Center Hospitalier University Of Besancon

Besançon, France

Center Hospitalier University Of Besancon

Besançon, France

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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.


Pivot X.,Center Hospitalier University Of Besancon | Marme F.,University of Heidelberg | Koenigsberg R.,Ludwig Boltzmann Research Institute | Koenigsberg R.,Ludwig Boltzmann Institute For Angewandte Krebsforschung Lbi Acr Vienna | And 3 more authors.
Annals of Oncology | Year: 2016

Background: Based on data from two multicenter, phase III clinical trials (Studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting. Data from Studies 305 and 301 were pooled to investigate the efficacy of eribulin in various subgroups of patients who matched the EU label, including those with human epidermal growth factor receptor 2 (HER2)-negative and triple-negative disease. Patients and methods: In Study 305 (NCT00388726), patients were randomized 2:1 to eribulin mesylate 1.4 mg/m2 (equivalent to eribulin 1.23 mg/m2 [expressed as free base]) intravenously on days 1 and 8 every 21 days] or treatment of physician's choice after 2-5 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane (in early/advanced setting). In Study 301 (NCT00337103), patients were randomized 1:1 to eribulin (as above) or capecitabine (1.25 g/m2 orally twice daily on days 1-14 every 21 days) following ≥3 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane. Efficacy end points were investigated in the intent-to-treat population and subgroups, pooled as discussed above. Results: Overall, 1644 patients were included (eribulin: 946; control: 698); baseline characteristics were well matched. Overall survival was significantly longer with eribulin versus control (P < 0.01), as were progression-free survival and clinical benefit rate (both P < 0.05). Significant survival benefits with eribulin versus control were observed in a wide range of patient subgroups, including HER2-negative or triple-negative disease (all P < 0.05). Conclusion: Our findings underline the survival benefit achieved by eribulin used according to EU label in the overall MBC population and in various subgroups of interest, including patients with HER2-negative and triple-negative disease. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.


Patent
French National Center for Scientific Research, Etablissement Francais Du Sang, University of Franche Comte and Center Hospitalier University Of Besancon | Date: 2010-10-29

The invention relates to a secure system for the perfusion of a body liquid, enabling a final control of compatability of a treatment with the patient and/or the medical situation previously diagnosed by a doctor, in a simple, efficient and energy-saving manner. To this end, the system according to the invention comprises: a fluidic circuit of a perfusion (100, 1000) comprising a perfusion catheter (101), a perfusion tubing (102, 1002) and a container (103, 1003) for the determined perfusion product to be perfused to a patient (B); a means (400) for taking a body liquid sample from a patient; a sampling container (303) provided with a means (300) for fluidic connection to the means (400) for taking the sample; a means (710, 721) of analysis and comparison (710, 721) of the body liquid taken and a sample (810) of the determined product; a means for fluidic connection between the analysis means and the sampling container; and a means (731) for controlling the flow of the perfusion product in the tubing, the analysis and comparison means transmitting information (I_(C)) for comparing the body liquid (302) taken and the determined production sample (810) to the flow control means.


Patent
French National Center for Scientific Research, Etablissement Francais Du Sang, University of Franche Comte and Center Hospitalier University Of Besancon | Date: 2010-10-29

The invention relates to a device (200) for taking a sample of a body fluid, such as blood, to be incorporated into a fluid circuit of a perfusion (100) of a patient who has a perfusion catheter (104), said device having a tubular structure (202) for connecting to the fluid circuit of the perfusion, provided with a zone for intubation, during use, of a sampling channel (300) comprising a distal end (301); and a means (203) for holding, during use, in the tubular structure, the part of the sampling channel (300) comprising a distal end (301) in such a way that the distal end (301) is oriented towards the perfusion catheter (104), in the direction of flow (F1) of the perfusion product (102), from a perfusion product reservoir (101) towards the perfusion catheter (104).


Rival G.,University of Québec | Rival G.,Center Hospitalier University Of Besancon | Lacasse Y.,University of Québec | Martin S.,University of Québec | 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.


Dannaoui E.,Institute Pasteur Paris | Desnos-Ollivier M.,Institute Pasteur Paris | Garcia-Hermoso D.,Institute Pasteur Paris | Grenouillet F.,Center Hospitalier University Of Besancon | And 5 more authors.
Emerging Infectious Diseases | Year: 2012

We report 20 episodes of infection caused by acquired echinocandin-resistant Candida spp. harboring diverse and new Fksp mutations. For 12 patients, initial isolates (low MIC, wild-type Fksp sequence) and subsequent isolates (after caspofungin treatment, high MIC, mutated Fksp) were genetically related.


Cholley P.,Center Hospitalier University Of Besancon | Thouverez M.,Center Hospitalier University Of Besancon | Hocquet D.,Center Hospitalier University Of Besancon | Van Der Mee-Marquet N.,University of Tours | And 2 more authors.
Journal of Clinical Microbiology | Year: 2011

This study aimed to determine the genetic diversity of clinical multidrug-resistant Pseudomonas aeruginosa. We used pulsed-field gel electrophoresis and multilocus sequence typing to analyze 187 strains isolated in different French hospitals. To illustrate the diversity of resistance mechanisms to antibiotics in a given clone, we identified β-lactamases with an extended spectrum by using phenotypic and genotypic methods. Typing results showed that the majority of our multidrug-resistant isolates belong to a few clonal types (ST235, ST111, and ST175) that are already spreading worldwide. These successful international clones sporadically produced extended-spectrum β-lactamase-encoding genes but mostly became extensively resistant to β-lactams after derepression of intrinsic resistance mechanisms (i.e., AmpC cephalosporinase). Our results indicate that cross-transmission plays a major role in the spread of multidrug-resistant P. aeruginosa in hospital settings. Copyright © 2011, American Society for Microbiology. All Rights Reserved.


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.


Patent
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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