RESUMEN
Outcome of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) remains poor, highlighting the need for novel treatment approaches. The multicentre randomised phase II LEGEND trial evaluated lenalidomide in combination with rituximab, methylprednisolone and gemcitabine (R-GEM-L) vs. standard R-GEM-P as second-line treatment of DLBCL. The study closed early to recruitment after the planned interim analysis failed to demonstrate a complete response (CR) rate of ≥ 40% in either arm. Among 34 evaluable patients, 7/18 (38.9%) achieved CR with R-GEM-L and 3/16 (18.8%) with R-GEM-P. Median event-free and overall survival was 3.5/3.8 months and 10.8/8.3 months for R-GEM-L and R-GEM-P, respectively. The incidence of grade ≥ 3 toxicities was 52% in R-GEM-L and 83% in R-GEM-P. Efficacy and tolerability of R-GEM-L seem comparable with R-GEM-P and other standard salvage therapies, but a stringent design led to early trial closure. Combination of lenalidomide with gemcitabine-based regimens should be further evaluated in r/r DLBCL.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/mortalidad , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Metilprednisolona/administración & dosificación , Metilprednisolona/efectos adversos , Persona de Mediana Edad , Rituximab/administración & dosificación , Rituximab/efectos adversos , Tasa de Supervivencia , GemcitabinaAsunto(s)
Fibrinolíticos/uso terapéutico , Indicadores de Salud , Tromboembolia Venosa/prevención & control , Anciano , Femenino , Humanos , Modelos Logísticos , Masculino , Selección de Paciente , Guías de Práctica Clínica como Asunto , Valor Predictivo de las Pruebas , Curva ROC , Sistema de Registros , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de Riesgo , Sensibilidad y Especificidad , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologíaAsunto(s)
Neoplasias/complicaciones , Neoplasias/mortalidad , Tromboembolia Venosa/complicaciones , Tromboembolia Venosa/mortalidad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Riesgo , Tasa de SupervivenciaRESUMEN
A P2X7 receptor gene polymorphism 1513 A-->C has recently been suggested as playing a role in the pathogenesis and disease progression of chronic lymphocytic leukemia, although several studies have failed to show any effect of the polymorphism. The effects of this polymorphism were analysed in 136 patients with multiple myeloma. The frequency of the polymorphism in the myeloma samples was not significantly different from that found in normal healthy controls. There was no significant difference in age at diagnosis, creatinine, hemoglobin, beta-2 microglobulin, immunoglobulin sub-type, duration of first response and overall survival. These results are in keeping with findings in a cohort of 121 chronic lymphocytic leukemia and do not support a role for this polymorphism in multiple myeloma.