RESUMEN
Lenalidomide and dexamethasone (RD) is a standard of care for relapsed/refractory multiple myeloma (RRMM), but there is limited published data on its efficacy and safety in the "real world" (RW), according to the International Society of Pharmacoeconomics and Outcomes Research definition. We studied 212 RRMM patients who received RD in RW. Objective response (≥PR (partial response)) rate was 77.4 % (complete response (CR), 20.2 %). Median time to first and best response was 2 and 5 months, respectively. Median time to CR when RD was given as 2nd or >2(nd)-line treatment at 4 and 11 months, respectively. Quality of response was independent of previous lines of therapies or previous exposure to thalidomide or bortezomib. Median duration of response was 34.4 months, and it was higher in patients who received RD until progression (not reached versus 19 months, p < 0.001). Improvement of humoral immunity occurred in 60 % of responders (p < 0.001) and in the majority of patients who achieved stable disease. Adverse events were reported in 68.9 % of patients (myelosuppression in 49.4 %) and 12.7 % of patients needed hospitalization. Peripheral neuropathy was observed only in 2.5 % of patients and deep vein thrombosis in 5.7 %. Dose reductions were needed in 31 % of patients and permanent discontinuation in 38.9 %. Median time to treatment discontinuation was 16.8 months. Performance status (PS) and initial lenalidomide dose predicted for treatment discontinuation. Extra-medullary relapses occurred in 3.8 % of patients. Our study confirms that RD is effective and safe in RRMM in the RW; it produces durable responses especially in patients who continue on treatment till progression and improves humoral immunity even in patients with stable disease.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Mieloma Múltiple/tratamiento farmacológico , Anciano , Anticoagulantes/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Terapia Combinada , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Erupciones por Medicamentos/etiología , Evaluación de Medicamentos , Femenino , Estudios de Seguimiento , Enfermedades Gastrointestinales/inducido químicamente , Grecia , Enfermedades Hematológicas/inducido químicamente , Humanos , Lenalidomida , Masculino , Persona de Mediana Edad , Mieloma Múltiple/genética , Mieloma Múltiple/cirugía , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Modelos de Riesgos Proporcionales , Recurrencia , Inducción de Remisión , Estudios Retrospectivos , Terapia Recuperativa , Talidomida/administración & dosificación , Talidomida/efectos adversos , Talidomida/análogos & derivados , Resultado del Tratamiento , Trombosis de la Vena/inducido químicamente , Trombosis de la Vena/prevención & controlRESUMEN
Deletions of the long arm of chromosome 5 [del(5q)] are frequent chromosome aberrations with known prognosis in myelodysplastic syndromes and acute myeloid leukemia (AML). However, in chronic lymphocytic leukemia (CLL), they are rare and have been reported only as karyotypic results without known prognosis. In the present study, we report a novel conventional and molecular cytogenetic study of two CLL patients carrying interstitial del(5q) in order to contribute to the identification of rare recurrent aberrations and their prognostic impact in CLL. Karyotypic and fluorescence in situ hybridization analysis that used probes for the most common aberrations of CLL demonstrated that del(5q) was the sole chromosome abnormality in both patients at the time of diagnosis. None of these patients had a history of exposure to chemotherapy or radiotherapy. Both patients had disease that was still staged as Binet A at 28 and 18 months after diagnosis, respectively, without receiving any therapy because of their good clinical condition. Therefore, it could be suggested that del(5q) may not be associated with an adverse prognosis in CLL and is not related with therapy-induced chromosome changes. Further studies are required to elucidate the prognostic value of these deletions in more CLL patients, which could be advisable for prognostic and therapeutic purposes, as well as to identify candidate genes that may potentially play a role in the pathogenesis of CLL.