03552nam a2200277 4500 ESSALUD ta t pe ||||| |||| 00| 0 spa d BMG eng Galsky, Matthew D. Autor 53782 Enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer páginas: 338-348 Background: Neoadjuvant cisplatin-based chemotherapy is a standard therapy for muscle-invasive bladder cancer. The efficacy and safety of neoadjuvant and adjuvant (perioperative) enfortumab vedotin–pembrolizumab as compared with neoadjuvant cisplatin-based chemotherapy in persons with this cancer are unclear. Methods: We conducted a phase 3, open-label, randomized trial involving adults with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy and radical cystectomy with pelvic lymph-node dissection (cystectomy). Participants were assigned to receive neoadjuvant enfortumab vedotin–pembrolizumab (4 cycles; enfortumab vedotin [1.25 mg per kilogram of body weight on days 1 and 8] and pembrolizumab [200 mg on day 1] every 3 weeks), cystectomy, and 5 cycles of enfortumab vedotin and 13 cycles of pembrolizumab as adjuvant therapy or to receive neoadjuvant cisplatin–gemcitabine (4 cycles; cisplatin [70 mg per square meter of body-surface area on day 1] plus gemcitabine [1000 mg per square meter on days 1 and 8] every 3 weeks) and cystectomy. The primary end point was event-free survival; key secondary end points were overall survival and pathological complete response. Safety was assessed. Results: A total of 405 participants were assigned to receive enfortumab vedotin–pembrolizumab and 403 to receive cisplatin–gemcitabine. The median time from randomization to the data-cutoff date was 33.6 months (range, 22.5 to 53.6). A total of 86.7% of the participants in the enfortumab vedotin–pembrolizumab group and 89.6% of those in the cisplatin–gemcitabine group underwent cystectomy. At 2 years, estimated event-free survival was 79.4% with enfortumab vedotin–pembrolizumab and 66.2% with cisplatin–gemcitabine (hazard ratio for an event or death, 0.53; 95% confidence interval [CI], 0.41 to 0.70; P<0.001); estimated overall survival was 86.9% and 81.3%, respectively (hazard ratio for death, 0.65; 95% CI, 0.48 to 0.89; two-sided P=0.006). A pathological complete response occurred in 55.8% and 32.5% of the participants (P<0.001). The incidence of grade 3 or higher adverse events of any cause was 75.7% with enfortumab vedotin–pembrolizumab and 67.2% with cisplatin–gemcitabine. Conclusions: Among participants with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy, perioperative enfortumab vedotin–pembrolizumab led to significantly better event-free and overall survival outcomes and a significantly higher incidence of pathological complete response than neoadjuvant cisplatin–gemcitabine, but with more adverse events of grade 3 or higher. ENFERMEDADES DE LA PRÓSTATA 53783 UROLOGÍA 6502 TRATAMIENTO EN ONCOLOGÍA 53713 CANCER GENITOURINARIO 53654 Valderrama, Begoña P. 53784 Maruzzo, Marco 53785 Font, Albert 53786 Ciuleanu, Tudor 53787 Chatzkel, Jonathan 53788 22717 22637 Massachusetts NEJM Group NEJM004 The New England Journal of Medicine ESSALUD 0028-4793 ARTICULOS 2026-07-31 SQB 22745 22745