Ospedale Civile di Livorno

Livorno, Italy

Ospedale Civile di Livorno

Livorno, Italy
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Dentali F.,University of Insubria | Mumoli N.,Ospedale Civile di Livorno | Prisco D.,University of Florence | Fontanella A.,Ospedale Fatebenefratelli | Di Minno M.N.D.,University of Naples Federico II
Thrombosis and Haemostasis | Year: 2017

Compelling evidence suggests that the risk of pulmonary embolism (PE) and deep-vein thrombosis (DVT) persists after hospital discharge in acutely-ill medical patients. However, no studies consistently supported the routine use of extended-duration thromboprophylaxis (ET) in this setting. We performed a meta-analysis to assess efficacy and safety of ET in acutely-ill medical patients. Efficacy outcome was defined by the prevention of symptomatic DVT, PE, venous thromboembolism (VTE) and VTE-related mortality. Safety outcome was the occurrence of major bleeding (MB) and fatal bleeding (FB). Pooled odds ratios (ORs) and 95 % confidence intervals (95 %CI) were calculated for each outcome using a random effects model. Four RCTs for a total of 28,105 acutely-ill medical patients were included. ET was associated with a significantly lower risk of DVT (0.3 % vs 0.6 %, OR 0.504, 95 %CI: 0.287-0.885) and VTE (0.5 % vs 1.0 %, OR: 0.544, 95 %CI: 0.297-0.997); a non-significantly lower risk of PE (0.3 % vs 0.4 %, OR 0.633, 95 %CI: 0.388-1.034) and of VTE-related mortality (0.2 % vs 0.3 %, OR 0.687, 95 %CI: 0.445-1.059) and with a significantly higher risk of MB (0.8 % vs 0.4 %, OR 2.095, 95 %CI: 1.333-3.295). No difference in FB was found (0.06 % vs 0.03 %, OR 1.79, 95 %CI: 0.384-8.325). The risk benefit analysis showed that the NNT for DVT was 339, for VTE was 239, and the NNH for MB was 247. Results of our meta-analyses focused on clinical important outcomes did not support a general use of antithrombotic prophylaxis beyond the period of hospitalization in acutely-ill medical patients. © Schattauer 2017.

PubMed | Johannes Gutenberg University Mainz, University of Insubria, Ospedale Maggiore della Carita, Ospedale Civile di Livorno and Ospedale Fatebenefratelli
Type: | Journal: Internal and emergency medicine | Year: 2016

The decision concerning the introduction of primary and secondary prophylaxis of venous thromboembolism (VTE) in patients with solid brain neoplasms and brain metastases is often challenging due to the concomitant increasedrisk of intracranial hemorrhage and to limited evidence from available literature. A standardized questionnaire composed of nine multiple-choice questions regarding primary VTE prevention in non-surgical patients during high-risk conditions and VTE secondary prevention in patients with a solid brain neoplasm or cerebral metastases was sent via electronic mail to all the members (n=2420) of the Italian Federation of the Internal Medicine Hospital Executives Associations (FADOI) in June 2015. Three hundred and fifty two physicians (14.5%) returned it (participants median age 51years; females 46.9%). The majority of respondents prescribe primary thromboprophylaxis (usually with heparin) in non-surgical patients with solid brain neoplasms and brain metastases in concomitance with high-risk conditions. Full-dose anticoagulation with either low-molecular-weight heparin or fondaparinux is the preferred option for acute VTE (69.6%), while a reduced dose is chosen by 21.0% of physicians. The presence of a highly vascular brain neoplasm histotype mandates the prescription of a reduced-dose antithrombotic regimen in a minority of respondents. Vena cava filter placement is an option for the treatment of acute VTE in more than 6% of respondents. Anticoagulants are often prescribed for both VTE primary prevention and treatment. In conclusion, physicians managements are partially in contrast to recent guidelines, reinforcing the need for educational programs and other studies in this setting.

PubMed | Shizuoka Cancer Center, National Hospital Organization Shikoku Cancer Center, prus Oncology Center, Norris Comprehensive Cancer Center and Hospital and 19 more.
Type: Journal Article | Journal: Gut | Year: 2015

We aimed to better clarify the role of germline variants of the FCG2 receptor, FCGR2A-H131R and FCGR3A-V158F, on the therapeutic efficacy of cetuximab in metastatic colorectal cancer (mCRC). A large cohort with sufficient statistical power was assembled.To show a HR advantage of 0.6 in progression-free survival (PFS) for FCGR2A-HH versus the rest and FCGR3A-VV versus the rest, with an 80% power, 80 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type (KRAS-WT) and 52 KRAS-WT patients are required, respectively. This leads to a total sample size of 952 and 619 patients, respectively. Samples were collected from 1123 mCRC patients from 15 European centres treated with cetuximab alone or in combination with chemotherapy. Fc gamma receptor (FCGR) status was centrally genotyped. Two additional externally genotyped series were included.Incidences of FCGR2A-HH and FCGR3A-VV in KRAS-WT patients were 220/660 (33%) and 109/676 (16.1%) respectively. There was no difference in median PFS (mPFS) for KRAS-WT patients with FCGR2A-HH (22.0weeks; 95% CI18.8 to 25.2) versus non-HH (22.0weeks; 95% CI 19.4 to 24.6) or for FCGR3A-VV (16.4weeks; 95% CI 13.0 to 19.8) versus non-VV (23weeks; 95% CI 21.1 to 24.9) (p=0.06). Median overall survival, response rate and disease control rate assessments showed no benefit for either HH or VV.No differences in mPFS were found between the FCGR polymorphisms HH and the others and VV versus the others in KRAS-WT mCRC patients refractory to irinotecan, oxaliplatin and 5-fluorouracil treated with cetuximab. We cannot confirm the effects of other IgG1 antibodies, which may be weaker than previously suggested. Other markers may be needed to study the actual host antibody response to cetuximab.

Coudert B.,Center Georges Francois Leclerc | Ciuleanu T.,Institute of Oncology Ion Chiricuta | Park K.,Sungkyunkwan University | Wu Y.-L.,Guangdong General Hospital | And 4 more authors.
Annals of Oncology | Year: 2012

Background: In the placebo-controlled phase III SATURN study, maintenance erlotinib after first-line chemotherapy demonstrated significantly prolonged progression-free survival (PFS) and overall survival (OS) in the overall study population of patients with advanced non-small-cell lung cancer (NSCLC). Methods: After four cycles of platinum-based doublet chemotherapy, patients without progressive disease (PD) were randomised to erlotinib (150 mg/day) or placebo until PD or unacceptable toxicity. In this pre-planned analysis, data are assessed according to response to first-line chemotherapy (complete/partial response [CR/PR] or stable disease [SD]). Results: Following first-line chemotherapy, 889 non-PD patients were included in the intention-to-treat population (55% SD; 44% CR/PR; <1% unknown response). Erlotinib maintenance therapy significantly prolonged PFS in both the SD (hazard ratio [HR] = 0.68; P < 0.0001) and CR/PR (HR = 0.74; P = 0.0059) groups, while OS was significantly prolonged in the SD group only (HR = 0.72; P = 0.0019). The erlotinib-related OS benefit in the SD group remained significant across subgroups, irrespective of tumour histology and/or EGFR mutation status. The incidence of adverse events was similar in the SD group and the overall population, and erlotinib treatment did not negatively impact quality of life. Conclusions: Patients with advanced NSCLC and SD following first-line platinum-based doublet chemotherapy derive a significant OS benefit from maintenance erlotinib therapy. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Cappuzzo F.,Ospedale Civile di Livorno | Ciuleanu T.,Institute of Oncology Ion Chiricuta | Stelmakh L.,St. Petersburg State Medical University | Cicenas S.,Vilnius University | And 9 more authors.
The Lancet Oncology | Year: 2010

Background: First-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) is usually limited to four to six cycles. Maintenance therapy can delay progression and prolong survival. The oral epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib has proven efficacy and tolerability in second-line NSCLC. We designed the phase 3, placebo-controlled Sequential Tarceva in Unresectable NSCLC (SATURN; BO18192) study to assess use of erlotinib as maintenance therapy in patients with non-progressive disease following first-line platinum-doublet chemotherapy. Methods: Between December, 2005, and May, 2008, 1949 patients were included in the run-in phase (four cycles of platinum-based chemotherapy). At the end of the run-in phase, 889 patients who did not have progressive disease were entered into the main study, and were randomly allocated using a 1:1 adaptive randomisation method through a third-party interactive voice response system to receive erlotinib (150 mg/day; n=438) or placebo (n=451) until progression or unacceptable toxicity. Patients were stratified by EGFR immunohistochemistry status, stage, Eastern Cooperative Oncology Group performance status, chemotherapy regimen, smoking history, and region. Co-primary endpoints were progression-free survival (PFS) in all analysable patients irrespective of EGFR status, and PFS in patients whose tumours had EGFR protein overexpression, as determined by immunohistochemistry. This study is registered with www.ClinicalTrials.gov, number NCT00556712. Findings: 884 patients were analysable for PFS; 437 in the erlotinib group and 447 in the placebo group. After a median follow-up of 11·4 months for the erlotinib group and 11·5 months for the placebo group, median PFS was significantly longer with erlotinib than with placebo: 12·3 weeks for patients in the erlotinib group versus 11·1 weeks for those in the placebo group (HR 0·71, 95% CI 0·62-0·82; p<0·0001). PFS was also significantly longer in patients with EGFR-positive immunohistochemistry who were treated with erlotinib (n=307) compared with EGFR-positive patients given placebo (n=311; median PFS 12·3 weeks in the erlotinib group vs 11·1 weeks in the placebo group; HR 0·69, 0·58-0·82; p<0·0001). The most common grade 3 or higher adverse events were rash (37 [9%] of 443 patients in the erlotinib group vs none of 445 in the placebo group) and diarrhoea (seven [2%] of 443 patients vs none of 445). Serious adverse events were reported in 47 patients (11%) on erlotinib compared with 34 patients (8%) on placebo. The most common serious adverse event was pneumonia (seven cases [2%] with erlotinib and four [<1%] with placebo). Interpretation: Maintenance therapy with erlotinib for patients with NSCLC is well tolerated and significantly prolongs PFS compared with placebo. First-line maintenance with erlotinib could be considered in patients who do not progress after four cycles of chemotherapy. Funding: F Hoffmann-La Roche Ltd. © 2010 Elsevier Ltd.

Dentali F.,University of Insubria | Cei M.,Ospedale Civile di Livorno | Mumoli N.,Ospedale Civile di Livorno | Gianni M.,Hospital of Tradate
Polskie Archiwum Medycyny Wewnetrznej | Year: 2015

Pulmonary embolism (PE) is a common disease with a considerable short-and long-term risk of death. An adequate evaluation of the prognosis in patients with PE may guide decision making in terms of the intensity of the initial treatment during the acute phase, duration of treatment, and intensity of follow-up control visits in the long term. Patients with shock or persistent hypotension are at high risk of early mortality and may benefit from immediate reperfusion. Several tools are available to define the short-term prognosis of hemodynamically stable patients. The Pulmonary Embolism Severity Index (PESI) score, simplified PESI score, and N-terminal pro-B-type natriuretic peptide levels are particularly useful for identifying patients at low risk of early complications who might be safely treated at home. However, the identification of patients who are hemodynamically stable at diagnosis but are at a high risk of early complications is more challenging. The current guidelines recommended a multiparametric prognostic algorithm based on the clinical status and comorbidities. Unfortunately, only a few studies have evaluated the role of risk factors potentially affecting the long-term prognosis of these patients. The available studies suggest a potential role of the PESI score and troponin levels evaluated at the time of an index event. However, further studies are warranted to confirm these preliminary findings and to identify other long-term prognostic factors in this setting.

Cei M.,Ospedale Civile di Livorno | Mumoli N.,Ospedale Civile di Livorno | Vitale J.,University of Insubria | Dentali F.,University of Insubria
Internal and Emergency Medicine | Year: 2015

Elderly patients admitted to the hospital are at increased risk for both in-hospital and post-discharge mortality. Risk assessment models (RAMs) for in-hospital mortality are based mainly on physiological variables and a few laboratory data, whereas RAMs for late mortality usually include other domains such as disability and comorbidities. We aim to evaluate if a previous validated model for 1-year mortality (the Walter Score) would also work well in predicting in-hospital mortality. We retrospectively revised the medical records of patients admitted on our ward, from April to December, 2013. Data regarding gender, activities of daily living (ADLs), comorbidities, and routine laboratory tests were used to calculate a Modified Walter Score (MoWS). The main outcome measure was all cause, in-hospital mortality. The analysis involved 1,004 patients. Of these, 888 were discharged alive, and 116 (11.5 %) died during the hospitalization. The mean MoWS was 4.9 (±3.6) in the whole sample. Stratification into risk classes parallels with in-hospital mortality (Chi square for trend p < 0.001). When dichotomized, MoWS has a sensitivity of 97.4 % (95 % CI 92.1–99.3), and a specificity of 48.2 % (95 % CI 44.9–51.5) with a good prognostic accuracy (area under the ROC = 0.81; 95 % CI 0.78, 0.84). Subgroup analysis according to different age groups gives similar results. A simple RAM based on multiple domains, previously validated for predicting mortality of older adults within 1 year from the index hospitalization, can be useful at the moment of admission to Internal Medicine wards to accurately identify patients at low risk of in-hospital mortality. © 2015, SIMI.

Mumoli N.,Ospedale Civile di Livorno | Vitale J.,Ospedale di Circolo | Cocciolo M.,Ospedale Civile di Livorno | Cei M.,Ospedale Civile di Livorno | And 8 more authors.
Journal of Thrombosis and Haemostasis | Year: 2014

Summary: Background: Compression ultrasonography (CUS) has been recognized as the diagnostic procedure of choice for the investigation of patients with suspected deep vein thrombosis (DVT); the aim of this study was to assess the diagnostic accuracy of nurse-performed CUS for symptomatic proximal DVT of the lower limb. Material and Methods: We prospectively evaluated all consecutive outpatients referred for suspected DVT from January 2011 to December 2012. All patients underwent bilateral proximal lower limb CUS, first by trained nurses and then by physicians expert in vascular ultrasonography, with every group blinded with respect to each other. This test was repeated after 5-7 days in all negative or unclear examinations. Interobserver agreement and accuracy of nurse-performed CUS were calculated, considering the physician's final diagnosis as the reference test. Results: Six hundred ninety-seven patients were included in the study. DVT was diagnosed in 122 patients by expert ultrasound physicians with an overall prevalence of 17.5% (95% confidence interval [CI] 15.8%-20.6%). Nurse agreement with the physician in DVT diagnosis was excellent (Cohen's κ 0.82, 95% CI 0.79-0.85). Nurse-performed CUS had a sensitivity of 84.4% (95% CI 81.7%-87.1%) and a specificity of 97.0% (95% CI 95.8%-98.3%) with a diagnostic accuracy of 94.8% (95% CI 93.2%-96.5%). Conclusion: Our results suggest that nurse-performed CUS may be a potential useful alternative to physician performed CUS with a good accuracy. However, sensibility of nurse-performed CUS appeared suboptimal and future studies should incorporate in the evaluation of this technique other pretest tools that may increase its accuracy. © 2014 International Society on Thrombosis and Haemostasis.

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