14 research outputs found

    Análisis critico de la respuesta completa estricta en mieloma múltiple. actualización de los datos basados en el estudio fase 3 PETHEMA/GEM2012MENOS65

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    CO-001 Introducción: Para establecer diferencias pronósticas entre los pacientes con MM que alcanzan RC, el IMWG introdujo un criterio de respuesta más estricto (RC estricta) añadiendo al criterio de RC, la existencia de cadenas ligeras en suero (CLLs) normales y la ausencia de CP clonales en MO por IHQ. En el año 2011 la CMF de baja sensibilidad se incluyó como técnica alternativa a la IHQ para establecer RC estricta (RCs). Sin embargo, el valor pronóstico de la ratio kappa/lambda no está claro (Blood 2015. 126:858-62). Métodos: Se incluyeron 458 pacientes =65 años del ensayo clínico GEM2012MENOS65 (NCT01916252). Ocho discontinuaron pronto y no fueron evaluables. Las CLLs fueron clasificadas como normal (0.26- 1.65) o anormal (1.65 si el paciente era ) (FREELITE assay). La EMR fue evaluada mediante citometria de flujo (CMF). El límite de detección fue de 3x10-6. Todas las RC con CLLs normales y ausencia de CP por CMF con una sensibilidad de 10-2 fueron considerados en RCs. La mediana de seguimiento fue 47.5 meses. , ,

    Europeização e/ou africanização da Espanha Medieval: diversidade e unidade cultural européia em debate Europeanization and / or africanization of Medieval Spain: european cultural diversity and unity in discussion

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    Os conflitos políticos e sociais dos últimos anos na Europa, como os com a imigração e o terrorismo, orientam muitas questões levantadas pelas ciências humanas na atualidade. No que se refere à medievalística, muitas obras e projetos europeus apresentam a discussão em torno da diversidade cultural européia, a qual pode ser fundamentada desde a Idade Média através do convívio e trocas culturais entre cristão, judeus e muçulmanos. No centro destas discussões, está a crítica à idéia de centro e periferia dentro da própria Europa e no mundo, além da reflexão sobre conceitos de europeização e africanização, utilizados pela historiografia européia desde a primeira metade do século XX até poucos anos atrás. Neste artigo, serão apresentadas, à luz da Nova História Cultural Alemã (Neue Kulturgeschichte), algumas críticas aos conceitos de europeização, africanização, centro, periferia e unidade cultural na Idade Média européia. Questões estas que acaloram os debates na Alemanha atual.<br>Political and social conflicts during recent years in Europe - such as immigration and terrorism - have guided humanities issues today. Regarding Middle Age research, many works and projects present a debate on European cultural diversity, which lay the foundations since the Middle Ages through interaction and cultural exchanges between Christians, Jews and Muslims. Within the discussion, is the criticism to the idea of center and periphery within Europe itself and the world, as well as the consideration of concepts such as europeanization and africanization, used by European historiography, from the first half of the twentieth century until a few years ago. This article presents criticism to the concepts of europeanization, africanization, center, periphery, and cultural unity in the Middle Ages, in light of the New German Cultural History (Neue Kulturgeschichte), issues that inflame the debate in Germany today

    Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma

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    The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.</p

    Real-world experience among patients with relapsed/refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor failure in Europe : The SCHOLAR-2 retrospective chart review study

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    Mantle cell lymphoma (MCL) after relapse is associated with poor prognosis. No standard of care exists and available evidence for treatments is limited, particularly in patients who fail Bruton tyrosine kinase inhibitor (BTKi) therapy. This multicentre retrospective chart review study, SCHOLAR-2, addresses this knowledge gap and reports on data collected from 240 patients with relapsed/refractory MCL in Europe who were treated with BTKi-based therapy between July 2012 and July 2018, and had experienced disease progression while on BTKi therapy or discontinued BTKi therapy due to intolerance. The median overall survival (OS) from initiation of first BTKi therapy was 14.6 months (95% confidence interval [CI] 11.6–20.0) in the overall cohort, 5.5 months (95% CI 3.9–8.2) in 91 patients without post-BTKi therapy, and 23.8 months (95% CI 18.9–30.1) in 149 patients who received post-BTKi therapy (excluding chimeric antigen receptor T-cell treatment). In the latter group, patients received a median of one (range, one to seven) line of post-BTKi therapy, with lenalidomide-containing regimens and bendamustine plus rituximab being the most frequently administered; the median OS from initiation of first post-BTKi therapy was 9.7 months (95% CI 6.3–12.7). These results provide a benchmark for survival in patients with R/R MCL receiving salvage therapy after BTKi failure
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