Enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer (Registro nro. 22745)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 03552nam a2200277 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 007 - Tipo material - Descripcion fisica - info general | |
| Tipo material - Descripcion fisica - info general | ta |
| 008 - Elementos de Longitud Fija - Información General | |
| Elementos de Longitud Fija - Información | t pe ||||| |||| 00| 0 spa d |
| 040 ## - Origen de la Catalogación | |
| Origen de la Catalogación | BMG |
| 041 ## - Idioma | |
| Idioma | eng |
| 100 ## - Autor | |
| Autor | Galsky, Matthew D. |
| Rol del Autor | Autor |
| 9 (RLIN) | 53782 |
| 245 ## - Titulo | |
| Titulo | Enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer |
| 300 ## - Páginas | |
| Paginación | páginas: 338-348 |
| 520 ## - Resumen | |
| Resumen | 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. <br/>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. |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENFERMEDADES DE LA PRÓSTATA |
| 9 (RLIN) | 53783 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | UROLOGÍA |
| 9 (RLIN) | 6502 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | TRATAMIENTO EN ONCOLOGÍA |
| 9 (RLIN) | 53713 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | CANCER GENITOURINARIO |
| 9 (RLIN) | 53654 |
| 700 ## - Autor Personal | |
| Autor Personal | Valderrama, Begoña P. |
| 9 (RLIN) | 53784 |
| 700 ## - Autor Personal | |
| Autor Personal | Maruzzo, Marco |
| 9 (RLIN) | 53785 |
| 700 ## - Autor Personal | |
| Autor Personal | Font, Albert |
| 9 (RLIN) | 53786 |
| 700 ## - Autor Personal | |
| Autor Personal | Ciuleanu, Tudor |
| 9 (RLIN) | 53787 |
| 700 ## - Autor Personal | |
| Autor Personal | Chatzkel, Jonathan |
| 9 (RLIN) | 53788 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22637 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM004 |
| Titulo de la Revista | The New England Journal of Medicine |
| Número de control de registro | ESSALUD |
| ISSN | 0028-4793 |
| 942 ## - Elementos de Koha | |
| Tipo de Documento | Artículos |
| Fecha procesamiento | 2026-07-31 |
| Catalogador | SQB |
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