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1.
Blood ; 119(4): 933-9; quiz 1093, 2012 Jan 26.
Artículo en Inglés | MEDLINE | ID: mdl-21835953

RESUMEN

Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma (MM) but is associated with an increased risk of venous thromboembolism (VTE). This prospective, open-label, randomized substudy of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin (ASA) or low-molecular-weight heparin (LMWH) in patients with newly diagnosed MM, treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were randomly assigned to receive ASA 100 mg/d (n = 176) or LMWH enoxaparin 40 mg/d (n = 166). The incidence of VTE was 2.27% in the ASA group and 1.20% in the LMWH group. Compared with LMWH, the absolute difference in the proportion of VTE was 1.07% (95% confidence interval, -1.69-3.83; P = .452) in the ASA group. Pulmonary embolism was observed in 1.70% of patients in the ASA group and none in the LMWH group. No arterial thrombosis, acute cardiovascular events, or sudden deaths were reported. No major hemorrhagic complications were reported. In previously untreated patients with MM receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis.


Asunto(s)
Anticoagulantes/uso terapéutico , Aspirina/uso terapéutico , Enoxaparina/uso terapéutico , Mieloma Múltiple/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Talidomida/análogos & derivados , Tromboembolia Venosa/prevención & control , Adulto , Anticoagulantes/efectos adversos , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Aspirina/efectos adversos , Enoxaparina/efectos adversos , Femenino , Humanos , Incidencia , Israel/epidemiología , Italia/epidemiología , Lenalidomida , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Embolia Pulmonar/inducido químicamente , Embolia Pulmonar/epidemiología , Embolia Pulmonar/prevención & control , Factores de Riesgo , Talidomida/administración & dosificación , Talidomida/efectos adversos , Talidomida/uso terapéutico , Tromboembolia Venosa/inducido químicamente , Tromboembolia Venosa/epidemiología , Trombosis de la Vena/inducido químicamente , Trombosis de la Vena/epidemiología , Trombosis de la Vena/prevención & control
2.
Eur J Haematol ; 93(3): 207-13, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24673398

RESUMEN

OBJECTIVES: In vitro studies have shown synergistic anti-myeloma effects of bortezomib combined with alkylating agents or anthracycline. We tested safety and efficacy of the combination of bortezomib, doxorubicin cyclophosphamide, and dexamethasone (ABCD) in the treatment of relapsed/refractory myeloma. METHODS: ABCD consisted of bortezomib given intravenous (IV) at dosage 1.3 mg/m(2) , dexamethasone 40 mg IV on days 1, 4, 8, and 15, pegylated liposomal doxorubicin (PLD) 20 mg IV on days 1 and 15, plus cyclophosphamide 100 mg/d per os for 15 d. Between January 2008 and February 2009, 24 patients received a median of four 28-d ABCD cycles (range 1-6). All patients had been already treated with a median of two previous lines of treatment (range 1-6): 38% were resistant to previous therapies and 62% were relapsed. RESULTS: Clinical response was observed in 12 patients (50%), including 29% of very good partial remissions or better. Side effects included hematological toxicity (31% any grade), grades 3-4 thrombocytopenia (9%), grades 3-4 anemia (17%). Non-hematological toxicity affected 32% of administered cycles and included gastrointestinal disturbances (54%), peripheral neuropathy (8%), and infections (8%). After a median follow-up of 21.5 months (range 2-44 months), median of progression-free survival (PFS) was 8.7 months and median overall survival was 22.5 months. Achieving at least partial response within the second cycle was associated with a better PFS (19.5 months vs. 3.5 months), P = 0.03, HR 0.35 (CI 95% 0.13-0.90). CONCLUSION: ABCD is safe and effective for relapsed/refractory MM subjects previously treated with novel agents.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Mieloma Múltiple/tratamiento farmacológico , Terapia Recuperativa , Anciano , Ácidos Borónicos/administración & dosificación , Ácidos Borónicos/efectos adversos , Bortezomib , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Doxorrubicina/administración & dosificación , Doxorrubicina/efectos adversos , Doxorrubicina/análogos & derivados , Esquema de Medicación , Femenino , Enfermedades Gastrointestinales/etiología , Humanos , Masculino , Persona de Mediana Edad , Mieloma Múltiple/mortalidad , Mieloma Múltiple/patología , Enfermedades del Sistema Nervioso Periférico/etiología , Polietilenglicoles/administración & dosificación , Polietilenglicoles/efectos adversos , Pirazinas/administración & dosificación , Pirazinas/efectos adversos , Recurrencia , Análisis de Supervivencia , Trombocitopenia/etiología , Resultado del Tratamiento
3.
Am J Hematol ; 89(4): 355-62, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24273190

RESUMEN

Novel agents in combination with melphalan and prednisone (MP) significantly improved progression-free survival (PFS) and overall survival (OS) in multiple myeloma (MM). Randomized trials comparing MP plus bortezomib (VMP) versus MP plus thalidomide (MPT) are lacking. Nine hundred and fifty-six elderly (>65 years) newly diagnosed MM patients from six European randomized trials were retrospectively analyzed and matched for age, albumin, and beta2-microglobulin at diagnosis, 296 patients were selected from the VMP groups, and 294 from MPT. Complete response rate was 21% in the VMP patients and 13% in the MPT patients (P = 0.007). After a median follow-up of 34 months (range, 1-92), VMP significantly prolonged both PFS (median 32.5 vs. 22.9 months, HR 0.65; 95% CI 0.52-0.82; P < 0.001) and OS (median 79.7 vs. 45.1 months, HR 0.44; 95% CI 0.32-0.59; P < 0.001) in comparison with MPT. The benefit in terms of OS of the VMP group was quite similar among patients with different risk factors defined by sex, ISS, ECOG performance status, or serum creatinine but not among patients ≥ 75 years. Multivariate analysis confirmed that VMP was an independent predictor of longer PFS and OS. In a control-case matched analysis, PFS and OS were prolonged in patients who received VMP in comparison with those treated with MPT.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Mieloma Múltiple/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Ácidos Borónicos/administración & dosificación , Ácidos Borónicos/efectos adversos , Bortezomib , Estudios de Casos y Controles , Supervivencia sin Enfermedad , Evaluación de Medicamentos , Femenino , Enfermedades Hematológicas/inducido químicamente , Humanos , Estimación de Kaplan-Meier , Masculino , Melfalán/administración & dosificación , Melfalán/efectos adversos , Mieloma Múltiple/genética , Mieloma Múltiple/terapia , Enfermedades del Sistema Nervioso/inducido químicamente , Prednisona/administración & dosificación , Prednisona/efectos adversos , Pronóstico , Modelos de Riesgos Proporcionales , Pirazinas/administración & dosificación , Pirazinas/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Talidomida/administración & dosificación , Talidomida/efectos adversos , Resultado del Tratamiento
4.
Haematologica ; 98(6): 980-7, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23445873

RESUMEN

Thalidomide and bortezomib are extensively used to treat elderly myeloma patients. In these patients, treatment-related side effects are frequent and full drug doses difficult to tolerate. We retrospectively analyzed data from 1435 elderly patients enrolled in 4 European phase III trials including thalidomide and/or bortezomib. After a median follow up of 33 months (95%CI: 10-56 months), 513 of 1435 patients (36%) died; median overall survival was 50 months (95%CI: 46-60 months). The risk of death was increased in patients aged 75 years or over (HR 1.44, 95%CI: 1.20-1.72; P<0.001), in patients with renal failure (HR 2.02, 95%CI: 1.51-2.70; P<0.001), in those who experienced grade 3-4 infections, cardiac or gastrointestinal adverse events during treatment (HR 2.53, 95%CI: 1.75-3.64; P<0.001) and in those who required drug discontinuation due to adverse events (HR 1.67, 95%CI; 1.12-2.51; P=0.01). This increased risk was restricted to the first six months after occurrence of adverse events or drug discontinuation and declined over time. More intensive approaches, such as the combination of bortezomib-thalidomide, negatively affected outcome. Bortezomib-based combinations may overcome the negative impact of renal failure. Age 75 years or over or renal failure at presentation, occurrence of infections, cardiac or gastrointestinal adverse events negatively affected survival. A detailed geriatric assessment, organ evaluation and less intense individualized approaches are suggested in elderly unfit subjects.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Mieloma Múltiple/mortalidad , Factores de Edad , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Causas de Muerte , Femenino , Humanos , Masculino , Mieloma Múltiple/tratamiento farmacológico , Mieloma Múltiple/patología , Estadificación de Neoplasias , Pronóstico , Modelos de Riesgos Proporcionales , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
5.
Int J Cancer ; 131(9): 2197-203, 2012 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-22322883

RESUMEN

Disulfiram (DSF) is an aldehyde dehydrogenase inhibitor currently used for the treatment of alcoholism. Here, we show that multiple myeloma (MM) cell lines and primary cells from newly diagnosed and relapsed/resistant patients affected by MM, acute myeloid and lymphoblastic leukemia are significantly sensitive to DSF alone and in combination with copper. These effects are present at doses lower than those achievable in vivo after DSF standard administration. The cytotoxic effect achieved by this treatment is comparable to that obtained by conventional chemotherapy and is absent in normal hematopoietic cells. In addition, we found that DSF plus copper induces loss of mitochondrial membrane potential, triggers reactive oxygen species (ROS) production and activates executioner caspases. DSF-copper-induced apoptosis and caspases activation are strongly reversed by antioxidant N-acetylcysteine, thus indicating a critical role of ROS. These results might suggest the use of the old drug DSF, alone or in combination with copper, in the treatment of hematological malignancies.


Asunto(s)
Antineoplásicos/farmacología , Cobre/farmacología , Disulfiram/farmacología , Leucemia Mieloide Aguda/tratamiento farmacológico , Mieloma Múltiple/tratamiento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamiento farmacológico , Acetilcisteína/farmacología , Antineoplásicos/uso terapéutico , Apoptosis/efectos de los fármacos , Caspasas/biosíntesis , Línea Celular Tumoral , Disulfiram/uso terapéutico , Inhibidores Enzimáticos/farmacología , Depuradores de Radicales Libres/farmacología , Humanos , Leucemia Mieloide Aguda/metabolismo , Leucemia Mieloide Aguda/patología , Potenciales de la Membrana/efectos de los fármacos , Membranas Mitocondriales/efectos de los fármacos , Mieloma Múltiple/metabolismo , Mieloma Múltiple/patología , Estrés Oxidativo/efectos de los fármacos , Leucemia-Linfoma Linfoblástico de Células Precursoras/metabolismo , Leucemia-Linfoma Linfoblástico de Células Precursoras/patología , Especies Reactivas de Oxígeno/metabolismo
6.
Blood ; 116(23): 4745-53, 2010 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-20807892

RESUMEN

In a recent phase 3 trial, bortezomib-melphalan-prednisone-thalidomide followed by maintenance treatment with bortezomib-thalidomide demonstrated superior efficacy compared with bortezomib-melphalan-prednisone. To decrease neurologic toxicities, the protocol was amended and patients in both arms received once-weekly instead of the initial twice-weekly bortezomib infusions: 372 patients received once-weekly and 139 twice-weekly bortezomib. In this post-hoc analysis we assessed the impact of the schedule change on clinical outcomes and safety. Long-term outcomes appeared similar: 3-year progression-free survival rate was 50% in the once-weekly and 47% in the twice-weekly group (P > .999), and 3-year overall survival rate was 88% and 89%, respectively (P = .54). The complete response rate was 30% in the once-weekly and 35% in the twice-weekly group (P = .27). Nonhematologic grade 3/4 adverse events were reported in 35% of once-weekly patients and 51% of twice-weekly patients (P = .003). The incidence of grade 3/4 peripheral neuropathy was 8% in the once-weekly and 28% in the twice-weekly group (P < .001); 5% of patients in the once-weekly and 15% in the twice-weekly group discontinued therapy because of peripheral neuropathy (P < .001). This improvement in safety did not appear to affect efficacy. This study is registered at http://www.clinicaltrials.gov as NCT01063179.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Ácidos Borónicos/administración & dosificación , Mieloma Múltiple/tratamiento farmacológico , Pirazinas/administración & dosificación , Anciano , Ácidos Borónicos/efectos adversos , Bortezomib , Supervivencia sin Enfermedad , Esquema de Medicación , Femenino , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Melfalán/administración & dosificación , Melfalán/efectos adversos , Persona de Mediana Edad , Mieloma Múltiple/mortalidad , Mieloma Múltiple/patología , Estadificación de Neoplasias , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/epidemiología , Prednisona/administración & dosificación , Prednisona/efectos adversos , Pirazinas/efectos adversos , Talidomida/administración & dosificación , Talidomida/efectos adversos , Resultado del Tratamiento
7.
Skeletal Radiol ; 41(4): 459-64, 2012 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22086119

RESUMEN

PURPOSE: In this prospective multicenter study, we evaluate the effectiveness of corticosteroid plus vertebroplasty rather than vertebroplasty alone in the analgesic treatment of single-level vertebral neoplasms or pathological fractures. MATERIALS AND METHODS: From January 2009 to February 2011, we prospectively enrolled 20 consecutive patients (11 women, nine men; age range 46-78 years; mean age 65.1 years) with single-level vertebral neoplasm or pathological fractures totally or partially refractory to analgesic treatment, with indication to vertebroplasty. Institutional review board approval and informed consent were obtained. The inclusion criteria for the study were the presence of a single-level pathological fracture not extended to the posterior wall or symptomatic localization of primary or secondary neoplasms, visual analogue score (VAS) ≥5, and life expectancy more than 3 months. Exclusion criteria where all contraindications either to corticosteroid injection included allergy (local sepsis, bacteremia, allergy) or vertebroplasty included coagulopathy, etc. The population was randomly divided into two groups: in group A, patients underwent intrasomatic injections of 4 mg/ml of dexamethasone phosphate followed by a cement injection; patients in group B underwent standard vertebroplasty. VAS score was evaluated and compared between both groups of patients at 6 h, 24 h, 48 h, 7 days, 30 days, and 3 months after the intervention plus last available follow-up. Statistical analyses were performed by application of the t test. RESULTS: Technical success was achieved in all cases. In group A, we treated six male and six female patients (age range 46-73 years, average 60.2 years). Pre-intervention VAS in group A ranged between 7 and 10 points, average 8 points. In group B, we treated three male and five female patients (age range 52-78 years, average 67.3 years). Pre-intervention VAS score in group B ranged between 7 and 9 points, with an average 8 points. Patients in group A in respect to patients in group B had a higher reduction in VAS, with a difference of 25.4% (VAS reduction average 5.5 versus 4.1) at 6 h post-intervention, 24.5% (VAS average 5.7 versus 4.3) at 24 h, 25% (VAS average 6 versus 4.5) at 48 h, 23% (VAS average 6.5 versus 5) at 7 days, 16.4% (VAS average 6.7 versus 5.6) at 30 days, 8.9% (VAS average 6.7 versus 6, .1) at 3 months. The last available follow-up ranged from 3 to 24 months in group A and from 5 to 20 months in group B. CONCLUSIONS: In our preliminary experience, pre-vertebroplasty injection of intrasomatic corticosteroid in comparison to vertebroplasty alone is able to increase the early pain relief of the procedure.


Asunto(s)
Dolor de Espalda/etiología , Dolor de Espalda/terapia , Dexametasona/administración & dosificación , Fracturas Espontáneas/complicaciones , Fracturas Espontáneas/terapia , Glucocorticoides/administración & dosificación , Neoplasias de la Columna Vertebral/complicaciones , Neoplasias de la Columna Vertebral/terapia , Vertebroplastia , Anciano , Cementos para Huesos/uso terapéutico , Dexametasona/uso terapéutico , Femenino , Glucocorticoides/uso terapéutico , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Dolor Intratable/etiología , Dolor Intratable/terapia , Estudios Prospectivos
8.
Skeletal Radiol ; 40(7): 913-9, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21359976

RESUMEN

AIM: The goal of this study was to specifically address the incidence of dorsal leakage when performing vertebroplasty in patients with posterior wall osteolysis or fracture, by using a delayed injection of cement with the aim of increasing its viscosity. MATERIALS AND METHODS: We prospectively reviewed the records of 24 patients (13 women, 11 men; age range 42-67 years; mean age 54.7) with diagnosis of multiple myeloma (MM) who underwent 34 vertebroplasties between January 2007 and January 2010 for painful osteolytic localization of MM with dorsal cortical osteolysis or fracture. All vertebroplasties were performed with an 8 min delay, which was half of the allotted injecting time given for the chosen cement. In 11 cases there were fractures involving the posterior wall, in 1 case with dorsal fragment dislocation, and in 33 cases there was dorsal cortical osteolysis. All of the patients showed no response to standard treatments such as radiotherapy, chemotherapy, and analgesic treatments. RESULTS: Technical success was achieved in all cases. In 20 patients, we treated only one high-risk vertebral lesion, in six patients we treated two segments, and in one patient we treated three segments. All patients experienced improvement in symptoms after the procedure as demonstrated by improved visual analogue scores (VAS) and performance status (PS) and decreased doses of analgesic. There was a dorsal leakage in 2/34 (5.8%) treated vertebral bodies in which an epidural space tumor extension was also diagnosed, without increasing neurological symptoms after the intervention. CONCLUSION: From these results vertebroplasty with delayed injection of cement is safe and effective in the treatment of vertebral localization of myeloma with osteolysis or fracture of the posterior vertebral wall.


Asunto(s)
Cementos para Huesos/uso terapéutico , Neoplasias Óseas/terapia , Mieloma Múltiple/terapia , Osteólisis/terapia , Fracturas de la Columna Vertebral/terapia , Vertebroplastia/métodos , Adulto , Anciano , Neoplasias Óseas/complicaciones , Femenino , Humanos , Inyecciones Espinales , Persona de Mediana Edad , Mieloma Múltiple/complicaciones , Osteólisis/etiología , Fracturas de la Columna Vertebral/etiología , Resultado del Tratamiento
10.
Biomed Res Int ; 2014: 198539, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25013764

RESUMEN

Multiple Myeloma (MM) is a systemic hematologic disease due to uncontrolled proliferation of monoclonal plasma cells (PC) in bone marrow (BM). Emerging in other solid and liquid cancers, the host immune system and the microenvironment have a pivotal role for PC growth, proliferation, survival, migration, and resistance to drugs and are responsible for some clinical manifestations of MM. In MM, microenvironment is represented by the cellular component of a normal bone marrow together with extracellular matrix proteins, adhesion molecules, cytokines, and growth factors produced by both stromal cells and PC themselves. All these components are able to protect PC from cytotoxic effect of chemo- and radiotherapy. This review is focused on the role of immunome to sustain MM progression, the emerging role of myeloid derived suppressor cells, and their potential clinical implications as novel therapeutic target.


Asunto(s)
Carcinogénesis , Terapia Molecular Dirigida , Mieloma Múltiple/inmunología , Microambiente Tumoral/inmunología , Células de la Médula Ósea/metabolismo , Células de la Médula Ósea/patología , Proliferación Celular/genética , Células Dendríticas/inmunología , Humanos , Mieloma Múltiple/genética , Mieloma Múltiple/patología , Linfocitos T Reguladores/inmunología , Linfocitos T Reguladores/patología , Microambiente Tumoral/genética
11.
Biomed Res Int ; 2014: 456037, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24967371

RESUMEN

During the past decade, overall results of treatment of multiple myeloma (MM) have been improved and survival curves are now significantly better with respect to those obtained with historical treatment. These improvements are linked to a deeper knowledge of the biology of disease and to the introduction in clinical practice of drugs with different mechanism of action such as proteasome inhibitors and immunomodulatory drugs (IMiDs). However, MM remains in most cases an incurable disease. For patients who relapse after treatment with novel agents, the prognosis is dismal and new drugs and therapeutic strategies are required for continued disease control. In this review, we summarize new insights in salvage therapy for relapsed/refractory MM as emerging from recent clinical trials exploring the activity of bendamustine, new generation proteasome inhibitors, novel IMiDs, monoclonal antibodies, and drugs interfering with growth pathways.


Asunto(s)
Antineoplásicos/uso terapéutico , Factores Inmunológicos/uso terapéutico , Mieloma Múltiple/tratamiento farmacológico , Inhibidores de Proteasoma/uso terapéutico , Terapia Recuperativa/métodos , Ensayos Clínicos como Asunto , Humanos , Mieloma Múltiple/metabolismo , Mieloma Múltiple/patología
12.
Cardiovasc Intervent Radiol ; 33(6): 1270-7, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-19967372

RESUMEN

The purpose of this study was to assess the efficacy of cementoplasty in the treatment of sacral multiple myelomas. We retrospectively reviewed the records of eight patients (four women and four men; age range 47-68 years; mean age 57.8) who underwent cementoplasty for painful osteolytic localization of multiple myeloma between April 2007 and May 2009. The patients had difficulty walking because of increasing pain. Six patients had persistent pain despite other cementoplasties for vertebral and femoral localization, whereas two patients referred at the time of diagnosis had only sacral lesions. The clinical indication for treatment was (1) a pain intensity score ≥5 on visual analogue scale (VAS) and (2) pain totally or partially refractory to analgesic treatment in patients with a life expectancy >3 months. Technical planning was based on computed tomography and/or magnetic resonance imaging. Six patients had previously undergone radiotherapy or chemotherapy and were receiving varying doses of analgesics, whereas sacroplasty represented the first treatment for two patients. Five patients had monolateral local involvement, and the other patients had massive involvement of the sacrum; Technical success was achieved in all cases. We had only one small and asymptomatic foraminal leak. All patients experienced improvement in symptoms after the procedure, as demonstrated by improved VAS scores and performance status (PS) and decreased analgesic dose constant during follow-up. In our experience, percutaneous stabilization can be used effectively and safely in patients with focal or extensive involvement of the sacrum by multiple myeloma.


Asunto(s)
Mieloma Múltiple/cirugía , Sacro/cirugía , Neoplasias de la Columna Vertebral/cirugía , Vertebroplastia/métodos , Anciano , Femenino , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Mieloma Múltiple/patología , Dimensión del Dolor , Radiografía Intervencional , Estudios Retrospectivos , Sacro/patología , Neoplasias de la Columna Vertebral/secundario , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
13.
J Clin Oncol ; 28(34): 5101-9, 2010 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-20940200

RESUMEN

PURPOSE: The combination of bortezomib-melphalan-prednisone (VMP) is a new standard of care for newly diagnosed multiple myeloma. This phase III study examined the efficacy of the four-drug combination of bortezomib-melphalan-prednisone-thalidomide (VMPT) followed by maintenance with bortezomib-thalidomide (VMPT-VT) compared with VMP treatment alone in untreated multiple myeloma patients who are ineligible for autologous stem-cell transplantation. PATIENTS AND METHODS: A total of 511 patients were randomly assigned to receive nine cycles of VMPT followed by continuous VT as maintenance, or nine cycles of VMP at the same doses with no additional therapy. The primary end point was progression-free survival. RESULTS: The 3-year estimates of progression-free survival were 56% in patients receiving VMPT-VT and 41% in those receiving VMP (hazard ratio [HR], 0.67; 95% CI, 0.50 to 0.90; P = .008). At 3 years, the cumulative proportions of patients who did not go on to the next therapy were 72% with VMPT-VT and 60% with VMP (HR, 0.58; 95% CI, 0.50 to 0.90; P = .007). Complete response rates were 38% in the VMPT-VT group and 24% in the VMP group (P < .001). The 3-year overall survival was 89% with VMPT-VT and 87% with VMP (HR, 0.92; 95% CI, 0.53 to 1.60; P = .77). Grade 3 to 4 neutropenia (38% v 28%; P = .02), cardiologic events (10% v 5%; P = .04), and thromboembolic events (5% v 2%; P = .08) were more frequent among patients assigned to the VMPT-VT group than among those assigned to the VMP group; treatment-related deaths were 4% with VMPT-VT and 3% with VMP. CONCLUSION: VMPT followed by VT as maintenance was superior to VMP alone in patients with multiple myeloma who are ineligible for autologous stem-cell transplantation.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Mieloma Múltiple/tratamiento farmacológico , Ácidos Borónicos/administración & dosificación , Ácidos Borónicos/efectos adversos , Bortezomib , Supervivencia sin Enfermedad , Humanos , Estimación de Kaplan-Meier , Melfalán/administración & dosificación , Melfalán/efectos adversos , Mieloma Múltiple/mortalidad , Prednisona/administración & dosificación , Prednisona/efectos adversos , Modelos de Riesgos Proporcionales , Pirazinas/administración & dosificación , Pirazinas/efectos adversos , Talidomida/administración & dosificación , Talidomida/efectos adversos , Resultado del Tratamiento
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