Experiencia en el despliegue del piloto de galen clínicas en los laboratorios del instituto de hematología e inmunología

SOFTEL, es la empresa encargada por el Ministerio de las Comunicaciones de informatizar las entidades de Salud Pública. Para ello se han desarrollado varias aplicaciones, para ser desplegadas en hospitales, clínicas, policlínicos y bancos de sangre, fundamentalmente. Específicamente los laboratorios constituyen un área muy sensible debido a que en ellos se realizan todos los medios diagnósticos, que resultan de gran utilidad el almacenamiento de esta información para futuros estudios de los pacientes. Este trabajo expone la experiencia obtenida en el despliegue de dicho módulo, como una primera experiencia, conocida como despliegue de piloto o prueba beta. Esta experiencia sirve de base para las futuras instalaciones en otros clientes, reportó una serie de inconformidades que se resolvieron antes de concluir el mismo y finalmente quedo concluido el despliegue. Este tuvo complicaciones relacionadas con la existencia de laboratorios fuera del área de cobertura del Instituto y la preparación de las interfaces con los diferentes auto analizadores. Palabras Clave: galen laboratoriosssss, galen clínicas, piloto de software, auto analizadores

Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia

This phase I, dose-escalation study investigated the recommended dose for expansion (RDE) of siremadlin, a p53-MDM2 inhibitor, in patients with wild-type TP53 advanced solid or hematologic cancers. Initial dosing regimens were: 1A (day 1; 21-day cycle; dose 12.5-350 mg) and 2A (days 1-14; 28-day cycle; dose 1-20 mg). Alternative regimens included 1B (days 1 and 8; 28-day cycle) and 2C (days 1-7; 28-day cycle). The primary endpoint was incidence of dose-limiting toxicities (DLT) during cycle 1. Overall, 115 patients with solid tumors and 93 with hematologic malignancies received treatment. DLTs occurred in 8/92 patients with solid tumors and 10/53 patients with hematologic malignancies. In solid tumors, an RDE of 120 mg was defined in 1B. In hematologic tumors, RDEs were defined in 1A: 250 mg, 1B: 120 mg, and 2C: 45 mg. More patients with hematologic malignancies compared with solid tumors experienced grade 3/4 treatment-related adverse events (71% vs. 45%), most commonly resulting from myelosuppression. These were more frequent and severe in patients with hematologic malignancies; 22 patients exhibited tumor lysis syndrome. Overall response rates at the RDEs were 10.3% [95% confidence interval (CI), 2.2-27.4] in solid tumors and 4.2% (95% CI, 0.1-21.1), 20% (95% CI, 4.3-48.1), and 22.2% (95% CI, 8.6-42.3) in acute myeloid leukemia (AML) in 1B, 1A, and 2C, respectively. A common safety profile was identified and preliminary activity was noted, particularly in AML. Comprehensive investigation of dosing regimens yielded recommended doses/regimens for future combination studies