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Rosell R.,Catalan Institute of Nanoscience and Nanotechnology | Rosell R.,University of Barcelona | Carcereny E.,Catalan Institute of Nanoscience and Nanotechnology | Gervais R.,Center Francois Baclesse | And 55 more authors.
The Lancet Oncology | Year: 2012

Background: Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods: We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m 2 on day 1 plus docetaxel (75 mg/m 2 on day 1) or gemcitabine (1250 mg/m 2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m 2 or AUC 5 with gemcitabine 1000 mg/m 2) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov, number NCT00446225. Findings: Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5-5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25-0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes. Interpretation: Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors. Funding: Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer. © 2012 Elsevier Ltd.


Abdolrahimzadeh S.,Azienda Policlinico Umberto i | Recupero S.M.,SantAndrea Hospital
Drugs of Today | Year: 2014

Advanced biotechnological techniques and new polymers have led to the development of many innovative intravitreal drug delivery systems. Some designs are still in an experimental phase while others have gained widespread acceptance and are commercially available. Since steroids are a mainstay of therapy for uveitis and macular edema, new intravitreal implants have been developed to provide continuous release of corticosteroids over prolonged spans of time with reduced systemic adverse effects. Today, three long-acting corticosteroid implants are commercially available: the fluocinolone acetonide implants Retisert® and Iluvien® and the dexamethasone drug delivery system Ozurdex®. They offer an alternative route in the management of macular edema due to uveitis, retinal vein occlusion, diabetes and pseudophakia. Their advantage over treatment with steroid injections and the anti-vascular endothelial growth factor ranibizumab is the long-term control of inflammation and macular edema with a reduced frequency of administration. Their potential side effects are cataract and glaucoma, therefore, careful patient selection and monitoring is essential. Further studies are warranted to define the relative efficacy and indications for each treatment option. The development of new devices is a future challenge in the strive to improve drug delivery systems. © 2014 Prous Science, S.A.U. or its licensors. All rights reserved.


Paoloni M.,Azienda Policlinico Umberto i | Paoloni M.,University of Rome La Sapienza | Mangone M.,University of Rome La Sapienza | Scettri P.,University of Rome La Sapienza | And 5 more authors.
Neurorehabilitation and Neural Repair | Year: 2010

Background. Studies have described the effects of segmental muscle vibration (SMV) on brain plasticity and corticomotor excitability. Information on the treatment-induced effects of SMV in stroke patients is, however, still limited. Objectives. To assess whether the application of SMV to ankle dorsiflexor muscles of chronic stroke patients can improve walking. Methods. Forty-four patients were randomly assigned to either an experimental group (EG) or a control group (CG) and underwent 12 sessions over 4 weeks of general physical therapy. Patients in the EG also received SMV at 120 Hz over the peroneus longus and tibialis anterior for 30 minutes at the end of each session. All the participants underwent pretreatment and posttreatment gait analysis assessments. Time-distance, kinematic, and surface electromyography (EMG) data were used as outcome measures. Results. A moderate improvement in mean gait speed, normal-side swing velocity, bilateral stride length, and normal-side toe-off percentage was observed only in the EG. A significant increase in bilateral ankle dorsiflexion angle at heel contact was associated with increased maximum ankle dorsiflexion and plantarflexion degrees during the swing phase on the paretic side after treatment in EG. Surface EMG during the swing phase revealed a significant increase in the activation of the tibialis anterior muscle on the paretic side in the posttreatment assessment in the EG. Conclusions. SMV added to general physical therapy may improve gait performance in patients with foot drop secondary to chronic stroke. The authors hypothesize that this may be due to the mechanical vibration stimulation, probably as a consequence of effective brain reorganization.


Petti M.C.,Regina Elena Cancer Institute | Prignano G.,San Gallicano Dermatology Institute | Mengarelli A.,Regina Elena Cancer Institute | Spadea A.,Regina Elena Cancer Institute | And 2 more authors.
Diagnostic Microbiology and Infectious Disease | Year: 2013

We report a case of Listeria monocytogenes bacteremia in a leukemic patient having a positive assay for aspergillus galactomannan (GM), although no evidence of aspergillosis was found. Supernatant obtained from L. monocytogenes strain suspension was reactive with GM-assay. L. monocytogenes produces a soluble antigen that is cross-reactive with Aspergillus GM. © 2013 Elsevier Inc.


Pasta V.,University of Rome La Sapienza | Gullo G.,Messina University | Giuliani A.,Instituto Superiore Of Sanita | Harrath A.H.,King Saud University | And 5 more authors.
European Review for Medical and Pharmacological Sciences | Year: 2015

OBJECTIVE: Mammographic breast density is a recognized risk factor for breast cancer. The causes that lead to the proliferation of the glandular breast tissue and, therefore, to an increase of breast density are still unclear. However, a treatment strategy to reduce the mammary density may bring about very relevant clinical outcomes in breast cancer prevention. Myo-inositol is a six-fold alcohol of cyclohexane, has already been proved to modulate different pathways: inflammatory, metabolic, oxidative and endocrine processes, in a wide array of human diseases, including cancer and the genesis of mammary gland and breast diseases, like fibrosis, as well as metabolic and endocrine cues. Similarly, boswellic acid and betaine (threemethyl glycine) both inhibit inflammation and exert protective effects on breast physiology. Based on this scientific background, we hypothesized that a combinat ion including, boswellic acid, betaine and myo-inositol would be able to reduce breast density working on different pathways. PATIENTS AND METHODS: In this study, seventy-six premenopausal women were randomly assigned to the placebo and the experimental drug arms (Eumastós®) for six months. RESULTS: After 6 months of treatment, statistically significant difference between the two groups was recorded on the breast density reduction (60% vs. 9%), using mammographic as well as ultrasound examination. CONCLUSIONS: Preliminary data collected here with support the starting assumptions, that the association comprising boswellic acid, betaine and myo-inositol significantly reduces mammary density, providing the first evidence for a new and safe approach for the management of mammographic density treatment.


Di Sante L.,Azienda Policlinico Umberto I | Paoloni M.,Azienda Policlinico Umberto I | Dimaggio M.,University of Rome La Sapienza | Colella L.,University of Rome La Sapienza | And 5 more authors.
European Journal of Physical and Rehabilitation Medicine | Year: 2012

Background. Combining different therapies, physical therapy agents, pharmacological and physical therapies, generally produces better outcomes for symptoms of knee osteoarthritis (OA) than do isolated therapies. Aim. To demonstrate if horizontal therapy (HT) and aspiration alone and corticosteroid injection alone or in combination determine pain relief and functional improvement in a group of patients with knee OA complicated with Baker's cyst (BC). Design. We designed a randomized controlled trial (RCT). Setting. Outpatients. Population. Sixty patients with a knee OA and diagnosis of BC confirmed by means of standard ultrasound (US) evaluation. Methods. The trial was conducted as a randomized, controlled trial. Patients who satisfied the inclusion criteria were randomized to either the US-guided (Ultrasound Guided BC aspiration and corticosteroid injection group (Group A), the Horizontal Therapy group (Group B) or the US-guided BC aspiration and corticosteroid injection plus Horizontal therapy group (Group C). Outcome measures included: 1) pain reduction as measured by visual analogue scale (VAS); 2) functional improvement, as measured by WOMAC; and 3) US evaluation at baseline (TO), at one (T1) and four (T2) weeks follow-up. Results. A total of 60 patients were randomized into group A (N.=20), group B (N.=20) or Group C (N.=20). Patients in group A and in group C, but not those in group B maintained lower pain level at T2 than at baseline, with significant lower VAS values in Group C. As regards US measurements, the maximum axial area did not change as a consequence of the treatment in any of the three groups (P=0.259). Contrarily, sagittal area measurements were influenced by time (P<0.01). Conclusion. Our results show that the group with the best performance for pain, functionality and dimension of BC was that in which combined use was made of horizontal and corticosteroid injection therapies. Clinical Rehabilitation Impact. In this study we want to demonstrate the effectiveness of Horizontal Therapy in the treatment of knee OA complicated by BC.


PubMed | Azienda Policlinico Umberto I
Type: Journal Article | Journal: Stem cell reviews | Year: 2015

Family-directed umbilical cord blood (UCB) collection and banking is indicated in women delivering healthy babies who already have a member of their own family with a disease potentially treatable with an allogeneic hematopoietic stem cell (HSCs) transplantation (HSCT). The rapid availability of UCB is an important issue in HSCs procurement particularly for recipients with acute leukemia who urgently need HSCT. The aims of this study were to assess the usage rate of family UCB collections directed to patients with acute leukemia and to investigate the factors influencing the usage rate. A total of 113 families were enrolled, 118 UCB units were successfully collected and one collection failed due to emergency occurred during delivery. Among these, 7 collections were required for children who were in urgent need of a transplant: three HLA-matched units were successfully transplanted, respectively after 2, 5 and 6months from collection; three collections resulted HLA-mismatched, while HLA-typing is pending for one unit. The remaining collections were mostly required for potential future use, among these units only one was transplanted in a HLA compatible sibling after 3years and 4months from collection. After a median time of storage of 8.5years (range 0.1-20 years) a total of 4/118 (3.4%) collection has been transplanted. During this time interval, considering only patients who have had the need of a transplant, the main factor influencing low utilization rate of UCB collections was due to HLA disparity, indeed among typed UCB unit mostly (77%) resulted HLA mismatched with the intended recipient.


PubMed | Azienda Policlinico Umberto I
Type: Journal Article | Journal: Clinical rheumatology | Year: 2012

Patellofemoral pain syndrome (PFPS) is a common source of anterior knee pain. While treatment for PFPS may be successful in the short term, long-term results are less promising. The purpose of this study was to record long-term pain and functionality outcomes following rehabilitation in patients affected by PFPS. A prospective cohort study of 44 patients with a diagnosis of PFPS and an activation imbalance between the vastus medialis obliquus (VMO) and vastus lateralis (VL) muscles were enrolled. Patients underwent patellar taping (2weeks) followed by a rehabilitation program lasting until the end of the third month. Primary outcome measures were pain and the functional level of the patellofemoral joint. Secondary outcome measures were surface electromyographic (sEMG) onset timing of the VMO/VL during seated knee extension and squat and isometric knee extensor muscle strength. Significant differences in all the outcome measures were observed between the affected and unaffected sides before treatment. The pain score significantly decreased both posttreatment (=-4.7; 95% CI=-5.4 to -3.9) and at the 12-month follow-up (=-5.5; 95% CI=-6.1 to -4.8), while the functional level significantly increased both posttreatment (=24; 95% CI=18.3 to 30.2) and at the 12-month follow-up (=26; 95% CI=21.4 to 30.6). Posttreatment, 35/44 patients (79.5%) and 31/44 patients (70.5%) achieved normal sEMG onset timing of the VMO and VL in the seated knee extension exercise and in the squat exercise, respectively. A short period of patellar taping followed by an exercise program results in long-lasting pain control in PFPS associated with muscular dysfunction.


PubMed | Azienda Policlinico Umberto I
Type: Journal Article | Journal: Recenti progressi in medicina | Year: 2011

The aim of the Chest Pain Unit at Policlinico Umberto I in Rome was to implement simple diagnostic flow-charts in subjects with non-traumatic chest pain for an early identification of patients at high, intermediate and low risk of acute coronary syndrome (ACS). A total of 4.74% of all patients admitted to the Emergency Department were hospitalized in the Chest Pain Unit. 15.72% of them received a diagnosis of atypical chest pain with low risk of ACS; 26,42% were diagnosed of stable angina pectoris; 11.37% were affected by chronic coronary heart disease with medium risk of ACS and 12.83% were at high risk of acute coronary syndrome.


Paoloni M.,Azienda Policlinico Umberto I | Fratocchi G.,Azienda Policlinico Umberto I | Mangone M.,University of Rome La Sapienza | Murgia M.,Azienda Policlinico Umberto I | And 4 more authors.
Clinical Rheumatology | Year: 2012

Patellofemoral pain syndrome (PFPS) is a common source of anterior knee pain. While treatment for PFPS may be successful in the short term, long-term results are less promising. The purpose of this study was to record long-term pain and functionality outcomes following rehabilitation in patients affected by PFPS. A prospective cohort study of 44 patients with a diagnosis of PFPS and an activation imbalance between the vastus medialis obliquus (VMO) and vastus lateralis (VL) muscles were enrolled. Patients underwent patellar taping (2 weeks) followed by a rehabilitation program lasting until the end of the third month. Primary outcome measures were pain and the functional level of the patellofemoral joint. Secondary outcome measures were surface electromyographic (sEMG) onset timing of the VMO/VL during seated knee extension and squat and isometric knee extensor muscle strength. Significant differences in all the outcome measures were observed between the affected and unaffected sides before treatment. The pain score significantly decreased both posttreatment (Δ = -4.7; 95% CI = -5.4 to -3.9) and at the 12-month follow-up (Δ = -5.5; 95% CI = -6.1 to -4.8), while the functional level significantly increased both posttreatment (Δ = 24; 95% CI = 18.3 to 30.2) and at the 12-month follow-up (Δ = 26; 95% CI = 21.4 to 30.6). Posttreatment, 35/44 patients (79.5%) and 31/44 patients (70.5%) achieved normal sEMG onset timing of the VMO and VL in the seated knee extension exercise and in the squat exercise, respectively. A short period of patellar taping followed by an exercise program results in long-lasting pain control in PFPS associated with muscular dysfunction. © 2011 Clinical Rheumatology.

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