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Cavanna L.,Piacenza Hospital | Mordenti P.,Piacenza Hospital | Berte R.,Piacenza Hospital | Palladino M.A.,Piacenza Hospital | And 6 more authors.
World Journal of Surgical Oncology | Year: 2014

Background: Malignant pleural effusion (MPE) is an extremely common problem affecting cancer patients, and thoracentesis is an essential procedure in an attempt to delineate the etiology of the fluid collections and to relieve symptoms in affected patients. One of the most common complications of thoracentesis is pneumothorax, which has been reported to occur in 20% to 39% of thoracenteses, with 15% to 50% of patients with pneumothorax requiring tube thoracostomy.The present study was carried out to assess whether thoracenteses in cancer patients performed with ultrasound (US) guidance are associated with a lower rates of pneumothorax and tube thoracostomy than those performed without US guidance.Methods: A total of 445 patients were recruited in this retrospective study. The medical records of 445 consecutive patients with cancer and MPE evaluable for this study, undergoing thoracentesis at the Oncology-Hematology and Internal Medicine Departments, Piacenza Hospital (Italy) were reviewed.Results: From January 2005 to December 2011, in 310 patients (69.66%) thoracentesis was performed with US guidance and in 135 (30.34%) without it. On post-thoracentesis imaging performed in all these cases, 15 pneumothoraces (3.37%) were found; three of them (20%) required tube thoracostomy. Pneumothorax occurred in three out of 310 procedures (0.97%) performed with US guidance and in 12 of 135 procedures (8.89%) performed without it (P <0.0001). It must be emphasized that in all three patients with pneumothorax requiring tube thoracostomy, thoracentesis was performed without US guidance.Conclusions: The routine use of US guidance during thoracentesis drastically reduces the rate of pneumothorax and tube thoracostomy in oncological patients, thus improving safety as demonstrated in this study. © 2014 Cavanna et al.; licensee BioMed Central Ltd. Source

Bellanne-Chantelot C.,University Pierre and Marie Curie | Coste J.,Unit of Biostatistics and Epidemiology | Ciangura C.,University Pierre and Marie Curie | Fonfrede M.,AP HP | And 7 more authors.
Diabetes and Metabolism | Year: 2015

Aim: Low plasma levels of high-sensitivity C-reactive protein (hs-CRP) have been suggested to differentiate hepatocyte nuclear factor 1 alpha-maturity-onset diabetes of the young (HNF1A-MODY) from type 2 diabetes (T2D). Yet, differential diagnosis of HNF1A-MODY and familial young-onset type 2 diabetes (F-YT2D) remains a difficult challenge. Thus, this study assessed the added value of hs-CRP to distinguish between the two conditions. Methods: This prospective multicentre study included 143 HNF1A-MODY patients, 310 patients with a clinical history suggestive of HNF1A-MODY, but not confirmed genetically (F-YT2D), and 215 patients with T2D. The ability of models, including clinical characteristics and hs-CRP to predict HNF1A-MODY was analyzed, using the area of the receiver operating characteristic (AUROC) curve, and a grey zone approach was used to evaluate these models in clinical practice. Results: Median hs-CRP values were lower in HNF1A-MODY (0.25. mg/L) than in F-YT2D (1.14. mg/L) and T2D (1.70. mg/L) patients. Clinical parameters were sufficient to differentiate HNF1A-MODY from classical T2D (AUROC: 0.99). AUROC analyses to distinguish HNF1A-MODY from F-YT2D were 0.82 for clinical features and 0.87 after including hs-CRP. For the grey zone analysis, the lower boundary was set to miss. <. 1.5% of true positives in non-tested subjects, while the upper boundary was set to perform 50% of genetic tests in individuals with no HNF1A mutation. On comparing HNF1A-MODY with F-YT2D, 65% of patients were classified in between these categories-in the zone of diagnostic uncertainty-even after adding hs-CRP to clinical parameters. Conclusion: hs-CRP does not improve the differential diagnosis of HNF1A-MODY and F-YT2D. © 2015 Elsevier Masson SAS. Source

Michiels S.,Unit of Biostatistics and Epidemiology | Michiels S.,University Paris - Sud | Michiels S.,Free University of Colombia | Pugliano L.,Free University of Colombia | And 20 more authors.
Annals of Oncology | Year: 2016

Background: The gold standard end point in randomized clinical trials in metastatic breast cancer (MBC) is overall survival (OS). Although therapeutics have been approved based on progression-free survival (PFS), its use as a primary end point is controversial. We aimed to assess to what extent PFS may be used as a surrogate for OS in randomized trials of anti-HER2 agents in HER2+ MBC. Methods: Eligible trials accrued HER2+ MBC patients in 1992-2008. A correlation approach was used: at the individual level, to estimate the association between investigator-assessed PFS and OS using a bivariate model and at the trial level, to estimate the association between treatment effects on PFS and OS. Correlation values close to 1.0 would indicate strong surrogacy. Results: We identified 2545 eligible patients in 13 randomized trials testing trastuzumab or lapatinib. We collected individual patient data from 1963 patients and retained 1839 patients from 9 trials for analysis (7 first-line trials). During follow-up, 1072 deaths and 1462 progression or deaths occurred. The median survival time was 22 months [95% confidence interval (CI) 21-23 months] and the median PFS was 5.7 months (95% CI 5.5-6.1 months). At the individual level, the Spearman correlation was equal to ρ = 0.67 (95% CI 0.66-0.67) corresponding to a squared correlation value of 0.45. At the trial level, the squared correlation between treatment effects (log hazard ratios) on PFS and OS was provided by R2 = 0.51 (95% CI 0.22-0.81). Conclusions: In trials of HER2-targeted agents in HER2+ MBC, PFS moderately correlates with OS at the individual level and treatment effects on PFS correlate moderately with those on overall mortality, providing only modest support for considering PFS as a surrogate. PFS does not completely substitute for OS in this setting. © The Author 2016. Source

Corrao G.,Unit of Biostatistics and Epidemiology | Corrao G.,University of Milan Bicocca | Nicotra F.,Unit of Biostatistics and Epidemiology | Parodi A.,Unit of Biostatistics and Epidemiology | And 6 more authors.
Hypertension | Year: 2011

Guidelines recommend a combination of 2 drugs to be used as first-step treatment strategy in high-risk hypertensive individuals to achieve timely blood pressure control and avoid early events. The evidence that this is associated with cardiovascular (CV) benefits compared with initial monotherapy is limited, however. The objective of this study was to assess whether, compared with antihypertensive monotherapy, a combination of antihypertensive drugs provides a greater CV protection in daily clinical practice. A population-based, nested case-control study was carried out by including the cohort of 209 650 patients from Lombardy (Italy) aged 40 to 79 years who were newly treated with antihypertensive drugs between 2000 and 2001. Cases were the 10 688 patients who experienced a hospitalization for CV disease from initial prescription until 2007. Three controls were randomly selected for each case. Logistic regression was used to model the CV risk associated with starting on and/or continuing with combination therapy. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders. Patients starting on combination therapy had an 11% CV risk reduction with respect to those starting on monotherapy (95% CI: 5% to 16%). Compared with patients who maintained monotherapy also during follow-up, those who started on combination therapy and kept it along the entire period of observation had 26% reduction of CV risk (95% CI: 15% to 35%). In daily life practice, a combination of antihypertensive drugs is associated with a great reduction of CV risk. The indication for using combination of blood pressure drugs should be broadened. © 2011 American Heart Association, Inc. Source

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