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Le Touquet – Paris-Plage, France

Smith M.R.,Massachusetts General Hospital | Saad F.,University of Montreal | Oudard S.,Georges Pompidou Hospital | Shore N.,Carolina Urological Research Center | And 11 more authors.
Journal of Clinical Oncology | Year: 2013

Purpose: Denosumab, an anti-RANK ligand monoclonal antibody, significantly increases bone metastasis-free survival (BMFS; hazard ratio [HR], 0.85; P = .028) and delays time to first bone metastasis in men with nonmetastatic castration-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) ≥ 8.0 ng/mL and/or PSA doubling time (PSADT) ≤ 10.0 months. To identify men at greatest risk for bone metastasis or death, we evaluated relationships between PSA and PSADT with BMFS in the placebo group and the efficacy and safety of denosumab in men with PSADT ≤ 10, ≤ 6, and ≤ 4 months. Patients and Methods: A total of 1,432 men with nonmetastatic CRPC were randomly assigned 1:1 to monthly subcutaneous denosumab 120 mg or placebo. Enrollment began February 2006; primary analysis cutoff was July 2010, when approximately 660 men were anticipated to have developed bone metastases or died. Results: In the placebo group, shorter BMFS was observed as PSADT decreased below 8 months. In analyses by shorter baseline PSADT, denosumab consistently increased BMFS by a median of 6.0, 7.2, and 7.5 months among men with PSADT ≤ 10 (HR, 0.84; P = .042), ≤ 6 (HR, 0.77; P = .006), and ≤ 4 months (HR, 0.71; P = .004), respectively. Denosumab also consistently increased time to bone metastasis by PSADT subset. No difference in survival was observed between treatment groups for the overall study population or PSADT subsets. Conclusion: Patients with shorter PSADT are at greater risk for bone metastasis or death. Denosumab consistently improves BMFS in men with shorter PSADT and seems to have the greatest treatment effects in men at high risk for progression. © 2013 American Society of Clinical Oncology. All rights reserved. Source


Gagliardino J.J.,National University of La Plata | Kleinebreil L.,Georges Pompidou Hospital | Colagiuri S.,Diabetes and Metabolism | Flack J.,Diabetes and Metabolism | And 3 more authors.
Diabetes Research and Clinical Practice | Year: 2010

Aim: To compare clinical-metabolic monitoring and coronary risk status in people with type 2 diabetes from Australia, France and Latin America. Methods: Retrospective analysis of data collected at primary care (4540 participants from each population) matched for age, gender and disease duration. Measurements included participants' characteristics, performance frequency of clinical-metabolic process indicators, and percentage of clinical-metabolic outcomes at recommended target values. Results: The weighted mean of the percentage of process performance was within 68 to 81%; that of outcomes at target dropped to 29 to 45%. Although statistically significant, differences among groups were far from those in healthcare budgets, and probably only of marginal clinical impact. The percentage of patients with low, slight or high coronary risk was similar in the three groups, with most people at high or very high risk. Conclusions: Despite the high difference in health per capita investment and system characteristics among countries, the study populations had striking similarities regarding the low percentage of participants who achieved cardiovascular risk factor and diabetes treatment goals. Therefore, differences in health budget and system characteristics would not be the main drivers in care quality. Diabetes education at every level and quality care registries would contribute to improve this situation and assess such improvement. © 2010 Elsevier Ireland Ltd. All rights reserved. Source


Simon A.-L.,Mayo Medical School | Ferrero E.,Georges Pompidou Hospital | Noelle Larson A.,Mayo Medical School | Kaufman K.R.,Mayo Medical School
European Spine Journal | Year: 2016

Purpose: Stereoradiography imaging (SRI) is an accurate and reliable low-dose radiographic method. However, patients must remain motionless during image acquisition. Motion artifacts are frequently noted. The aims of the study were to determine the incidence of the SRI motion artifact and assess if motion during SRI acquisition affects radiographic measurements. Methods: In this retrospective study, 198 patients with spinal instrumentation had biplanar SRI radiographs performed, of whom 39 had concomitant conventional radiographs. Eight coronal and sagittal spinal parameters were independently measured on SRI and conventional radiographs for the 39 patients by 2 observers. Inclusion criteria were: presence of spinal instrumentation of more than six levels and an SRI motion artifact identified on the coronal and/or the sagittal views on either the spinal rods or on the limbs. Means were compared between both types of radiographs using the Student’s t test; intraclass correlation coefficients (ICCs) were used for intraobserver reproducibility and interrater reliability. Results: A motion artifact was identified in 19.7 % (n = 39, mean age 19.5 ± 1.7 years) of the cases. There were no differences in any of the coronal or sagittal plane measurements between SRI and X-rays. Intraobserver reliability and interrater reproducibility was high (range 0.81–0.98). Conclusions: Motion artifact during full-spine stereoradiography imaging acquisition is frequent, but does not affect spinal measurements. SRI with a motion artifact can be used to produce reliable measurements of the sagittal and coronal parameters. Some SRI images with a motion artifact may suggest loss of fixation or bending of the rods. However, after becoming familiar with the appearance of the motion artifact, repeat radiographs are rarely indicated. IRB number: 14-004872. Level of evidence: Level IV. © 2016 Springer-Verlag Berlin Heidelberg Source


Blons H.,French Institute of Health and Medical Research | Emile J.F.,University of Versailles | Le Malicot K.,Federation Francophone de Cancerologie Digestive | Julie C.,APHP Ambroise Pare Hospital | And 14 more authors.
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO | Year: 2014

BACKGROUND: The prognostic value of KRAS mutations in colon adenocarcinoma is controversial. We examined this question as an ancillary study of the PETACC8 phase III trial.PATIENTS AND METHODS: We analyzed the prognostic impact of KRAS exon 2 mutations in stage III colon cancer patients (n = 1657) receiving adjuvant FOLFOX ± cetuximab therapy included in the PETACC8 trial. Patients with BRAF-mutated cancers were excluded and, as no difference was found for time to recurrence (TTR) and disease-free survival (DFS) between treatment arms, both were pooled for analysis. Associations with TTR and DFS were analyzed using a Cox proportional hazards model.RESULTS: KRAS mutations were found in 638 of 1657 tumors and linked to shorter TTR (P < 0.001). However, when specific mutations were compared with wild-type, codon 12 mutations [hazard ratio (HR) 1.67, 95% confidence interval (CI) 1.35-2.04; P < 0.001] but not codon 13 (HR 1.23, 95% CI 0.85-1.79; P = 0.26) were significantly associated with shorter TTR, independently of other covariates. The interaction test showed that, regarding tumor location (distal versus proximal), KRAS genotype affects differently on recurrence (P = 0.02) and DFS (P = 0.042). Subgroup analysis showed that KRAS only affected TTR and DFS in distal tumors (n = 1043; 692 wild type; 351 mutated), with an increased risk of relapse (HR 1.96, 95% CI 1.51-2.56; P < 0.0001) for KRAS codon 12 mutations and a borderline significance for codon 13 mutations (HR 1.59, 95% CI 1.00-2.56; P = 0.051).CONCLUSION: KRAS exon 2 mutations are independent predictors of shorter TTR in patients with resected stage III distal colon cancers receiving adjuvant therapy. Future clinical trials in the adjuvant setting should consider both the tumor location and KRAS mutations as important stratification factors.CLINICAL TRIAL NUMBER: This is an ancillary study of the PETACC8 trial: EUDRACT 2005-003463-23. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. Source


Blesius A.,Institute Gustave Roussy | Beuselinck B.,Georges Pompidou Hospital | Chevreau C.,Institute Claudius Regaud | Ravaud A.,University Hospital | And 3 more authors.
Clinical Genitourinary Cancer | Year: 2013

Background: Because the response to treatment is limited, patients with metastatic renal cell carcinoma (mRCC) typically receive multiple treatments. Guidelines recommend everolimus for patients previously treated with tyrosine kinase inhibitors (TKI) sunitinib or sorafenib. This study evaluated the efficacy of TKI re-treatment in patients with disease progression after a TKI-everolimus sequence. Patients and Methods: Data were reviewed for patients enrolled in RECORD-1 (Renal Cell Cancer Treatment With Oral RAD001 Given Daily) at French sites. Response, progression-free survival (PFS), and overall survival were evaluated in patients treated with a TKI-everolimus-TKI sequence. Results: Thirty-six patients received a TKI after everolimus: sunitinib in 17 patients, sorafenib in 15, and dovitinib (TKI258) in 4. The response rate with TKI re-treatment was 8%, and the disease-control rate (response plus stable disease) was 75%. The median PFS with each component of the TKI-everolimus-TKI sequence was 10.7 months (95% CI, 1.8-28.5 months), 8.9 months (95% CI, 1.7-34.6 months), and 8.2 months (95% CI, 5.2-11.9 months), respectively. The median overall survival from the start of everolimus was 29.1 months (95% CI 21.1 to not reached months), which suggests a benefit in using TKI in this setting. Conclusions: Administration of a TKI-everolimus-TKI sequence may be associated with clinical benefit and should be prospectively investigated. © 2013 Elsevier Inc. All rights reserved. Source

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