Policlinico Universitario Campus Bio Medico

Rome, Italy

Policlinico Universitario Campus Bio Medico

Rome, Italy
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Hu M.I.,University of Houston | Glezerman I.G.,Sloan Kettering Cancer Center | Leboulleux S.,Institute Gustave Roussy | Insogna K.,Yale University | And 11 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Context: Hypercalcemia of malignancy (HCM) in patients with advanced cancer is often caused by excessive osteoclast-mediated bone resorption. Patients may not respond to or may relapse after iv bisphosphonate therapy. CopyrightObjective: We investigated whether denosumab, a potent inhibitor of osteoclast-mediated bone resorption, reduces serum calcium in patients with bisphosphonate-refractory HCM. Design, Setting, and Participants: In this single-arm international study, participants had serum calcium levels corrected for albumin (CSC) >12.5 mg/dL (3.1 mmol/L) despite bisphosphonates given >7 and ≤30 days before screening.Intervention: Patients received 120 mg sc denosumab on days 1, 8, 15, and 29 and then every 4 weeks.Main Outcome Measures: The primary endpoint was the proportion of patients with CSC ≤11.5 mg/dL (2.9 mmol/L) (response) by day 10. Secondary endpoints included response by visit, duration of response, and the proportion of patients with a complete response (CSC ≤10.8 mg/dL [2.7 mmol/L]) by day 10 and during the study.Results: Patients (N = 33) had solid tumors or hematologic malignancies. By day 10, 21 patients (64%) reachedCSC≤11.5 mg/dL,and12 patients (33%) reachedCSC≤10.8 mg/dL. During the study, 23 patients (70%) reached CSC ≤11.5 mg/dL, and 21 patients (64%) reached CSC ≤10.8 mg/dL. Estimated median response duration was 104 days. The most common serious adverse events were hypercalcemia worsening (5 patients, 15%) and dyspnea (3 patients, 9%).Conclusions: In patients with HCM despite recent iv bisphosphonate treatment, denosumab lowered serum calcium in64%of patients within 10 days, inducing durable responses.Denosumabmay offer a new treatment option for HCM. © 2014 by the Endocrine Society.

PubMed | Regina Elena Cancer Institute, Medical Oncology, University of Verona, Policlinico Universitario Campus Bio Medico and 2 more.
Type: | Journal: Critical reviews in oncology/hematology | Year: 2016

We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy.

Cellini F.,Policlinico Universitario Campus Bio Medico | Morganti A.G.,Catholic University of the Sacred Heart | Genovesi D.,University of Chieti Pescara | Silvestris N.,Medical Oncology Unit Cancer Institute Giovanni Paolo II | Valentini V.,Catholic University of the Sacred Heart
Molecules | Year: 2014

MicroRNAs (miRNA) are small, non-coding, RNAs with gene expression regulator roles. As an important class of regulators of many cellular pathways, miRNAs are involved in many signaling pathways and DNA damage repair processes, affecting cellular radiosensitivity. Their role has led to interest in oncological implications to improve treatment results. MiRNAs represent a great opportunity to enhance the efficacy of radiotherapy treatments-they can be used to profile the radioresistance of tumors before radiotherapy, monitor their response throughout the treatment, thus helping to select intensification strategies, and also to define the final response to therapy along with risks of recurrence or metastatization. Even though many interesting studies support such potential, nowadays most studies on patient data are limited to experiments profiling tumor aggressiveness and response to radiotherapy. Moreover many studies report different although not conflicting results on the miRNAs evaluated for each tumor type. Without doubt, the clinical potential of such molecules for radiotherapy is striking and of high interest. © 2014 by the authors; licensee MDPI, Basel, Switzerland.

PubMed | U.O.C. Cardiologia UTIC, Policlinico Universitario Campus Bio Medico, University of Chieti Pescara and Daiichi Sankyo
Type: Journal Article | Journal: Giornale italiano di cardiologia (2006) | Year: 2016

Baseline data of the PREFER in AF (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation) Registry have shown undertreatment of patients with atrial fibrillation (AF), particularly in Italy, where greater difficulties in the management of antithrombotic drugs compared with other European countries were also observed. The aim of the follow-up evaluation was to verify the trends of examined variables after 1 year.Clinical features, patterns of prescriptions and patient adherence to guidelines, quality-of-life and treatment satisfaction variables were evaluated at follow-up, similarly to baseline.In Italy, 88% of patients originally enrolled completed the 1-year follow-up. The incidence of major cardiovascular events was lower than at baseline (12.6 vs 30.8%, p<0.0001), but was higher compared with the European mean (12.6 vs 10.4%, p=0.0006). In particular, the incidence of heart failure (5.1 vs 3.6%, p=0.0003) and transient ischemic attacks (1.4 vs 0.7%, p<0.0001) were more frequent in Italy; on the other hand, the incidence of major bleeding was lower in Italy compared with the European mean (1.6 vs 2.4, p=0.0168). Patients with a high thromboembolic risk (CHA 2DS2-VASc 2) were >80%, similarly to baseline, with a mean CHA2DS2-VASc score of 3.3. However, about one fourth of high-risk patients continued not to be treated with anticoagulant drugs, and treated patients at follow-up were fewer than at baseline (65.1 vs 72.6%, p<0.0001). The percentage of patients treated with non-vitamin K antagonist oral anticoagulants (NOACs) was increased at follow-up compared with baseline (3.3 vs 0.3%, p<0.0001), although lower than the European mean (12.6 vs 6.1%, p<0.0001). The number of INR measurements was higher and related to a higher time in therapeutic range (TTR), compared with baseline, and exceeded the European mean TTR. However, similarly to baseline, a higher difficulty in managing anticoagulant therapy and a lower level of satisfaction for treatment was reported in Italian patients compared with the rest of Europe.The Italian data of the PREFER in AF Registry at 1-year follow-up continue to demonstrate undertreatment of patients with AF at increased risk of stroke and a high grade of unsatisfaction for anticoagulant treatment. The low percentage of patients treated with NOACs did not allow the evaluation of their impact on clinical events and acceptance of therapy.

Cellini F.,Policlinico Universitario Campus Bio Medico | Morganti A.G.,Fondazione di Ricerca e Cura Giovanni Paolo II | Morganti A.G.,Catholic University of the Sacred Heart | Di Matteo F.M.,Biomedical University of Rome | And 2 more authors.
Radiation Oncology | Year: 2014

Gastroesophageal cancers (such as esophageal, gastric and gastroesophageal-junction -GEJ- lesions) are worldwide a leading cause of death being relatively rare but highly aggressive. In the past years, a clear shift in the location of upper gastrointestinal tract tumors has been recorded, both affecting the scientific research and the modern clinical practice. The integration of pre- or peri-operative multimodal approaches, as radiotherapy and chemotherapy (often combined), seems promising to further improve clinical outcome for such presentations. In the past, the definition of GEJ led to controversies and confusion: GEJ tumors have been managed either grouped to gastric or esophageal lesions, following slightly different surgical, radiotherapeutic and systemic approaches. Recently, the American Joint Committee on Cancer (AJCC) changed the staging and classification system of GEJ to harmonize some staging issues for esophageal and gastric cancer. This review discusses the most relevant historical and recent evidences of neoadjuvant treatment involving Radiotherapy for GEJ tumors, and describes the efficacy of such treatment in the frame of multimodal integrated therapies, from the new point of view of the recent classification of such tumors. © 2014 Cellini et al.; licensee BioMed Central Ltd.

PubMed | Ospedale Casa Sollievo Della Sofferenza, Azienda Ospedaliera Universitaria Verona, Azienda Ospedaliera Universitaria, Ospedali Civili di Brescia and 8 more.
Type: | Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology | Year: 2016

This registry was created to describe the experience of 76 Italian centres with a large cohort of recipients of multipoint pacing (MPP) capable cardiac resynchronization therapy (CRT) devices.A total of 507 patients in whom these devices had been successfully implanted were enrolled between August 2013 and May 2015. We analysed: (i) current clinical practices for the management of such patients, and (ii) the impact of MPP on heart failure clinical composite response and on the absolute change in ejection fraction (EF) at 6 months. Multipoint pacing was programmed to ON in 46% of patients before discharge. Methods of optimizing MPP programming were most commonly based on either the greatest narrowing of the QRS complex (38%) or the electrical delays between the electrodes (34%). Clinical and echocardiographic follow-up data were evaluated in 232 patients. These patients were divided into two groups according to whether MPP was programmed to ON (n = 94) or OFF (n = 138) at the time of discharge. At 6 months, EF was significantly higher in the MPP group than in the biventricular-pacing group (39.1 9.6 vs. 34.7 7.6%; P < 0.001). Even after adjustments, early MPP activation remained an independent predictor of absolute increase in LVEF of 5% (odds ratio 2.5; P = 0.001). At 6 months, an improvement in clinical composite score was recorded in a greater proportion of patients with MPP-ON than in controls (56 vs. 38%; P = 0.009). On comparing optimal MPP and conventional vectors, QRS was also seen to have decreased significantly (P < 0.001).This study provides information that is essential in order to deal with the expected increase in the number of patients receiving MPP devices in the coming years. The results revealed different practices among centres, and establishing the optimal programming that can maximize the benefit of MPP remains a challenging issue. Compared with conventional CRT, MPP improved clinical status and resulted in an additional increase in EF.http://www.clinicaltrial.gov/. Unique identifier: NCT02606071.

PubMed | Policlinico Universitario Campus Bio Medico, Amgen and Free University of Colombia
Type: | Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer | Year: 2017

The balance between bone formation and resorption may be disrupted in patients with cancer, leading either to increased bone resorption, calcium release, and possibly hypercalcaemia, or to increased bone formation, sequestration of calcium, and possibly hypocalcaemia. In adults, hypercalcaemia of malignancy is most common in patients with tumours that produce factors that induce osteoclast activation and enhance bone resorption. Impaired renal function and increased renal tubular calcium resorption may further affect calcium levels.Inhibitors of bone resorption, first the bisphosphonates and, later, denosumab, have been shown to be effective in hypercalcaemia treatment. Bisphosphonates (which are administered intravenously) are approved for hypercalcaemia of malignancy and are the current mainstay of treatment, whereas denosumab (which is administered subcutaneously) may offer an option for patients who do not respond to bisphosphonates or suffer from renal insufficiency.TREATMENT AND PREVENTION: Hypocalcaemia is most common in patients with prostate cancer and osteoblastic bone metastases, but can occur in patients with a variety of tumour types who are receiving inhibitors of bone resorption. While patients often respond to calcium and vitamin D supplementation, prevention should be the aim; at-risk patients should be identified before starting treatment with inhibitors of bone resorption, be closely monitored during at least the first few months of treatment, and receive concomitant calcium and vitamin D supplementation unless hypercalcaemia is present.Both hypercalcaemia and hypocalcaemia can be serious if left untreated. It is therefore important that patients with cancer are closely monitored and receive adequate prevention and treatment measures to maintain normal blood calcium levels.

Cellini F.,Policlinico Universitario Campus Bio Medico | Valentini V.,University Cattolica ore
Current Medicinal Chemistry | Year: 2014

Oesophageal cancer is the sixth cause of cancer-related death worldwide. Nowadays radiochemotherapy (RTCT) plays a central role in the treatment settings of such disease. Evaluation of molecular targeted therapies is an attractive opportunity for the management of oesophageal, GEJ and gastric cancers to improve outcomes as for other primary tumours. Clinical trials focused on the potential of many molecular targeted agents included in CT schedules, and also on the possibility, efficacy and tolerance of their use combined with RT. This review will focus on the over 15 more promising agents studied in combination with RT for esophagogastric tumour, describing the mechanism and target of action, evidences and potential future role on over 50 trials evaluated. Mechanisms of action, studies and evidences about Human Epidermal Growth Factor type 2 Targeting Agents (one of the more promising), Epidermal Growth Factor's Receptor Inhibitors (nowadays showing a lower potential than expected), Vascular Endothelial Growth Factor Inhibitors, Mesenchymal Epithelial Transition Factor, Hepatocyte Growth Factor and other targeting agents are reviewed. © 2014 Bentham Science Publishers.

Giua R.,Policlinico Universitario Campus Bio Medico | Pedone C.,Policlinico Universitario Campus Bio Medico | Cortese L.,Policlinico Universitario Campus Bio Medico | Antonelli Incalzi R.,Policlinico Universitario Campus Bio Medico
Infection | Year: 2014

The multiresistant Acinetobacter species bacteria are frequently involved in urinary or respiratory tract infections, and one of the most effective drugs, colistine, is associated with significant nephrotoxicity and neurotoxicity. Given that very high concentrations of colistine into biological fluids are safe for the human organism, attempts have been made at delivering the drug topically, by aerosol, or, occasionally, intratechally or intraventricularly for meningitis. These topical treatments could eradicate the Pseudomonas sp. from the lung of patients with cystic fibrosis or bronchiectasis and the Acinetobacter baumannii from lung and meninges. However, only one case of colistin topic treatment in urinary tract infection is described. We report a case series of three patients successfully undergone colistin bladder instillations for multi drug resistant Acinetobacter urinary tract infection, and we review the literature about colistin topic treatment. © Springer-Verlag 2013.

PubMed | Policlinico Universitario Campus Bio Medico and Mashhad University of Medical Sciences
Type: Journal Article | Journal: British journal of clinical pharmacology | Year: 2016

The effects of statins on insulin sensitivity, metabolic homeostasis and adipokines in humans are controversial. Several studies have investigated the impact of statin therapy on plasma leptin concentrations but the results have been inconsistent. The aim of the present study was to conduct a systematic review and meta-analysis of available evidence to calculate the effect size of statin therapy in changing serum leptin concentrations.A systematic search in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases was performed to identify randomized placebo-controlled trials investigating the effect of statins on plasma leptin concentrations. A random-effects model and generic inverse variance method were used for meta-analysis. Sensitivity analysis, risk-of-bias evaluation and publication bias assessment were carried out using standard methods. Random-effects meta-regression was used to evaluate the impact of treatment duration on the estimated effect size.Six trials, with a total of 425 subjects, met the eligibility criteria. Overall, statin therapy had no significant effect on leptin levels (weighted mean difference -0.32ng mlUnless more consistent evidence becomes available in the future, the hypothesis of a relationship between statin use and serum leptin concentrations seem to be unfounded.

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