanishi, bilirubinning ko'payishi, kaliyning pasayishi va disgeuziya edi. TALAPRO-511 da talazoparib va enzalutamid bilan davolangan mCRPC bo'lgan barcha 2 bemorga qon quyish kerak bo'lib, 22% ga bir nechta kerak. Ikki bemorda miyelodisplastik sindrom/o‘tkir miyeloid leykemiya (MDS/AML) bo‘lgan.
Talazoparibning tavsiya etilgan dozasi kasallik kuchayguncha yoki yon ta'siri juda yomon bo'lguncha enzalutamid bilan kuniga bir marta og'iz orqali qabul qilingan 0.5 mg ni tashkil qiladi. Enzalutamidni kuniga bir marta 160 mg miqdorida og'iz orqali olish kerak. Talazoparib va enzalutamidni qabul qilgan bemorlar, shuningdek, GnRH analogini qabul qilishlari yoki ikkala moyaklarini olib tashlashlari kerak edi.
Talzenna uchun to'liq retsept ma'lumotlarini ko'ring
