Treviglio, Italy
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Gaspari F.,Mario Negri Institute for Pharmacological Research | Ruggenenti P.,Mario Negri Institute for Pharmacological Research | Porrini E.,Mario Negri Institute for Pharmacological Research | Porrini E.,Hospital Universitario Of Canarias | And 13 more authors.
Kidney International | Year: 2013

There are no adequate studies that have formally tested the performance of different estimating formulas in patients with type 2 diabetes both with and without overt nephropathy. Here we evaluated the agreement between baseline GFRs, GFR changes at month 6, and long-term GFR decline measured by iohexol plasma clearance or estimated by 15 creatinine-based formulas in 600 type 2 diabetics followed for a median of 4.0 years. Ninety patients were hyperfiltering. The number of those identified by estimation formulas ranged from 0 to 24:58 were not identified by any formula. Baseline GFR was significantly underestimated and a 6-month GFR reduction was missed in hyperfiltering patients. Long-term GFR decline was also underestimated by all formulas in the whole study group and in hyper-, normo-, and hypofiltering patients considered separately. Five formulas generated positive slopes in hyperfiltering patients. Baseline concordance correlation coefficients and total deviation indexes ranged from 32.1% to 92.6% and from 0.21 to 0.53, respectively. Concordance correlation coefficients between estimated and measured long-term GFR decline ranged from -0.21 to 0.35. The agreement between estimated and measured values was also poor within each subgroup considered separately. Thus, our study questions the use of any estimation formula to identify hyperfiltering patients and monitor renal disease progression and response to treatment in type 2 diabetics without overt nephropathy. © 2013 International Society of Nephrology.


Ruggenenti P.,Mario Negri Institute for Pharmacological Research | Porrini E.L.,Mario Negri Institute for Pharmacological Research | Gaspari F.,Mario Negri Institute for Pharmacological Research | Motterlini N.,Mario Negri Institute for Pharmacological Research | And 12 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - To describe the prevalence and determinants of hyperfiltration (glomerular filtration rate [GFR] ≥120 mL/min/1.73 m2), GFR decline, and nephropathy onset or progression in type 2 diabetic patients with normo- or microalbuminuria. RESEARCH DESIGN AND METHODS - We longitudinally studied 600 hypertensive type 2 diabetic patients with albuminuria <200 μg/min and who were retrieved from two randomized trials testing the renal effect of trandolapril and delapril. Target blood pressure (BP) was <120/80 mmHg, and HbA1c was <7%. GFR, albuminuria, and glucose disposal rate (GDR) were centrally measured by iohexol plasma clearance, nephelometry in three consecutive overnight urine collections, and hyperinsulinemic euglycemic clamp, respectively. RESULTS - Over a median (range) follow-up of 4.0 (1.7-8.1) years, GFR declined by 3.37 (5.71-1.31) mL/min/1.73 m2 per year. GFR change was bimodal over time: a larger reduction at 6 months significantly predicted slower subsequent decline (coefficient: -0.0054; SE: 0.0009), particularly among hyperfiltering patients. A total of 90 subjects (15%) were hyperfiltering at inclusion, and 11 of 47 (23.4%) patients with persistent hyperfiltration progressed to micro- or macroalbuminuria versus 53 (10.6%) of the 502 who had their hyperfiltration ameliorated at 6 months or were nonhyperfiltering since inclusion (hazard ratio 2.16 [95% CI 1.13-4.14]). Amelioration of hyperfiltration was independent of baseline characteristics or ACE inhibition. It was significantly associated with improved BP and metabolic control, amelioration of GDR, and slower long-term GFR decline on follow-up. CONCLUSIONS - Despite intensified treatment, patients with type 2 diabetes have a fast GFR decline. Hyperfiltration affects a subgroup of patients and may contribute to renal function loss and nephropathy onset or progression. Whether amelioration of hyperfiltration is renoprotective is worth investigating. © 2012 by the American Diabetes Association.


Ditto A.,Italian National Cancer Institute | Martinelli F.,Italian National Cancer Institute | Reato C.,Treviglio Hospital | Kusamura S.,Italian National Cancer Institute | And 4 more authors.
Annals of Surgical Oncology | Year: 2012

Background. Lymphadenectomy is important in the surgical treatment of apparent early epithelial ovarian cancers (eEOC); however, its extent is not well defined. We evaluated the role of systematic lymphadenectomy, the risk factors related with lymph node metastases, the implications, and the morbidity of comprehensive surgical staging. Methods. We prospectively recruited 124 patients diagnosed with apparent eEOC [International Federation of Gynecology and Obstetrics (FIGO) stage I and II] between January 2003 and January 2011. Demographics, surgical procedures, morbidities, pathologic findings, and correlations with lymph node metastases were assessed. Results. A total of 111 patients underwent complete surgical staging, including lymphadenectomy, and were therefore analyzed. A median of 23 pelvic and 20 paraaortic nodes were removed. Node metastases were found in 15 patients (13.5 %). The para-aortic region was involved in 13 (86.6 %) of 15 cases. At univariate analysis, age, menopause, FIGO stage, grading, and laterality were found to be significant factors for lymph node metastases, while CA125 of >35 U/ml and positive cytology were not. No lymph node metastases were found in mucinous histotypes. At multivariate analysis, only bilaterality (p = 0.018) and menopause (p = 0.032) maintained a statistically significant association with lymph node metastases. Lymphadenectomy-related complications (lymphocyst formation and lymphorrhea) were found in 14.4 % patients. Conclusions. The data of this prospective study demonstrate the prognostic value of lymphadenectomy in eEOC. Menopause, age, bilaterality, histology, and tumor grade are identifiable factors that can help the surgeon decide whether to perform comprehensive surgical staging with lymph node dissection. These parameters may be used in planning subsequent treatment. © Society of Surgical Oncology 2012.


Butera G.,GUCH Unit | Saracino A.,GUCH Unit | Danna P.,Sacco Hospital | Sganzerla P.,Treviglio Hospital | And 2 more authors.
Catheterization and Cardiovascular Interventions | Year: 2013

Background Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure. However the "quest" for the ideal device is still ongoing. Here we present the procedural and early results of transcatheter closure of PFO with the GORE® Septal Occluder. Methods Three Italian centers participated in a registry and collected data from 122 consecutive patients undergoing PFO closure by using GSO device. Indication for closure was previous stroke or transient cerebral ischemia in 110 and migraine in 12 subjects. Results The procedure was successful in all patients. The procedure was performed under general anesthesia, fluoroscopic, and trans-esophageal echocardiographic imaging in 80 subjects while it was performed with local anesthesia, fluoroscopic, and intracardiac echocardiographic monitoring in 42 subjects. Twenty patients received a 20 mm device, 70 patients received a 25 mm device, and 32 received a 30 mm device. Procedure and fluoroscopy times were 30 ± 20 and 5 ± 4 min, respectively. In three cases, the implanted device was retrieved because of unsatisfactory position. Four subjects (2.5%) experienced vascular complications. During a median follow-up of 9 months (range 1-18 months) seven patients experienced atrial arrhythmias and four of them required medical treatment. At six months follow-up, at chest X-ray in two cases there was evidence of fracture of two wires of the device. Devices were stable and no treatment was required. Moderate residual shunting was found in two patients at 6- and 12-months follow-up. No other complication occurred. Conclusion GORE® Septal Occluder is an easy, safe, and effective device in closing PFO. © 2013 Wiley Periodicals, Inc.


Ruggenenti P.,Mario Negri Institute for Pharmacological Research | Porrini E.,Mario Negri Institute for Pharmacological Research | Motterlini N.,Mario Negri Institute for Pharmacological Research | Perna A.,Mario Negri Institute for Pharmacological Research | And 11 more authors.
Journal of the American Society of Nephrology | Year: 2012

Micro- or macroalbuminuria is associated with increased cardiovascular risk factors among patients with type 2 diabetes, but whether albuminuria within the normal range predicts long-term cardiovascular risk is unknown. We evaluated the relationships between albuminuria and cardiovascular events in 1208 hypertensive, normoalbuminuric patients with type 2 diabetes from the BErgamo NEphrologic Diabetes Complication Trial (BENEDICT), all of whom received angiotensin-converting enzyme inhibitor (ACEI) therapy at the end of the trial and were followed for a median of 9.2 years. The main outcome was time to the first of fatal or nonfatal myocardial infarction; stroke; coronary, carotid, or peripheral artery revascularization; or hospitalization for heart failure. Overall, 189 (15.6%) of the patients experienced a main outcome event (2.14 events/100 patient-years); 24 events were fatal. Albuminuria independently predicted events (hazard ratio [HR], 1.05; 95% confidence interval [CI], 1.02-1.08). Second-degree polynomial multivariable analysis showed a continuous nonlinear relationship between albuminuria and events without thresholds. Considering the entire study population, even albuminuria at 1-2 μg/min was significantly associated with increased risk compared with albuminuria <1 μg/min (HR, 1.04; 95%CI, 1.02-1.07). This relationship was similar in the subgroup originally randomly assigned to non-ACEI therapy. Among those originally receiving ACEI therapy, however, the event rate was uniformly low and was not significantly associated with albuminuria. Taken together, among normoalbuminuric patients with type 2 diabetes, any degree of measurable albuminuria bears significant cardiovascular risk. The association with risk is continuous but is lost with early ACEI therapy. Copyright © 2012 by the American Society of Nephrology.


Petrelli F.,Treviglio Hospital | Borgonovo K.,Treviglio Hospital | Ghilardi M.,Treviglio Hospital | Cabiddu M.,Treviglio Hospital | Barni S.,Treviglio Hospital
Reviews on Recent Clinical Trials | Year: 2010

Advanced pancreatic cancer is usually treated with first-line gemcitabine (GEM) (alone or in combination). More recently, GEM has become an established part of an adjuvant therapy based on two recently-reported randomized trials. There remains unresolved the problem of second-line therapy in patients relapsed during or after adjuvant or firstline GEM-based treatment. As of today, platinum analogues in combination with fluoropyrimidine or with GEM represent the most common schedule in clinical practice with data from single-centre or multicentric phase II studies. In 2008, for the first time, a randomized phase III trial conducted on good performance status GEM-refractory patients (CONKO 003) confirmed their benefit in progression-free and overall survival by adding oxaliplatin to a bolus 5-FU/folinic acid schedule. Other agents (irinotecan, taxanes, antifolates, biological) have been tested, although only dismal results have been achieved, as they turned out to be too toxic in combination and to have too low activity when used as single agents. Which is the optimal candidate for second-line therapies, is debatable. Good performance status and discrete progressionfree survival since the beginning of the GEM therapy (more than 6 months?) are likely to be the best indicators of subsequent line benefit. The benefit of biological agents is unknown, also given the poor results achieved in the first-line treatment. In summary, as of today, there is one randomized study that confirms the benefit of second-line chemotherapy for the treatment of GEM-relapsed pancreatic cancer. Current data indicate 5-FU plus a platinum agent (oxaliplatin) as the standard of care for PS 0-1 patients. Ongoing clinical trials will clarify whether there is obviously a place for improvement and for other agents. At present, even though no data on benefits in unfit patients (Karnofsky < 70) are available, a fluopyrimidine agent still remains a reasonable treatment option. © 2010 Bentham Science Publishers Ltd.


Petrelli F.,Treviglio Hospital | Barni S.,Treviglio Hospital
Oncology Reviews | Year: 2010

Metastatic breast cancer (BC) remains an incurable disease and clinical benefit and prolongation of time to progression are the main end-points in advanced setting. A safe and feasible schedule of administration is the principal option in pre-treated and symptomatic patients, as in the elderly too. Oral vinorelbine represents a good choice for its toxicity profile and activity in anthracycline and taxane-pre-treated BC patients. A 20-30% response rate (RR) can be obtained when used as single agent. In phase II trials, involving fit patients, and when oral vinorelbine is used in combination with other agents (e.g., capecitabine) a RR of 50-60% has been observed. In HER2-positive BC a combination of oral vinorelbine and trastuzumab has a dramatic activity in first-line therapy and is a reasonable choice in trastuzumab pre-treated patients. In conclusion, oral vinorelbine represents a pivotal choice in advanced and pre-treated BC both as single agent and in combination with others. © 2010 Springer-Verlag.


Barni S.,Treviglio Hospital | Cabiddu M.,Treviglio Hospital | Petrelli F.,Treviglio Hospital
Expert Review of Anticancer Therapy | Year: 2010

Approximately 50% of breast cancer (BC) cases occur in women aged 65 and older, and more than 30% occur in those aged over 70, yet very old (older than 70) patients are under-represented in clinical trials. In the Oxford meta-analysis, the hazard ratios for recurrence and BC mortality in women aged over 70 were 0.88 and 0.87, respectively, suggesting a benefit from chemotherapy in this group of patients as well; however, the large confidence intervals surrounding reductions in this subgroup reflect the small number of older patients recruited in randomized trials in Early Breast Cancer Trialists' Collaborative Group meta-analyses. If we consider the tumor biology of BC in older adults, we will see that they are more likely to develop a tumor with high estrogen receptor (ER)- and/or progesterone receptor-positive status and a lower proliferative index. However, the biology of these tumors appears to change according to chronological age into aggressive forms diagnosed in these patients as well. This subgroup analysis for the benefit of adjuvant chemotherapy in elderly patients (at least 65 years) is reported in a few studies, even though a limited statistical significance has been revealed. Retrospective evidences suggest that even more aggressive treatments such as taxanes and dose-dense schedule appear feasible (but probably more toxic) in the elderly. Age is no longer considered the only criterion for choosing the right treatment for patients with BC; in fact, functional status and comorbidity have to be taken into consideration as well. Fit elderly patients with more aggressive forms (node-positive and ER-poor disease) seem to obtain the same benefits as younger patients, and thus have to be treated in the same manner. © 2010 Expert Reviews Ltd.


Colombo S.,Treviglio Hospital | Buonocore M.,Treviglio Hospital | Del Poggio A.,Treviglio Hospital | Jamoletti C.,Treviglio Hospital | And 4 more authors.
Journal of Gastroenterology | Year: 2012

Background: Real-time tissue elastography (RTE), acoustic radiation force impulse (ARFI) imaging, and transient elastography (TE) are new technologies that are used for liver stiffness evaluation. The aim of this study was to compare these methods in the same population and to determine their diagnostic accuracy in the prediction of liver fibrosis. Methods: Forty-five consecutive, previously biopsied, patients with chronic liver disease and 27 normal subjects underwent TE, RTE, and ARFI on the right liver lobe. Correlation coefficients between measurements, Metavir fibrosis stage, and histological necro-inflammatory activity (adjusted for fibrosis stage) were evaluated via Spearman's rank order correlation coefficients. Areas under the receiver operating characteristic curve (AUROCs) were calculated to predict each fibrosis stage. Results: Failure or inconsistent results occurred in 12.5% of the attempts at TE, but in none of the attempts at RTE and ARFI. The three methods showed high correlation with fibrosis and poor correlation with necro-inflammatory activity. TE and ARFI exhibited high diagnostic accuracy (AUROCs ≥0.9) in diagnosing cirrhosis (F4 Metavir). All three methods presented fair (AUROCs >0.7) to good (AUROCs>0.8) diagnostic accuracy in diagnosing fibrosis (F1-4 Metavir) and significant fibrosis (F2-4 Metavir), with TE showing the best performance (AUROCs were 0.878 for fibrosis and 0.897 for significant fibrosis). Conclusions: TE and ARFI provide high diagnostic accuracy in the diagnosis of cirrhosis. When feasible, TE may perform better than RTE and ARFI in predicting fibrosis and significant fibrosis, but larger studies are needed. © Springer 2012.


Petrelli F.,Treviglio Hospital | Barni S.,Treviglio Hospital
Medical Oncology | Year: 2011

There are many controversies regarding the treatment of very early-stage (pT1a/bN0M0) breast cancer (BC), generally considered to have a very good prognosis. The debate is the benefit of an adjuvant treatment of HER2-neu (namely HER-2)-positive subcentimetric carcinoma with trastuzumab. Current guidelines do not suggest, with the highest level of evidence, whether trastuzumab should be administered after adjuvant chemotherapy in the treatment of high-risk pT1a/bN0M0 breast cancer. The major phase III trials that confirmed the benefit of adjuvant immunotherapy did not include small (<1 cm diameter) node-negative breast cancer. Several retrospective case series of HER-2-positive pT1a/bN0M0 carcinoma seem to demonstrate that they have a higher risk of relapse compared to the HER-2-negative counterpart. HER-2 also seems to confer an independent risk of recurrence and/or death in a multivariate analysis within large node-negative breast cancer populations. In particular, the best way to select higher-risk tumours that may achieve the best results from a trastuzumab-based therapy appears to be the in situ hybridization, which should follow the new recommended algorithm of the ASCO/CAP guidelines in case of doubtful results. According to the evidence that the survival of HER-2-positive BC can be improved with the introduction of trastuzumab respect to the HER-2-negative counterpart, there is today less uncertainty about the curative role of anti-HER-2 therapy in very early disease. © 2010 Springer Science+Business Media, LLC.

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