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Background: 15-20% of all patients initially diagnosed with colorectal cancer develop metastatic disease and surgical resection remains the only potentially curative treatment available. Current 5-year survival following R0-resection of liver metastases is 28-39%, but recurrence eventually occurs in up to 70%. To date, adjuvant chemotherapy has not improved clinical outcomes significantly. The primary objective of the ongoing LICC trial (L-BLP25 In Colorectal Cancer) is to determine whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer patients following R0/R1 resection of hepatic metastases. L-BLP25 targets MUC1 glycoprotein, which is highly expressed in hepatic metastases from colorectal cancer. In a phase IIB trial, L-BLP25 has shown acceptable tolerability and a trend towards longer survival in patients with stage IIIB locoregional NSCLC.
Methods: This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 patients from 20 centers in 3 countries. Patients with stage IV colorectal adenocarcinoma limited to liver metastases are included. Following curative-intent complete resection of the primary tumor and of all synchronous/metachronous metastases, eligible patients are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with s.c. L-BLP25 930 mug once weekly for 8 weeks, followed by s.c. L-BLP25 930 mug maintenance doses at 6-week (years 1&2) and 12-week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint is the comparison of recurrence-free survival (RFS) time between groups. Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. The primary endpoint will be assessed in Q3 2016. Follow-up will end Q3 2017. Interim analyses are not planned.
Discussion: The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrence-free and overall survival rates of groups in an unbiased fashion. Trial Registration EudraCT Number 2011-000218-20
Library Catalog
(2000)
Library Buildings around the World" is a survey based on researches of several years. The objective was to gather library buildings on an international level starting with 1990.
The parts Germany, France, United Kingdom, United States have been thoroughly revised, supplemented and completed for this 2nd edition. A revision of the other countries is planned for the next edition.
Libra – a global virtual currency project initiated by Facebook – has been the subject of many controversial discussions since its announcement in June 2019. This paper provides a differentiated view on Libra, recognising that different development scenarios of Libra are conceivable.
Libra could serve purely as an alternative payment system in combination with a dedicated payment token, the Libra coin. Alternatively, the Libra project could develop into a broader financial infrastructure for advanced financial services such as savings and loan products operating on the Libra blockchain. Based on a comparison of the Libra architecture with other cryptocurrencies, the opportunities and challenges for the development of the respective Libra ecosystems are investigated form a commercial, regulatory and monetary policy perspective.
Partiendo de una breve descripción de las características del modelo comunitarista de integración social con el propósito de marcar distancia y aclarar algunos malentendidos en lo relativo a sus vínculos con la Sittlichkeit hegeliana, en el presente trabajo se analizan algunos de los textos claves de Hegel en los cuales se aprecia su comprensión de la unidad política. Ligado a ello, se intenta reconstruir la noción de integración que se desprende de dichos textos para, finalmente, concluir con algunas reflexiones en torno al potencial de una teoría de inspiración hegeliana para analizar determinados fenómenos vinculados, en la actualidad, con los conceptos de desintegración y exclusión social.
Emancipação tem sido, na teoria crítica da Escola de Frankfurt, o critério normativo último à luz do qual tanto a reconstrução de teorias sociais como a análise de realidades sociais específicas foram avaliadas. Como na Teoria da Ação Comunicativa, de Habermas, houve uma certa restrição ao mundo da vida em detrimento dos subsistemas político-administrativo e econômico, Axel Honneth propôs, em sua Teoria do Reconhecimento, retomar o projeto de uma teoria crítica que analise todas as dimensões da vida social à luz de critérios éticos imanentes, tendo a emancipação como horizonte teleológico. Em seu livro O direito da liberdade: esboço de uma eticidade democrática, lançado em junho de 2011, ele desenvolve uma teoria da justiça que, em distinção à tradição em que se insere o autor, coloca a liberdade como o critério ético nas diferentes esferas da vida. O texto analisa as raízes da obra perguntando-se como a questão da emancipação foi relacionada ao propósito de uma teoria da justiça. Sua atenção está menos voltada para o conteúdo concreto do diagnóstico de época e mais para a proposta metodológica de reconstrução normativa como uma ferramenta para a análise da sociedade.
The most fundamental difference between developing and developed societies is technology, in a broad yet specific sense; so states the author of this important study, Liberation and Technology: Development possibilities in pursuing technological autonomy. The ways in which technology is developed, institutionalized, animated and celebrated, form the core of development (human, economic, environmental, etc.) and ultimately civilization itself. But techno-spheres are not only technical. They are also social, political, and ideological. For societies and countries that have long been kept from realizing their own prosperity and dignity, development is also liberation. The main treatise of this book is that each developing society ought to seek to achieve technological autonomy in its quest for positive transformations and prosperity for its people. Technological autonomy is about attaining a high level of self-determination in planning and managing technological affairs. Attaining endogenous capacity to guide and execute decisions on production and innovation; creating and transferring key technological products and services; steering relevant foreign and local investment as well as trade; setting own priorities of development free from external manipulation; are goals that must be central to such planning efforts. With evidence and argument, and in plain language, this book suggests a novel way of thinking about development, through envisioning and building better techno-social systems. For these reasons this book is a welcome addition to the body of ideas informing practitioners and theorists in the field of developmentpolitical leaders, economists, sociologists, engineers, technologists, scientists, scholars, planners and activists who are involved in relevant development processes and liberation struggles.