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Nodal peripheral T-cell lymphoma (PTCL) with a T follicular helper phenotype (PTCL-TFH) is a new type of PTCL. We aimed to define its clinical characteristics and prognosis compared to PTCL not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). This retrospective observational study included 175 patients diagnosed with PTCL between 2008 and 2013 in 13 Spanish sites. Patient diagnosis was centrally reviewed, and patients were reclassified according to the World Health Organization (WHO) 2016 criteria: 21 patients as PTCL-NOS, 55 as AITL and 23 as PTCL-TFH. Median follow-up was 56.07 months (95% CI 38.7-73.4). Progression-free survival (PFS) and overall survival (OS) were significantly higher in patients with PTCL-TFH than in those with PTCL-NOS and AITL (PFS, 24.6 months vs. 4.6 and 7.8 months, respectively, p = 0.002; OS, 52.6 months vs. 10.0 and 19.3 months, respectively, p < 0.001). Histological diagnosis maintained an independent influence on both PFS (hazard ratio [HR] 4.1 vs. PTCL-NOS, p = 0.008; HR 2.6 vs. AITL, p = 0.047) and OS (HR 5.7 vs. PTCL-NOS, p = 0.004; HR 2.6 vs. AITL, p = 0.096), regardless of the International Prognostic Index. These results suggest that PTCL-TFH could have more favourable features and prognosis than the other PTCL subtypes, although larger series are needed to corroborate these findings.
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Linfadenopatía Inmunoblástica , Linfoma de Células T Periférico , Humanos , Linfadenopatía Inmunoblástica/genética , Pronóstico , Fenotipo , Estudios RetrospectivosRESUMEN
BACKGROUND: An accurate assessment of tumor viability after first-line treatment is critical for predicting treatment failure in peripheral T-cell lymphomas (PTCLs). 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) has been adopted as the preferred assessment method in clinical trials, but its impact in clinical practice should be examined. This study aims to determine the prognostic significance of18F-FDG-PET/CT for survival following first-line treatment in PTCL patients. RESEARCH DESIGN AND METHODS: Retrospective observational study including 175 patients diagnosed with PTCL between 2008 and 2013 in 13 Spanish sites. RESULTS: Fifty patients were evaluated with18F-FDG-PET/CT following first-line therapy: 58% were18F-FDG-PET/CT-negative and 42% were18F-FDG-PET/CT-positive. Disease progression occurred in 37.9% of18F-FDG-PET/CT-negative patients and in 80.9% of18F-FDG-PET/CT-positive patients (p = 0.0037). Median progression-free survival and overall survival were 67 and 74 months for18F-FDG-PET/CT-negative patients, and 5 (p < 0.0001) and 10 months (p < 0.0001), respectively, in18F-FDG-PET/CT-positive patients. After multivariate analysis, only B symptoms emerged as a negative predictive factor of complete response (RR 7.08; 95% CI 1.60-31.31; p = 0.001). CONCLUSIONS: 18F-FDG-PET/CT identifies high-risk PTCL patients who will have poor prognosis and survival following first-line treatment. However, more research is needed to confirm the best treatment options for PTCL patients.
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Linfoma de Células T Periférico , Tomografía Computarizada por Tomografía de Emisión de Positrones , Humanos , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Fluorodesoxiglucosa F18/uso terapéutico , Pronóstico , Linfoma de Células T Periférico/terapia , Linfoma de Células T Periférico/tratamiento farmacológico , Estudios RetrospectivosRESUMEN
BACKGROUND: Most patients with multiple myeloma (MM) relapse or become refractory, resulting in high health care costs. However, real-world data regarding the utilization of health care services among the relapsed/refractory MM (RRMM) population are scarce. METHODS: Observational, cross-sectional, multicenter study of the utilization of health care services by RRMM patients who had relapsed within the previous 6 months in Spain in a real-world setting. Data were collected from the clinical records and during a single structured interview and included sociodemographic and clinical characteristics at last relapse, the treatment and health care services nature, and were presented using descriptive statistics. RESULTS: The 276 patients enrolled (53.3% males), with a mean [SD] age of 67.4 [10.5] years, had experienced their most recent relapse a median (IQR) of 1.61 (0.74, 3.14) months before entering the study. Patients lived a median (IQR) of 9.0 (3.0, 30.0) km away from the hospital and visited the hospital a median (IQR) of 3.0 (2.0, 5.0) times/month to receive treatment for their most recent relapse. They spent a median (IQR) of 15.84 (5.0, 42.0) euros/month on transportation. Since their most recent relapse, most patients had been admitted to a hospital unit (n = 155, 56.2%), had required ≥1 diagnostic tests (n = 227, 82.2%), and had consulted the hematologist (n = 270, 97.8%) a mean (SD) of 5.5 (5.4) times. In half of the visits, patients were accompanied by an actively working caregiver (n = 112, 54.4%). CONCLUSIONS: RRMM treatments are associated with a high utilization of health care services and pose a significant burden for patients and caregivers. TRIAL REGISTRATION NUMBER: NCT03188536.
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Mieloma Múltiple , Masculino , Humanos , Niño , Femenino , Mieloma Múltiple/epidemiología , Mieloma Múltiple/terapia , Mieloma Múltiple/diagnóstico , España/epidemiología , Estudios Transversales , Utilización de Instalaciones y Servicios , Salud Global , Recurrencia Local de Neoplasia/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéuticoRESUMEN
We evaluated the psychometric properties of the Spanish version of the European Organization for Research and Treatment of Multiple Myeloma (MM) specific quality-of-life (QoL) questionnaire module (QLQ-MY20) in relapsed/refractory MM (RRMM) patients. This was an observational, cross-sectional, multicenter study using EORTC QLQ-C30 and QLQ-MY20 in RRMM patients (ClinicalTrials.gov ID NCT03188536). We assessed the non-response rate, ceiling/floor effects, internal consistency, test-retest reliability, and validity. The study included 276 patients (53.3% males, mean [SD] age of 67.4 [10.5] years). The EORTC QLQ-MY20 showed a low non-response rate, very low ceiling and floor effects, and good internal consistency. The test-retest reliability assessment revealed good temporary stability, the construct validity analysis stated four main factors similar to the ones of the original version, and the criterion validity assessment showed no differences between groups. In conclusion, the Spanish version of EORTC QLQ-MY20 is a reliable and valid tool for assessing QoL in RRMM patients.
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Mieloma Múltiple , Femenino , Humanos , Masculino , Estudios Transversales , Mieloma Múltiple/diagnóstico , Mieloma Múltiple/epidemiología , Mieloma Múltiple/terapia , Psicometría , Calidad de Vida , Reproducibilidad de los Resultados , España/epidemiología , Persona de Mediana Edad , AncianoRESUMEN
INTRODUCTION: Treatment of relapsed and/or refractory multiple myeloma (RRMM) should be established based on multiple factors, including previous treatment and the sociodemographic/clinical characteristics of the patients. However, patients enrolled in randomized-controlled trials often do not mirror the scenario encountered in real-world practice, thus challenging therapeutic decisions in day-to-day practice. PATIENTS AND METHODS: This observational, cross-sectional, multicenter study aimed to investigate the sociodemographic and clinical characteristics of patients with RRMM treated in routine practice in Spain and their influence on treatment regimens. RESULTS: The study included 276 RRMM patients (median age 69 years; no gender predominance). Seventy-four percent of patients had CRAB features at the time of study inclusion, 65.9% bone lesions, 28.7% high-risk cytogenetics, and 27.0% were at ISS stage III; 65.1% were retired and lived in urban areas (75.7%) with their relatives (85.8%); 28.7% had some dependence degree. Patients had experienced their last relapse in a median of 1.61 months before enrollment and had received a median of 2 treatment lines (range 1-10). Second-and third-line therapies were mostly based on immunomodulatory drugs, followed by proteasome inhibitors (PIs), whereas monoclonal antibodies prevailed in later treatment lines. The presence of extramedullary plasmacytomas, the absence of osteopenia, and being in the second or third treatment line (vs. later lines) significantly increased the odds of receiving PIs. CONCLUSIONS: RRMM treatment in the real-world setting is highly heterogeneous and is primarily influenced by the number of previous lines. The consideration of patients' clinical and sociodemographic characteristics may support clinicians in making therapeutic decisions.
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Mieloma Múltiple , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Estudios Transversales , Humanos , Mieloma Múltiple/tratamiento farmacológico , Mieloma Múltiple/epidemiología , Recurrencia Local de Neoplasia/tratamiento farmacológico , España/epidemiologíaRESUMEN
Around 3-7% of patients with non-small cell lung cancer (NSCLC), which represent 85% of diagnosed lung cancers, have a rearrangement in the ALK gene that produces an abnormal activity of the ALK protein cell signaling pathway. The developed ALK tyrosine kinase inhibitors (TKIs), such as crizotinib, ceritinib, alectinib, brigatinib and lorlatinb present good performance treating ALK+ NSCLC, although all patients invariably develop resistance due to ALK secondary mutations or bypass mechanisms. In the present study, we compare the potential differences between brigatinib and alectinib's mechanisms of action as first-line treatment for ALK+ NSCLC in a systems biology-based in silico setting. Therapeutic performance mapping system (TPMS) technology was used to characterize the mechanisms of action of brigatinib and alectinib and the impact of potential resistances and drug interferences with concomitant treatments. The analyses indicate that brigatinib and alectinib affect cell growth, apoptosis and immune evasion through ALK inhibition. However, brigatinib seems to achieve a more diverse downstream effect due to a broader cancer-related kinase target spectrum. Brigatinib also shows a robust effect over invasiveness and central nervous system metastasis-related mechanisms, whereas alectinib seems to have a greater impact on the immune evasion mechanism. Based on this in silico head to head study, we conclude that brigatinib shows a predicted efficacy similar to alectinib and could be a good candidate in a first-line setting against ALK+ NSCLC. Future investigation involving clinical studies will be needed to confirm these findings. These in silico systems biology-based models could be applied for exploring other unanswered questions.
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Este trabalho tem como finalidade realizar uma análise sobre a produção da Educação Superior no Brasil, em uma atualidade de intensa instabilidade acerca das controvérsias da Educação a Distância EAD. Para tal, utilizaremos o referencial teórico-metodológico da Teoria Ator-Rede, visto que tal abordagem se apresenta como bastante potente para análise de instáveis coletivos. A TAR nos remete a alianças, fluxos de elementos heterogêneos, mediações entendidas como humanas e não humanas capazes de mobilizar, modificar, potencializar as conexões que articulam seus processos. A pesquisa tem como objetivo traçar, portanto, um relato cartográfico de mediações que produzem e são produzidas por aquilo que entendemos por educação a distância. Buscamos produzir um relato, através de diversos mediadores, onde é possível identificar o posicionamento de grupos e antigrupos. Encontramos argumentos articulados a EAD como uma educação superior em expansão, tendo o avanço da tecnologia atrelada a esse desenvolvimento e porta-vozes importantes que lutam por uma tradução do ensino superior articulado ao ensino público, laico e presencial.Trata-se de um relato descritivo de controvérsias concebidas como um importante observatório para o rastreamento de redes, visto que um coletivo, quando fortemente instável, deixa mais exposto o trabalho dos mediadores e acaba por facilitar sua própria cartografia.
This work aims to conduct an analysis on the production of Higher Educationin Brazil in a current of intense controversy about the instability of Distance Education - Distance Education. To this end, we use the theoretical and methodological framework of Actor-Network Theory, as this approach presents itself as powerful enough to analyze collective unstable. The TAR alliances leads us to flows of heterogeneous elements, a mediation understood as a human and non-human aspect can mobilize, modify, enhance the connections that articulate their processes. The research aims, therefore, outline a mapping report of mediations that produce and are produced by what we mean by distance education. We seek to produce a report, through various mediators, where it is possible to identify the placement of groups and antigrupos. We find articulated arguments the EAD as an expanding higher education and the advancement of technology linked to this development and important spokespeople who are fighting for a translation of higher education articulated to the secular public education, and attendance. This is a descriptive account of disputes seen as an important observatory for tracking networks, as a collective, when stronglyunstable, leaves more exposed the work of mediators and ultimately facilitate their own cartography.
Este trabajo tiene como objetivo realizar un análisis sobre la producción de la Educación Superior en Brasil, en una corriente de intensa controversia sobre la inestabilidad de la Educación a Distancia - Educación a Distancia. Para ello , se utiliza el marco teórico y metodológico de la teoría del actorred, ya que este enfoque se presenta como lo suficientemente potente como para analizar inestable colectiva. Las alianzas TIE nos lleva a los flujos de elementos heterogéneos, una mediación entendida como un aspecto humano y no humano puede movilizar , modificar, mejorar las conexiones que articulan sus procesos. Los objetivos de la investigación , por lo tanto , describen un informe de mapeo de las mediaciones que producen y sonproducidas por lo que entendemos por educación a distancia. Buscamos producir un informe, a través de diversos mediadores, donde es posibleidentificar la ubicación de los grupos y antigrupos. Encontramos argumentos articulados de la EAD como una expansión de la educación superior y elavance de la tecnología vinculada a este desarrollo y voceros importantes que están luchando por una traducción de la educación superior articulada a la educación pública laica y asistencia. Se trata de un relato descriptivo de lascontroversias visto como un observatorio importante para las redes de seguimiento , como un colectivo , cuando es fuertemente inestable , dejamás expuestos al trabajo de los mediadores y en última instancia facilitar su propia cartografía.
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Educación a Distancia , Universidades , BrasilRESUMEN
OBJETIVO: A dor é um importante e prevalente sintoma em pacientes oncológicos, que pode resultar em perda de qualidade de vida e ônus financeiro considerável devido ao custo de medicamentos analgésicos, intervenções e hospitalizações. O cloridrato de oxicodona de liberação prolongada é um opioide de ação semelhante à morfina com eficácia comprovada no tratamento da dor de moderada a intensa. O objetivo deste estudo foi avaliar custos de medicamentos e hospitalizações em pacientessubmetidos ao tratamento com oxicodona de liberação prolongada comparado à morfina, em regime "se necessário" no manejo da dor relacionada ao câncer, sob as perspectivas dos sistemas de saúde público e privado, no Brasil. MÉTODOS: Um modelo de decisão foi desenvolvido para análise das seguintes estratégias: grupo 1, 20 mg de oxicodona de liberação prolongada; grupo 2, 10 mg de oxicodona de liberação prolongada; e grupo 3, placebo. Custos foram obtidos a partir de listas de preços oficiais. O horizonte temporal foi determinado através do período de alta hospitalar nos grupos. Taxas de desconto não foram aplicadas. Dados de eficácia foram obtidos a partir do estudo de Zhou e Wang, 2012. Uma análise de sensibilidade univariada foi realizada para avaliar diferentes categoriashospitalares. RESULTADOS: Na análise realizada sob perspectiva do sistema de saúde público, os custos totais foram R$ 1.103, R$ 1.071 e R$ 1.214 por paciente tratado nos grupos 1, 2 e 3, respectivamente.Na perspectiva do sistema de saúde privado, os custos totais foram R$ 2.372, R$ 2.367 e R$ 2.759 por paciente tratado nos grupos 1, 2 e 3, respectivamente. Na análise de sensibilidade univariada, todos os cenários avaliados continuaram consistentes e favoráveis à utilização da oxicodona deliberação prolongada em adição ao tratamento com opioide em regime "se necessário". CONCLUSÃO: Por diminuir o tempo de hospitalização, a inclusão da oxicodona de liberação prolongada pode ocasionar redução de custos totais do tratamento da dor em pacientes oncológicos.
OBJECTIVES: Pain is an important and prevalent symptom in cancer patients, which can result in loss of quality of life and considerable financial burden due to the cost of analgesic drugs, interventions and hospitalizations. The extended-release oxycodone hydrochloride is an opioid with similaraction to morphine with proven efficacy in moderate to severe pain treatment. The objective of this study was to evaluate drug and hospitalizations costs for patients undergoing treatment withextended-release oxycodone compared to morphine in an "if necessary" regime in the management of cancer-related pain, from public and private health care systems perspectives in Brazil. METHODS: A decision model was developed to analyze the following strategies: group 1, 20 mg ofextended-release oxycodone; group 2, 10 mg of extended-releaseoxycodone; and group 3, placebo. Costs were obtained from officialprice lists. Time horizon was determined through the hospital dischargeperiod. Discount rates were not applied. Efficacy data were obtained from Zhou e Wang, 2012. An univariate sensitivity analysis was performed to evaluate different hospital categories. RESULTS: From the public perspective, total costs were 1,103 BRL, 1,071 BRL and 1,214 BRL per patient treated in groups 1, 2 and 3, respectively. From the private perspective, total costs were 2,372 BRL, 2,367 BRL and 2,759 BRL per patient treated in groups 1, 2 and 3, respectively. In the univariate sensitivity analysis, all evaluated scenarios remained consistent and favorable to the use of extended-release oxycodone in addition to treatment with opioid in an "if necessary" regime. CONCLUSION: By reducing total length of hospital stay, the inclusion of extended-release oxycodone can lead to reduction intotal cost of pain treatment in cancer patients.
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Humanos , Costos y Análisis de Costo , Neoplasias , Oxicodona , DolorRESUMEN
OBJETIVO: Muitos pacientes apresentam intensa dor após artroplastia, que pode resultar em perda de qualidade de vida e ônus financeiro considerável devido ao custo de medicamentos analgésicos, intervenções e hospitalizações. O cloridrato de oxicodona de liberação prolongada é um opioide de ação semelhante à morfina com eficácia comprovada no tratamento da dor de moderada a forte intensidade. O objetivo deste estudo foi avaliar custos de medicamentos e hospitalizações em pacientessubmetidos ao tratamento com oxicodona de liberação prolongada comparado à morfina, em regime "se necessário" no manejo da dor pós artroplastia, sob as perspectivas dos sistemas de saúde público e privado, no Brasil. MÉTODOS: Um modelo de decisão foi desenvolvido para análisede dois cenários. Em ambos, os pacientes do grupo 1 receberam oxicodona de liberação prolongada e opioide de liberação imediata. Em relação ao grupo 2, no cenário 1, os pacientes receberam opioide de liberação imediata e, no cenário 2, opioide de liberação imediata e placebo. Custos foramobtidos a partir de listas de preços oficiais. No cenário 1, o horizonte temporal foi relativo ao período de tratamento de 3 semanas e, no cenário 2, determinado através do período de hospitalização. Taxas de desconto não foram aplicadas. Uma análise de sensibilidade univariada foi realizada para avaliar diferentes categorias hospitalares. RESULTADOS: No cenário 1, sob a perspectiva do sistema de saúde público, os custos totais foram R$ 1.486 e R$ 1.520 por paciente tratado nos grupos 1 e 2, respectivamente. Na perspectiva do sistema de saúde privado, os custos totais foram R$ 3.132 e R$ 3.457 por paciente tratado nos grupos 1 e 2, respectivamente. No cenário 2, sob perspectiva do sistema de saúde público, os custos totais foram R$ 3.299 e R$ 3.591 por paciente tratado nos grupos 1 e 2, respectivamente. Na perspectiva do sistema de saúde privado, os custos totais foram R$ 7.197 e R$ 8.181 por paciente tratado nos grupos 1 e 2, respectivamente. Na análise de sensibilidade univariada, todos os cenários avaliados continuaram consistentes e favoráveis à utilização da oxicodonade liberação prolongada. CONCLUSÃO: Por diminuir o tempo de hospitalização, a utilização da oxicodona de liberação prolongada pode ocasionar redução de custos totais do tratamento da dor em pacientes submetidos a artroplastia
OBJECTIVE: Many patients have severe pain after arthroplasty, which can result in loss of quality of life and considerable financial burden due to the cost of analgesic drugs, interventions and hospitalizations. The extended-release oxycodone hydrochloride is an opioid with similar action to morphine with proven efficacy in the treatment of moderate to severe pain. The objective of this study was to evaluate drug and hospitalizations costs for patients undergoing treatment with extended-release oxycodone comparedto morphine in a "if necessary" regime in the management of pain post-arthroplasty, from public and private health care systems perspectives in Brazil. METHODS: A decision model was developed to analyze two scenarios. In both, patients in group 1 received extended-release oxycodone and immediate-release opioid. Regarding group 2, in scenario 1, patients received immediate-release opioid and, in scenario 2, immediate-release opioid and placebo. Costs were obtained from official prices lists. In scenario1, time horizon was related to a 3-week treatment period and, in scenario 2, determined by the hospitalization period. Discount rates were not applied. Univariate sensitivity analysis was performed to evaluate different hospital categories. RESULTS: In scenario 1, from the public perspective, total costs were 1,486 BRL and 1,520 BRL per patient treated in groups 1 and 2, respectively. From the private perspective, total costs were 3,132 BRL and 3,457 BRL per patient treated in groups 1 and 2, respectively. In scenario 2, from the public perspective, total costs were 3,299 BRL and 3,591 BRL per patient treated in groups 1 and 2, respectively. From the private perspective,total costs were 7,197 BRL and 8,181 BRL per patient treated in groups 1 and 2, respectively. In the univariate sensitivity analysis, all evaluated scenarios remained consistent and favorable to the use of extended-release oxycodone. CONCLUSION: By decreasing the length of hospital stay, extended-release oxycodone can result in reduction of total post-arthroplasty pain related costs