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3.
Rev Clin Esp ; 208(4): 187-92, 2008 Apr.
Article in Spanish | MEDLINE | ID: mdl-18381003

ABSTRACT

INTRODUCTION: Bortezomib has presently become a significant rescue treatment in multiple myeloma (MM) due to its observed effectiveness and safety in multicenter trials. We have aimed to verify both aspects in a setting of non-selected patients. PATIENTS AND METHODS: This is an observational, prospective study of the cohort of relapsed or refractory MM patients treated with bortezomib in our Department. The variables analyzed were response, its duration, time to the treatment failure (TTF), overall survival (OS), response related conditions and toxicity. Statistical methods used were Fisher's exact test, log rank-test and Kaplan-Meier survival tables. RESULTS: A total of 39 patients, 25 relapsed and 14 refractory to chemotherapy, started the treatment. The mean number of previous treatment was 2.3 and they received an average of 5.8 cycles of bortezomib. Complete response was achieved in 14 patients (36%), partial response in 12 (31%) and minor or no response in 13 ones (33%). Median duration of response was 8 months, median TTF was 10 months and median OS, from the onset of bortezomib was 16.5 months, with a median observation of live patients of 12.5 months. The response was more frequent in males (p = 0.019) and in patients with one previous treatment (p = 0.15). There were no significant differences regarding to TTF when we considered the cause of treatment (relapse or no response to chemotherapy) nor in the number of previous treatment regimes. The most frequent adverse events were reversible thrombocytopenia (31%), polyneuropathy (28%) and asthenia-anorexia (23%). CONCLUSIONS: In our cohort of non-selected, relapsed or refractory MM patients, the observations found in the multicenter randomized trials results regarding response rate and duration, TTF OS and safety of bortezomib therapy were verified.


Subject(s)
Antineoplastic Agents/therapeutic use , Boronic Acids/therapeutic use , Multiple Myeloma/drug therapy , Pyrazines/therapeutic use , Aged , Aged, 80 and over , Bortezomib , Female , Humans , Male , Middle Aged , Prospective Studies , Recurrence
4.
Rev. clín. esp. (Ed. impr.) ; 208(4): 187-192, abr. 2008. ilus, tab
Article in Es | IBECS | ID: ibc-63893

ABSTRACT

Introducción. Bortezomib se ha incorporado como tratamiento de rescate en el mieloma múltiple (MM) por la eficacia y perfil de seguridad observados en estudios multicéntricos. Pretendemos verificar ambos aspectos en un entorno de pacientes no seleccionados. Pacientes y métodos. Estudio observacional prospectivo de los pacientes con MM en recaída o refractarios tratados con bortezomib en nuestro Servicio. Variables analizadas: respuesta, duración, tiempo hasta el fallo del tratamiento (TFT), supervivencia global (SVG) y variables relacionadas con la respuesta y toxicidad. Métodos estadísticos: prueba exacta de Fisher, log rank-test y tablas de supervivencia de Kaplan-Meier. Resultados. Iniciaron el tratamiento 39 pacientes, refractarios a quimioterapia (14) o en recidiva (25), con una media de 2,3 líneas de tratamiento previas, administrándose un promedio de 5,8 ciclos de bortezomib. Alcanzan respuesta completa (RC) 14 pacientes (36%), parcial (RP) 12 (31%), y menor o nula 13 (33%). La duración mediana de la respuesta fue de 8 meses, de TFT 10 meses, y de SVG desde el inicio de bortezomib 16,5 meses, con una mediana de observación de los pacientes vivos de 12,6 meses. La respuesta fue más frecuente en varones (p = 0,019) y en pacientes con sólo una pauta previa de tratamiento (p = 0,15), sin variaciones significativas en TFT al considerar motivo de su instauración (recidiva o refractariedad) o número de pautas previas. Efectos adversos más frecuentes: trombocitopenia reversible (31%), polineuropatía (28%) y astenia-anorexia (23%). Conclusiones. En nuestra serie de pacientes no seleccionados con MM recurrente o refractario se ratifican las observaciones de estudios multicéntricos con bortezomib en la frecuencia, duración de la respuesta, TFT, SVG y perfil de efectos secundarios


Introduction. Bortezomib has presently become a significant rescue treatment in multiple myeloma (MM) due to its observed effectiveness and safety in multicenter trials. We have aimed to verify both aspects in a setting of non-selected patients. Patients and methods: This is an observational, prospective study of the cohort of relapsed or refractory MM patients treated with bortezomib in our Department. The variables analyzed were response, its duration, time to the treatment failure (TTF), overall survival (OS), response related conditions and toxicity. Statistical methods used were Fisher's exact test, log rank-test and Kaplan-Meier survival tables. Results. A total of 39 patients, 25 relapsed and 14 refractory to chemotherapy, started the treatment. The mean number of previous treatment was 2.3 and they received an average of 5.8 cycles of bortezomib. Complete response was achieved in 14 patients (36%), partial response in 12 (31%) and minor or no response in 13 ones (33%). Median duration of response was 8 months, median TTF was 10 months and median OS, from the onset of bortezomib was 16.5 months, with a median observation of live patients of 12.5 months. The response was more frequent in males (p = 0.019) and in patients with one previous treatment (p = 0.15).There were no significant differences regarding to TTF when we considered the cause of treatment (relapse or no response to chemotherapy) nor in the number of previous treatment regimes. The most frequent adverse events were reversible thrombocytopenia (31%), polyneuropathy (28%) and asthenia-anorexia (23%). Conclusions. In our cohort of non-selected, relapsed or refractory MM patients, the observations found in the multicenter randomized trials results regarding response rate and duration, TTF OS and safety of bortezomib therapy were verified


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Multiple Myeloma/drug therapy , Boronic Acids/pharmacokinetics , Protease Inhibitors/pharmacokinetics , Prospective Studies , Recurrence/prevention & control , Treatment Outcome , Paraproteins/analysis
5.
Rev Clin Esp ; 201(2): 75-80, 2001 Feb.
Article in Spanish | MEDLINE | ID: mdl-11345609

ABSTRACT

OBJECTIVE: The objective of this study were: a) to investigate vitamin B12 deficiency among and advanced aged, clinically healthy, asymptomatic population, presumably with a high prevalence of vitamin B12 deficiency. This deficiency was defined as an increase in the MMA/creatinine ratio in urine and/or basal plasma HT levels which normalize after the administration of vitamin B12; b) its relationship with plasma vitamin B12 levels. SUBJECTS AND METHODS: A total of 45 subjects were studied, 19 in the Group of Gastrectomized patients, who were selected on the basis of an age over 60 years and partial gastrectomy of more than five years, and 26 in the Geriatric Group selected in two nursing homes. All of them were asymptopatic and "healthy" according to data in the clinical records and clinical examination, analytical studies, and none of them was taking any drug that might alter results. After basal analytical studies, which included B12, folates, metilmalonic acid/creatinine (MMA/creatinine) in urine and total plasma homocysteine (TH), i.m. vitamin B12 was administered for 15 days to the gastrectomized patients and oral B12 for 28 days with 2.5 mg folic acid for the last 14 days to the patients in the Geriatric Group. Basal analytical studies were repeated at the end of the study. RESULTS: Basal analytical studies were normal with the exception of two subjects with low levels of hemoglobin and 8 with decreased MCV. Only one subject had decreased serum cobalamines. Nine subjects (20%) were identified with increased basal levels of MMA/creatinine which normalized after decreasing between 97% and 12% after the administration of vitamin B12. TH and MCV also decreased significantly. Basal levels of vitamin B12 ranged from 244 pg/ml to 483 pg/ml (n = 220 pg/ml-980 pg/ml). CONCLUSIONS: Vitamin B12 deficiency, defined as an increase in the MMA/creatinine ratio and TH normalized with B12, is highly prevalent among elderly subjects and may occur in absence of clinical and/or analytical manifestations. Given the widespread recommendation of quantitating MMA and TH for the diagnosis of borderline cases of vitamin B12 deficiency, such disturbance may occur in clinically and biochemically normal subjects. Thus, a special caution should be exerted, given the existing comorbidity in advanced ages, before attributing B12 deficiency to a condition which may be the expression of another concomitant condition.


Subject(s)
Gastrectomy , Vitamin B 12 Deficiency , Age Factors , Aged , Creatinine/urine , Data Interpretation, Statistical , Homocysteine/blood , Humans , Methylmalonic Acid/urine , Middle Aged , Vitamin B 12/blood , Vitamin B 12/therapeutic use , Vitamin B 12 Deficiency/blood , Vitamin B 12 Deficiency/diagnosis , Vitamin B 12 Deficiency/drug therapy
6.
Rev. clín. esp. (Ed. impr.) ; 201(2): 75-80, feb. 2001.
Article in Es | IBECS | ID: ibc-6821

ABSTRACT

Objetivo: El objetivo de este trabajo es investigar en una población de edad avanzada, clínicamente 'sana' y asintomática, en la que se supone una alta prevalencia de carencia de B12, el déficit de esta vitamina definido por un aumento del ácido metilmalónico (AMM)/creatinina en orina y/o de la homocisteína total plasmática (HT) plasmática basal que se normalizan tras la administración de B12, así como su relación con los niveles plasmáticos de dicha vitamina.Sujetos y métodos: Se estudian un total de 45 sujetos pertenecientes 19 al Grupo de Gastrectomizados y seleccionados por ser mayores de 60 años y una gastrectomía parcial de más de 5 años de antigüedad y 26 al Grupo Geriátrico seleccionados en dos residencias geriátricas. Todos estaban asintomáticos y 'sanos' de acuerdo a los datos de la historia y exploración clínica, estudios analíticos, y ninguno tomaba ninguna vitamina ni ningún fármaco que pudiese alterar los resultados. Después de los estudios analíticos basales, que incluían B12, folatos, AMM/creatinina en orina y HT, se administró B12 por vía intramuscular durante 15 días al Grupo de Gastrectomizados y B12 por vía oral durante 28 días con 2,5 mg de ácido fólico durante los últimos 14 días al Grupo Geriátrico. Al finalizar se repitieron los estudios analíticos basales. Resultados: Los estudios analíticos basales fueron normales excepto en dos sujetos con niveles bajos de hemoglobina y ocho con VCM disminuidos. Sólo un sujeto tenía cobalaminas séricas disminuidas. Se identificaron nueve sujetos (20 por ciento) con niveles basales elevados de AMM/creatinina que se normalizaron después de disminuir entre el 97 por ciento y 12 por ciento tras la administración de B12. También descendieron significativamente la HT y el volumen corpuscular medio (VCM). Los valores basales de B12 oscilaban entre 244 y 483 pg/ml (valores normales = 220-980 pg/ml). Conclusiones: La carencia de B12 definida por el aumento del AMM/creatinina y de la HT que se normalizan con B12 tiene una elevada prevalencia en las edades avanzadas y puede ocurrir en ausencia de manifestaciones clínicas y/o analíticas. Dada la recomendación cada vez más extendida de cuantificar el AMM y la HT en el diagnóstico de los casos dudosos de carencia de B12, debe conocerse que dicha alteración puede ocurrir en sujetos clínica y analíticamente normales, lo que aconseja, dada la comorbilidad existente en las edades avanzadas, una especial prudencia antes de atribuir a la carencia de B12 una patología que puede ser la expresión de otra enfermedad concomitante (AU)


No disponible


Subject(s)
Middle Aged , Aged , Humans , Vitamin B 12 Deficiency , Gastrectomy , Vitamin B 12 , Creatinine , Data Interpretation, Statistical , Age Factors , Homocysteine , Methylmalonic Acid
7.
Rev Esp Med Nucl ; 19(4): 288-92, 2000 Aug.
Article in Spanish | MEDLINE | ID: mdl-11062100

ABSTRACT

The PET-FDG is a useful method to assess the post-radiotherapy residual masses in supradiaphragmatic lymphoma patients. We present the case of a patient with residual mediastinic mass revealed by CT after the patient had completed treatment for Hodgkin's disease and in whom the PET study demonstrated a typical pattern of post-radiation pneumonitis. When these patients are re-assessed early after radiotherapy, the different tracer uptake patterns should be taken into account in order to identify the existence of radiotherapy sequela and avoid false positive results.


Subject(s)
Fluorodeoxyglucose F18 , Hodgkin Disease , Mediastinal Neoplasms/secondary , Radiation Pneumonitis/etiology , Radiopharmaceuticals , Tomography, Emission-Computed , Adult , Humans , Male
8.
Rev. esp. med. nucl. (Ed. impr.) ; 19(4): 288-292, ago. 2000.
Article in Es | IBECS | ID: ibc-5802

ABSTRACT

El PET-FDG es útil en la valoración de masas residuales postradioterapia en pacientes con linfomas supradiafragmáticos. Presentamos el caso de un paciente con masa residual mediastínica en TAC tras completar el tratamiento por enfermedad de Hodgkin y que una exploración PET mostraba un patrón de captación típica de neumonitis postradiación. En la reevaluación temprana de estos pacientes debe tenerse en cuenta los patrones de captación del radiofármaco para identificar la existencia de secuelas de la radioterapia y evitar falsos positivos (AU)


No disponible


Subject(s)
Adult , Male , Humans , Tomography, Emission-Computed , Hodgkin Disease , Radiopharmaceuticals , Radiation Pneumonitis , Fluorodeoxyglucose F18 , Mediastinal Neoplasms , Fluorodeoxyglucose F18
9.
An Med Interna ; 8(2): 69-73, 1991 Feb.
Article in Spanish | MEDLINE | ID: mdl-1893006

ABSTRACT

The benefit of the immunomodulation properties of thymic hormones in patients receiving chemotherapy for malignant diseases is yet to be defined. The efficacy of thymostimulin (TP-1) on hematological tolerance is evaluated, the performance level, the number and severity of the infections and skin reactions in two groups of homogeneous and randomized patients, diagnosed as having lymphoma and myeloma. Both patient groups (receiving or not receiving treatment) consisted of 20 persons. This observation was carried out in 96 courses of chemotherapy in each group; no significant differences having been noted in respect of the performance status at the beginning nor at the end of the study period between the 2 treatment groups. The hematological tolerance to chemotherapy, skin reactions and number and severity of infections registered were not significantly different between the 2 groups. In conclusion, we were unable to confirm an improvement in the clinical parameters of the myeloma and lymphoma patients receiving chemotherapy and thymostimulin during the period of observation.


Subject(s)
Hodgkin Disease/therapy , Lymphoma, Non-Hodgkin/therapy , Multiple Myeloma/therapy , Thymus Extracts/therapeutic use , Humans
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