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1. Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer (STREAM): an academic, multicenter, single-arm, two-stage, phase II study

Author

Cardone, C., De Stefano, A., Rosati, G., Cassata, A., Silvestro, L., Borrelli, M., Di Gennaro, E., Romano, C., Nappi, A., Zanaletti, N., Foschini, F., Casaretti, R., Tatangelo, F., Lastoria, S., Raddi, M., Bilancia, D., Granata, V., Setola, S., Petrillo, A., Vitagliano, C., Gargiulo, P., Arenare, L., Febbraro, A., Martinelli, E., Ciardiello, F., Delrio, P., Budillon, A., Piccirillo, M.C., and Avallone, A.

Published
2023
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7. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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8. 1534TiP Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients-VESPA trial

Author

Budillon, A., Silvestro, L., Reni, M., Milella, M., Tortora, G., Rodriguez, M., Fiore, F., Petrillo, A., De Bellis, M., Cavalcanti, E., Macchini, M., Leone, A., Di Gennaro, E., Passaro, E., Borrelli, M., García Bermejo, M.L., Hewitt, E., Fuchs, C., Giannarelli, D., and Avallone, A.

Published
2024
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9. P-68 Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer (STREAM): An academic, multicenter, single-arm, two-stage, phase 2 study

Author

Cardone, C., primary, Piccirillo, M., additional, Rosati, G., additional, De Stefano, A., additional, Romano, C., additional, Nappi, A., additional, Zanaletti, N., additional, Foschini, F., additional, Cassata, A., additional, Casaretti, R., additional, Silvestro, L., additional, Tatangelo, F., additional, Lastoria, S., additional, Raddi, M., additional, Bilancia, D., additional, Febbraro, A., additional, Martinelli, E., additional, Ciardiello, F., additional, Delrio, P., additional, Perrone, F., additional, Budillon, A., additional, and Avallone, A., additional

Published
2022
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14. P-198 Prevalence of deleterious DPYD variants in patients with gastrointestinal malignancies: Real-world data from a single institution in Italy

Author

Cardone, C., primary, Collina, F., additional, Brogna, M., additional, Casaretti, R., additional, Cassata, A., additional, De Stefano, A., additional, Di Giovanni, I., additional, Nappi, A., additional, Romano, C., additional, Silvestro, L., additional, Viscardi, G., additional, Zanaletti, N., additional, Di Bonito, M., additional, and Avallone, A., additional

Published
2021
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17. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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20. SO-26 Intermittent or continuous panitumumab plus FOLFIRI for first-line treatment of patients with RAS/BRAF wild-type metastatic colorectal cancer: An update of survival/toxicity and preliminary results of genomic alterations from IMPROVE study

Author

De Stefano, A., Giuliani, F., Nasti, G., Montesarchio, V., Santabarbara, G., Leo, S., Malapelle, U., Rosati, G., Lolli, I., Tamburini, E., Colombo, A., Santini, D., Silvestro, L., Leone, A., Vitagliano, C., Troncone, G., Sobrero, A., Giannarelli, D., Budillon, A., and Avallone, A.

Published
2023
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35. Pharmacokinetic Bioequivalence Study of Two Formulations of Teriflunomide in Healthy Male Volunteers under Fasting Conditions

Author

Neatu A, Rizea-Savu S, Roffé C, Sevinsky E, and Silvestro L

Subjects
business.industry, Cmax, Pharmaceutical Science, Pharmacology, Bioequivalence, Coated tablets, Bioequivalence study, chemistry.chemical_compound, Pharmacokinetics, chemistry, Teriflunomide, Healthy volunteers, Medicine, Statistical analysis, business
Abstract

A generic formula containing 14 mg of teriflunomide (Terflimida® test formulation) in oral coated tablets was compared to the reference product (Aubagio®) in a pharmacokinetic, open label, two-periods, two sequences, two-way crossover; block randomized single dose study in healthy male volunteers under fasting conditions.The statistical analysis of the pharmacokinetic data obtained in this study showed that the Teriflunomide formulations: Terflimida® coated tablets 14 (test formulation) and Aubagio® 14 mg coated tablets (reference formulation), were bioequivalent regarding the rate (Cmax) and the extent of absorption (AUC0-72), under fasting conditions. The Teriflunomide treatments (TEST and REFERENCE formulations), administered orally in single dose, to male healthy volunteers, under fasting conditions, were very well tolerated by all the participating subjects.

Published
2018

36. Pancreatic cancer detection and characterization: state of the art and radiomics.

Author

GRANATA, V., GRASSI, R., FUSCO, R., GALDIERO, R., SETOLA, S. V., PALAIA, R., BELLI, A., SILVESTRO, L., COZZI, D., BRUNESE, L., PETRILLO, A., and IZZO, F.

Abstract

Pancreatic ductal adenocarcinoma (PDAC) represents a challenge for a multidisciplinary oncology team. Diagnosis of PDAC remains challenging due to overlapping imaging features with benign lesions, notwithstanding great advances with computed tomography (CT) and magnetic resonance imaging (MRI). The term "Radiomics" has recently been introduced to define a mathematical process to extract countless quantitative features from medical images (including each diagnostic technique) with high throughput computing for diagnosis and prediction. This article is an updated overview of the imaging techniques to be employed during detection and characterization of pancreatic cancer diagnostic workup. Particularly, the limitations and advantages of the different imaging techniques are discussed, with a particular focus on functional imaging. This overview is the result of a self-study without protocol and registration number. Articles published in the English language from January 2000 to January 2021 were included. We analyzed 15 papers on radiomics. The possibility of functional imaging, such as CT, MRI, and radiomics has revolutionized pancreatic imaging, improving the detection and characterization of the lesions and allowing a prognosis related to radiological features, favoring the process of personalized medicine. [ABSTRACT FROM AUTHOR]

Published
2021

37. Mollisol: biological characterization under zero tillage with different crops sequences

Author

Silvestro, L. B., Fernando Biganzoli, Forjan, H., Albanesi, A., Arambarri, A. M., Manso, L., and Moreno, M. V.

Subjects
Tipos de Suelo, Rotación de Cultivos, Soil Types, Crops, Cultivos, Enzyme Activity, Crop Rotation, Agronomía, reproducción y protección de plantas, Ciencias Naturales, Enzyme activities, Basal respiration, Soil organic carbon, Agricultura, fungi, food and beverages, Actividad Enzimática, Zero tillage, Microbial activity, Crop sequences, CIENCIAS AGRÍCOLAS, purl.org/becyt/ford/4.1 [https], Molisoles, Long term assay, Agricultura, Silvicultura y Pesca, purl.org/becyt/ford/4 [https], Cero-labranza
Abstract

Zero tillage practices have a direct effect on soil microbial communities modifying soil productivity and sustainability. The crop sequences used can be change afore mentioned properties too. In this study we evaluated the effect of crop sequences under zero till management on soil biological and chemical properties. These were soil vertical distribution of soil organic carbon, soil basal respiration, and dehydrogenase, acid phosphatase, and urease activity along a seasonal year and at different soil depths, on a long-term field experiment The sequences included in this study were: I. single crop per year (sunflower-wheat-sorghum-soybean); II. mixed agriculture/livestock with pastures, without using winter or summer 9forages (wheat sorghum/soybean-canola-pasture); III. winter management (wheat-canola- barley-late soybean); IV. mixed with annual feed crop (wheat-oat/Vicia sativa- soybean or sunflower) and V. intensive management (wheat-barley-canola, with alternation of soybean or late soybean). Soil organic carbon decreased with increasing depth, depending on sequences 13(Pseq x depth = 0.0173). Soil basal respiration was higher in the 0-5 cm layer than in the 10-20 cm layer of the topsoil irrespectively of the crop sequences (Pdepth = 0.0062). Dehydrogenase, acid phosphatase and urease activity were affected by crop sequences, sampling season and depth. Mixed sequences (sequences II and IV), including perennial pastures or annual feedcrop could favor dehydrogenase and phosphatase activity. Sequences with cover crops (sequences II and IV) could favor microbial activity and therefore improve soil quality., Instituto de Botánica "Dr. Carlos Spegazzini"

Published
2017

38. Preoperative nivolumab in patients(pts) with locally advanced colon cancer (T3 or T4): A window-of-opportunity study (NICOLE)

Author

Avallone, A., primary, Delrio, P., additional, Nasti, G., additional, Cassata, A., additional, Silvestro, L., additional, De Stefano, A., additional, Lastoria, S., additional, Casaretti, R., additional, Romano, C., additional, Ottaiano, A., additional, Di gennaro, E., additional, Nappi, A., additional, Maiolino, P., additional, Cavalcanti, E., additional, Petrillo, A., additional, Tatangelo, F., additional, Giannarelli, D., additional, Galon, J., additional, Ascierto, P.A., additional, and Budillon, A., additional

Published
2018
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39. Survival analysis of a multicentre, randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in patients with metastatic colorectal cancer (mCRC)

Author

Avallone, A., primary, Nasti, G., additional, Rosati, G., additional, Carlomagno, C., additional, Romano, C., additional, Bilancia, D., additional, De Stefano, A., additional, Silvestro, L., additional, Ottaiano, A., additional, Cassata, A., additional, Bianco, F., additional, Izzo, F., additional, Delrio, P., additional, De Gennaro, E., additional, Casaretti, R., additional, Tafuto, S., additional, Albino, V., additional, Pace, U., additional, Lastoria, S., additional, Gallo, C., additional, Budillon, A., additional, and Piccirillo, M., additional

Published
2018
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41. Vox clamantis in deserto: a survey among Italian psychiatrists on defensive medicine and professional liability

Author

Pasquale Scognamiglio, Donato Morena, Nicola Di Fazio, Giuseppe Delogu, Valeria Iniziato, Silvestro La Pia, Pasquale Saviano, Paola Frati, and Vittorio Fineschi

Subjects
defensive medicine, professional liability, position of guarantee, forensic psychiatry, survey, duty of care, Psychiatry, RC435-571
Abstract

Due to recent events, professional liability for psychiatrists in Italy is currently a matter of lively debate. Specifically, overwhelming pressure on psychiatrists’ duties has been brought by regulatory developments, such as the closure of forensic psychiatric hospitals, with the consequent return of offenders to community-based care, and the mental health consequences of the pandemic. According to Italian courts, psychiatrists are not only responsible for diagnostic and therapeutic appropriateness but also for the effects of their interventions on patients, and their behaviors. The aim of this study was to explore the attitude and behaviors of Italian psychiatrists regarding defensive medicine and professional liability. A total sample of 254 psychiatrists was surveyed by means of a quantitative online questionnaire. Most psychiatrists reported practicing defensive medicine (no. 153/254, 60.2%) and felt that their position of guarantee compromised their work in healthcare for patients (no. 138/253, 54.3%). Age correlated inversely with acknowledgment of defensive practices (r = −0.245, p 0.05). Anxiety, anger, and restlessness were common reactions to legal complaints, involving no. 50/254 (19.7%) respondents, with 40% reporting impaired functioning. Most psychiatrists (no. 175/253, 68.9%) were concerned about both civil and criminal laws regarding their professional responsibility, but many were not fully informed about recent legislative regulations and younger physicians resulted scarcely trained in risk management (p

Published
2023
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43. A prognostic model comprising pT stage, N status, and the chemokine receptors CXCR4 and CXCR7 powerfully predicts outcome in neoadjuvant resistant rectal cancer patients

Author

D'Alterio C, Avallone A, Tatangelo F, Delrio P, Pecori B, Cella L, Pelella A, Bianco F, Silvestro L, Napolitano M, Iaffaioli RV, D'ARMIENTO, FRANCESCO PAOLO, CARLOMAGNO, Chiara, PACELLI, ROBERTO, SCALA, STEFANIA, D'Alterio, C, Avallone, A, Tatangelo, F, Delrio, P, Pecori, B, Cella, L, Pelella, A, D'Armiento, FRANCESCO PAOLO, Carlomagno, Chiara, Bianco, F, Silvestro, L, Pacelli, Roberto, Napolitano, M, Iaffaioli, Rv, and Scala, Stefania

Subjects
predictive factor, prognosis, rectal cancer
Abstract

Despite the optimization of the local treatment of advanced rectal cancer (LARC), combination of preoperative chemoradiotherapy (CRT) and surgery, approximately one third of patients will develop distant metastases. Since the chemokine receptor CXCR4 has been implicated in metastasis development and prognosis in colorectal cancer, the role of the entire axis CXCR4-CXCL12-CXCR7 was evaluated to identify high relapse risk rectal cancer patients. Tumor specimens of 68 LARC patients undergoing surgery after neoadjuvant-CRT were evaluated for CXCR4, CXCR7, and CXCL12 expression through immunohistochemistry. Multivariable prognostic model was developed using classical prognostic factors along with chemokine receptor expression profiles. High CXCR4 correlated with a shorter relapse-free survival (RFS) (p = 0.0006) and cancer specific survival (CSS) (p = 0.0004). Concomitant high CXCR4-negative/low CXCR7 or high CXCR4-negative/low CXCL12 significantly impaired RFS (p = 0.0003 and p = 0.0043) and CSS (p = 0.0485 and p = 0.0026). High CXCR4/N+ identified the worst prognostic category for RFS (p < 0.0001) and CSS (p = 0.0003). The optimal multivariable predictive model for RFS was a five-variable model consisting of gender, pT stage, N status, CXCR4, and CXCR7 (AUC = 0.92, 95% CI = 0.77-0.98). The model is informative and supportive for adjuvant treatment and identifies CXCR4 as a new therapeutic target in rectal cancer.

Published
2014
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44. Pregnancy outcomes after kidney graft in Italy: are the changes over time the result of different therapies or of different policies? A nationwide survey (1978-2013)

Author

Piccoli, Gb, Cabiddu, G, Attini, R, Gerbino, M, Todeschini, P, Perrino, Ml, Manzione, Am, Piredda, Gb, Gnappi, E, Caputo, F, Montagnino, G, Bellizzi, V, Di Loreto, P, Martino, F, Montanaro, D, Rossini, M, Castellino, S, Biolcati, M, Fassio, F, Loi, V, Parisi, S, Versino, E, Pani, A, Todros, T, Manna, G, Colussi, G, Biancone, L, Piredda, G, Maxia, S, Maggiore, U, Buscemi, B, Messa, P, Palladino, G, De Silvestro, L, Ronco, C, Groppuzzo, M, Gesualdo, L, Davoli, D, Cappelli, G, Postorino, M, Rocca, Ar, Dei Malatesta ML, Stratta, P, Izzo, C, Quaglia, M, Setti, G, Cancarini, Giovanni, Del Prete, D, Bonfante, L, Esposito, C, Montagna, G, Veroux, M, Santoro, D, Paloschi, V, Secchi, A, Credendino, O, Tranquilli, A, Buscicchio, G, Gammaro, L, Gernone, G, Giacchino, F, Limardo, M., Piccoli, Giorgina Barbara, Cabiddu, Gianfranca, Attini, Rossella, Gerbino, Martina, Todeschini, Paola, Perrino, Maria Luisa, Manzione, Ana Maria, Piredda, Gian Benedetto, Gnappi, Elisa, Caputo, Flavia, Montagnino, Giuseppe, Bellizzi, Vincenzo, Di Loreto, Pierluigi, Martino, Francesca, Montanaro, Domenico, Rossini, Michele, Castellino, Santina, Biolcati, Marilisa, Fassio, Federica, Loi, Valentina, Parisi, Silvia, Versino, Elisabetta, Pani, Antonello, and Todros, Tullia

Subjects
Adult, medicine.medical_specialty, medicine.medical_treatment, 030232 urology & nephrology, Péregnancy, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, Surveys and Questionnaires, medicine, Humans, Registries, Renal replacement therapy, Kidney transplantation, Dialysis, Transplantation, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, Incidence, Infant, Newborn, Pregnancy Outcome, medicine.disease, Kidney Transplantation, Kidney graft, Pregnancy Complications, Italy, Nephrology, Premature birth, Cohort, Premature Birth, Small for gestational age, Female, pregnancy, kidney transplant, immunosuppression, Transplantation, Péregnancy, business, Immunosuppressive Agents
Abstract

BACKGROUND Kidney transplantation is the treatment of choice to restore fertility to women on renal replacement therapy. Over time, immunosuppressive, support therapies and approaches towards high-risk pregnancies have changed. The aim of this study was to analyse maternal-foetal outcomes in two cohorts of transplanted women who delivered a live-born baby in Italy in 1978-2013, dichotomized into delivery before and after January 2000. METHODS A survey involving all the Italian transplant centres was carried out, gathering data on all pregnancies recorded since the start of activity at each centre; the estimated nationwide coverage was 75%. Data on cause of ESRD, dialysis, living/cadaveric transplantation, drug therapy, comorbidity, and the main maternal-foetal outcomes were recorded and reviewed. Data were compared with a low-risk cohort of pregnancies from two large Italian centres (2000-14; Torino and Cagliari Observational Study cohort). RESULTS The database consists of 222 pregnancies with live-born babies after transplantation (83 before 2000 and 139 in 2000-13; 68 and 121 with baseline and birth data, respectively), and 1418 low-risk controls. The age of the patients significantly increased over time (1978-99: age 30.7 ± 3.7 versus 34.1 ± 3.7 in 2000-13; P < 0.001). Azathioprine, steroids and cyclosporine A were the main drugs employed in the first time period, while tacrolimus emerged in the second. The prevalence of early preterm babies increased from 13.4% in the first to 27.1% in the second period (P = 0.049), while late-preterm babies non-significantly decreased (38.8 versus 33.1%), thus leaving the prevalence of all preterm babies almost unchanged (52.2 and 60.2%; P = 0.372). Babies below the 5th percentile decreased over time (22.2 versus 9.6%; P = 0.036). In spite of high prematurity rates, no neonatal deaths occurred after 2000. The results in kidney transplant patients are significantly different from controls both considering all cases [preterm delivery: 57.3 versus 6.3%; early preterm: 22.2 versus 0.9%; small for gestational age (SGA): 14 versus 4.5%; P < 0.001] and considering only transplant patients with normal kidney function [preterm delivery: 35 versus 6.3%; early preterm: 10 versus 0.9%; SGA: 23.7 versus 4.5% (P < 0.001); risks increase across CKD stages]. Kidney function remained stable in most of the patients up to 6 months after delivery. Multiple regression analysis performed on the transplant cohort highlights a higher risk of preterm delivery in later CKD stages, an increase in preterm delivery and a decrease in SGA across periods. CONCLUSIONS Pregnancy after transplantation has a higher risk of adverse outcomes compared with the general population. Over time, the incidence of SGA babies decreased while the incidence of 'early preterm' babies increased. Although acknowledging the differences in therapy (cyclosporine versus tacrolimus) and in maternal age (significantly increased), the decrease in SGA and the increase in prematurity may be explained by an obstetric policy favouring earlier delivery against the risk of foetal growth restriction.

Published
2016

45. Mental health in Italy after two years of COVID-19 from the perspective of 1281 Italian physicians: looking back to plan forward

Author

Alessandro Cuomo, Mario Amore, Maria Felice Arezzo, Sergio De Filippis, Alessandra De Rose, Silvestro La Pia, Alessandro Pirani, Riccardo Torta, and Andrea Fagiolini

Subjects
COVID-19, Mental health, Anxiety, Agitation, Physician, Psychiatry, RC435-571
Abstract

Abstract Background The COVID-19 pandemic has generated an unprecedented global crisis that is profoundly affecting mental health and mental health care. The aim of this study was to survey a relatively large group of Italian physicians about their perceived impact of COVID-19 on the mental health of the Italian population and about their suggestions on the best strategies to address the current and future challenges. Methods One thousand two hundred eighty-one (1,281) physicians were surveyed between November 2021 and February 2022. Results Eighty-one percent of respondents reported an increase in the number of people with mental illness presenting to their practice during the COVID-19 pandemic. Thirty-four percent reported a 26–50% increase in the number of people with mental illness in their community; approximately 33% reported a 1–25% increase; and 26.9% reported a 51–75% increase. The most commonly reported mental issues that increased because of COVID-19 were agitation, mood and anxiety disorders. Regarding the suggested strategies to address future challenges related to the COVID-19 pandemic, 34.6% of respondents recommended providing psychoeducation to the general population for early detection of mental illness and developing strategies to reduce the impact of COVID-19-related stress. In addition, 12.6% of respondents suggested improving telehealth services, while 12.3% suggested the need for increased funding for community-based care. When asked about physicians' opinion on the possibility of an increased prevalence of mental illness in the next 12 months, more than 30% of them predicted an increase in stress-related illnesses, while 25.2% were more concerned about a worsening of the ongoing clinical conditions of patients with previous psychiatric disorders. However, 21% of respondents believed that people's ability to cope with the pandemic would increase in the next 12 months. Conclusions This study confirmed a strong and negative impact on the mental health of the past 2 years of COVID-19 pandemic in the Italian population. Providing psychoeducation to the general population and improving the availability of telemedicine services could reduce the impact of future challenges related to the pandemic.

Published
2022
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46. Optimization of the combination of bevacizumab with FOLFOX/OXXEL in patients with metastatic colorectal cancer (mCRC): the multicentre, randomized phase 3 study OBELICS

Author

Avallone, A., primary, Nasti, G., additional, Rosati, G., additional, Carlomagno, C., additional, Romano, C., additional, Bilancia, D., additional, De Stefano, A., additional, Ottaiano, A., additional, Cassata, A., additional, Bianco, F., additional, Del Rio, P., additional, Izzo, F., additional, Silvestro, L., additional, Tafuto, S., additional, Di Gennaro, E., additional, Lastoria, S., additional, Gallo, C., additional, Perrone, F., additional, Budillon, A., additional, and Piccirillo, M.C., additional

Published
2017
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47. A multicentre, randomized phase 3 study on the optimization of the combination of bevacizumab with mFOLFOX/OXXEL in patients with metastatic colorectal cancer (mCRC)

Author

Avallone, A., primary, Nasti, G., additional, Rosati, G., additional, Carlomagno, C., additional, Romano, C., additional, Bilancia, D., additional, De Stefano, A., additional, Ottaiano, A., additional, Cassata, A., additional, Silvestro, L., additional, Tafuto, S., additional, Bianco, F., additional, Delrio, P., additional, Izzo, F., additional, Di Gennaro, E., additional, Lastoria, S., additional, Gallo, C., additional, Perrone, F., additional, Budillon, A., additional, and Piccirillo, M.C., additional

Published
2017
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48. Population pharmacokinetics of fluticasone propionate/salmeterol using two different dry powder inhalers

Author

Soulele, K. Macheras, P. Silvestro, L. Rizea Savu, S. Karalis, V.

Abstract

The combination of fluticasone propionate (FLP) and salmeterol (SAL) is often used in clinical practice for the treatment of pulmonary disorders. The purpose of this study was to explore the pharmacokinetics (PK) of inhaled FLP and SAL, after concomitant administration, in healthy male and female subjects using two dry powder inhalers. Plasma concentration (C)-time (t) data were obtained from a single dose, two-sequence, two-period, crossover (2 × 2) bioequivalence (BE) study. Activated charcoal was co-administered in order to prohibit absorption from the gastrointestinal tract. A number of 60 subjects were recruited, while 57 of them completed the study and were included in the PK analysis. Initially, PK parameters of FLP and SAL were estimated using the classic non-compartmental methods. Subsequently, BE assessment was applied to the estimated PK parameters of the two dry powder inhalers. Special focus was placed on the population PK analysis of the C-t data, which were pooled together. 'Treatment' (i.e., test or reference) and 'period' of the BE study were considered as covariates. A variety of structural and residual error models were tested to find the one which best described the plasma C-t data of FLP and SAL. Demographic data were also evaluated for their impact on the PK parameters. Several goodness-of-fit criteria were utilized. The non-compartmental PK estimates of this study were in agreement with previously reported values. The population PK analysis showed that FLP data were described by a two-compartment model with first-order absorption and elimination kinetics. Body weight was found to affect significantly absorption rate constant, inter-compartmental clearance, and volume of distribution of the peripheral compartment. As body weight increases, the values of these PK parameters also rise. For SAL, the best results were obtained when a two-compartment disposition model was used assuming very rapid absorption kinetics (like intravenous bolus) and first-order elimination kinetics. Gender was found to be a significant covariate on clearance, with men exhibiting higher clearance than women. © 2015 Elsevier B.V.

Published
2015

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