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Rival G.,University of Quebec | Rival G.,Center Hospitalier University Of Besancon | Lacasse Y.,University of Quebec | Martin S.,University of Quebec | And 2 more authors.
Chest | Year: 2014

RESULTS: The literature search identified 1,172 titles. Seventeen articles reporting on 14 trials were retrieved, all of which were associated with a low risk of bias. The median study duration of the different trials was 12 weeks. Most patients had idiopathic PAH or PAH associated with connective tissue disease. A variety of HRQoL questionnaires were used in these trials, and most were generic. HRQoL results were most commonly minimally detailed, and some pivotal trials did not even assess HRQoL. Nevertheless, these trials consistently demonstrated statistically significant improvements in HRQoL with PAH-specific therapies, especially for the physical domains. In most cases, however, these improvements were smaller than the minimal important difference in HRQoL previously reported in PAH.CONCLUSION: This review shows that PAH-specific therapies improve HRQoL in PAH. However it remains difficult to draw any firm conclusion about the clinical significance of these improvements. Further work is mandatory to validate PAH-specific questionnaires that are responsive to clinical changes as well as to establish their interpretability. © 2014 AMERICAN COLLEGE OF CHEST PHYSICIANS.BACKGROUND: Health-related quality of life (HRQoL) is severely impaired in pulmonary arterial hypertension (PAH). We aimed to assess the effect of PAH-specific therapies on HRQoL.METHODS: A literature search was performed in MEDLINE and Embase databases (January 1990 to September 2013) to retrieve prospective placebo-controlled randomized trials of at least 6 weeks duration reporting the effect of PAH-specific therapies on HRQoL in adult patients with PAH. The articles were independently reviewed, and the validity of the trials was assessed using the Cochrane's Risk of Bias Tool.

Miles D.W.,Mount Vernon Cancer Center | De Haas S.L.,Hoffmann-La Roche | Dirix L.Y.,St Augustinus Hospital | Romieu G.,Center Re Gionale Of Lutte Contre Le Cancer | And 7 more authors.
British Journal of Cancer | Year: 2013

Background: Combining bevacizumab with first-line chemotherapy significantly improves progression-free survival (PFS) in HER2-negative metastatic breast cancer (mBC). However, identification of patients benefitting most from bevacizumab remains elusive. The AVADO trial included an extensive optional exploratory biomarker programme. Methods: Patients with HER2-negative mBC were randomised to receive docetaxel with placebo or bevacizumab. The primary end point was PFS. Plasma samples were analysed using a multiplex ELISA. Blood mRNA expression was assessed using quantitative PCR. Tumour tissue samples were analysed by immunohistochemistry. Single-nucleotide polymorphisms (SNPs) involved in the VEGF pathway were analysed in germline DNA.Results:Samples for biomarker analysis were available from 24-54% of the 736 treated patients (depending on specimen type). The most consistent potential predictive effect was observed with plasma VEGF-A and VEGFR-2; high baseline concentrations were associated with greater treatment effect. Blood mRNA analyses suggested a greater bevacizumab effect in patients with high VEGF 121. No consistent predictive effect was seen for tumour neuropilin or other candidate tumour markers by immunohistochemistry, or for any of the SNPs investigated. Conclusion: Plasma VEGF-A and VEGFR-2 are potential predictive markers for bevacizumab efficacy, supporting findings in gastric and pancreatic cancers. Plasma VEGF-A is being evaluated prospectively in mBC in the MERiDiAN trial. © 2013 Cancer Research UK. All rights reserved.

von Minckwitz G.,Neu Isenburg and University Womens Hospital | Puglisi F.,University of Udine | Cortes J.,University of Barcelona | Vrdoljak E.,University of Split | And 13 more authors.
The Lancet Oncology | Year: 2014

Background: Combining bevacizumab with first-line or second-line chemotherapy improves progression-free survival in HER2-negative locally recurrent or metastatic breast cancer. We assessed the efficacy and safety of further bevacizumab therapy in patients with locally recurrent or metastatic breast cancer whose disease had progressed after treatment with bevacizumab plus chemotherapy. Methods: In this open-label, randomised, phase 3 trial, we recruited patients who had HER2-negative locally recurrent or metastatic breast cancer that had progressed after receiving 12 weeks or more of first-line bevacizumab plus chemotherapy from 118 centres in 12 countries. Patients were randomly assigned (1:1) by use of a central interactive voice response system using a block randomisation schedule (block size four) stratified by hormone receptor status, first-line progression-free survival, selected chemotherapy, and lactate dehydrogenase concentration, to receive second-line single-agent chemotherapy either alone or with bevacizumab (15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks). Second-line therapy was continued until disease progression, unacceptable toxicity, or consent withdrawal. At progression, patients randomly assigned to chemotherapy alone received third-line chemotherapy without bevacizumab; those randomly assigned to bevacizumab continued bevacizumab with third-line chemotherapy. The primary endpoint was progression-free survival from randomisation to second-line progression or death in the intention-to-treat population. This trial is ongoing, and registered with ClinicalTrials.gov, number NCT01250379. Findings: Between Feb 17, 2011, and April 3, 2013, 494 patients were randomly assigned to treatment (247 in each group). The median duration of follow-up at the time of this prespecified primary progression-free survival analysis was 15·9 months (IQR 9·1-21·7) in the chemotherapy-alone group and 16·1 months (10·6-22·7) in the combination group. Progression-free survival was significantly longer for those patients treated with bevacizumab plus chemotherapy than for those with chemotherapy alone (median: 6·3 months [95% CI 5·4-7·2] vs 4·2 months [3·9-4·7], respectively, stratified hazard ratio [HR] 0·75 [95% CI 0·61-0·93], two-sided stratified log-rank p=0·0068). The most common grade 3 or more adverse events were hypertension (33 [13%] of 245 patients receiving bevacizumab plus chemotherapy vs 17 [7%] of 238 patients receiving chemotherapy alone), neutropenia (29 [12%] vs 20 [8%]), and hand-foot syndrome (27 [11%] vs 25 [11%]). Grade 3 proteinuria occurred in 17 (7%) of 245 patients receiving combination therapy and one (<1%) of 238 patients receiving chemotherapy alone. Serious adverse events were reported in 61 (25%) of 245 patients receiving bevacizumab plus chemotherapy versus 44 (18%) of 238 patients receiving chemotherapy alone. Interpretation: These results suggest that continued VEGF inhibition with further bevacizumab is a valid treatment option for patients with locally recurrent or metastatic HER2-negative breast cancer whose disease was stabilised or responded to first-line bevacizumab with chemotherapy. Funding: F Hoffmann-La Roche. © 2014 Elsevier Ltd.

The invention relates to a method for producing an unshrunken tissue equivalent. Said method is comprising in that: a mixture is produced that contains at least one element of an extracellular matrix; at least one pluridimensional medium is soaked with said mixture; from the components of the mixture, a lattice comprising at least one element of an extracellular matrix is produced, at least at the medium; at least part of the components of said mixture is attached to the structure of the medium; the shrinking of at least the lattice is prevented and at least said lattice is tensioned on said medium; fibroblasts are integrated into the lattice and at least one cell culture of said fibroblasts is carried out, at least in the lattice. The invention also relates to a method for producing a skin equivalent that comprises at least one dermal equivalent formed by an unshrunken tissue equivalent and at least one epidermal equivalent.

Center Hospitalier University Of Besancon and University of Franche Comte | Date: 2011-07-28

A screening tool includes: a compression body for engaging with a portion of a limb of the patient to be compressed; a compression element for compressing the contact surface against the portion of the patients limb to be compressed; a measurement element for structurally and functionally engaging with a portion of the limb to be examined, as well as generating, via the optical detection of one or more component(s) of the blood, a measurement signal that is characteristic of an arterial pulse in the portion of the limb to be examined during a measurement phase. The compression element generates a measurement pressure substantially equal to a threshold pressure value during the entire measurement phase, and the screening tool also includes: a calculation element for transmitting a negative signal when the arterial pulse is greater than a threshold diagnostic value, and a positive signal it is lower than the threshold value.

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