Ospedali Galliera

Genova, Italy

Ospedali Galliera

Genova, Italy

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Bonelli L.,Secondary Prevention and Screening | Puntoni M.,Ospedali Galliera | Gatteschi B.,AOU San Martino IST Unit of Pathology | Massa P.,Gastroenterology Unit | And 6 more authors.
Journal of Gastroenterology | Year: 2013

Background: Patients who undergo polypectomy are at increased risk of adenoma recurrence. The preventive potential of vitamins (A, C and E) and selenium supplementation represent an interesting opportunity for colorectal cancer prevention. Methods: To assess the efficacy of a combination of these micronutrients in reducing the incidence of recurrent adenomas in subjects on post-polypectomy endoscopic follow-up, a double-blind placebo-controlled randomized trial was started in Italy in 1988. A total of 411 patients were randomized to receive either an active compound (200 μg selenium, 30 mg zinc, 2 mg vitamin A, 180 mg vitamin C, 30 mg vitamin E) or a placebo daily for 5 years. Of them, 330 had follow-up colonoscopy (164 in the intervention and 166 in the placebo group). Results: After a median follow-up of 4 years (range 1-15 years), 100 patients had recurrence: 38 in the intervention and 62 in the placebo arm. The 15-year cumulative incidence of recurrence was 48.3 % in the intervention and 64.5 % in the placebo arm (HR = 0.59; log-rank P = 0.009). A 39 % reduction of the risk of recurrence was observed in the intervention compared to the placebo group (adjusted HR = 0.61; 95 % CI 0.41-0.92): the risk reduction was similar for small tubular (adjusted HR = 0.61; 95 % CI 0.37-0.99) and advanced adenomas (adjusted HR = 0.50; 95 % CI 0.24-1.01). Conclusions: Our study showed a statistically significant effect of antioxidant supplementation on adenoma recurrence. Further clinical trials are needed to address the role of antioxidants in subgroups of subjects at increased risk for colorectal cancer. © 2012 Springer Japan.


Cicconi P.,University of Milan | Cozzi-Lepri A.,University College London | Castagna A.,Clinic of Infectious Disease | Trecarichi E.M.,Catholic University of the Sacred Heart | And 5 more authors.
HIV Medicine | Year: 2010

Objectives: The aim of the study was to determine whether the incidence of first-line treatment discontinuations and their causes changed according to the time of starting highly active antiretroviral therapy (HAART) in an Italian cohort. Methods: We included in the study patients from the Italian COhort Naïve Antiretrovirals (ICoNA) who initiated HAART when naïve to antiretroviral therapy (ART). The endpoints were discontinuation within the first year of ≥1 drug in the first HAART regimen for any reason, intolerance/toxicity, poor adherence, immunovirological/clinical failure and simplification. We investigated whether the time of starting HAART (stratified as 'early', 1997-1999; 'intermediate', 2000-2002; 'recent', 2003-2007) was associated with the probability of reaching the endpoints by a survival analysis. Results: Overall, the 1-year probability of discontinuation of ≥1 drug in the first regimen was 36.1%. The main causes of discontinuation were intolerance/toxicity (696 of 1189 patients; 58.5%) and poor adherence (285 of 1189 patients; 24%). The hazards for all-reason change were comparable according to calendar period [2000-2002, adjusted relative hazard (ARH) 0.82, 95% confidence interval (CI) 0.69-0.98; 2003-2007, ARH 0.94, 95% CI 0.76-1.16, vs. 1997-1999; global P-value=0.08]. Patients who started HAART during the 'recent' period were less likely to change their initial regimen because of intolerance/toxicity (ARH 0.67, 95% CI 0.51-0.89 vs. 'early' period). Patients who started in the 'intermediate' and 'recent' periods had a higher risk of discontinuation because of simplification (ARH 15.26, 95% CI 3.21-72.45, and ARH 37.97, 95% CI 7.56-190.64, vs. 'early' period, respectively). Conclusions: It seems important to evaluate reason-specific trends in the incidence of discontinuation in order to better understand the determinants of changes over time. The incidence of discontinuation because of intolerance/toxicity has declined over time while simplification strategies have become more frequent in recent years. Intolerance/toxicity remains the major cause of drug discontinuation. © 2009 British HIV Association.


Todiere G.,CNR Institute of Neuroscience | Aquaro G.D.,CNR Institute of Neuroscience | Piaggi P.,University of Pisa | Formisano F.,Ospedali Galliera | And 7 more authors.
Journal of the American College of Cardiology | Year: 2012

This study sought to assess the rate of progression of fibrosis by 2 consecutive cardiac magnetic resonance (CMR) examinations and its relation with clinical variables. In hypertrophic cardiomyopathy (HCM) myocardial fibrosis, detected by late gadolinium enhancement (LGE), is associated to a progressive ventricular dysfunction and worse prognosis. A total of 55 HCM patients (37 males; mean age 43 ± 18 years) underwent 2 CMR examinations (CMR-1 and CMR-2) separated by an interval of 719 ± 410 days. Extent of LGE was measured, and the rate of progression of LGE (LGE-rate) was calculated as the ratio between the increment of LGE (in grams) and the time (months) between the CMR examinations. At CMR-1, LGE was detected in 45 subjects, with an extent of 13.3 ± 15.2 g. At CMR-2, 53 (96.4%) patients had LGE, with an extent of 24.6 ± 27.5 g. In 44 patients, LGE extent increased significantly (<1 g). Patients with apical HCM had higher increments of LGE (p = 0.004) and LGE-rate (p < 0.001) than those with other patterns of hypertrophy. The extent of LGE at CMR-1 and the apical pattern of hypertrophy were independent predictors of the increment of LGE. Patients with worsened New York Heart Association functional class presented higher increase of LGE (p = 0.031) and LGE-rate (p < 0.05) than those with preserved functional status. Myocardial fibrosis in HCM is a progressive and fast phenomenon. LGE increment, related to a worse clinical status, is more extensive in apical hypertrophy than in other patterns. © 2012 American College of Cardiology Foundation.


Spirito P.,Ospedali Galliera | Boni L.,Instituto Toscano Tumori AOU Careggi
European Heart Journal | Year: 2012

AimsThe recent American College of Cardiology and American Heart Association Guidelines on hypertrophic cardiomyopathy (HCM) have confirmed surgical myectomy as the gold standard for non-pharmacological treatment of obstructive HCM. However, during the last 15 years, an extensive use of alcohol septal ablation has led to the virtual extinction of myectomy programmes in several European countries. Therefore, many HCM candidates for myectomy in Europe cannot be offered the option of this procedure. The purpose of our study is to report the difficulties and results in developing a myectomy programme for HCM in a centre without previous experience with this procedure. Methods and resultsThe clinical course is reported of 124 consecutive patients with obstructive HCM and heart failure symptoms who underwent myectomy at a single European centre between 1996 and 2010. The median follow-up was 20.3 months (inter-quartile range: 3.940.6 months). No patients were lost to follow-up. A cumulative incidence of HCM-related death after myectomy was 0.8, 3.3, and 11.2 at 1, 5, and 10 years, respectively, including one operative death (procedural mortality 0.8). The left ventricular (LV) outflow gradient decreased from 95 ± 36 mmHg before surgery to 12 ± 6 mmHg at most recent evaluation (P < 0.001), with none of the patients having a significant residual LV outflow gradient. Of the 97 patients in New York Heart Association functional class IIIIV before surgery, 93 (96) were in class III at most recent evaluation (P < 0.001). ConclusionOur results show that the development of a myectomy programme at a centre without previous experience with this procedure is feasible and can lead to highly favourable clinical results. © 2012 The Author.


Tunn U.W.,Facharztzentrum | Canepa G.,Ospedali Galliera | Kochanowsky A.,Urological Practice | Kienle E.,Medical Consultant
Prostate Cancer and Prostatic Diseases | Year: 2012

Background: Intermittent androgen deprivation (IAD) for prostate cancer was studied with the objective of reducing the side effects of treatment and potentially delaying the development of hormone resistance. There also appears to be a quality of life benefit during off-treatment intervals owing to the recovery of serum testosterone levels. Methods: In this multicentre European prospective randomised phase III trial EC507, testosterone serum concentrations were analysed in prostate cancer patients with PSA progression after radical prostatectomy. Patients were randomised to a continuous androgen deprivation (CAD) and IAD therapy using a 3-month depot with 11.25 mg leuprorelin acetate as microcapsule formulation. A complete IAD cycle comprises both a 6-month androgen deprivation therapy plus the off-treatment time (OTT). Results: Serum testosterone recovery was recorded in 109 patients during OTT in the IAD group. Testosterone recovery to baseline values was achieved in 79.3% during the first and in 64.9% during the second IAD cycle, respectively. Median time to testosterone normalisation was 100 days in the first and 115 days in the second cycle, respectively. No significant difference was observed up to 1000 days between IAD and CAD with regard to time to androgen-independent progression. This is the first prospective study of leuprorelin acetate 11.25 mg demonstrating normalisation of testosterone levels in the off-treatment period in patients undergoing IAD. Conclusions: The prerequisite of an IAD treatment is the testosterone recovery during off-treatment periods. In this study, in patients with PSA relapse after radical prostatectomy, a real achievement of intermittent castration with normalisation of testosterone levels during off-treatment periods could be confirmed. © 2012 Macmillan Publishers Limited All rights reserved.


PubMed | ASST Fatebenefratelli Sacco, San Martino Hospital, Azienda Ospedaliera Universitaria di Padua, Ospedali Galliera and 5 more.
Type: | Journal: Antiviral therapy | Year: 2016

Dolutegravir plus darunavir provide high genetic barrier to HIV-1 resistance and fit for simple salvage regimens.All HIV-1 infected subjects treated with dolutegravir plus boosted darunavir dual therapy between March 2011 and September 2015 were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48.We enrolled 113 subjects. After week 24 one was lost at follow-up, one dropped out for grade 2 elevation of liver enzimes, one died from illicit drug abuse and one from cancer-related sepsis. The mean age was 51, females 26.5%, non-caucasians 9.7%. Twenty had never experienced failure. Ninety-nine had reverse-trascriptase (RT) mutations, 87 had protease inhibitor mutations, and 12 had integrase strand transfer inhibitor (INSTI) mutations. : Viremic patients declined from baseline to week 24 from 43.4% to 6.2%, the remainder being due to high baseline viremia or adherence issues. The proportion of subjects with viraemia 1 - 49 copies/mL remained at 20.4% while those in whom no virus was detected (NVD) increased from 36.3% to 73.5% by week 24. All the 47 subjects who have a 48-week follow-up had < 50 copies/mL and 42 (89.4%) had NVD. Eighteen subjects had reduced sensitivity to darunavir (Stanford median score 15, range 15 - 40), but none rebounded, 6 having a 24-week and 7 a 48-week follow-up. The median variation in serum creatinine was -0,01 (range + 0.2 to - 0.21).This dual regimen provides a simple salvage regimen and proved safe and effective in this cohort.


Cenderello G.,Ospedali Galliera | De Maria A.,University of Genoa | De Maria A.,Instituto Nazionale per la Ricerca sul Cancro
Expert Review of Anti-Infective Therapy | Year: 2016

The goal of antiretroviral treatment (ART) in HIV-1 patients is immune reconstitution following control of viral replication. CD4+ cell number/proportions are a crude but essential correlate of immune reconstitution. Despite suppression of HIV replication, a fraction of ART-treated patients still fails to fully reconstitute CD4+ T cell numbers (immunological nonresponders, INRs). New drugs, regimens and treatment strategies led to increased efficacy, lower side effects and higher virological success rates in clinical practice. The multitude of described immune defects and clinical events accompanying INR opposed to the marginal effect of antiretroviral intensification or immunotherapy trials underline the need for continuing efforts at understanding the mechanisms that underlie INR. Here, we reassess INR definition, frequency, and the achievements of active clinical and translational research suggesting a shared definition for insufficient, partial and complete CD4+ cell number recovery thus improving homogeneity in patient selection and mechanism identification. © 2015 Taylor & Francis.


Aquaro G.D.,CNR Institute of Neuroscience | Positano V.,CNR Institute of Neuroscience | Pingitore A.,CNR Institute of Clinical Physiology | Strata E.,University of Florence | And 4 more authors.
Journal of Cardiovascular Magnetic Resonance | Year: 2010

Background. Cardiovascular Magnetic resonance (CMR) with the late gadolinium enhancement (LGE) technique allows the detection of myocardial fibrosis in Hypertrophic cardiomyopathy (HCM). The aim of this study was to compare different methods of automatic quantification of LGE in HCM patients. Methods: Forty HCM patients (mean age 48 y, 30 males) and 20 normal subjects (mean age 38 y, 16 males) underwent CMR, and we compared 3 methods of quantification of LGE: 1) in the SD2 method a region of interest (ROI) was placed within the normal myocardium and enhanced myocardium was considered as having signal intensity >2 SD above the mean of ROI; 2) in the SD6 method enhanced myocardium was defined with a cut-off of 6 SD above mean of ROI; 3) in the RC method a ROI was placed in the background of image, a Rayleigh curve was created using the SD of that ROI and used as ideal curve of distribution of signal intensity of a perfectly nulled myocardium. The maximal signal intensity found in the Rayleigh curve was used as cut-off for enhanced myocardium. Parametric images depicting non enhanced and enhanced myocardium was created using each method. Three investigators assigned a score to each method by the comparison of the original LGE image to the respective parametric map generated. Results. Patients with HCM had lower concordance between the measured curve of distribution of signal intensity and the Rayleigh curve than controls (63.7 12.3% vs 92.2 2.3%, p < 0.0001). A cut off of concordance < 82.9% had a 97.1% sensitivity and 92.3% specificity to distinguish HCM from controls. The RC method had higher score than the other methods. The average extent of enhanced myocardium measured by SD6 and Rayleigh curve method was not significant different but SD6 method showed underestimation of enhancement in 12% and overestimation in 5% of patients with HCM. Conclusions. Quantification of fibrosis in LGE images with a cut-off derived from the Rayleigh curve is more accurate than using a fixed cut-off. © 2010 Aquaro et al; licensee BioMed Central Ltd.


Bertagna F.,University of Brescia | Treglia G.,Catholic University of the Sacred Heart | Piccardo A.,Ospedali Galliera | Giovannini E.,Catholic University of the Sacred Heart | And 5 more authors.
Endocrine | Year: 2013

Thyroid incidental uptake is defined as a thyroid uptake incidentally and newly detected by imaging techniques performed for an unrelated purpose and especially for non-thyroid diseases. Aim of the study was to establish the prevalence and pathological nature of focal thyroid incidentalomas detected at F18-FDG-PET/CT in patients studied for oncological purposes and not for thyroid disease. Secondary end point was to establish a possible maximum standardised uptake value cut-off over which a malignant lesion should be suspected. We have retrospectively evaluated 49519 patients who underwent F18-FDG-PET/CT for oncologic purposes in three Nuclear Medicine Centres (N.1 = 11278, N.2 = 31076, N.3 = 7165). A focal incidental thyroid uptake was diagnosed in 729 (1.5 %) patients (287-39.4 % male and 442-60.6 % female; average age: 65.26). Of 729 thyroid incidentalomas 211 (28.9 %) underwent further investigation to determine the nature of the nodule; 124/211 (58.8 %) incidentalomas were benign, 72/211 (34.1 %) malignant, 4/211 (1.9 %) non-diagnostic at cytological examination in the absence of surgery and histological evaluation and 11/211 (5.2 %) were indeterminate at cytological examination. A centre-based receiver operating curve (ROC) analysis of the patients with a definitive diagnosis was performed to identify a SUVmax cut-off useful in differentiating benign from malignant incidentalomas. In the centre N.1 it was 4.8 (sensitivity = 95.7 %, specificity = 46.4 %, area under the curve = 0.758); 5.3 in the centre N.2 (sensitivity = 76.3 %, specificity = 72.5 %, area under the curve = 0.815); 7 in the centre N.3 (sensitivity = 57.1 %, specificity = 79.3 %, area under the curve = 0.627). F18-FDG-PET/CT thyroid incidentalomas are a relevant diagnostic reality which requires further investigations and clinical management especially considering that, despite mainly benign, approximately one third of focal thyroid uptakes are malignant. © 2012 Springer Science+Business Media New York.


PubMed | Spedali Civili di Brescia, Oncology Institute of Southern Switzerland, Ospedali Galliera, Instituto Oncologico Veneto IOV IRCCS and University of Brescia
Type: Journal Article | Journal: Revista espanola de medicina nuclear e imagen molecular | Year: 2015

Our study has aimed to establish the prevalence and pathological nature of fluorine-18-fluorodeoxyglucose ((18)F-FDG) breast incidental uptake (BIU) in patients studied for non-malignant breast tumours and then to compare our data obtained in three Italian nuclear medicine centres with those available in literature.We retrospectively evaluated 42,927 (18)F-FDG-PET/CT scans performed on patients studied in three Italian Nuclear Medicine Centres. All patients underwent (18)F-FDG-PET/CT for oncologic purposes not related to breast disease.Among 42,927 scans, a BIU was identified in 79 (0.18%) patients, 75 (95%) female and 4 (5%) male with an average age of 62 17 years. Twenty-five out of 35 (71.5%) BIUs were malignant and 10/35 (28.5%) benign. Among the 25/35 incidentalomas that were malignant, 12/25 (48%) were infiltrating ductal carcinoma, 5/25 (20%) ductal carcinoma (infiltrating and in situ), 4/25 (16%) lobular carcinoma, 2/25 (8%) ductal carcinoma in situ and 2/25 (8%) were metastases from the primary tumour under investigation. Of the 10 BIUs that were benign in the histological examination, after further investigations it was found that 9/10 (90%) were fibroadenomas and 1/10 (10%) was a benign lesion not better specified. The lesion to liver or to blood-pool SUVmax ratio in malignant lesions is significantly higher than in benign ones.Our multicenter study demonstrates that, although they are uncommon, BIUs show a high percentage of malignancy and therefore requires further research.

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