Iulii 2023: Cibus et medicamentum Administrationis talazoparib (Talzenna, Pfizer, Inc.) cum enzalutamide purgavit pro reparatione homologorum recombinationis (HRR) generum mutationum in metastatica castratione-resistentia cancer prostatae (mCRPC).
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 prostate cancer (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).
Progressio radiographica liberorum superstes (rPFS) secundum RECIST versionem 1.1 mollis textus et prostatae Cancri Societas laborantis 3 signa ossis maxima erat mensura efficaciae. Hoc factum est a media recensione independentium caecata.
In HRR globo gene-mutato, talazoparib cum enzalutamide peraeque signanter emendationem ostendit in rPFS comparato placebo cum enzalutamide, cum mediana non perlatae ad vs. 13.8 menses (HR 0.45; 95% CI: 0.33, 0.61; p0.0001). . In exploratorio per mutationem status BRCA, ratio aleae pro rPFS patientibus BRCA mutatis mCRPC (n=155) erat 0.20 (95% CI: 0.11-0.36) et in patientibus gene-mCRPC non BRCAm HRR mutatis; erat 0.72 (0.49-1.07).
Laboratorium abnormitates et effectus laterales, qui plus quam 10% temporis accidebant, lassitudine, platelets decrescebant, calcium decrescebant, nausea, appetitus decrescebant, sodium decrescebant, phosphas minuebantur, fracturae, magnesium minuebantur, vertigo, bilirubin augebatur, potassae decrescebat, et dysgeusia. Omnes 511 cum mCRPC aegroti qui cum talazoparib et enzalutamide in TALAPRO-2 tractata sunt, sanguinis transfusio necessaria est, cum 22% plus quam unum. Inventi sunt duo aegroti cum syndrome myelodysplastic / acuta myeloidea leukemia (MDS/AML).
Dosis talazoparib 0.5 mg sumpta viva voce semel in die cum enzalutamide sumpta est donec morbus ingravescat vel latus effectus nimium mali sunt. Enzalutamide capi debet ore semel in die ad quantitatem CLX mg. Aegris, qui talazoparib et enzalutamide sumpserunt, habere etiam analogum GnRH, vel utrumque testiculorum eorum remotum esse.
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