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- 저자 : Di Leo, Angelo (검색결과 11 건)
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Di Leo, Angelo,Johnston, Stephen,Lee, Keun Seok,Ciruelos, Eva,Lønning, Per E,Janni, Wolfgang,O'Regan, Ruth,Mouret-Reynier, Marie-Ange,Kalev, Dimitar,Egle, Daniel,Cső,szi, Tibor,Bordonaro, Roberto Elsevier 2018 The Lancet. Oncology Vol.19 No.1
<P><B>Summary</B></P> <P><B>Background</B></P> <P>Activation of the PI3K/AKT/mTOR pathway occurs frequently in breast cancer that is resistant to endocrine therapy. Approved mTOR inhibitors effectively inhibit cell growth and proliferation but elicit AKT phosphorylation via a feedback activation pathway, potentially leading to resistance to mTOR inhibitors. We evaluated the efficacy and safety of buparlisib plus fulvestrant in patients with advanced breast cancer who were pretreated with endocrine therapy and mTOR inhibitors.</P> <P><B>Methods</B></P> <P>BELLE-3 was a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Postmenopausal women aged 18 years or older with histologically or cytologically confirmed hormone-receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, who had relapsed on or after endocrine therapy and mTOR inhibitors, were recruited from 200 trial centres in 22 countries. Eligible patients were randomly assigned (2:1) via interactive response technology (block size of six) to receive oral buparlisib (100 mg per day) or matching placebo starting on day 1 of cycle 1, plus intramuscular fulvestrant (500 mg) on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles. Randomisation was stratified by visceral disease status. The primary endpoint was progression-free survival by local investigator assessment as per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in the full analysis population (all randomised patients, by intention-to-treat). Safety was analysed in all patients who received at least one dose of treatment and at least one post-baseline safety assessment. This study is registered with ClinicalTrials.gov, number NCT01633060, and is ongoing but no longer enrolling patients.</P> <P><B>Findings</B></P> <P>Between Jan 15, 2013, and March 31, 2016, 432 patients were randomly assigned to the buparlisib (n=289) or placebo (n=143) groups. Median progression-free survival was significantly longer in the buparlisib versus placebo group (3·9 months [95% CI 2·8–4·2] <I>vs</I> 1·8 months [1·5–2·8]; hazard ratio [HR] 0·67, 95% CI 0·53–0·84, one-sided p=0·00030). The most frequent grade 3–4 adverse events in the buparlisib versus placebo group were elevated alanine aminotransferase (63 [22%] of 288 patients <I>vs</I> four [3%] of 140), elevated aspartate aminotransferase (51 [18%] <I>vs</I> four [3%]), hyperglycaemia (35 [12%] <I>vs</I> none), hypertension (16 [6%] <I>vs</I> six [4%]), and fatigue (ten [3%] <I>vs</I> two [1%]). Serious adverse events were reported in 64 (22%) of 288 patients in the buparlisib group versus 23 (16%) of 140 in the placebo group; the most frequent serious adverse events (affecting ≥2% of patients) were elevated aspartate aminotransferase (six [2%] <I>vs</I> none), dyspnoea (six [2%] <I>vs</I> one [1%]), and pleural effusion (six [2%] <I>vs</I> none). On-treatment deaths occurred in ten (3%) of 288 patients in the buparlisib group and in six (4%) of 140 in the placebo group; most deaths were due to metastatic breast cancer, and two were considered treatment-related (cardiac failure [n=1] in the buparlisib group and unknown reason [n=1] in the placebo group).</P> <P><B>Interpretation</B></P> <P>The safety profile of buparlisib plus fulvestrant does not support its further development in this setting. Nonetheless, the efficacy of buparlisib supports the rationale for the use of PI3K inhibitors plus endocrine therapy in patients with <I>PIK3CA</I> mutations.</P> <P><B>Funding</B></P> <P>Novartis Pharmaceuticals Corporation.</P>
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Dynamic response of a linear two d.o.f system visco-elastically coupled with a rigid block
Di Egidio, Angelo,Pagliaro, Stefano,Fabrizio, Cristiano,de Leo, Andrea M. Techno-Press 2019 Coupled systems mechanics Vol.8 No.4
The present work investigates the use of a rigid rocking block as a tool to reduce vibrations in a frame structure. The study is based on a simplified model composed by a 2-DOF linear system, meant to represent a general M-DOF frame structure, coupled with a rocking rigid block through a linear visco-elastic device, which connects only the lower part of the 2-DOF system. The possibility to restrain the block directly to the ground, by means of a second visco-elastic device, is investigated as well. The dynamic response of the model under an harmonic base excitation is then analysed in order to evaluate the effectiveness of the coupling in reducing the displacements and the drift of the 2-DOF system. The nonlinear equations of motion of the coupled assemblage 2-DOF-block are obtained by a Lagrangian approach and then numerically integrated considering some reference mechanical and geometrical quantities as variable parameters. It follows an extensive parametric analysis, whose results are summarized through behaviour maps, which portray the ratio between the maximum displacements and drifts of the system, with and without the coupling with the rigid block, for several combinations of system's parameters. When the ratio of the displacements is less than unity, the coupling is considered effective. Results show that the presence of the rocking rigid block improves the dynamics of the system in large ranges of the characterizing parameters.
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A CFD approach to rubble mound breakwater design
Dentale, Fabio,Reale, Ferdinando,Di Leo, Angela,Carratelli, Eugenio Pugliese The Society of Naval Architects of Korea 2018 International Journal of Naval Architecture and Oc Vol.10 No.5
The paper provides some developments of a numerical approach ("Numerical Calculation of Flow Within Armour Units", FWAU) to the design of rubble mound breakwaters. The hydrodynamics of wave induced flow within the interstices of concrete blocks is simulated by making use of advanced, but well tested, CFD techniques to integrate RANS equations. While computationally very heavy, FWAU is gaining ground, due to its obvious advantages over the "porous media", i.e. the possibility of accounting for the highly non stationary effects, the reduced need of ad hoc calibration of filtration parameters and also - in perspective - the evaluation of hydrodynamic forces on single blocks. FWAU however is a complex technique, and in order to turn it into a practical design tool, a number of difficulties have to be overcome. The paper presents recent results about this validation, as well as insight into fluid dynamical aspects.
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A CFD approach to rubble mound breakwater design
Fabio Dentale,Ferdinando Reale,Angela Di Leo,Eugenio Pugliese Carratelli 대한조선학회 2018 International Journal of Naval Architecture and Oc Vol.10 No.5
The paper provides some developments of a numerical approach (“Numerical Calculation of Flow Within Armour Units”, FWAU) to the design of rubble mound breakwaters. The hydrodynamics of wave induced flow within the interstices of concrete blocks is simulated by making use of advanced, but well tested, CFD techniques to integrate RANS equations. While computationally very heavy, FWAU is gaining ground, due to its obvious advantages over the “porous media”, i.e. the possibility of accounting for the highly non stationary effects, the reduced need of ad hoc calibration of filtration parameters and also e in perspective e the evaluation of hydrodynamic forces on single blocks. FWAU however is a complex technique, and in order to turn it into a practical design tool, a number of difficulties have to be overcome. The paper presents recent results about this validation, as well as insight into fluid dynamical aspects.
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Static wind loads on rigid roof model with complex hyperbolic geometry
Juan S. Delnero,Julio Marañón Di Leo,Mariano A. Martinez 한국풍공학회 2021 Wind and Structures, An International Journal (WAS Vol.33 No.3
The use of tensioned structures, such as membranes, as solutions for roofing and other kinds of covers has become more and more frequent. Current regulations do not provide detailed information about the coefficients needed to develop efficient designs, regarding wind loads. A lot of simulations and tests have been performed on different geometries which are typically used in these kinds of designs. However, no precise and clear standard has been established, yet, in order to regulate efficiently this application. Current regulations consider only simple geometries, while the effects of the interference between multiple covers or between a cover and the near urban environment is completely absent. In this paper are presented the results obtained from testing a 1:75 scale complex geometry model in a boundary layer wind tunnel. More precisely a model of a parking lot for vans, roofed with a complex geometry tensioned membrane was tested in order to measure its pressure distribution. Due to the high complexity of the geometry and in order to obtain a better description of the effects of the wind it was decided to lead wind tunnel tests to validate and to verify the load conditions over the roof. Information about wind load distributions for simple geometries such as cones, hyperboloids, etc. alone can be easily found in current technical bibliography. However, when designs are based on more complex shapes, including arrays of simpler shapes, a profound lack of information is observed. Therefore, it is not possible to calculate the wind loads over the membrane which are needed to dimension the supporting structure.
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Use of the ultrasound-based total malignancy score in the management of thyroid nodules
Giovanni Guido Pompili,Silvia Tresoldi,Anna Ravell,Alessandra Primolevo,Giovanni Di Leo,Gianpaolo Carrafiello 대한초음파의학회 2018 ULTRASONOGRAPHY Vol.37 No.4
Purpose: The purpose of this study was to validate the role of the total malignancy score (TMS)in identifying thyroid nodules suspicious for malignancy through the sum of their ultrasoundfeatures. Methods: The local ethical committee approved this prospective observational study. Weexamined 231 nodules in 231 consecutive patients (164 females and 67 males; age range, 20 to87 years; median age, 59 years; interquartile range, 48 to 70 years) who underwent ultrasoundfollowed by fine-needle aspiration cytology (FNAC). The nodules were further classified usingthe TMS, which considers ultrasound features (number, echogenicity, structure, halo, margins,Doppler signal, calcifications, and growth), and the Bethesda System for Reporting ThyroidCytopathology (TBSRTC), which considers cytological features. Patients with non-negativenodules (TBSRTC categories III to VI) underwent histological analysis, repeated FNAC, or 2years of regular ultrasound follow-up. The associations between the final diagnosis, each of theultrasound features, and the TMS were estimated using the chi-square test, the Mann-WhitneyU test, and multivariate logistic regression. A receiver operating characteristic (ROC) curve wasused to evaluate the diagnostic accuracy of the TMS. Results: On ultrasound, 47% of the nodules (108 of 231) had a TMS <3, 18% (42 of 231) hada TMS of 3, and 35% (81 of 231) had a TMS >3. The FNAC results of 85% of the nodules (196of 231) were benign, while 15% (35 of 231) had non-negative results. Hypoechogenicity, solidstructure, the presence of microcalcifications, and the number of nodules were independentpredictors of the final diagnosis, and the diagnostic accuracy of the TMS was good (area underthe ROC curve, 0.82). Conclusion: The TMS system is simple to use, reliable, easily reproducible, and closely reflectsmalignancy risk. Based on our results, FNAC could be limited to nodules with a TMS ≥3 withoutmissing any cases of carcinoma.
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( Giuseppe Losurdo ),( Gioacchino Leandro ),( Enzo Ierardi ),( Francesco Perri ),( Michele Barone ),( Mariabeatrice Principi ),( Alfredo Di Leo ) 대한소화기 기능성질환·운동학회 2020 Journal of Neurogastroenterology and Motility (JNM Vol.26 No.1
Background/Aims Small intestinal bacterial overgrowth (SIBO) diagnosis is usually based on non-invasive breath tests (BTs), namely lactulose BT (LBT) and glucose BT (GBT). However, divergent opinions and problems of parameter standardization are still controversial aspects. We aim to perform a meta-analysis to analyze diagnostic performance of LBT/GBT for SIBO diagnosis. Methods We searched in main literature databases articles in which SIBO diagnosis was achieved by LBT/GBT in comparison to jejunal aspirate culture (reference gold standard). We calculated pooled sensitivity, specificity, positive, and negative likelihood ratios and diagnostic odd ratios. Summary receiver operating characteristic curves were drawn and pooled areas under the curve were calculated. Results We selected 14 studies. Pooled sensitivity of LBT and GBT was 42.0% and 54.5%, respectively. Pooled specificity of LBT and GBT was 70.6% and 83.2%, respectively. When delta over baseline cut-off > 20 H<sup>2</sup> parts per million (ppm) was used, GBT sensitivity and specificity were 47.3% and 80.9%; when the cutoff was other than and lower than > 20 ppm, sensitivity and specificity were 61.7% and 86.0%. In patients with abdominal surgery history, pooled GBT sensitivity and specificity gave the impression of having a better performance (81.7% and 78.8%) compared to subjects without any SIBO predisposing condition (sensitivity = 40.6% and specificity = 84.0%). Conclusions GBT seems to work better than LBT. A cut-off of delta H2 expired other than and lower than > 20 ppm shows a slightly better result than > 20 ppm. BTs demonstrate the best effectiveness in patients with surgical reconstructions of gastrointestinal tract.
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