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Sant'Ambrogio di Torino, Italy

Santoro N.,University of Bari | Colombini A.,University of Milan Bicocca | Silvestri D.,University of Milan Bicocca | Grassi M.,University of Bari | And 8 more authors.
Journal of Pediatric Hematology/Oncology | Year: 2013

Introduction: Venous thromboembolic events (VTEs) are frequent complications of childhood acute lymphoblastic leukemia (ALL) treatment. The aim of the study was to evaluate the rate of symptomatic VTEs in children with ALL and the predictive value of clinical and biological factors and routine monitoring of coagulation parameters in identifying children at a higher risk of this complication. Materials and Methods: Between September 2000 and July 2006, 2042 children (Z1 and younger than 18 y) with newly diagnosed ALL were enrolled in Italy in the AIEOP (Italian Association of Pediatric Hematology and Oncology)-BFM (Berlin-Frankfurt-Muenster) ALL 2000 trial. Patients with symptomatic VTEs (deep venous thromboses or cerebral venous thromboses) were identified after a careful review of clinical records. The impact of coagulation derangement at the onset of VTEs was evaluated by a nested casecontrol study. Results: Forty-eight (2.4%) children presented with a VTE. The rate of VTEs was higher in male patients (P=0.001); patients randomized to receive dexamethasone tended to have a higher rate of VTE compared with those who received prednisone (P=0.10). The coagulation derangement at the onset of VTE was not associated with VTE occurrence. The prevalence of a factor V Leiden G1691A mutation and the prothrombin G20210A variant was higher in children with VTE than that expected in the general population. Copyright © 2013 by Lippincott Williams & Wilkins. Source

Marini D.,Ospedale Infantile Regina Margherita | Kenny D.,Rush University Medical Center
EuroIntervention | Year: 2012

Aims: The aim of this study was to assess the midterm results of percutaneous closure of very large atrial septal defects (ASD) in children with transthoracic echocardiography (TTE) and multislice computed tomography (MSCT). Methods and results: Among 142 children who underwent percutaneous ASD closure with the AMPLATZER® Septal Occluder (ASO) (AGA Medical Corporation, Plymouth, MN, USA) during an eight year period, 51 patients with very large defects, were evaluated by TTE and MSCT after a period of at least two years following ASD closure. Median age at ASD closure was six years (range 4-10), with mean ASD size 20.9±2.9 mm. Median device size was 20 mm (range 15-26) and median device:septal length ratio 0.95 (range 0.8-1). Early complications included one transient complete atrioventricular block and one device embolisation. At a median follow-up of 55 months (range 25-92) all patients were clinically asymptomatic and had a normal ECG. TTE did not demonstrate device protrusion across the lumen of either the systemic or pulmonary veins. The mean device:septal length ratio had decreased from 0.96±0.05 to 0.8±0.02 (p<0.001). There was good correlation between the measure of atrial septum length by TTE and MSCT (r: 0.79, p<0.001). MSCT identified moderate dynamic device protrusion into the lumen of systemic or pulmonary veins in five patients and partial device malpositioning in two patients. Conclusions: Occlusion of very large ASD in children can be performed with low complications rate. MSCT provides detailed information regarding the location of the device with respect to surrounding anatomic structures and reveals anomalies not evident by TTE. © Europa Edition 2012. All rights reserved. Source

Spreafico F.,Pediatric Unit Fondazione | Gandola L.,Fondazione Istituto Nazionale Tumori | D'Angelo P.,Pediatric Oncology | Terenziani M.,Pediatric Unit Fondazione | And 10 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: We analyzed whether the prognosis can differ among Wilms tumors (WT) labeled as Stage III according to currently adopted classification systems. Methods and Materials: Patients with nonanaplastic Stage III WT consecutively registered in two Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) trials (CNR-92, TW-2003) were the subjects in the present analysis. The steady mainstay of therapy was primary nephrectomy, followed by three-drug chemotherapy with vincristine, dactinomycin, doxorubicin, and abdominal radiotherapy (RT). Results: Ninety-nine WT patients met the criteria for classification as Stage III according to a revised version of the National Wilms Tumor Study-3 staging system (51 patients in CNR-92, 48 patients in TW-2003). Regional lymph nodes (LN) were not biopsied in 16 patients. After a median follow-up of 66 months, the 4-year disease-free survival (DFS) and overall survival (OS) rates were 85% ± 4% and 92% ± 3%, respectively, for the whole group. For 38 children with positive LN, the 4-year DFS rate was 73% ± 7%, as opposed to 98% ± 2% for the 45 children with Stage III WT according to the other criteria but with negative biopsied LN (p = 0.001). The subgroup with the worst prognosis consisted of children more than 2 years old with positive LN (DFS 67% ± 8%). A delay between surgery and RT > 30 days had an adverse impact on the abdominal tumor relapse rate. Conclusions: This study provides further evidence that Stage III tumors with LN metastases might be distinguished from WTs meeting the other criteria for classification as Stage III. The worse outcome of the former may warrant a prospective study on the effects of intensified therapy. A subclassification of Stage III tumors is discussed. Copyright © 2012 Elsevier Inc. Printed in the USA. All rights reserved. Source

Styczynski J.,Nicolaus Copernicus University | Balduzzi A.,University of Milan Bicocca | Gil L.,Poznan University of Medical Sciences | Labopin M.,University Pierre and Marie Curie | And 20 more authors.
Blood | Year: 2012

We investigated prospectively factors influencing the safety of hematopoietic stem cell (HSC) collection in 453 pediatric donors. The children in the study donated either BM or peripheral blood stem cells (PBSCs) according to center policy. A large variability in approach to donor issues was observed between the participating centers. Significant differences were observed between BM and PBSC donors regarding pain, blood allotransfusion, duration of hospital stay, and iron supplementation; however, differences between the groups undergoing BM vs PBSC donation preclude direct risk comparisons between the 2 procedures. The most common adverse event was pain, reported mainly by older children after BM harvest, but also observed after central venous catheter (CVC) placement for PBSC collection. With regard to severe adverse events, one patient (0.7%) developed a pneumothorax with hydrothorax after CVC placement for PBSC collection. The risk of allotransfusion after BM harvest was associated with a donor age of < 4 years and a BM harvest volume of > 20 mL/kg. Children < 4 years were at higher risk than older children for allotransfusion after BM harvest and there was a higher risk of complications from CVC placement before apheresis.We conclude that PBSC and BM collection are safe procedures in children. © 2012 by The American Society of Hematology. Source

Conter V.,University of Milan Bicocca | Bartram C.R.,University of Heidelberg | Valsecchi M.G.,University of Milan Bicocca | Schrauder A.,University of Kiel | And 23 more authors.
Blood | Year: 2010

The Associazione Italiana di Ematologia Oncologia Pediatrica and the Berlin-Frankfurt-Münster Acute Lymphoblastic Leukemia (AIEOP-BFM ALL 2000) study has for the first time introduced standardized quantitative assessment of minimal residual disease (MRD) based on immunoglobulin and T-cell receptor gene rearrangements as polymerase chain reaction targets (PCR-MRD), at 2 time points (TPs), to stratify patients in a large prospective study. Patients with precursor B (pB) ALL (n = 3184) were considered MRD standard risk (MRD-SR) if MRD was already negative at day 33 (analyzed by 2 markers, with a sensitivity of at least 10-4); MRD high risk (MRD-HR) if 10-3 or more at day 78 and MRD intermediate risk (MRD-IR): others. MRD-SR patients were 42% (1348): 5-year event-free survival (EFS, standard error) is 92.3% (0.9). Fifty-two percent (1647) were MRD-IR: EFS 77.6% (1.3). Six percent of patients (189) were MRD-HR: EFS 50.1% (4.1; P < .001). PCR-MRD discriminated prognosis even on top of white blood cell count, age, early response to prednisone, and genotype. MRD response detected by sensitive quantitative PCR at 2 predefined TPs is highly predictive for relapse in childhood pB-ALL. The study is registered at http://clinicaltrials.gov: NCT00430118 for BFM and NCT00613457 for AIEOP. (Blood. 2010;115(16):3206-3214) © 2010 by The American Society of Hematology. Source

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