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Napoli, Italy

Zaja F.,Azienda Ospedaliero Universitaria S. Maria della Misericordia | Baccarani M.,Institute Of Hematology L A Seragnoli | Mazza P.,Ospedale Nord | Bocchia M.,Ematologia e Trapianti | And 17 more authors.
Blood | Year: 2010

Previous observational studies suggest that rituximab may be useful in the treatment of primary immune thrombocytopenia (ITP). This randomized trial investigated rituximab efficacy in previously untreated adult ITP patients with a platelet count of 20 × 109/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m2 rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count ≥ 50 × 10 9/L at month 6 after treatment initiation), evaluable in 101 patients, was greater in patients treated with dexamethasone plus rituximab (n = 49) than in those treated with dexamethasone alone (n = 52; 63% vs 36%, P = .004, 95% confidence interval [95% CI], 0.079-0.455). Patients in the experimental arm showed increased incidences of grade 3 to 4 adverse events (10% vs 2%, P = .082, 95% CI, -0.010 to 0.175), but incidences of serious adverse events were similar in both arms (6% vs 2%, P = .284, 95% CI, -0.035 to 0.119). Dexamethasone plus rituximab was an effective salvage therapy in 56% of patients refractory to dexamethasone. The combination of dexamethasone and rituximab improved platelet counts compared with dexamethasone alone. Thus, combination therapy may represent an effective treatment option before splenectomy. This study is registered at http://clinicaltrials.gov as NCT00770562. © 2010 by The American Society of Hematology. Source


Nersita R.,The Second University of Naples | Matrone A.,The Second University of Naples | Klain M.,University of Naples Federico II | Scavuzzo F.,Ospedale Cardarelli | And 6 more authors.
Clinical Endocrinology | Year: 2012

Objective Vascular endothelial growth factor-D (VEGF-D) has been identified as one of the lymphangiogenic growth factors involved in metastatic diffusion. The aim of this study is to evaluate the serum VEGF-D levels in patients with differentiated thyroid cancer at different conditions of disease. Design and Patients We studied prospectively the VEGF-D plasma levels in 96 subjects affected by differentiated thyroid cancer. The patients were divided into three groups according to the clinical and biochemical findings: patients with no evidence of disease (Cured), patients with pathological (>1 ng/ml) stimulated thyroglobulin (Tg) (Path-Tg/rhTSH) levels only after rhTSH and patients with elevated basal Tg levels (Path-Tg/LT4). Results The serum VEGF-D concentrations in patients of group Cured were not different from the controls, while group Path-Tg/rhTSH showed baseline serum VEGF-D levels significantly lower than group Cured and controls (P < 0·001 and P < 0·01, respectively). Moreover, the patients of group Path-Tg/LT4 showed median serum cytokine concentrations at baseline not significantly different from the patients of group Path-Tg/rhTSH. The rhTSH stimulation did not modify the difference in serum VEGF-D levels in patients of group Cured and group Path-Tg/rhTSH. Conclusions Our data demonstrate that the VEGF-D serum levels are reduced in patients with metastases of differentiated thyroid cancer, regardless of the degree of metastatic spread. It is possible that some other molecule produced by the tumoral tissue could affect the VEGF-D physiologically produced of from different tissues, thus conducting to a decrease in the VEGF-D found in blood of patients with evidence of metastatic differentiated thyroid cancer. © 2011 Blackwell Publishing Ltd. Source


Huynh B.T.,University Pierre and Marie Curie | Tual S.,University Pierre and Marie Curie | Turbelin C.,University Pierre and Marie Curie | Pelat C.,University Pierre and Marie Curie | And 4 more authors.
Primary Care Respiratory Journal | Year: 2010

Aims: To investigate for the first time the short-term effects of airborne pollen counts on general practitioner (GP) consultations for asthma attacks in the Greater Paris area between 2003-2007. Methods: Counts were available for common pollens (Betula, Cupressa, Fraxinus and Poaceae). Weekly data on GP visits for asthma attacks were obtained from the French GP Sentinel Network. A quasi-Poisson regression with generalised additive models was implemented. Short-term effects of pollen counts were assessed using single and multi-pollen models after adjustment for air pollution and influenza. Results: A mean weekly incidence rate of 25.4 cases of asthma attacks per 100,000 inhabitants was estimated during the study period. The strongest significant association between asthma attacks and pollen counts was registered for grass (Poaceae) in the same week of asthma attacks, with a slight reduction of the effect observed in the multi-pollen model. Adjusted relative risk for Poaceae was 1.54 (95% CI: 1.33-1.79) with an inter-quartile range increase of 17.6 grains/m3 during the pollen season. Conclusions: For the first time, a significant short-term association was observed between Poaceae pollen counts and consultations for asthma attacks as seen by GPs. These findings need to be confirmed by more consistent time-series and investigations on a daily basis. © 2010 Primary Care Respiratory Society UK. Source


Lo-Coco F.,University of Rome Tor Vergata | Avvisati G.,Biomedical University of Rome | Vignetti M.,Data Center | Thiede C.,Universitatsklinikum Carl Gustav Carus | And 38 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: All-trans retinoic acid (ATRA) with chemotherapy is the standard of care for acute promyelocytic leukemia (APL), resulting in cure rates exceeding 80%. Pilot studies of treatment with arsenic trioxide with or without ATRA have shown high efficacy and reduced hematologic toxicity. METHODS: We conducted a phase 3, multicenter trial comparing ATRA plus chemotherapy with ATRA plus arsenic trioxide in patients with APL classified as low-to-intermediate risk (white-cell count, ≤10×109per liter). Patients were randomly assigned to receive either ATRA plus arsenic trioxide for induction and consolidation therapy or standard ATRA- idarubicin induction therapy followed by three cycles of consolidation therapy with ATRA plus chemotherapy and maintenance therapy with low-dose chemotherapy and ATRA. The study was designed as a noninferiority trial to show that the difference between the rates of event-free survival at 2 years in the two groups was not greater than 5%. RESULTS: Complete remission was achieved in all 77 patients in the ATRA-arsenic trioxide group who could be evaluated (100%) and in 75 of 79 patients in the ATRA-chemotherapy group (95%) (P = 0.12). The median follow-up was 34.4 months. Two-year event-free survival rates were 97% in the ATRA-arsenic trioxide group and 86% in the ATRA-chemotherapy group (95% confidence interval for the difference, 2 to 22 percentage points; P<0.001 for noninferiority and P = 0.02 for superiority of ATRA-arsenic trioxide). Overall survival was also better with ATRA-arsenic trioxide (P = 0.02). As compared with ATRA-chemotherapy, ATRA-arsenic trioxide was associated with less hematologic toxicity and fewer infections but with more hepatic toxicity. CONCLUSIONS: ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with low-to-intermediate-risk APL. Copyright © 2013 Massachusetts Medical Society. Source


Barbato M.,Ospedale G. Bernabeo | D'Angelo E.,Ospedale G. Bernabeo | Di Loreto G.,Ospedale G. Bernabeo | Menna A.,University of Chieti Pescara | And 5 more authors.
Journal of Orthopaedics and Traumatology | Year: 2012

Background: In spite of the proven efficacy of pharmacological prophylaxis of heterotopic ossification following total hip arthroplasty, its routine use is still debated, and no data are available regarding the adherence to its administration in clinical practice. Materials and methods: In this prospective, observational, multicenter study, 480 consecutive patients operated on for primary total hip arthroplasty during the year 2009 were followed radiographically for 12 months after surgery in order to assess the incidence of periprosthetic heterotopic ossification. Surgeons were free to choose whether to administer pharmacological prophylaxis, and were asked to keep a record of the duration of the prophylaxis (if used) or the reasons for not using it. To facilitate the statistical analysis, all of the participating centers agreed to use only one drug (celecoxib) that had already proven to be effective. Results: 368 patients were administered celecoxib and 112 patients did not receive any prophylaxis. Reported reasons for not administering celecoxib prophylaxis were the surgeon's opinion that prophylaxis was not needed on a routine basis (84/112 patients, 75%), previous history of gastrointestinal bleeding (17.8%), and concomitant cardiorenal pathologies (7.1%). The overall incidence of heterotopic ossification in the celecoxib-treated patients was 23% (no cases of Brooker grade 3 or 4 ossifications), compared to 55% in the untreated patients (Brooker grade 3 and 4: 8.9%). Multivariate analysis showed that celecoxib prophylaxis was the single most important variable when predicting the occurrence of heterotopic ossification. Conclusions: This study confirms the efficacy and tolerability of celecoxib for the prophylaxis of heterotopic ossification after total hip arthroplasty, and shows how the surgeon's belief that routine prevention is not required sti plays an important role in the determination of this complication, together with the fear of possible unwanted side effects. © The Author(s) 2012. Source

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