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PubMed | AOU Policlinico Vittorio Emanuele, Nuclear Medicine Center, ARNAS Garibaldi, University of Palermo and 2 more.
Type: Journal Article | Journal: Oncotarget | Year: 2016

Neutrophilia is hallmark of classic Hodgkin Lymphoma (cHL), but its precise characterization remains elusive. We aimed at investigating the immunosuppressive role of high-density neutrophils in HL.First, N-HL function was evaluated in vitro, showing increased arginase (Arg-1) expression and activity compared to healthy subjects. Second, we measured serum level of Arg-1 (s-Arg-1) by ELISA in two independent, training (N = 40) and validation (N = 78) sets.s-Arg-1 was higher in patients with advanced stage (p = 0.045), B-symptoms (p = 0.0048) and a positive FDG-PET scan after two cycles of chemotherapy (PET-2, p = 0.012). Baseline levels of s-Arg-1 > 200 ng/mL resulted in 92% sensitivity and 56% specificity to predict a positive PET-2.Patients showing s-Arg-1 levels > 200 ng/mL had a shorter progression free survival (PFS). In multivariate analysis, PET-2 and s-Arg-1 at diagnosis were the only statistically significant prognostic variables related to PFS (respectively p = 0.0004 and p = 0.012).Moving from PET-2 status and s-Arg-1 level we constructed a prognostic score to predict long-term treatment outcome: low s-Arg-1 and negative PET-2 scan (score 0, N = 63), with a 3-Y PFS of 89.5%; either positive PET-2 or high s-Arg-1 (score 1, N = 46) with 3-Y PFS of 67.6%, and both positive markers (score 2, N = 9) with a 3-Y PFS of 37% (p = 0.0004).We conclude that N-HL are immunosuppressive through increased Arg-1 expression, a novel potential biomarker for HL prognosis.


PubMed | UNIMORE, Central Hospital, f UO Ematologia E Centro Trapianti, University of Piemonte Orientale and 15 more.
Type: Journal Article | Journal: Leukemia & lymphoma | Year: 2016

Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCLs). This retrospective multicenter study was conducted in patients with relapsed/refractory TCL treated with romidepsin monotherapy through a Named Patient Program (NPP) in Italy. Principal endpoints were overall response rate (ORR), safety, and overall survival (OS). The ORR in 33 evaluable patients was 24.2% with an ORR in the cutaneous TCL of 35.7%. Global OS was 39.3% at 30 months. There were not any specific differences on hematological and extrahematological adverse events. Data from patients treated with romidepsin outside a controlled clinical trial give additional information about the clinical use, efficacy, and toxicity of the drug given to relapsed or refractory TCL patients in a real life context as TCLs are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients.


PubMed | Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele and Italfarmaco S.p.A.
Type: | Journal: Rheumatology international | Year: 2016

Intravenous iloprost is a first-line option for the treatment of scleroderma-related digital vasculopathy, and some studies have suggested its favourable role on disease progression. The aim of our study is to evaluate the disease progression, specifically in terms of cardiopulmonary function, in a group of consecutive patients chronically treated with intravenous iloprost. Our retrospective study enrolled 68 scleroderma patients (68 F, 54.412.3years) treated with iloprost for 7.12.9years, with a schedule of 5-6 consecutive daily infusions per month (6h/day, 0.5-2.0ng/kg/min). In all patients, modified Rodnan skin score (4.75.3 vs. 3.75.3, p<0.0001), systolic pulmonary arterial pressure (sPAP) (30.96.4 vs. 24.03.2mmHg, p<0.0001), tricuspid annular plane systolic excursion (22.12.4 vs. 23.83.5mm, p=0.0001), pro-brain natriuretic peptide (97.269.3 vs. 65.831.7pg/ml, p=0.0005) showed statistically significant improvement from baseline. In the subgroup of patients with baseline sPAP 36mmHg (n=17), a significant sPAP reduction was observed (from 39.53.8 to 25.14.5mmHg, p<0.0001) after 7.62.5years of follow-up. The number of patients with digital ulcers (DUs) at follow-up was reduced from baseline (42.6 vs. 11.8%, p<0.001), and none of the free-DU patients at baseline presented DUs at follow-up. An intensive and chronic regimen of IV iloprost administration seems to stabilize and potentially improve the long-term development of disease in SSc patients, as suggested by stabilization or significant improvement of cardiopulmonary parameters and vasculopathy.


De Nunzio C.,University of Rome La Sapienza | Franco G.,University of Rome La Sapienza | Cindolo L.,Ospedale Padre Pio da Pietrelcina | Autorino R.,2nd University of Naples | And 8 more authors.
European Journal of Surgical Oncology | Year: 2014

Introduction To evaluate the applicability of a modified Clavien classification system (CCS) in grading postoperative complications of transurethral resection of bladder tumours (TURB). Materials and methods A series of patients undergoing monopolar TURB from April 2011 to March 2012 at five Italian centers were enrolled. All complications occurring within the first 30-day postoperative period were prospectively recorded and graded according to the CCS. Results Overall, 275 patients were included. Median age was 71 (63/78) years; median BMI was 28 (25.4/30.8) Kg/m2, median tumour size was 2 (1-3) cm; median number of tumour lesions was 1 (1-3). Median operative time was 30 (20/45) min. Fifty-seven complications were recorded in 43 patients. Overall postoperative morbidity rate was 16%. Most of the complications were not serious and classified as Clavien type I (42 cases; 74%) or II (8 cases, 14%). Higher grade complications were scarce: CCS IIIa in 1 case (2%) and CCS IIIb in six cases (10%). No TURB related death was reported. Six patients were re-operated due to significant bleeding or clot retention on postoperative days 2-7. On univariate (73.5 ± 38 versus 36.7 ± 21.6 min) and multivariate analysis longer operative time was an independent predictor of complications (OR: 1.06 per min, 95%CI 1.04-1.08, p = 0.001). Conclusions A modified CCS can be used as a standardized tool to objectively define the complications of TURB which confirms to be a safe procedure with a low surgical morbidity. This tool can be used to aid in patient counselling and to facilitate scientific assessment. © 2013 Elsevier Ltd. All rights reserved.


Morandi M.M.,Louisiana State University Health Sciences Center | Rose K.M.,Louisiana State University Health Sciences Center | Mangano S.S.,A.O.U. Policlinico Vittorio Emanuele
Techniques in Orthopaedics | Year: 2014

Since the first description of modern intramedullary tibia nails by Kuntscher and through the subsequent introduction of the locked nails by Gross and colleagues, infrapatellar access routes have been utilized. The discussion on the correlation between different entry points and the incidence of anterior knee pain has been extensive. Furthermore, nailing of proximal tibia fracture can be complicated by malalignment, typically an apex anterior with valgus angulation, coupled with posterior displacement of the distal fragment. The insertion of an intramedullary nail in the tibia utilizing a lateral suprapatellar percutaneous entry point, with the knee in semiextension, appears to mitigate the establishment of malreduction. Because the suprapatellar route does not directly injure the tendon, it consequently appears to lead to reduced incidence of knee pain. Originally indicated for proximal tibia fractures, this modification of the classical tibial nailing has been proven effective in all tibial locations. It allows for fast setup of the operating room, without the need for cumbersome traction tables; it simplifies the treatment in polytrauma patients with injuries to the soft tissue surrounding the patellar tendon area and it reduces the manipulation of concomitant fractures, such as femur and pelvis. © 2014 by Lippincott Williams & Wilkins.


Sciacca P.,Pediatric Cardiology | Giacchi V.,AOU Policlinico Vittorio Emanuele | Mattia C.,NICU | Greco F.,AOU Policlinico Vittorio Emanuele | And 3 more authors.
BMC Cardiovascular Disorders | Year: 2014

Background: Rhabdomyomas are the most common type of cardiac tumors in children. Anatomically, they can be considered as hamartomas. They are usually randomly diagnosed antenatally or postnatally sometimes presenting in the neonatal period with haemodynamic compromise or severe arrhythmias although most neonatal cases remain asymptomatic. Typically rhabdomyomas are multiple lesions and usually regress spontaneously but are often associated with tuberous sclerosis complex (TSC), an autosomal dominant multisystem disorder caused by mutations in either of the two genes, TSC1 or TSC2. Diagnosis of tuberous sclerosis is usually made on clinical grounds and eventually confirmed by a genetic test by searching for TSC genes mutations.Methods: We report our experience on 33 cases affected with rhabdomyomas and diagnosed from January 1989 to December 2012, focusing on the cardiac outcome and on association with the signs of tuberous sclerosis complex. We performed echocardiography using initially a Philips Sonos 2500 with a 7,5/5 probe and in the last 4 years a Philips IE33 with a S12-4 probe. We investigated the family history, brain, skin, kidney and retinal lesions, development of seizures, and neuropsychiatric disorders.Results: At diagnosis we detected 205 masses, mostly localized in interventricular septum, right ventricle and left ventricle. Only in 4 babies (12%) the presence of a mass caused a significant obstruction. A baby, with an enormous septal rhabdomyoma associated to multiple rhabdomyomas in both right and left ventricular walls died just after birth due to severe heart failure. During follow-up we observed a reduction of rhabdomyomas in terms of both number and size in all 32 surviving patients except in one child. Eight patients (24,2%) had an arrhythmia and in 2 of these cases rhabdomyomas led to Wolf-Parkinson-White Syndrome. For all patients the arrhythmia spontaneously totally disappeared or was reduced gradually. With regarding to association with tuberous sclerosis, we diagnosed tuberous sclerosis clinically in 31 babies (93,9%).Conclusion: Rhabdobyomas are tumors with favorable prognosis because they frequently do not cause symptoms and they often regress in numbers and size. Nevertheless, due to frequent association with tuberous sclerosis complex and the resulting neurological impairment, the prognosis can result unfavorable. © 2014 Sciacca et al.; licensee BioMed Central Ltd.


PubMed | Pediatric Endocrinology, Pediatric Cardiology and AOU Policlinico Vittorio Emanuele
Type: | Journal: BMC research notes | Year: 2016

Adolescents with type 1 diabetes and obesity present higher cardiovascular risk and ambulatory blood pressure measurements (ABPM) has been shown to predict vascular events, especially by identifying the nondipper status. The aim of our observational cross-sectional study conducted in adolescents with type 1 diabetes, overweight subjects and healthy controls was to assess mean blood pressure parameters to identify subclinical cardiovascular risk.The study included adolescents patients with type 1 diabetes followed in our Pediatric Department in University of Catania between January 2011 and 2013. A total of 60 patients were enrolled, and 48 (32 male and 16 female) completed the study. For each subject we performed systolic and diastolic Ambulatory Blood Pressure Measurements (ABPM) during wakefulness and sleep recording blood pressure every 30 min for 24 h with the Tonoport V/2 GE CardioSoft V6.51 device. We compared the data of patients with those of overweight subjects and healthy controls.ABPM revealed no significant difference between type 1 diabetic patients and overweight subjects in 24 h Systolic, 24 h Diastolic, Day-time Systolic, Night-time systolic and Day-time Diastolic blood pressure values but significantly different values in Night-time Diastolic blood pressure values (p < 0.001). We found significant differences between type 1 diabetic patients and healthy controls in all 24 h Systolic (p < 0.001), 24 h Diastolic (p < 0.01), Day-time Systolic (p < 0.01), Night-time Systolic (p < 0.001), Day-time Diastolic (p < 0.05) and Night-time Diastolic (p < 0.001) blood pressure values. We detected hypertension in 12/48 (25%) type 1 diabetic patients and in 10/48 overweight subjects (p = 0.62; OR 1.2; CI 0.48-3.29), whereas no-one of healthy controls presented hypertension (p < 0.001). We observed nondipper pattern in 40/48 (83.3%) type 1 diabetic patients, in 33/48 (68.8%) overweight subjects (p = 0.094; OR 2.27; CI 0.85-6.01), and in 16/48 (33.3%) of healthy controls (p < 0.001; OR 10; CI 3.79-26.3).ABPM studies might help to define a subset of patients at increased risk for the development of hypertension. In evaluating blood pressure in type 1 diabetes and overweight subjects, ABPM should be used since a reduced dipping can indicate incipient hypertension.


Navarria A.,University of Catania | Drago V.,University of Piemonte Orientale | Gozzo L.,University of Catania | Longo L.,A.O.U. Policlinico Vittorio Emanuele | And 3 more authors.
Value in Health | Year: 2015

Background Drug costs have risen rapidly in the last decade, driving third-party payers to adopt performance-based agreements that provide either a discount before payment or an ex post reimbursement on the basis of treatments' effectiveness and/or safety issues. Objectives This article analyses the strategies currently approved in Italy and proposes a novel model called "success fee" to improve payment-by-result schemes and to guarantee patients rapid access to novel therapies. Methods A review of the existing risk-sharing schemes in Italy has been performed, and data provided by the Italian National report (2012) on drug use have been analyzed to assess the impact on drug expenditure deriving from the application of "traditional" performance-based strategies since their introduction in 2006. Results Such schemes have poorly contributed to the fulfillment of the purpose in Italy, producing a trifling refund, compared with relevant drugs costs for the National Health System: €121 million out of a total of €3696 million paid. The novel risk-sharing agreement called "success fee" has been adopted for a new high-cost therapy approved for idiopathic pulmonary fibrosis, pirfenidone, and consists of an ex post payment made by the National Health System to the manufacturer for those patients who received a real benefit from treatment. Conclusions "Success fee" represents an effective strategy to promote value-based pricing, making available to patients a rapid access to innovative and expensive therapies, with an affordable impact on drug expenditure and, simultaneously, ensuring third-party payers to share with manufacturers the risk deriving from uncertain safety and effectiveness. © 2015 Published by Elsevier Inc.


Romano A.,University of Catania | Parrinello N.L.,University of Catania | Vetro C.,University of Catania | Forte S.,IOM Ricerca s.r.l. | And 7 more authors.
British Journal of Haematology | Year: 2015

Summary: In the attempt to find a peripheral blood biological marker that could mirror the dysregulated microenvironment of Hodgkin Lymphoma (HL), we analysed the amount of myeloid-derived suppressor cells (MDSC), including the three main sub-types (monocytic, granulocytic and CD34 + fraction). The absolute MDSC count was investigated in 60 consecutive newly diagnosed HL patients and correlated with clinical variables at diagnosis and outcome. Patients received standard-of-care chemotherapy with the exception of interim fluorodeoxyglucose positron emission tomography (PET-2)-positive patients, who were switched early to a salvage regimen. All MDSC subsets were increased in HL patients compared to normal subjects (P < 0·0001) and were higher in non-responders. However, a strong prognostic significance was limited to immature (CD34+) MDSC. A cut-off level of 0·0045 × 109/l for CD34+MDSC resulted in 89% (95% confidence interval [CI] 52-99%) sensitivity and 92% (95% CI 81-98%) specificity. The positive predictive value to predict progression-free survival was 0·90 for PET-2 and 0·98 for CD34+MDSC count; the negative predictive value was 0·57 for PET-2 and 0·73 for CD34+MDSC. PFS was significantly shorter in patients with more than 0·0045 × 109 CD34+MDSC cells/l at diagnosis and/or PET-2 positivity (P < 0·0001). In conclusion, all circulating MDSC subsets are increased in HL; CD34+MDSC predict short PFS, similarly to PET-2 but with the advantage of being available at diagnosis. © 2014 John Wiley & Sons Ltd.


Romano A.,University of Catania | Conticello C.,AOU Policlinico Vittorio Emanuele | Cavalli M.,AOU Policlinico Vittorio Emanuele | Vetro C.,University of Catania | And 3 more authors.
BioMed Research International | Year: 2014

Multiple Myeloma (MM) is a systemic hematologic disease due to uncontrolled proliferation of monoclonal plasma cells (PC) in bone marrow (BM). Emerging in other solid and liquid cancers, the host immune system and the microenvironment have a pivotal role for PC growth, proliferation, survival, migration, and resistance to drugs and are responsible for some clinical manifestations of MM. In MM, microenvironment is represented by the cellular component of a normal bone marrow together with extracellular matrix proteins, adhesion molecules, cytokines, and growth factors produced by both stromal cells and PC themselves. All these components are able to protect PC from cytotoxic effect of chemo- and radiotherapy. This review is focused on the role of immunome to sustain MM progression, the emerging role of myeloid derived suppressor cells, and their potential clinical implications as novel therapeutic target. © 2014 Alessandra Romano et al.

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