000			03308nam a2200277 4500
001			ESSALUD
007			ta
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040			_aBMG
041			_aspa
100			_aAgarwal, Neeraj _eAutor _953807
245			_aPARP and androgen-signaling inhibition plus ADT in metastatic prostate cancer
300			_apáginas: 427-439
520			_aBackground: A previous trial involving patients with metastatic prostate cancer that was resistant to androgen pathway modulation (formerly referred to as castration-resistant) showed that adding talazoparib to enzalutamide significantly improved imaging-based progression-free survival and overall survival, with the greatest benefit observed in the cohort with alterations in homologous recombination repair genes. Methods: In this ongoing, phase 3, double-blind trial assessing talazoparib in patients with metastatic androgen pathway modulation–sensitive [APMS] prostate cancer harboring alterations in homologous recombination repair genes, we randomly assigned patients in a 1:1 ratio to receive talazoparib at a dose of 0.5 mg plus enzalutamide at a dose of 160 mg once daily (talazoparib group) or placebo plus enzalutamide at a dose of 160 mg once daily (control group). Randomization was stratified according to disease status (new or relapsed), disease volume (high or low), and BRCA (vs. non-BRCA) mutation status. The primary end point was investigator-assessed imaging-based progression-free survival. The key secondary end point was overall survival. Results: A total of 300 patients were assigned to the talazoparib group and 299 to the control group. At 3 years, progression-free survival was 77% in the talazoparib group and 56% in the control group (hazard ratio for disease progression or death, 0.48; 95% confidence interval [CI], 0.36 to 0.65; P<0.001). In this interim analysis, overall survival at 3 years was 78% in the talazoparib group and 72% in the control group (hazard ratio for death, 0.77; 95% CI, 0.56 to 1.04). Serious adverse events were reported in 42% and 32% of the patients in the talazoparib group and the control group, respectively. In the talazoparib group, the most common adverse events were anemia, fatigue, and decreased neutrophil count, and the most common event of grade 3 or higher was anemia, reported in 51% of the patients; two treatment-related deaths occurred. Conclusions: Talazoparib added to enzalutamide led to significantly better imaging-based progression-free survival than placebo plus enzalutamide among patients with metastatic APMS prostate cancer harboring alterations in homologous recombination repair genes. Serious adverse events were more common with talazoparib plus enzalutamide than with placebo plus enzalutamide.
650			_aCANCER GENITOURINARIO _953654
650			_aTRATAMIENTOS EN ONCOLOGÍA _953734
650			_aUROLOGÍA _96502
650			_aENFERMEDADES DE LA PRÓSTATA _953783
700			_aMatsubara, Nobuaki _953808
700			_aAzad, Arun A. _953809
700			_aSaad, Fred _953810
700			_aMateo, Joaquin _953811
700			_aJiang, Shusuan _953812
773	0		_022717 _922638 _dMassachusetts NEJM Group _oNEJM005 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-07-31 _zSQB
999			_c22750 _d22750