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1.
N Engl J Med ; 387(2): 132-147, 2022 07 14.
Artículo en Inglés | MEDLINE | ID: mdl-35660812

RESUMEN

BACKGROUND: In patients with newly diagnosed multiple myeloma, the effect of adding autologous stem-cell transplantation (ASCT) to triplet therapy (lenalidomide, bortezomib, and dexamethasone [RVD]), followed by lenalidomide maintenance therapy until disease progression, is unknown. METHODS: In this phase 3 trial, adults (18 to 65 years of age) with symptomatic myeloma received one cycle of RVD. We randomly assigned these patients, in a 1:1 ratio, to receive two additional RVD cycles plus stem-cell mobilization, followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Both groups received lenalidomide until disease progression, unacceptable side effects, or both. The primary end point was progression-free survival. RESULTS: Among 357 patients in the RVD-alone group and 365 in the transplantation group, at a median follow-up of 76.0 months, 328 events of disease progression or death occurred; the risk was 53% higher in the RVD-alone group than in the transplantation group (hazard ratio, 1.53; 95% confidence interval [CI], 1.23 to 1.91; P<0.001); median progression-free survival was 46.2 months and 67.5 months. The percentage of patients with a partial response or better was 95.0% in the RVD-alone group and 97.5% in the transplantation group (P = 0.55); 42.0% and 46.8%, respectively, had a complete response or better (P = 0.99). Treatment-related adverse events of grade 3 or higher occurred in 78.2% and 94.2%, respectively; 5-year survival was 79.2% and 80.7% (hazard ratio for death, 1.10; 95% CI, 0.73 to 1.65). CONCLUSIONS: Among adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed. (Funded by the National Heart, Lung, and Blood Institute and others; DETERMINATION ClinicalTrials.gov number, NCT01208662.).


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Quimioterapia de Mantención , Mieloma Múltiple , Trasplante de Células Madre , Adulto , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bortezomib/administración & dosificación , Bortezomib/efectos adversos , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Humanos , Lenalidomida/administración & dosificación , Lenalidomida/efectos adversos , Quimioterapia de Mantención/métodos , Melfalán/administración & dosificación , Mieloma Múltiple/diagnóstico , Mieloma Múltiple/tratamiento farmacológico , Mieloma Múltiple/cirugía , Trasplante Autólogo
2.
Cancer ; 127(23): 4339-4347, 2021 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-34375439

RESUMEN

LAY SUMMARY: People who have advanced myelodysplastic syndromes (MDS) may live longer if they get a bone marrow transplant (BMT) instead of other therapies. However, only 15% of people with MDS actually get BMT. Experts say community physicians and transplant physicians should team up with insurance companies and patient advocacy groups to 1) spread this news about lifesaving advances in BMT, 2) ensure that everyone can afford health care, 3) provide emotional support for patients and families, 4) help patients and families get transportation and housing if they need to travel for transplant, and 5) improve care for people of under-represented racial and ethnic backgrounds.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Síndromes Mielodisplásicos , Médula Ósea , Humanos , Síndromes Mielodisplásicos/terapia , Acondicionamiento Pretrasplante , Trasplante Homólogo
3.
Oncologist ; 21(3): 327-32, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26865590

RESUMEN

BACKGROUND: Patient blood management (PBM) programs are associated with reduced transfusion usage, reduced hospital costs, and improved patient outcomes. The application of PBM principles in patients with malignant disease might achieve similar results. However, this population presents unique challenges. The aim of the present study was to investigate the impact of a PBM program on blood usage and patient outcomes in cancer patients, particularly in the setting of restricted use of erythropoiesis-stimulating agents (ESAs). MATERIALS AND METHODS: A retrospective observational study was performed of patients admitted with a primary diagnosis of malignancy treated at Eastern Maine Medical Center as inpatients or outpatients, or both, from January 2008 through July 2013. RESULTS: The proportion of inpatients and outpatients receiving ESAs decreased from 2.9% in 2008 to 1.1% in 2013 (p < .001). During the same period, an increase occurred in the mean dose of intravenous (IV) iron from 447 mg (95% confidence interval [CI], 337-556) to 588 mg (95% CI, 458-718). The mean red blood cell (RBC) units transfused per inpatient and outpatient episode decreased from 0.067 to 0.038 unit (p < .001). In inpatients, significant increases occurred in the proportion of single-unit RBC transfusions (p < .001) and patients infused with IV iron (p = .02), and significant decreases in the mean pretransfusion hemoglobin (p = .02) and RBC transfusion rate (p = .04). In-hospital mortality and length of stay did not change significantly during this period. CONCLUSION: Despite the decreased use of ESA therapy, the implementation of a PBM program and outpatient anemia management protocol in cancer patients at our medical center was associated with significant reductions in RBC usage.


Asunto(s)
Anemia/tratamiento farmacológico , Transfusión de Eritrocitos/estadística & datos numéricos , Hematínicos/uso terapéutico , Mortalidad Hospitalaria , Tiempo de Internación/estadística & datos numéricos , Anciano , Anemia/inducido químicamente , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Femenino , Hematínicos/efectos adversos , Humanos , Pacientes Internos , Masculino , Neoplasias/tratamiento farmacológico , Pacientes Ambulatorios , Estudios Retrospectivos
4.
Thromb Haemost ; 87(1): 47-51, 2002 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-11858188

RESUMEN

We studied the association of D-dimer with the risk of deep vein thrombosis (DVT). D-dimer was measured in 474 patients more than 6 months after diagnosis of a first DVT and in 474 age- and sex-matched controls. For D-dimer above the 70th percentile (130.5 ng/ml), the odds ratio (OR) for DVT was 2.2 (95% CI, 1.6-2.9). The association was unchanged with adjustment for other risk factors. Excluding participants with Factor V Leiden, prothrombin 20210A, or factors VIIIc or IX above the 90th percentile, the OR was 1.6 (95% CI, 1.1-2.3). The risks of DVT with the joint presence of high D-dimer and either factor V Leiden or prothrombin 20210A were increased 12.4-fold (95% CI 5.6-27.7) and 7.2-fold (95% CI 2.1-25.1), respectively. Higher D-dimer concentration was associated with the risk of DVT, and was supra-additive to the risks associated with factor V Leiden and the prothrombin 20210A variant. Persistence of this association in the absence of other hemostatic risk factors for DVT suggests that high D-dimer may be related to other, as yet unknown, risk factors for venous thrombosis. Confirmation of these findings is desirable.


Asunto(s)
Productos de Degradación de Fibrina-Fibrinógeno/análisis , Trombofilia/sangre , Trombosis de la Vena/epidemiología , Regiones no Traducidas 3'/genética , Resistencia a la Proteína C Activada/epidemiología , Adolescente , Adulto , Anciano , Estudios de Casos y Controles , Comorbilidad , Anticonceptivos Hormonales Orales/efectos adversos , Factor V/análisis , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Obesidad/epidemiología , Oportunidad Relativa , Flebotomía , Protrombina/genética , Factores de Riesgo , Factores de Tiempo , Trombosis de la Vena/sangre
5.
Br J Haematol ; 128(3): 386-8, 2005 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-15667542

RESUMEN

Cancer patients have an increased risk of venous thrombosis (VT). The association of factor V Leiden (FVL) and the prothrombin 20210A variant with VT in cancer patients is not established. We genotyped 101 cancer patients with VT and 101 cancer patients without VT for these polymorphisms. Five cases and three controls were heterozygous for FVL, yielding an odds ratio of 1.7 (95% confidence interval (CI) 0.3-10.7). Five cases and no controls were heterozygous for prothrombin 20210A, for an odds ratio of 6.7 (95% CI 0.9-infinity). Prothrombin 20210A may be associated with VT risk among cancer patients.


Asunto(s)
Factor V/genética , Neoplasias/genética , Polimorfismo Genético , Protrombina/genética , Trombosis de la Vena/genética , Anciano , Estudios de Casos y Controles , Femenino , Predisposición Genética a la Enfermedad , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Factores de Riesgo , Trombosis de la Vena/etiología
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