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1.
Am J Hematol ; 98(6): E134-E138, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36882876

RESUMO

(A) Correlation matrix of unsupervised co-regulated genes, based on the 208 genes included in the NanoString platform. Some of the clusters of co-regulated genes corresponded to the following: Inflammatory cells; Epstein-Barr virus; B-cells; Cytotoxic T-cells; T-cells; and Proliferation. (B) Analysis of genomic alterations by targeted sequencing. Distribution of mutations in the 62 analyzed genes. Rows correspond to sequenced genes, columns represent individual patients. Color coding: green, missense; blue, synonymous; pink, frameshift; violet, Indel; red, stop gained; yellow, UTR.


Assuntos
Infecções por Vírus Epstein-Barr , Linfoma Extranodal de Células T-NK , Humanos , Herpesvirus Humano 4/genética , Infecções por Vírus Epstein-Barr/complicações , Infecções por Vírus Epstein-Barr/genética , Infecções por Vírus Epstein-Barr/patologia , Linfoma Extranodal de Células T-NK/terapia , Mutação , Células Matadoras Naturais/patologia
2.
Hematol Oncol ; 40(3): 370-380, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35168291

RESUMO

Rapid infusion (RI) of the rituximab biosimilar CT-P10 is currently only an approved treatment regimen for the treatment of rheumatoid arthritis. Although both CT-P10 and reference rituximab are known to be frequently administered using a RI regimen (≤90 min) in clinical practice, published data on the safety of RI of CT-P10 in patients with NHL and CLL are limited. Hence, this study collected real-world safety and effectiveness data on RI-CT-P10 from the medical records of 196 patients with NHL or CLL in 10 European centers, 6 months after the date of the first RI (index date); the infusion-related reaction (IRR) rate was compared to previously published data. Ten percent (95% confidence interval 6%-15%; n = 20/196) of patients experienced an infusion-related reaction (IRR) on day 1-2 post-index, which was not significantly different (p = 0.45) to the IRR rate for rituximab described in a previous meta-analysis (8.8%). During the observation period, 2% of patients experienced grade 3-5 IRRs and 85% (n = 166) experienced an adverse event (non-IRR). The most common reason for discontinuation of first-line CT-P10 was planned treatment completion (81%; n = 158). Complete response and partial response to CT-P10 was observed in 74% (n = 142/192) and 22% (n = 42/192) of patients, respectively. The results of this real-world study demonstrate that the safety and effectiveness profile of RI-CT-P10 is similar to RI of reference rituximab and therefore support the current use of RI-CT-P10 in patients with NHL and CLL.


Assuntos
Medicamentos Biossimilares , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Leucemia Linfocítica Crônica de Células B , Linfoma não Hodgkin , Anticorpos Monoclonais Murinos , Medicamentos Biossimilares/efeitos adversos , Humanos , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Linfoma não Hodgkin/tratamento farmacológico , Estudos Retrospectivos , Rituximab/efeitos adversos , Resultado do Tratamento
3.
Pharmacogenet Genomics ; 27(2): 70-77, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27977511

RESUMO

OBJECTIVE: Rituximab in combination with chemotherapy has been proven to increase progression-free and overall survival in follicular lymphoma (FL), but there is considerable interindividual variability in the response. Extrinsic pathway apoptosis triggered by death receptors seems to be involved in the mechanism of action of monoclonal antibodies. This study aimed to assess the association between TRAILR1/TRAIL polymorphisms (rs20575, rs20576, rs2230229, rs12488654) and rituximab response and the relationship with FASL rs763110, previously found to be associated with rituximab response. PATIENTS AND METHODS: Polymorphisms were determined in a study cohort of 125 FL patients treated with rituximab as first-line treatment and correlated with response, which was scored according to the International Working Group Consensus Revised as complete response, partial response, stable disease, and progressive disease. RESULTS: No significant association with response was found for rs20576, rs2230229, and rs12488654 polymorphisms. In contrast, rs20575 GC/GG carriers were more partial/nonresponders (88.2%) than complete responders (72.5%), showing a trend toward statistical significance (P=0.064). In a multivariable setting, we found that female sex [odds ratio=0.355, 95% confidence interval (CI): 0.137-0.922, P=0.033] and the TRAILR1 rs20575 CC genotype (odds ratio=0.162, 95% CI: 0.035-0.757, P=0.021) were independent positive predictive factors of complete clinical response to rituximab, constructing a parsimonious model with good calibration [χ of 5.719 (d.f.=6, P=0.455)] and discrimination (C-statistic=0.739, 95% CI: 0.636-0.842). CONCLUSION: After studying the pharmacogenetic role of TRAILR1/TRAIL polymorphisms in rituximab-treated FL patients, we found that the rs20575 CC genotype is an independent predictive factor of better rituximab response, indicating the possible involvement of death receptors in anti-CD20 mechanisms of action.


Assuntos
Antineoplásicos/administração & dosagem , Proteína Ligante Fas/genética , Linfoma Folicular/tratamento farmacológico , Polimorfismo de Nucleotídeo Único , Receptores do Ligante Indutor de Apoptose Relacionado a TNF/genética , Rituximab/administração & dosagem , Adulto , Idoso , Antineoplásicos/farmacocinética , Apoptose , Intervalo Livre de Doença , Feminino , Humanos , Linfoma Folicular/genética , Masculino , Pessoa de Meia-Idade , Variantes Farmacogenômicos , Rituximab/farmacocinética , Análise de Sobrevida , Resultado do Tratamento
4.
Acta Haematol ; 136(2): 76-84, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27188649

RESUMO

BACKGROUND/AIMS: Rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) every 14 days seems to achieve better outcomes than R-CHOP every 21 days in diffuse large B-cell lymphoma (DLBCL) patients. Currently, the standard regimen is R-CHOP every 21 days. METHODS: This is a phase II clinical trial of treatment with 6 cycles of R-CHOP-14 with pegfilgrastim support in 2 populations of previously untreated DLBCL patients aged ≥65 years (n = 73) or <65 years (n = 51) with low-risk International Prognostic Index scores (0-2). RESULTS: With a median follow-up of 63.7 months, the 5-year event-free survival rate was 53.8% in patients aged ≥65 years and 71.0% in patients aged <65 years. The 5-year overall survival rate was 71.4 and 89.8%, respectively. The complete remission rate was 69.9% for older and 80.4% for younger patients. The median relative dose intensity of cytotoxic drugs was 143.2% in the elderly and 149.1% in the young patients. Febrile neutropenia was the most common grade 3-4 adverse event, being higher in elderly patients (21.3 vs. 9.3%). Eight deaths (7 in elderly patients) were considered treatment related. CONCLUSION: In conclusion, the R-CHOP-14 regimen is feasible and very active, though it is more toxic in elderly patients mainly due to an increased incidence of infections. New strategies, such as new monoclonal antibodies or new targeted therapies, are needed to improve the outcomes of DLBCL patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Esquema de Medicação , Feminino , Filgrastim , Fator Estimulador de Colônias de Granulócitos/efeitos adversos , Humanos , Estudos Longitudinais , Linfoma Difuso de Grandes Células B/mortalidade , Linfoma Difuso de Grandes Células B/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neutropenia/induzido quimicamente , Neutropenia/diagnóstico , Neutropenia/patologia , Polietilenoglicóis , Prednisona/administração & dosagem , Prednisona/efeitos adversos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Indução de Remissão , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento , Vincristina/administração & dosagem , Vincristina/efeitos adversos
5.
Am J Hematol ; 90(8): 686-90, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25925613

RESUMO

Bone marrow infiltration (BMI), categorized as an extra-nodal site, affects stage and is associated with poor prognosis in newly diagnosed lymphoma patients. We have evaluated the accuracy of PET/CT and bone marrow biopsy (BMB) to assess BMI in 372 lymphoma patients [140 Hodgkin Lymphoma (HL) and 232 High Grade B-cell non-Hodgkin Lymphoma (HG B-NHL), among them 155 Diffuse Large B-Cell Lymphoma (DLCL)]. For HL cases, and taking into account PET/CT, sensitivity, negative predictive value (NPV) and accuracy were 96.7, 99.3, and 99.3% while those of BMB were 32.3, 83.8, and 85%, respectively. For HG B-NHL and considering PET/CT, sensitivity, NPV, and accuracy were 52.7, 81.7, and 84.1%, while those of BMB were 77.6, 90.2, and 90.7%, respectively. In the HG B-NHL group, 25 patients would have been under-staged without BMB. These results lead us to recommend PET/CT and the avoidance of BMB to assess BMI in HL. In the case of HG B-NHL, bone marrow status should be assessed firstly by means of PET/CT; only in either focal or diffuse PET/CT with low borderline SUV max values or in negative cases, should BMB be carried out afterwards. In the HG B-NHL setting and at the present moment, both techniques are complementary.


Assuntos
Medula Óssea/patologia , Doença de Hodgkin/diagnóstico , Linfoma não Hodgkin/diagnóstico , Adolescente , Adulto , Idoso , Biópsia , Feminino , Fluordesoxiglucose F18/metabolismo , Doença de Hodgkin/metabolismo , Doença de Hodgkin/patologia , Humanos , Linfoma não Hodgkin/classificação , Linfoma não Hodgkin/metabolismo , Linfoma não Hodgkin/patologia , Masculino , Pessoa de Meia-Idade , Imagem Multimodal/métodos , Gradação de Tumores , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons , Tomografia Computadorizada por Raios X
7.
Clin Cancer Res ; 2024 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-38900037

RESUMO

PURPOSE: This phase II clinical trial evaluated the combination of Ibrutinib with rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with non-germinal centre B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). PATIENTS AND METHODS: The IBDCL trial (NCT02692248) included patients with histological diagnosis of non-GCB DLBCL with relapsed or refractory disease and non-candidates for stem cell transplantation. Patients received an induction treatment consisting of 6 or 8 cycles of R-GemOx at standard doses every 2 weeks, in combination with ibrutinib (560 mg daily), followed by a maintenance treatment with ibrutinib for a maximum of 2 years. The primary objective was to evaluate the overall response rate (ORR) after 4 cycles. RESULTS: Sixty-four patients were included, 72% of them refractory to the last regimen. The ORR and CR rate after the 4th cycle were 53% (95% confidence interval [CI], 41-65) and 34% (95% CI, 24-46), respectively. Twenty-four (37%) patients started maintenance and 7 (11%) completed the planned 2 years. After a median follow-up of 29.7 months (range: 0.4-48.6), the estimated 2-year PFS and OS were 18% (95% CI, 8 - 28) and 26% (95% CI, 14 - 37), respectively. The most common grade ≥3 treatment-related adverse events (TRAEs) were thrombocytopenia (44%), neutropenia (30%) and anemia (14%). Grade ≥3 infectious and cardiovascular TRAEs were reported in 6 (9%) and 1 (2%) patient, respectively. CONCLUSIONS: Ibrutinib in combination with R-GemOx, followed by ibrutinib maintenance, demonstrated encouraging antitumor activity with durable responses and a manageable toxicity in patients with non-GCB DLBCL.

8.
Cancer Med ; 12(6): 6536-6546, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36373169

RESUMO

BACKGOUND: In the workup of follicular lymphoma (FL), bone marrow biopsy (BMB) assessment is a key component of FLIPI and FLIPI2, the most widely used outcome scores. During the previous decade, several studies explored the role of FDG-PET/CT for detecting nodal and extranodal disease, with only one large study comparing both techniques. METHODS: The aim of our study was to evaluate the diagnostic accuracy and the prognostic impact of both procedures in a retrospective cohort of 299 FL patients with both tests performed at diagnosis. In order to avoid a collinearity bias, FLIPI2 was deconstructed in its founding parameters, and the bone marrow involvement (BMI) parameter separately included as: a positive BMB, a positive PET/CT, the combined "PET/CT and BMB positive" or "PET/CT or BMB positive". These variables were also confronted independently with the POD24 in 233 patients treated with intensive regimens. RESULTS: In the total cohort, bone marrow was involved in 124 and 60 patients by BMB and PET/CT, respectively. In terms of overall survival, age > 60 y.o. and the combined "PET/CT or BMB positive" achieved statistical independence as a prognostic factor. In patients treated with an intensive regimen, only the combined "PET/CT or BMB positive" added prognostic value for a shorter overall survival, when confronted with the POD24. CONCLUSION: Our results show that in FL both BMB and PET/CT should be considered at diagnosis, as their combined assessment provides independent prognostic value in the context of the most widely use clinical scores.


Assuntos
Linfoma Folicular , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Humanos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Fluordesoxiglucose F18 , Linfoma Folicular/diagnóstico por imagem , Linfoma Folicular/patologia , Medula Óssea/diagnóstico por imagem , Medula Óssea/patologia , Prognóstico , Estudos de Coortes , Estudos Retrospectivos , Tomografia por Emissão de Pósitrons/métodos , Biópsia
10.
Int J Rheum Dis ; 22(12): 2170-2177, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31659854

RESUMO

AIM: In common clinical practice, potentially traumatic life events and the possible attribution of such events to fibromyalgia often go undetected. Having demonstrated in a previous study that hypnosis facilitates the exploration of such events, we now aim to explore and classify the content of these events and to determine whether there is an association between the type of event, the state of consciousness in which the patient verbalized it, and possible causal attributions of the disorder. METHOD: Thirty-two women (age 52 ± 7 years) suffering from fibromyalgia and receiving care in a primary healthcare center participated in the same semi-structured interview twice: once in a wakeful state and once under hypnosis. They answered two questions: what other events in your life coincided with the onset of fibromyalgia? Are those events related to your fibromyalgia in any way? To counteract biases related to order or recall, the order of the two interviews was randomized with a 3-month period in between. RESULTS: The patients verbalized 23 different types of events, which we classified into eight categories, mostly psychosocial events. Although the relationship between the three variables was not statistically significant, two of the bivariate associations predicted (type of event and state of consciousness; and state of consciousness and causal attribution) were confirmed (χ2 , P values of .01 and <.001 respectively). CONCLUSION: Potentially traumatic life events could remain undetected in primary healthcare consultations and hypnosis could prove a useful tool for their detection.


Assuntos
Fibromialgia/etiologia , Hipnose , Acontecimentos que Mudam a Vida , Estresse Psicológico/complicações , Estado de Consciência , Feminino , Fibromialgia/diagnóstico , Fibromialgia/psicologia , Humanos , Entrevistas como Assunto , Estudos Longitudinais , Pessoa de Meia-Idade , Medição de Risco , Fatores de Risco , Estresse Psicológico/diagnóstico , Estresse Psicológico/psicologia , Fatores de Tempo
11.
Int J Clin Exp Hypn ; 66(1): 3-18, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29319461

RESUMO

To determine whether hypnosis is more effective than conventional interviewing to find traumatic life events in patients with fibromyalgia, we carried out a within-subject experimental design with complete intragroup counterbalancing. Thirty-two women under care in a public primary care center gave 2 identical interviews, with an interval of 3 months, in which the occurrence of traumatic life events was explored, once in a state of wakefulness and once in a state of hypnosis. The state of consciousness was evaluated using 3 measures: bispectral index, skin conductance level, and pain intensity. In the hypnotic state, the patients expressed 9.8 times more traumatic life events than in the waking state, a statistically significant difference with a large effect size.


Assuntos
Fibromialgia/psicologia , Hipnose , Entrevista Psicológica , Estresse Psicológico/diagnóstico , Feminino , Fibromialgia/etiologia , Humanos , Hipnose/métodos , Entrevista Psicológica/métodos , Pessoa de Meia-Idade , Estresse Psicológico/complicações , Estresse Psicológico/psicologia
12.
Cancer Med ; 6(11): 2507-2514, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28960797

RESUMO

Several studies have reported uneven results when evaluating the prognostic value of bone marrow biopsy (BMB) and PET/CT as part of the staging of diffuse large B-cell lymphoma (DLBCL). The heterogeneity of the inclusion criteria and not taking into account selection and collinearity biases in the analysis models might explain part of these discrepancies. To address this issue we have carried a retrospective multicenter study including 268 DLBCL patients with a BMB and a PET/CT available at diagnosis where we estimated both the prognosis impact and the diagnostic accuracy of each technique. Only patients treated with R-CHOP/21 as first line (n = 203) were included in the survival analysis. With a median follow-up of 25 months the estimated 3-year progression-free survival (PFS) and overall survival (OS) were 76.3% and 82.7% respectively. In a multivariate analysis designed to avoid a collinearity bias with IPI categories, BMB-BMI [bone marrow involvement](+) (HR: 3.6) and ECOG PS > 1 (HR: 2.9) were independently associated with a shorter PFS and three factors, age >60 years old (HR: 2.4), ECOG PS >1 (HR: 2.4), and abnormally elevated B2-microglobulin levels (HR: 2.2) were independently associated with a shorter OS. In our DLBCL cohort, treated with a uniform first-line chemotherapy regimen, BMI by BMB complemented performance status in predicting those patients with a higher risk for relapse or progression. In this cohort BMI by PET/CT could not independently predict a shorter PFS and/or OS.


Assuntos
Medula Óssea/diagnóstico por imagem , Medula Óssea/patologia , Linfoma Difuso de Grandes Células B/diagnóstico por imagem , Linfoma Difuso de Grandes Células B/patologia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Murinos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biópsia , Ciclofosfamida/uso terapêutico , Intervalo Livre de Doença , Doxorrubicina/uso terapêutico , Feminino , Seguimentos , Nível de Saúde , Humanos , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Prednisona/uso terapêutico , Estudos Retrospectivos , Rituximab/administração & dosagem , Taxa de Sobrevida , Vincristina/uso terapêutico , Adulto Jovem , Microglobulina beta-2/sangue
13.
Arch Surg ; 141(1): 82-5, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16415416

RESUMO

HYPOTHESIS: Complications associated with thyroidectomy for intrathoracic goiters have been underestimated because of the lack of a precise definition of high-risk patients. DESIGN: Retrospective multicenter multinational review of medical records and radiographic images of patients who underwent thyroidectomy for intrathoracic goiters reaching the carina tracheae. Demographic, clinical, operative, anatomical, and pathological data were recorded. RESULTS: There were 35 patients (mean +/- SE age, 63 +/- 11 years) included in the study. In 4 patients, the goiter was asymptomatic; 10 patients had dysphagia, 24 patients had dyspnea, and 3 patients had superior vena cava syndrome. A median sternotomy was required in 12 patients and a right-sided thoracotomy in 1 patient. The mean +/- SE operative time was 145 +/- 72 minutes (range, 50-360 minutes). Transient hypoparathyroidism developed in 13 patients. Four patients experienced transient hoarseness, and 1 patient had permanent vocal cord paralysis. There were no significant differences between the proportion of patients who underwent or did not undergo sternotomy or thoracotomy regarding vocal cord dysfunction (2 [15%] of 13 patients vs 3 [13%] of 22 patients) or hypoparathyroidism (5 [38%] of 13 vs 6 [28%] of 22 patients). The mean postoperative hospital stay was 10 days (range, 2-84 days). Four patients required reoperation. Two patients died. Nine of 14 patients with thyroid glands weighing at least 260 g required sternotomy vs 3 of 14 patients with thyroid glands weighing less than 260 g (P = .02). Overall, 18 [52%] of 35 patients were discharged without any complication. CONCLUSION: Intrathoracic goiters reaching the carina tracheae carry a high unreported risk of sternotomy, postoperative complications, reoperation, and death.


Assuntos
Bócio Subesternal/cirurgia , Tireoidectomia/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Bócio Subesternal/patologia , Humanos , Hipoparatireoidismo/etiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Reoperação , Esterno/cirurgia , Tireoidectomia/mortalidade
14.
Int Surg ; 88(4): 205-10, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14717526

RESUMO

Retrosternal goiters still pose a problem to expert endocrine surgeons. Whether surgery should be the treatment of choice or not remains controversial because of hypothetical increased morbidity rates associated with the surgical approach. Eighty-three patients were retrospectively reviewed for anesthetic risk, fibrobronchoscopic guidance for intubation, surgical technique, mortality and morbidity rates, and pathological findings. We found 6.09% of American Society of Anesthesiologists (ASA) I, 41.46% of ASA II, 40.24% of ASA III, and 12.19% of ASA IV risk. Twelve patients (14.45%) required fibrobronchoscopic guidance for intubation. Only one patient required a sternotomy. No mortality occurred. Seven patients (8.43%) had major complications, but there were no instances of permanent recurrent laryngeal palsy or hypocalcemia. Pathological examination revealed 9.63% incidence of malignancy. Surgery should be the treatment of choice for retrosternal goiters because there is a significant incidence of malignancy and an acceptable morbidity rate.


Assuntos
Bócio Subesternal/cirurgia , Complicações Pós-Operatórias/etiologia , Tireoidectomia/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tireoidectomia/mortalidade , Resultado do Tratamento
15.
Med Clin (Barc) ; 123(11): 401-5, 2004 Oct 02.
Artigo em Espanhol | MEDLINE | ID: mdl-15482712

RESUMO

BACKGROUND AND OBJECTIVE: Peripheral blood hematopoietic progenitor cell transplantation (PCT), both autologous and allogeneic, has been consolidated in the last decades as an important tool in the treatment of a number of oncohematologic malignancies. Nevertheless, there are scarce data about the real cost of the autologous procedure in our setting, and to date the economic impact of allogeneic PCT in our health system is unknown. PATIENTS AND METHOD: In the present study a comparative analysis of the economic cost of both methods of PCT was carried out in a series of 67 consecutive patients who were eligible for autologous PCT (n = 48), or allogeneic PCT (n = 19) in a 2 year study period. The expenses derived from pretransplant studies, from the collection and processing of hematopoietic progenitors, and from the transplantation procedure itself were evaluated. RESULTS: The collection of hematopoietic progenitors was significantly more expensive in autologous than in allogeneic PCT (p = 0.0001), owing both to the difficulty in the mobilization of such cells in patients who have been treated for the underlying disease and to the higher costs derived from the criopreservation of the collected material. Nevertheless, the costs of the pretransplant studies were significantly higher in allogeneic PCT due to the expenses of histocompatibility studies (p = 0.0001). Similarly, the costs derived from the transplantation procedure itself were significantly higher in allogeneic procedures (p = 0.0002) as those patients required a longer hospitalization, and also because of the higher number of patients requiring conditioning regimens including total body irradiation. CONCLUSIONS: From these data we conclude that the real cost of PCT in our setting is 24,000 Euros for the autologous procedure, while it is 34,000 Euros in the context of allogeneic transplantation.


Assuntos
Transplante de Células-Tronco de Sangue Periférico/economia , Adulto , Feminino , Humanos , Masculino , Espanha
16.
Lancet Haematol ; 1(3): e104-11, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27029228

RESUMO

BACKGROUND: No standard first-line systemic treatment for mucosa-associated lymphoid tissue (MALT) lymphoma is available. In a phase 2 study we aimed to assess the safety and activity of a response-adapted combination of bendamustine plus rituximab as upfront treatment for this type of lymphoma. METHODS: In a multicentre, single-arm, non-randomised, phase 2 trial, we enrolled patients with MALT lymphoma at any site and stage and treated them with bendamustine (90 mg/m(2) on days 1 and 2) plus rituximab (375 mg/m(2) on day 1), every 4 weeks. Inclusion criteria were measurable or evaluable disease, age 18-85 years, and unequivocal active lymphoma; we also enrolled patients with MALT lymphoma arising in the stomach after failure of Helicobacter pylori eradication and primary cutaneous cases after failure of local therapies. Exclusion criteria included evidence of histological transformation, CNS involvement, and active hepatitis B or C virus or HIV infection. After three cycles, patients achieving complete response received one additional cycle (total four cycles) and those achieving partial response received three additional cycles (total six cycles). The primary endpoint was 2-year event-free survival. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01015248. FINDINGS: 60 patients from 19 centres in Spain were enrolled between May 27, 2009, and May 23, 2011, and received treatment; 57 patients were evaluable for the primary endpoint. Only 14 (25%) patients needed more than four cycles of treatment. After a median follow-up of 43 months (IQR 37-51), median event-free survival was not reached. Event-free survival at 2 years was 93% (95% CI 84-97) and at 4 years was 88% (95% CI 74-95). The most frequently observed grade 3-4 adverse events were haematological: lymphopenia in 20 (33%) patients, neutropenia in 12 (20%) patients, and leucopenia in three (5%) patients. Grade 3-4 febrile neutropenia or infections were reported in three (5%) and four (7%) patients, respectively. INTERPRETATION: This response-adapted schedule of bendamustine plus rituximab appears to be an active and well tolerated first-line treatment for patients with MALT lymphoma. FUNDING: Grupo Español de Linfomas/Trasplante de Médula Ósea (GELTAMO), Mundipharma Spain, and Roche Pharma Spain.

17.
Cir Esp ; 84(3): 154-7, 2008 Sep.
Artigo em Espanhol | MEDLINE | ID: mdl-18783674

RESUMO

INTRODUCTION: Spigelian hernias in childhood are extremely uncommon. The aim of this study was to analyse the pathogenetic factors of paediatric Spigelian hernias. PATIENTS AND METHOD: A retrospective review of worldwide literature for infants who had undergone surgical repair of a Spigelian hernia from 1950 to 2006. Descriptive statistical techniques were applied and percentages and means were calculated. RESULTS: There were 33 patients in whom 40 Spigelian hernias were repaired, 26 males and 7 females, with a sex ratio of 3.7/1. The mean age was 2.7 years. 7 hernias are bilateral. RISK FACTORS: anal stenosis (n = 1). Associated defects: cryptorchidism (n = 22), inguinal hernia (n = 5), umbilical hernia (n = 2). The most common hernia contents are testicle (40%), small intestine ( 27.5%) and omentum (15%). CONCLUSIONS: The mean age of Spigelian hernia in children was 2.7 years, which would suggest a congenital cause. Spigelian hernias in infants are more common in males. There were 21.2% bilateral hernias. No risk factors were detected. Combined hernias accounted for 15.1% of the total. The most frequent hernia content is the testicle (40%). Interestingly, 48.4% of those infants with Spigelian hernias had ipsilateral cryptorchidism, which may suggest a new syndrome.


Assuntos
Criptorquidismo/cirurgia , Hérnia/congênito , Herniorrafia , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Cuidados Pré-Operatórios , Estudos Retrospectivos , Fatores de Risco
18.
Cir Esp ; 80(4): 206-13, 2006 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-17040670

RESUMO

INTRODUCTION: The recent reintroduction of local/regional anesthesia (LRA) for thyroidectomy has enabled this intervention to be performed in the outpatient setting. The aim of this study was to compare the results of thyroidectomy using two anesthesia methods. PATIENTS AND METHODS: One hundred twenty-five patients requiring thyroidectomy and who met the criteria for outpatient surgery were prospectively selected. The patients were offered LRA plus sedation; patients who did not accept this option were offered LRA combined with orotracheal intubation (CLRA). LRA was accepted by 58 patients and CLRA by 67. Age, sex, anesthesia risk, body mass index, and thyroid function were similar in both groups. Postoperative vomiting, pain at discharge, need for admission, postoperative morbidity, and complaints occurring at home were evaluated. RESULTS: Sixty-one bilateral and 64 unilateral thyroidectomies were performed, with no statistically significant difference between the two groups. There were no differences in surgical time, conversion to general anesthesia, intraoperative events, pathological diagnosis, or size and weight of the surgical specimen. The only difference between the two groups was the hour of discharge (LRA: 6.5 +/- 1.2 hours; CLRA: 7.76 +/- 2.07 hours; p = 0.0003). The admission rate was higher in the CLRA group (22.4%) than in the LRA group (8.62%); this difference was not statistically significant (p = 0.06) and the main cause was personal preference in patients in the CLRA group. Rates of postoperative morbidity, vomiting (7.2%) and nausea (6.4%), postoperative pain (2.47 +/- 1.85 on a visual analog scale), and analgesic requirements showed no differences between the two groups. One patient in the LRA group developed a noncompressive asymptomatic neck hematoma 36 hours after discharge. The patient was admitted for observation but did not require reoperation. Complaints occurring at home were minor. Satisfaction with the procedure was high or very high in 95% of the patients, with no differences between the two groups. CONCLUSIONS: In selected patients, outpatient thyroidectomy is safe and produces good patient satisfaction. Both anesthesia methods were valid, but postoperative recovery was faster with LRA than with CLRA.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/métodos , Anestesia por Condução , Tireoidectomia/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Complicações Pós-Operatórias , Estudos Prospectivos , Tireoidectomia/efeitos adversos , Resultado do Tratamento
19.
Cir Esp ; 80(1): 23-6, 2006 Jul.
Artigo em Espanhol | MEDLINE | ID: mdl-16796949

RESUMO

INTRODUCTION: Nodular goiter (NG) is frequent among the general population and is considered a diffuse disease. Although NGs are rarely unilateral, they pose a dilemma in terms of the extent of the thyroidectomy. The aim of the present study was to evaluate the remaining thyroid in patients with NG compared with those with follicular adenoma who underwent hemithyroidectomy. PATIENTS AND METHODS: Patients who underwent surgery for unilateral NG with over 10 years of postoperative follow-up and normal findings on ultrasonography of the contralateral thyroid lobe were selected to form the study group (SG). Patients with follicular adenoma (with normal contralateral ultrasonography) who underwent hemithyroidectomy during the same period were selected to form the control group (CG). The selected patients underwent clinical, laboratory and ultrasound examinations. Both groups were compared statistically. No significant differences were found in age, gender, anesthetic risk, side, postoperative complications, length of hospital stay, or postoperative outcome. RESULTS: Less than 10% of the patients reported symptoms, and all symptoms were of little significance. Ultrasonographic nodules were found in the remaining thyroid lobe in 70% of patients in the SG and in 60% of those in the CG, with no statistically significant differences. The mean size of the largest nodule was 13.58 +/- 8.01 in the SG and 9.15 +/- 5.93 in the GC (p = 0.048). No differences were found in the anterior-posterior, transverse or longitudinal diameters of the remaining lobe. None of the patients underwent reintervention for nodular disease. CONCLUSIONS: After hemithyroidectomy, both groups of patients developed nodules in the remaining thyroid lobe, with no statistically significant differences. Hemithyroidectomy due to unilateral NG involves less risk to the patient and therefore we consider it to be a valid option. Long-term ultrasonographic follow-up seems advisable.


Assuntos
Bócio Nodular/cirurgia , Glândula Tireoide/patologia , Tireoidectomia/métodos , Adulto , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Glândula Tireoide/cirurgia , Fatores de Tempo
20.
Cir Esp ; 78(5): 323-7, 2005 Nov.
Artigo em Espanhol | MEDLINE | ID: mdl-16420850

RESUMO

INTRODUCTION: The aim of this study was to analyze the influence of superspecialization in endocrine surgery on the standard of thyroidectomy, both before and after the creation of an endocrine surgery unit. PATIENTS AND METHODS: We performed a retrospective, comparative study of two 7-year periods. Three hundred forty thyroidectomies (G1) were performed before the instauration of the unit, and 583 were carried out afterwards (G2). The variables of age, gender, anesthesia risk, surgeon expertise (staff vs. resident), thyroid function, pathological features, intrathoracic growth, extent of the procedure (unilateral or bilateral), neck drainage, morbidity and mortality and length of hospital stay were compared. RESULTS: Age was older in G2 (G1: 44.7 +/- 15 years old, G2: 48.09 +/- 16.3 years old; p < 0.001). There were no differences (p NS) between the two groups in gender, anesthesia risk, thyroid function or rate of benign/malignant disease, but there was a greater frequency of nodular (p = 0.009) and intrathoracic goiters (p = 0.0004) in the second period. Residents operated on more patients in G2 (p < 0.001). Bilateral thyroidectomy was more frequent in G2 (G1: 155, G2: 315; p = 0.016) as was the rate of total thyroidectomy vs. subtotal or near total thyroidectomy (p < 0.001). Neck drainage also showed statistically significant differences (G1: 75.29%, G2: 12.18%; p < 0.001). No differences were found in overall postoperative complications. Although the procedures used were more aggressive in G2, similar rates of transient asymptomatic hypocalcemia (p NS) and transient symptomatic (p NS) and permanent hypocalcemia were found (G1: 1.17%, G2: 0.68%, p NS). The rate of transitory recurrent laryngeal nerve paralysis was similar with regard to patients (p NS) or nerves at risk (p NS). Permanent inferior laryngeal nerve paralysis was no different regarding patients (p = 0.083) but statistically significant differences were found with regard to nerves at risk (G1: 1.44%, G2: 0.33%; p = 0.04). One patient in G2 died (p NS). Length of hospital stay was shorter in G2 (p < 0.001) and more patients in this group stayed in hospital for only one day (p < 0.001) or were operated on in the outpatient setting (0 versus 71; p < 0.001). CONCLUSIONS: An endocrine surgical unit allows more efficient management of thyroidectomy. It increases the rate of total thyroidectomy, reduces definitive complications and improves training of resident surgeons. In addition, it reduces resource use and allows the development of programs of outpatient thyroid surgery.


Assuntos
Especialidades Cirúrgicas , Centro Cirúrgico Hospitalar/organização & administração , Tireoidectomia/normas , Adulto , Procedimentos Cirúrgicos Endócrinos/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
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