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1. Associations of Cognitive Function and Education Level With All-Cause Mortality in Adults on Hemodialysis: Findings From the COGNITIVE-HD Study

Author

David W. Johnson, Giancarlo Logroscino, R. Fichera, A. Failla, Jörgen Hegbrant, R. Antinoro, M. Meconizzi, A. Bua, Patrizia Natale, D. Rallo, A. Marangelli, A.V. Cagnazzo, S. Messina, Marinella Ruospo, M. Sambati, C. Donatelli, Rosanna Tortelli, F. Grippaldi, Giovanni F.M. Strippoli, G. Matera, Jonathan C. Craig, P. Nasisi, Annalisa Iurillo, D. Bertino, L. Moscardelli, G. Marino, S. Papagni, A. D’Angelo, S. Pagano, Charlotta Wollheim, M. Mantuano, Suetonia C. Palmer, C. Saturno, Germaine Wong, A. Maniscalco, Maria Rosaria Barulli, N. Dambrosio, M. Fici, Marco Murgo, A. Lupo, G. Randazzo, N. Sanfilippo, Marcello Tonelli, Armando Teixeira-Pinto, Clement T. Loy, A. Molino, A. Flammini, G. Latassa, G. Montalto, Letizia Gargano, M. Benevento, S. Campo, E. Boccia, Anita van Zwieten, C. Capostagno, F. Alicino, R. Di Toro Mammarella, F. Pedone, and Valeria Saglimbene

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Population, 030232 urology & nephrology, Cohort Studies, 03 medical and health sciences, Cognition, 0302 clinical medicine, Renal Dialysis, Internal medicine, medicine, Humans, Cognitive Dysfunction, Prospective Studies, 030212 general & internal medicine, Neuropsychological assessment, Mortality, Cognitive decline, education, Prospective cohort study, Dialysis, Aged, Aged, 80 and over, education.field_of_study, medicine.diagnostic_test, Proportional hazards model, business.industry, Middle Aged, 16. Peace & justice, 3. Good health, Nephrology, Educational Status, Kidney Failure, Chronic, Female, Hemodialysis, business
Abstract

Rationale & Objective In the general population, cognitive impairment is associated with increased mortality, and higher levels of education are associated with lower risks for cognitive impairment and mortality. These associations are not well studied in patients receiving long-term hemodialysis and were the focus of the current investigation. Study Design Prospective cohort study. Setting & Participants Adult hemodialysis patients treated in 20 Italian dialysis clinics. Exposures Patients’ cognitive function across 5 domains (memory, attention, executive function, language, and perceptual-motor function), measured using a neuropsychological assessment comprising 10 tests; and patients’ self-reported years of education. Outcome All-cause mortality. Analytical Approach Nested multivariable Cox regression models were used to examine associations of cognition (any domain impaired, number of domains impaired, and global function score from principal components analysis of unadjusted test scores) and education with mortality and whether there were interactions between them. Results 676 (70.6%) patients participated, with a median age of 70.9 years and including 38.8% women. Cognitive impairment was present in 79.4% (527/664; 95% CI, 76.3%-82.5%). During a median follow-up of 3.3 years (1,874 person-years), 206 deaths occurred. Compared to no cognitive impairment, adjusted HRs for mortality were 1.77 (95% CI, 1.07-2.93) for any impairment, 1.48 (95% CI, 0.82-2.68) for 1 domain impaired, 1.88 (95% CI, 1.01-3.53) for 2 domains, and 2.01 (95% CI, 1.14-3.55) for 3 to 5 domains. The adjusted HR was 0.68 (95% CI, 0.51-0.92) per standard deviation increase in global cognitive function score. Compared with primary or lower education, adjusted HRs were 0.79 (95% CI, 0.53-1.20) for lower secondary and 1.13 (95% CI, 0.80-1.59) for upper secondary or higher. The cognition-by-education interaction was not significant (P = 0.7). Limitations Potential selection bias from nonparticipation and missing data; no data for cognitive decline; associations with education were not adjusted for other socioeconomic factors. Conclusions Cognitive impairment is associated with premature mortality in hemodialysis patients. Education does not appear to be associated with mortality.

Published
2019
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2. Dietary Patterns and Mortality in a Multinational Cohort of Adults Receiving Hemodialysis

Author

S. Erkalkan, M.C. Guimont, M. Peñalver, A.R. Scuturdean, S. Dzimira, L. Cermeño, V. Doria, Amparo G. Bernat, R.I. Marian, L. Albarracín, F. Ros, D. Daniewska, R. Gonzalez, D. Grbavac, S. Marone, M. Sambati, M. Grabowska, S. Albitar, M. Martínez, Marietta Török, D. Dumitrache, M. Casanú, J. Corral, J. Farto, A. Diago, M. Lankester, R. Bargna, H. López, Saleem Muhammad Rana, A. Badino, L. Ziombra, Patrizia Natale, C. Engler, M. Lentini Deuscit, G. Randazzo, B. Lococo, M. Capdevila, E. Varga, C. Tursky, Tevfik Ecder, Maria C. Garcia, M. Alonso, M. Simon, P.F. Steri, E. Agapi, M. Acosta, Alina Rodriguez, K.S. Katzarski, Alejandra Jaramillo Garcia, Martin Hansis, A. Całka, A. Maniscalco, A. Ozlu, E. Abrego, M. Piechowska, M. Otero, S. Ongun, S. Messina, L. Baumgart, C.M. Incardona, S. Hint, C. Blasco, S. Menardi, E. Fernnandez, R. Paparone, E. Kiss, E. García, N. Kamin, C. Marinaro, C. Capostagno, G. Corpacci, D. Bischoff, D. Kozicka, G. Valle, J. Kunow, S. Papagni, C.M. Gavra, M. Navarro, D. Florio, A. Orosz, G. Wyrwicz-Zielińska, A. Fernandez, E. Gonzalez, M. López, G. Latassa, R. Fichera, D. Novello, A. Romero, N.A. Millán, O. Da Cruz, C. Recalde, C. Villalba, A. Soto, F. Popescu, P. Vergara, T. Merzouk, G. Scuto, C. Galli, Delia Timofte, J. García, J. Drabik, D.V. Di Benedetto, J.L. Lopez, R. Álvarez, F. Alicino, S. Traver, S. Arentowicz, A. Pajot, A. Buyukkiraz, A. Gutierrez, F. Villalba, S. Luengo, Letizia Gargano, M. Soto, C. Ljubich, S. Grosser, N. Sonmez Turksoz, E. Morales, D. Lopez, B. Vázquez, M. Fóns, A. Toth, F. Montoya, D. Galarce, M.Q. Cunill, J. Leibovich, A. Malimar, S. Grueger, G. Marino, C. Jorge, M. Meconizzi, H. Arslan, C. Moscatelli, S. Bea, J. Vinczene, C. Todaro, L. Petracci, C. Boriceanu, S. Ferrás, C. Strano, M. Popa, F. Ranieri, S.z. Szummer, I. Csaszar, C. Favalli, R. Martinez, D. Bueno, N. Ozveren, A. Guerin, B. Ferreiro, J. Csikos, Elisabeth Fabricius, M. Drobisz, E. Bodurian, A.G.M. Mandita, E. Orero, N. Junqueras, Giovanni F.M. Strippoli, Paolo Felaco, A.M. Murgo, E. Railean, S. Chiarenza, M. Brahim-Bounab, W. Dżugan, J. Ostrowski, R. Ilies, M. Benevento, R. Mocanu, F. Villemain, L. Rosu, A. Wulcan, K. Doskocz, Eduardo Celia, Vanessa Garcia-Larsen, S. Filimon, R. Antinoro, K. Steiner, V. Greco, H.M. Sifil, P. González, P.P. Buta, U. Hark, J. Redl, L. Mitea, A. Robert, C. Romero, Ruben Gelfman, E. Iravul, M. Barb, D.C. Moro, A. Lupo, Armando Teixeira-Pinto, Anna Bednarek-Skublewska, M.L. Popa, J. Santini, J. Carreras, G. Bako, V. Pesqueira, W. Ślizień, I. Leocadio, S. Mitea, S.L. Medrihan, M. Szabo, K. Szentendrey, C.L. Teodoru, P. Soler, R. Munteanu, L. Duzy, J.L. Pizarro, A. Barrera, K. Albert, M. Corbalán, S. Campo, F. Torsello, A. Bua, V. Abujder, Valeria Saglimbene, N. Dambrosio, K. Mengu, I. Lluch, S. Esteller, W. Cruz, J. Goch, G. Peñaloza, A. Failla, G. Cuesta, V. Benages, Angelo M. Murgo, F. Tollis, Charlotta Wollheim, M. Mantuano, J. Mora, R. Celik, C.L. Ardelean, R. Cejas, M.I. Cardo, M. Wypych-Birecka, S. Abal, P. Chávez, A. Ertas, L. Kovacs, M. Fici, C. Focsaner, I. Garcia, A. Peñalba, J. Fernández, A. Mahi, M. Cernadas, J. Saupe, K. Magyar, M. Rapetti, E. Tanase, A. Varga, E. Nattiello, N. Havasi, A. D’Angelo, V. de Sá Martins, O. Hermida, L. López, E. Boccia, C. Riccardi, Y. Saingra, T. Ballester, T. Pinheiro, M. Carro, C. Campos, P. Nasisi, M. Maza, G. di Leo, A. Molino, C. Mato Mira, E. Dragan, A. Maciel, A. Flammini, M. Myślicki, M. Hubeli, Alan D. Lopez, D. Bertino, A. Bereczki, I.S. Dogan, M. Coombes, J. Torres, Katrina L. Campbell, L. Cucuiat, M. Karakaya, G. Montalto, D. Prades, M.J. Soler, P. Bouvier, N. Sanfilippo, S. Morales, L. Alcalde, H. Akbiber, S. Araujo, M. May, Paul Stroumza, V. Aguilera, Z. Ozkan, Marcello Tonelli, D. Cáceres, M. Nitu, P. Rutkowski, Juan Jesus Carrero, S. Pagano, I. Rico, M. Diaconita, Marinella Ruospo, J. Forcano, G. Redondo, Z. Yilmaz, M. Mazur, A. Salerno, I. Vilamajó, David M. Pereira, Suetonia C. Palmer, Manuel Arias, A. Blaga, A. Jaroszynski, E. Nemeth, David W. Johnson, V. Alonso, A. Kosicki, E. Vescovo, E. Bochenska-Nowacka, O.M. Trovato, F. Vera, E. Ros, A. Echavarría, Peter Stenvinkel, C. Saturno, Germaine Wong, Marco A Avila, J. Dayer, M.J. Agost, M. Farré, B. Noroña, I. Ullmann, E. Zajko, C. Donatelli, A. Mike, J.L. Poignet, A. Ramos, M. Roesch, S. Mansilla, P. Worch, E. Geandet, T. Pfab, N. Centurión, M. Gravielle, E. Perez, T. Grzegorczyk, M. Szilvia, A. Coco, J. de Dios Ramiro, L. Moscardelli, S. Narci, C. Villareal, A. Dino, S. Frydelund, P. Ciobotaru, Susanne Hoischen, A. Puglisi, L. Florescu, F. Sagau, Domingo Del Castillo, K. Tolnai, G. Matera, A.R. Mira, Jonathan C. Craig, R. Trioni, A. Baidog, E. Kerekes, S. Laudani, R. Di Toro Mammarella, A. Benmoussa, B. Velez, F. Pedone, E. De Orta, F. Grippaldi, V. Bumbea, A. Milán, S. Tirado, Jörgen Hegbrant, Jan Duława, N. Austa Bel, Elmi Muller, E. Tanyi, I. Herrero, M. Indreies, D. Rallo, C. Garcia, A.V. Cagnazzo, J. Benders, Y. Diaz, M. Olaya, M. Arrigo, L. Bicen, C. Miracle, V. Quispe, L. Aguiar, O. Delicia, A. Hardaman, J. Tajahuerce, M. Chauque, A. Marangelli, E. Marileo, D. Kosa, and G. Carrizo

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, 030232 urology & nephrology, Global Health, 03 medical and health sciences, 0302 clinical medicine, Renal Dialysis, Internal medicine, Cause of Death, Western diet, medicine, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Dialysis, Cardiovascular mortality, business.industry, Public health, Feeding Behavior, Middle Aged, Diet, Survival Rate, Quartile, Nephrology, Cardiovascular Diseases, Cohort, Kidney Failure, Chronic, Female, Hemodialysis, business, Follow-Up Studies
Abstract

Rationale & Objective Clinical practice guidelines for dietary intake in hemodialysis focus on individual nutrients. Little is known about associations of dietary patterns with survival. We evaluated the associations of dietary patterns with cardiovascular and all-cause mortality among adults treated by hemodialysis. Study Design Prospective cohort study. Setting & Participants 8,110 of 9,757 consecutive adults on hemodialysis (January 2014 to June 2017) treated in a multinational private dialysis network and with analyzable dietary data. Exposures Data-driven dietary patterns based on the GA2LEN food frequency questionnaire. Participants received a score for each identified pattern, with higher scores indicating closer resemblance of their diet to the identified pattern. Quartiles of standardized pattern scores were used as primary exposures. Outcomes Cardiovascular and all-cause mortality. Analytical Approach Principal components analysis with varimax rotation to identify common dietary patterns. Adjusted proportional hazards regression analyses with country as a random effect to estimate the associations between dietary pattern scores and mortality. Associations were expressed as adjusted HRs with 95% CIs, using the lowest quartile score as reference. Results During a median follow-up of 2.7 years (18,666 person-years), there were 2,087 deaths (958 cardiovascular). 2 dietary patterns, “fruit and vegetable” and “Western,” were identified. For the fruit and vegetable dietary pattern score, adjusted HRs, in ascending quartiles, were 0.94 (95% CI, 0.76-1.15), 0.83 (95% CI, 0.66-1.06), and 0.91 (95% CI, 0.69-1.21) for cardiovascular mortality and 0.95 (95% CI, 0.83-1.09), 0.84 (95% CI, 0.71-0.99), and 0.87 (95% CI, 0.72-1.05) for all-cause mortality. For the Western dietary pattern score, the corresponding estimates were 1.10 (95% CI, 0.90-1.35), 1.11 (95% CI, 0.87-1.41), and 1.09 (95% CI, 0.80-1.49) for cardiovascular mortality and 1.01 (95% CI, 0.88-1.16), 1.00 (95% CI, 0.85-1.18), and 1.14 (95% CI, 0.93-1.41) for all-cause mortality. Limitations Self-reported food frequency questionnaire, data-driven approach. Conclusions These findings did not confirm an association between mortality among patients receiving long-term hemodialysis and the extent to which dietary patterns were either high in fruit and vegetables or consistent with a Western diet.

Published
2018

3. P2.04-92 Neoadjuvant Durvalumab With or Without Sub-Ablative Stereotactic Radiotherapy (SBRT) in Patients with Resectable NSCLC (NCT02904954)

Author

Benjamin Lee, R. Scheff, Ashish Saxena, Paul J. Christos, J. Gakuria, B. Stiles, N. Sanfilippo, Alain C. Borczuk, Cathy F. Spinelli, Silvia C. Formenti, Vivek Mittal, Nasser K. Altorki, J. Port, J. Gruden, E. Ko, Bradley B. Pua, and Timothy E. McGraw

Subjects
Pulmonary and Respiratory Medicine, Stereotactic radiotherapy, medicine.medical_specialty, Durvalumab, Oncology, business.industry, Ablative case, Medicine, In patient, Radiology, business
Published
2019
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4. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial

Author

Marco Dauriz, Giovanni Targher, Pier Luigi Temporelli, Donata Lucci, Lucio Gonzini, Gian Luigi Nicolosi, Roberto Marchioli, Gianni Tognoni, Roberto Latini, Franco Cosmi, Luigi Tavazzi, Aldo Pietro Maggioni, Simona Barlera, Maria Grazia Franzosi, Aldo P. Maggioni, Maurizio Porcu, Salim Yusuf, Fulvio Camerini, Jay N. Cohn, Adriano Decarli, Bertram Pitt, Peter Sleight, Philip A. Poole‐Wilson, Enrico Geraci, Marino Scherillo, Gianna Fabbri, Barbara Bartolomei, Daniele Bertoli, Franco Cobelli, Claudio Fresco, Antonietta Ledda, Giacomo Levantesi, Cristina Opasich, Franco Rusconi, Gianfranco Sinagra, Fabio Turazza, Alberto Volpi, Martina Ceseri, Gianluca Alongi, Antonio Atzori, Filippo Bambi, Desiree Bastarolo, Francesca Bianchini, Iacopo Cangioli, Vittoriana Canu, Concetta Caporusso, Gabriele Cenni, Laura Cintelli, Michele Cocchio, Alessia Confente, Eva Fenicia, Giorgio Friso, Marco Gianfriddo, Gianluca Grilli, Beatrice Lazzaro, Giuseppe Lonardo, Alessia Luise, Rachele Nota, Mariaelena Orlando, Rosaria Petrolo, Chiara Pierattini, Valeria Pierota, Alessandro Provenzani, Velia Quartuccio, Anna Ragno, Chiara Serio, Alvise Spolaor, Arianna Tafi, Elisa Tellaroli, Stefano Ghio, Elisa Ghizzardi, Serge Masson, Lella Crociati, Maria Teresa La Rovere, Ugo Corrà, Andrea Finzi, Marco Gorini, Valentina Milani, Giampietro Orsini, Elisa Bianchini, Silvia Cabiddu, Ilaria Cangioli, Laura Cipressa, Maria Lucia Cipressa, Giuseppina Di Bitetto, Barbara Ferri, Luisa Galbiati, Andrea Lorimer, Carla Pera, Paola Priami, Antonella Vasamì, T. Moccetti, M.G. Rossi, E. Pasotti, F. Vaghi, P. Roncarolo, M.T. Zunino, F. Matta, E. Actis Perinetto, F. Gaita, G. Azzaro, M. Zanetta, A.M. Paino, U. Parravicini, D. Vegis, R. Conte, P. Ferraro, A. De Bernardi, S. Morelloni, M. Fagnani, P. Greco Lucchina, L. Montagna, E. Bellone, D. Sappè, F. Ferraro, M. Delucchi, S.G. Reynaud, M. Dore, A. La Brocca, N. Massobrio, L. Bo, R. Trinchero, M. Imazio, G. Brocchi, A. Nejrotti, L. Rissone, S. Gabasio, C. Zocchi, S. Randazzo, A. Crenna, P. Giannuzzi, E. Bonanomi, A. Mezzani, M. De Marchi, G. Begliuomini, C.A. Gianonatti, A. Gavazzi, A. Grosu, L. Dei Cas, S. Nodari, P. Garyfallidis, A. Bertoletti, C. Bonifazi, S. Arisi, F. Mascaro, M. Fraccarollo, S. Dell'Orto, M. Sfolcini, F. Bortolini, D. Raccagni, A. Turelli, M. Santarone, E. Miglierina, L. Sormani, R. Jemoli, F. Tettamanti, S. Pirelli, C. Bianchi, S. Verde, M. Mariani, V. Ziacchi, A. Ferrazza, A. Russo, M. Bortolotti, G.F. Pasini, A. Volpi, K.N. Jones, D. Cuzzucrea, G. Gullace, C. Carbone, A. Granata, S. De Servi, G. Del Rosso, C. Inserra, E. Renaldini, C. Zappa, M. Moretti, R. Zanini, M. Ferrari, E. Moroni, A. Cei, C. Lissi, E. Dovico, C. Fiorentini, P. Palermo, B. Brusoni, M. Negrini, J. Heyman, G.B. Danzi, A. Finzi, M. Frigerio, F. Turazza, L. Beretta, A. Sachero, F. Casazza, L. Squadroni, F. Lombardi, L. Marano, A. Margonato, G. Fragasso, O.C. Febo, E. Aiolfi, F. Olmetti, A. Grieco, V. Antonazzo, G. Specchia, A. Mortara, F. Robustelli, M.G. Songini, C. Schweiger, A. Frisinghelli, M. Palvarini, C. Campana, L. Scelsi, N. Ajmone Marsan, F. Cobelli, A. Gualco, C. Opasich, S. De Feo, R. Mazzucco, M.A. Iannone, T. Diaco, D. Zaniboni, G. Milanesi, D. Nassiacos, S. Meloni, P. Giani, T. Nicoli, C. Malinverni, A. Gusmini, L. Pozzoni, G. Bisiani, P. Margaroli, A. Schizzarotto, A. Daverio, G. Occhi, N. Partesana, P. Bandini, M.G. Rosella, S. Giustiniani, G. Cucchi, R. Pedretti, R. Raimondo, R. Vaninetti, A. Fedele, I. Ghezzi, E. Rezzonico, J.A. Salerno Uriarte, F. Morandi, F. Salvucci, C. Valenti, G. Graziano, M. Romanò, C. Cimminiello, I. Mangone, M. Lombardo, P. Quorso, G. Marinoni, M. Breghi, M. Erckert, A. Dienstl, G. Mirante Marini, C. Stefenelli, G. Cioffi, E. Buczkowska, A. Bonanome, F. Bazzanini, L. Parissenti, C. Serafini, G. Catania, L. Tarantini, G. Rigatelli, S. Boni, A. Pasini, E. Masini, A.A. Zampiero, M. Zanchetta, L. Franceschetto, P. Delise, C. Marcon, A. Sacchetta, L. Borgese, L. Artusi, P. Casolino, F. Corbara, A. Banzato, M. Barbiero, M.P. Aldegheri, R. Bazzucco, G. Crivellenti, A. Raviele, C. Zanella, P. Pascotto, P. Sarto, S. Milan, E. Barbieri, P. Girardi, W. Dalla Villa, J. Dalle Mule, M.L. Di Sipio, R. Cazzin, D. Milan, P. Zonzin, M. Carraro, R. Rossi, E. Carbonieri, I. Rossi, P. Stritoni, P. Meneghetti, G. Risica, P.L. Tenderini, C. Vassanelli, L. Zanolla, G. Perini, G. Brighetti, R. Chiozza, G. Giuliano, R. Gortan, R. Cesanelli, G.L. Nicolosi, R. Piazza, L. Mos, O. Vriz, D. Pavan, G. Pascottini, E. Alberti, M. Werren, L. Solinas, G. Sinagra, F. Longaro, P. Fioretti, M.C. Albanese, D. Miani, R. Gianrossi, A. Pende, P. Rubartelli, O. Magaia, S. Domenicucci, D. Caruso, A.S. Faraguti, L. Magliani, F. Miccoli, G. Guglielmino, D. Bertoli, A. Cantarelli, S. Orlandi, A. Vallebona, A. Pozzati, G. Brega, L.G. Pancaldi, R. Vandelli, S. Urbinati, M.G. Poci, M. Zoli, G.M. Costa, U. Guiducci, G. Zobbi, F. Tartagni, A. Tisselli, A. Gentili, P. Pieri, E. Cagnetta, S. Bendinelli, A. Barbieri, R. Conti, R. Ferrari, F. Merlini, A. Fucili, P. Moruzzi, E. Buia, M. Galvani, D. Ferrini, G. Baggioni, P. Yiannacopulu, G. Canè, A. Bonfiglioli, R. Zandomeneghi, L. Brugioni, A. Giannini, R. Di Ruvo, M. Giuliani, L. Rusconi, P. Del Corso, G. Piovaccari, F. Bologna, P. Venturi, F. Melandri, E. Bagni, L. Bolognese, R. Perticucci, A. Zuppiroli, M. Nannini, N. Consoli, P. Petrone, C. Pipitò, L. Colombi, D. Bernardi, P.R. Mariani, R. Testa, F. Mazzinghi, F. Cosmi, D. Cosmi, A. Zipoli, A. Cecchi, G. Castelli, M. Ciaccheri, F. Mori, F. Pieri, P. Valoti, D. Chiarantini, G.M. Santoro, C. Minneci, F. Marchi, M. Milli, G. Zambaldi, A.A. Brandinelli Geri, M. Cipriani, M. Alessandri, S. Severi, S. Stefanelli, A. Comella, R. Poddighe, A. Digiorgio, M. Carluccio, S. Berti, A. Rizza, V. Bonatti, V. Molendi, A. Brancato, N. D'Aprile, G. Giappichini, S. Del Vecchio, G. Mantini, F. De Tommasi, G. Meucci, M. Cordoni, S. Bechi, L. Barsotti, P. Baldini, M. Romei, G. Scopelliti, G. Lauri, F. Pestelli, F. Furiozzi, M. Cocchieri, D. Severini, F. Patriarchi, P. Chiocchi, M. Buccolieri, S. Martinelli, A. Wee, F. Angelici, M. Bernardinangeli, G. Proietti, B. Biscottini, R. Panciarola, L. Marinacci, G.P. Perna, D. Gabrielli, A. Moraca, L. Moretti, L. Partemi, G. Gregori, R. Amici, G. Patteri, P. Capone, E. Savini, G.L. Morgagni, L. Paccaloni, F. Pezzuoli, S. Carincola, S. Papi, S. De Crescentini, P. Gerardi, P. Midi, E. Gallenzi, G. Pajes, C. Mancone, V. Di Spirito, M. Di Gennaro, S. Calcagno, S. Toscano, S. Antonicoli, F. Carta, G. Giorgi, F. Comito, E. Daniele, O. Ciarla, P.G. Gelfo, A. Acquaviva, D. Testa, G. Testa, F.A. Pagliaro, F. Russo, F. Vetta, I. Marchese, G. Di Sciascio, A. D'Ambrosio, F. Leggio, D. Del Sindaco, A. Lacchè, A. Avallone, M.P. Risa, P. Azzolini, E. Baldo, E. Giovannini, G. Pulignano, C. Tondo, E. Picchio, E. ani, P. Tanzi, F. Pozzar, F. Farnetti, M. Azzarito, M. Santini, A. Varveri, G. Ferraiuolo, C. Valtorta, A. Gaspardone, G. Barbato, V. Ceci, N. Aspromonte, F. Bellocci, C. Colizzi, F. Fedele, F.I. Perez, A. Galati, A. Rossetti, A. Mainella, D. etta, C. Matteucci, G. Busi, A. De Angelis, G. Farina, A. Granatelli, F. Leone, F. Frasca, R. Di Giovambattista, G. Castellani, G. Massaro, G. Mastrogiuseppe, A. Vacri, F. De Sanctis, M. Cioli, S. Di Luzio, C. Napoletano, L.L. Piccioni, G. De Simone, A. Ottaviano, V. Mazza, C. Spedaliere, D. Staniscia, E. Calgione, G. De Marco, T. Chiacchio, T. Di Napoli, S. Romanzi, G. Salvatore, P. Golino, A. Palermo, F. Mascia, A. Vetrano, A. Vinciguerra, L. Caliendo, R. Longobardi, G. De Caro, R. Di Nola, F. Piemonte, D. Prinzi, P. De Rosa, V. De Rosa, F. Riello, V. Capuano, G. Vecchio, M. Landi, S. Amato, M. Garofalo, M. D'Avino, P. Sensale, O. Maiolica, R. Santoro, P. Caso, D. Miceli, N. Maurea, U. Bianchi, C. Crispo, M. Chiariello, P. Perrone Filardi, L. Russo, N. Capuano, G. Ungaro, G. Vergara, F. Scafuro, G. D'Angelo, C. Campaniello, P. Bottiglieri, A. Volpe, R. Battista, L. De Risi, G. Cardillo, G. Sibilio, A.P. Marino, F. Silvestri, P. Predotti, A. Iervoglini, C. De Matteis, P. Sarnicola, M.M. Matarazzo, S. Baldi, V. Iuliano, C. Astarita, P. Cuccaro, A. Liguori, G. Liguori, G. Gregorio, L. Petraglia, G. Antonelli, G. Amodio, I. De Luca, D. Traversa, G. Franchini, M.L. Lenti, D. Cavallari, C. D'Agostino, G. Scalera, C.M. Altamura, M. Russo, A.R. Mascolo, G. Pettinati, S.A. Ciricugno, D. Scrutinio, A. Passantino, D. Mastrangelo, A. Di Masi, R. De Carne, M. Cannone, F. Dibiase, M. Pensato, F. Loliva, F. Trapani, I. Panettieri, L. Leone, M. Di Biase, M. Carrone, V. Gallone, F. Cocco, M. Costantini, C. Tritto, F. Cavalieri, L. Stella, F. Magliari, M. Callerame, A. De Giorgi, L. Pellegrino, M. Correra, V. Portulano, G.L. Nisi, G. Grassi, E. Cristallo, D. De Laura, C. Salerno, R. Fanelli, M. Villella, S. Pede, A. Renna, E. De Lorenzi, L. Urso, V. Lenti, A. Peluso, N. Baldi, G. Polimeni, P. Palma, R. Lauletta, E. Tagliamonte, T. Cirillo, B. Silvestri, G. Centonze, B. D'Alessandro, L. Truncellito, D. Mecca, M.A. Petruzzi, R.O.M. Coviello, A. Lopizzo, M. telli, S. Barbuzzi, S. Gubelli, G. Germinario, N. Cosentino, A. Mingrone, R. Vico, G. Borrello, M.L. Mazza, R. Cimino, D. Galasso, F. Cassadonte, U. Talarico, F. Perticone, S. Cassano, F. Catapano, S. Calemme, E. Feraco, C. Cloro, G. Misuraca, R. Caporale, L. Vigna, V. Spagnuolo, F. De Rosa, G. Spadafora, G. Zampaglione, R. Russo, F.A. Schipani, A.F. Ferragina, D. Stranieri, G. Musca, C. Carpino, P. Bencardino, F. Raimondo, D. Musacchio, G. Pulitanò, A. Ruggeri, A. Provenzano, S. Salituri, M. Musolino, S. Calandruccio, A. Marrari, E. Tripodi, R. Scali, L. Anastasio, A. Arone, P. Aragona, L. Donnangelo, M.G.A. Comito, F. Bilotta, I. Vaccaro, R. Rametta, V. Ventura, A. Bonvegna, A. Alì, C. Cinnirella, M. Raineri, F. Pompeo, N. Cascio Ingurgio, V. Carini, R. Coco, G. Giunta, G. Leonardi, V. Randazzo, V. Di Blasi, C. Tamburino, G. Russo, S. Mangiameli, R. Cardillo, D. Castelli, V. Inserra, A. Arena, M.M. Gulizia, S. Raciti, G. Rapisarda, R. Romano, P. Prestifilippo, G.B. Braschi, G. Ledda, R. Terrazzino, M. De Caro, G. Scilabra, B. agnino, R. Grassi, G. Di Tano, G.F. Scimone, L. Vasquez, C. Coppolino, A. Casale, M. Castelli, G. D'Urso, E. D'Antonio, L. Lo Presti, E. Badalamenti, P. Conti, N. Sanfilippo, V. Cirrincione, M.T. Cinà, G. Cusimano, A. Taormina, P. Giuliano, A. Bajardi, V. Mandalà, A. Canonico, G. Geraci, F.P. Sabella, F. Enia, A.M. Floresta, I. Lo Cascio, D. Gumina, A. Cavallaro, G. Piccione, R. Ferrante, M. Blandino, M.S. Iudicello, E. Mossuti, G. Romano, L. Lombardo, P. Monastra, D. Di Vincenzo, M. Porcu, P. Orrù, F. Muscas, G. Giardina, M. Corda, G. Locci, A. Podda, M. Ledda, P. Siddi, C. Lai, G. Pili, G. Mercuro, G. Mureddu, A. Ganau, G. Meloni, G. Poddighe, G. Sanna, Dauriz, Marco, Targher, Giovanni, Temporelli, Pier Luigi, Lucci, Donata, Gonzini, Lucio, Nicolosi, Gian Luigi, Marchioli, Roberto, Tognoni, Gianni, Latini, Roberto, Cosmi, Franco, Tavazzi, Luigi, Maggioni, Aldo Pietro, on behalf of the GISSI-HF, Investigator, Margonato, Alberto, Moccetti, T., Rossi, M. G., Pasotti, E., Vaghi, F., Roncarolo, P., Zunino, M. T., Matta, F., Actis Perinetto, E., Gaita, F., Azzaro, G., Zanetta, M., Paino, A. M., Parravicini, U., Vegis, D., Conte, R., Ferraro, P., De Bernardi, A., Morelloni, S., Fagnani, M., Greco Lucchina, P., Montagna, L., Bellone, E., Sappè, D., Ferraro, F., Delucchi, M., Reynaud, S. G., Dore, M., La Brocca, A., Massobrio, N., Bo, L., Trinchero, R., Imazio, M., Brocchi, G., Nejrotti, A., Rissone, L., Gabasio, S., Zocchi, C., Randazzo, S., Crenna, A., Giannuzzi, P., Bonanomi, E., Mezzani, A., De Marchi, M., Begliuomini, G., Gianonatti, C. A., Gavazzi, A., Grosu, A., Dei Cas, L., Nodari, S., Garyfallidis, P., Bertoletti, A., Bonifazi, C., Arisi, S., Mascaro, F., Fraccarollo, M., Dell'Orto, S., Sfolcini, M., Bortolini, F., Raccagni, D., Turelli, A., Santarone, M., Miglierina, E., Sormani, L., Jemoli, R., Tettamanti, F., Pirelli, S., Bianchi, C., Verde, S., Mariani, M., Ziacchi, V., Ferrazza, A., Russo, A., Bortolotti, M., Pasini, G. F., Volpi, A., Jones, K. N., Cuzzucrea, D., Gullace, G., Carbone, C., Granata, A., De Servi, S., Del Rosso, G., Inserra, C., Renaldini, E., Zappa, C., Moretti, M., Zanini, R., Ferrari, M., Moroni, E., Cei, A., Lissi, C., Dovico, E., Fiorentini, C., Palermo, P., Brusoni, B., Negrini, M., Heyman, J., Danzi, G. B., Finzi, A., Frigerio, M., Turazza, F., Beretta, L., Sachero, A., Casazza, F., Squadroni, L., Lombardi, F., Marano, L., Margonato, A., Fragasso, G., Febo, O. C., Aiolfi, E., Olmetti, F., Grieco, A., Antonazzo, V., Specchia, G., Mortara, A., Robustelli, F., Songini, M. G., Schweiger, C., Frisinghelli, A., Palvarini, M., Campana, C., Scelsi, L., Ajmone Marsan, N., Cobelli, F., Gualco, A., Opasich, C., De Feo, S., Mazzucco, R., Iannone, M. A., Diaco, T., Zaniboni, D., Milanesi, G., Nassiacos, D., Meloni, S., Giani, P., Nicoli, T., Malinverni, C., Gusmini, A., Pozzoni, L., Bisiani, G., Margaroli, P., Schizzarotto, A., Daverio, A., Occhi, G., Partesana, N., Bandini, P., Rosella, M. G., Giustiniani, S., Cucchi, G., Pedretti, R., Raimondo, R., Vaninetti, R., Fedele, A., Ghezzi, I., Rezzonico, E., Salerno Uriarte, J. A., Morandi, F., Salvucci, F., Valenti, C., Graziano, G., Romanò, M., Cimminiello, C., Mangone, I., Lombardo, M., Quorso, P., Marinoni, G., Breghi, M., Erckert, M., Dienstl, A., Mirante Marini, G., Stefenelli, C., Cioffi, G., Buczkowska, E., Bonanome, A., Bazzanini, F., Parissenti, L., Serafini, C., Catania, G., Tarantini, L., Rigatelli, G., Boni, S., Pasini, A., Masini, E., Zampiero, A. A., Zanchetta, M., Franceschetto, L., Delise, P., Marcon, C., Sacchetta, A., Borgese, L., Artusi, L., Casolino, P., Corbara, F., Banzato, A., Barbiero, M., Aldegheri, M. P., Bazzucco, R., Crivellenti, G., Raviele, A., Zanella, C., Pascotto, P., Sarto, P., Milan, S., Barbieri, E., Girardi, P., Dalla Villa, W., Dalle Mule, J., Di Sipio, M. L., Cazzin, R., Milan, D., Zonzin, P., Carraro, M., Rossi, R., Carbonieri, E., Rossi, I., Stritoni, P., Meneghetti, P., Risica, G., Tenderini, P. L., Vassanelli, C., Zanolla, L., Perini, G., Brighetti, G., Chiozza, R., Giuliano, G., Baldin, M. G., Gortan, R., Cesanelli, R., Nicolosi, G. L., Piazza, R., Mos, L., Vriz, O., Pavan, D., Pascottini, G., Alberti, E., Werren, M., Solinas, L., Sinagra, G., Longaro, F., Fioretti, P., Albanese, M. C., Miani, D., Gianrossi, R., Pende, A., Rubartelli, P., Magaia, O., Domenicucci, S., Caruso, D., Faraguti, A. S., Magliani, L., Miccoli, F., Guglielmino, G., Bertoli, D., Cantarelli, A., Orlandi, S., Vallebona, A., Pozzati, A., Brega, G., Pancaldi, L. G., Vandelli, R., Urbinati, S., Poci, M. G., Zoli, M., Costa, G. M., Guiducci, U., Zobbi, G., Tartagni, F., Tisselli, A., Gentili, A., Pieri, P., Cagnetta, E., Bendinelli, S., Barbieri, A., Conti, R., Ferrari, R., Merlini, F., Fucili, A., Moruzzi, P., Buia, E., Galvani, M., Ferrini, D., Baggioni, G., Yiannacopulu, P., Canè, G., Bonfiglioli, A., Zandomeneghi, R., Brugioni, L., Giannini, A., Di Ruvo, R., Giuliani, M., Rusconi, L., Del Corso, P., Piovaccari, G., Bologna, F., Venturi, P., Melandri, F., Bagni, E., Bolognese, L., Perticucci, R., Zuppiroli, A., Nannini, M., Consoli, N., Petrone, P., Pipitò, C., Colombi, L., Bernardi, D., Mariani, P. R., Testa, R., Mazzinghi, F., Cosmi, F., Cosmi, D., Zipoli, A., Cecchi, A., Castelli, G., Ciaccheri, M., Mori, F., Pieri, F., Valoti, P., Chiarantini, D., Santoro, G. M., Minneci, C., Marchi, F., Milli, M., Zambaldi, G., Brandinelli Geri, A. A., Cipriani, M., Alessandri, M., Severi, S., Stefanelli, S., Comella, A., Poddighe, R., Digiorgio, A., Carluccio, M., Berti, S., Rizza, A., Bonatti, V., Molendi, V., Brancato, A., D'Aprile, N., Giappichini, G., Del Vecchio, S., Mantini, G., De Tommasi, F., Meucci, G., Cordoni, M., Bechi, S., Barsotti, L., Baldini, P., Romei, M., Scopelliti, G., Lauri, G., Pestelli, F., Furiozzi, F., Cocchieri, M., Severini, D., Patriarchi, F., Chiocchi, P., Buccolieri, M., Martinelli, S., Wee, A., Angelici, F., Bernardinangeli, M., Proietti, G., Biscottini, B., Panciarola, R., Marinacci, L., Perna, G. P., Gabrielli, D., Moraca, A., Moretti, L., Partemi, L., Gregori, G., Amici, R., Patteri, G., Capone, P., Savini, E., Morgagni, G. L., Paccaloni, L., Pezzuoli, F., Carincola, S., Papi, S., De Crescentini, S., Gerardi, P., Midi, P., Gallenzi, E., Pajes, G., Mancone, C., Di Spirito, V., Di Gennaro, M., Calcagno, S., Toscano, S., Antonicoli, S., Carta, F., Giorgi, G., Comito, F., Daniele, E., Ciarla, O., Gelfo, P. G., Acquaviva, A., Testa, D., Testa, G., Pagliaro, F. A., Russo, F., Vetta, F., Marchese, I., Di Sciascio, G., D'Ambrosio, A., Leggio, F., Del Sindaco, D., Lacchè, A., Avallone, A., Risa, M. P., Azzolini, P., Baldo, E., Giovannini, E., Pulignano, G., Tondo, C., Picchio, E., Biffani, E., Tanzi, P., Pozzar, F., Farnetti, F., Azzarito, M., Santini, M., Varveri, A., Ferraiuolo, G., Valtorta, C., Gaspardone, A., Barbato, G., Ceci, V., Aspromonte, N., Bellocci, F., Colizzi, C., Fedele, F., Perez, F. I., Galati, A., Rossetti, A., Mainella, A., Ciuffetta, D., Matteucci, C., Busi, G., De Angelis, A., Farina, G., Granatelli, A., Leone, F., Frasca, F., Di Giovambattista, R., Castellani, G., Massaro, G., Mastrogiuseppe, G., Vacri, A., De Sanctis, F., Cioli, M., Di Luzio, S., Napoletano, C., Piccioni, L. L., De Simone, G., Ottaviano, A., Mazza, V., Spedaliere, C., Staniscia, D., Calgione, E., De Marco, G., Chiacchio, T., Di Napoli, T., Romanzi, S., Salvatore, G., Golino, P., Palermo, A., Mascia, F., Vetrano, A., Vinciguerra, A., Caliendo, L., Longobardi, R., De Caro, G., Di Nola, R., Piemonte, F., Prinzi, D., De Rosa, P., De Rosa, V., Riello, F., Capuano, V., Vecchio, G., Landi, M., Amato, S., Garofalo, M., D'Avino, M., Sensale, P., Maiolica, O., Santoro, R., Caso, P., Miceli, D., Maurea, N., Bianchi, U., Crispo, C., Chiariello, M., Perrone Filardi, P., Russo, L., Capuano, N., Ungaro, G., Vergara, G., Scafuro, F., D'Angelo, G., Campaniello, C., Bottiglieri, P., Volpe, A., Battista, R., De Risi, L., Cardillo, G., Sibilio, G., Marino, A. P., Silvestri, F., Predotti, P., Iervoglini, A., De Matteis, C., Sarnicola, P., Matarazzo, M. M., Baldi, S., Iuliano, V., Astarita, C., Cuccaro, P., Liguori, A., Liguori, G., Gregorio, G., Petraglia, L., Antonelli, G., Amodio, G., De Luca, I., Traversa, D., Franchini, G., Lenti, M. L., Cavallari, D., D'Agostino, C., Scalera, G., Altamura, C. M., Russo, M., Mascolo, A. R., Pettinati, G., Ciricugno, S. A., Scrutinio, D., Passantino, A., Mastrangelo, D., Di Masi, A., De Carne, R., Cannone, M., Dibiase, F., Pensato, M., Loliva, F., Trapani, F., Panettieri, I., Leone, L., Di Biase, M., Carrone, M., Gallone, V., Cocco, F., Costantini, M., Tritto, C., Cavalieri, F., Stella, L., Magliari, F., Callerame, M., De Giorgi, A., Pellegrino, L., Correra, M., Portulano, V., Nisi, G. L., Grassi, G., Cristallo, E., De Laura, D., Salerno, C., Fanelli, R., Villella, M., Pede, S., Renna, A., De Lorenzi, E., Urso, L., Lenti, V., Peluso, A., Baldi, N., Polimeni, G., Palma, P., Lauletta, R., Tagliamonte, E., Cirillo, T., Silvestri, B., Centonze, G., D'Alessandro, B., Truncellito, L., Mecca, D., Petruzzi, M. A., Coviello, R. O. M., Lopizzo, A., Chiaffitelli, M., Barbuzzi, S., Gubelli, S., Germinario, G., Cosentino, N., Mingrone, A., Vico, R., Borrello, G., Mazza, M. L., Cimino, R., Galasso, D., Cassadonte, F., Talarico, U., Perticone, F., Cassano, S., Catapano, F., Calemme, S., Feraco, E., Cloro, C., Misuraca, G., Caporale, R., Vigna, L., Spagnuolo, V., De Rosa, F., Spadafora, G., Zampaglione, G., Russo, R., Schipani, F. A., Ferragina, A. F., Stranieri, D., Musca, G., Carpino, C., Bencardino, P., Raimondo, F., Musacchio, D., Pulitanò, G., Ruggeri, A., Provenzano, A., Salituri, S., Musolino, M., Calandruccio, S., Marrari, A., Tripodi, E., Scali, R., Anastasio, L., Arone, A., Aragona, P., Donnangelo, L., Comito, M. G. A., Bilotta, F., Vaccaro, I., Rametta, R., Ventura, V., Bonvegna, A., Alì, A., Cinnirella, C., Raineri, M., Pompeo, F., Cascio Ingurgio, N., Carini, V., Coco, R., Giunta, G., Leonardi, G., Randazzo, V., Di Blasi, V., Tamburino, C., Russo, G., Mangiameli, S., Cardillo, R., Castelli, D., Inserra, V., Arena, A., Gulizia, M. M., Raciti, S., Rapisarda, G., Romano, R., Prestifilippo, P., Braschi, G. B., Ledda, G., Terrazzino, R., De Caro, M., Scilabra, G., Graffagnino, B., Grassi, R., Di Tano, G., Scimone, G. F., Vasquez, L., Coppolino, C., Casale, A., Castelli, M., D'Urso, G., D'Antonio, E., Lo Presti, L., Badalamenti, E., Conti, P., Sanfilippo, N., Cirrincione, V., Cinà, M. T., Cusimano, G., Taormina, A., Giuliano, P., Bajardi, A., Mandalà, V., Canonico, A., Geraci, G., Sabella, F. P., Enia, F., Floresta, A. M., Lo Cascio, I., Gumina, D., Cavallaro, A., Piccione, G., Ferrante, R., Blandino, M., Iudicello, M. S., Mossuti, E., Romano, G., Lombardo, L., Monastra, P., Di Vincenzo, D., Porcu, M., Orrù, P., Muscas, F., Giardina, G., Corda, M., Locci, G., Podda, A., Ledda, M., Siddi, P., Lai, C., Pili, G., Mercuro, G., Mureddu, G., Ganau, A., Meloni, G., Poddighe, G., Sanna, G., Barlera, Simona, Franzosi, Maria Grazia, Porcu, Maurizio, Yusuf, Salim, Camerini, Fulvio, Cohn, Jay N., Decarli, Adriano, Pitt, Bertram, Sleight, Peter, Poole-Wilson, Philip A., Geraci, Enrico, Scherillo, Marino, Fabbri, Gianna, Bartolomei, Barbara, Bertoli, Daniele, Cobelli, Franco, Fresco, Claudio, Ledda, Antonietta, Levantesi, Giacomo, Opasich, Cristina, Rusconi, Franco, Sinagra, Gianfranco, Turazza, Fabio, Volpi, Alberto, Ceseri, Martina, Alongi, Gianluca, Atzori, Antonio, Bambi, Filippo, Bastarolo, Desiree, Bianchini, Francesca, Cangioli, Iacopo, Canu, Vittoriana, Caporusso, Concetta, Cenni, Gabriele, Cintelli, Laura, Cocchio, Michele, Confente, Alessia, Fenicia, Eva, Friso, Giorgio, Gianfriddo, Marco, Grilli, Gianluca, Lazzaro, Beatrice, Lonardo, Giuseppe, Luise, Alessia, Nota, Rachele, Orlando, Mariaelena, Petrolo, Rosaria, Pierattini, Chiara, Pierota, Valeria, Provenzani, Alessandro, Quartuccio, Velia, Ragno, Anna, Serio, Chiara, Spolaor, Alvise, Tafi, Arianna, Tellaroli, Elisa, Ghio, Stefano, Ghizzardi, Elisa, Masson, Serge, Crociati, Lella, La Rovere, Maria Teresa, Corrà, Ugo, Di Giulio, Paola, Finzi, Andrea, Gorini, Marco, Milani, Valentina, Orsini, Giampietro, Bianchini, Elisa, Cabiddu, Silvia, Cangioli, Ilaria, Cipressa, Laura, Cipressa, Maria Lucia, Di Bitetto, Giuseppina, Ferri, Barbara, Galbiati, Luisa, Lorimer, Andrea, Pera, Carla, Priami, Paola, and Vasamì, Antonella

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, heart failure, Kaplan-Meier Estimate, prediabetes, 030204 cardiovascular system & hematology, time factors, Settore MED/11, cause of death, 0302 clinical medicine, Glycemic control, prediabetic state, Cause of Death, italy, middle aged, Prevalence, 80 and over, double-blind method, blood glucose, risk factors, 030212 general & internal medicine, Prediabetes, Rosuvastatin Calcium, humans, rosuvastatin calcium, Cause of death, Original Research, Metabolic Syndrome, Aged, 80 and over, adult, Chronic heart failure, Diabetes mellitus, Heart failure, Mortality, Cardiology and Cardiovascular Medicine, Hazard ratio, chronic heart failure, diabetes mellitus, glycemic control, mortality, Treatment Outcome, Adolescent, Biomarkers, Chronic Disease, Diabetes Mellitus, Fatty Acids, Omega-3, Double-Blind Method, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hospitalization, Heart Failure, Italy, Prediabetic State, Risk Assessment, Proportional Hazards Models, Risk Factors, Time Factors, risk assessment, Middle Aged, kaplan-meier estimate, aged, female, Prediabete, young adult, Female, omega-3, Human, hospitalization, Adult, medicine.medical_specialty, Diabetes mellitu, proportional hazards models, Time Factor, hydroxymethylglutaryl-coa reductase inhibitors, prevalence, fatty acids, 03 medical and health sciences, Young Adult, male, Internal medicine, Post-hoc analysis, glycated hemoglobin a, medicine, Intensive care medicine, Aged, Glycated Hemoglobin, Proportional hazards model, business.industry, Risk Factor, biomarkers, Biomarker, medicine.disease, Clinical trial, adolescent, Proportional Hazards Model, treatment outcome, aged, 80 and over, chronic disease, fatty acids, omega-3, cardiology and cardiovascular medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business
Abstract

Background The independent prognostic impact of diabetes mellitus ( DM ) and prediabetes mellitus (pre‐ DM ) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐ DM on survival outcomes in the GISSI ‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial. Methods and Results We assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI ‐ HF trial, who were stratified by presence of DM (n=2852), pre‐ DM (n=2013), and non‐ DM (n=2070) at baseline. Compared with non‐ DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐ DM patients and those with pre‐ DM . Cox regression analysis showed that DM , but not pre‐ DM , was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI , 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI , 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI , 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI , 1.01–1.29, respectively). Conclusions Presence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00336336.

Published
2017
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5. Congenitally corrected transposition of great vessels: MRI and echocardiographic appearance

Author

Roberto Lagalla, Massimo Midiri, M. Finazzo, M. Di Francesco, and N. Sanfilippo

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, Heart malformation, Ultrasound, Interventional radiology, General Medicine, Congenitally corrected transposition, Great vessels, Internal medicine, cardiovascular system, medicine, Cardiology, CARDIAC ANOMALY, Radiology, Nuclear Medicine and imaging, Radiology, business, Mri findings, Neuroradiology
Abstract

This paper presents the case of a 36-year-old male with congenitally corrected transposition of great vessels (CTGV). This is a rare cardiac anomaly characterized by atrioventricular and ventriculoarterial discordance, occuriing in less than 1% of all congenital heart diseases. This was diagnosed by echocardiography and MRI. The MRI findings demonstrated cardiac abnormality.

Published
1995
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7. Effective management of treatment-related enteritis during preoperative chemoradiation for locally advanced rectal cancer

Author

Paulo M. Hoff, Lee M. Ellis, N Sanfilippo, R. Wiatrek, F Sinicrope, Matthew D. Callister, Pamela K. Allen, Phyllis A. Evetts, Barry W. Feig, Robert A. Wolff, S. A. Curley, John M. Skibber, Annette Bisanz, Thomas Brown, Christopher H. Crane, Shao Chun Wang, Charles S. Cleeland, Kelly K. Hunt, Tito R. Mendoza, and Nora A. Janjan

Subjects
Cancer Research, medicine.medical_specialty, Preoperative chemoradiotherapy, Radiation, business.industry, Colorectal cancer, Locally advanced, Effective management, medicine.disease, Enteritis, Oncology, medicine, Radiology, Nuclear Medicine and imaging, Radiology, business
Published
2000
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9. Host-Microbiome Cross-talk in Oral Mucositis.

Author

Vasconcelos RM, Sanfilippo N, Paster BJ, Kerr AR, Li Y, Ramalho L, Queiroz EL, Smith B, Sonis ST, and Corby PM

Subjects
Humans, Microbiota, Mouth microbiology, Mouth pathology, Stomatitis pathology, Host-Pathogen Interactions, Stomatitis microbiology
Abstract

Oral mucositis (OM) is among the most common, painful, and debilitating toxicities of cancer regimen-related treatment, resulting in the formation of ulcers, which are susceptible to increased colonization of microorganisms. Novel discoveries in OM have focused on understanding the host-microbial interactions, because current pathways have shown that major virulence factors from microorganisms have the potential to contribute to the development of OM and may even prolong the existence of already established ulcerations, affecting tissue healing. Additional comprehensive and disciplined clinical investigation is needed to carefully characterize the relationship between the clinical trajectory of OM, the local levels of inflammatory changes (both clinical and molecular), and the ebb and flow of the oral microbiota. Answering such questions will increase our knowledge of the mechanisms engaged by the oral immune system in response to mucositis, facilitating their translation into novel therapeutic approaches. In doing so, directed clinical strategies can be developed that specifically target those times and tissues that are most susceptible to intervention., (© International & American Associations for Dental Research 2016.)

Published
2016
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10. HIV Infection Is Associated With Poor Outcomes for Patients With Anal Cancer in the Highly Active Antiretroviral Therapy Era.

Author

Grew D, Bitterman D, Leichman CG, Leichman L, Sanfilippo N, Moore HG, and Du K

Subjects
Adenocarcinoma complications, Adenocarcinoma therapy, Adult, Aged, Anus Neoplasms complications, Anus Neoplasms therapy, Carcinoma, Squamous Cell complications, Carcinoma, Squamous Cell therapy, Case-Control Studies, Chemoradiotherapy, Colostomy, Female, Follow-Up Studies, HIV Infections drug therapy, Humans, Male, Middle Aged, Multivariate Analysis, Retrospective Studies, Survival Analysis, Treatment Outcome, Adenocarcinoma mortality, Antiretroviral Therapy, Highly Active, Anus Neoplasms mortality, Carcinoma, Squamous Cell mortality, HIV Infections complications
Abstract

Background: HIV status may affect outcomes after definitive chemoradiotherapy for anal cancer., Objective: Here, we report a large series in the highly active antiretroviral therapy era comparing outcomes between HIV-positive and HIV-negative patients with anal cancer., Design: This was a retrospective chart review., Settings: The study was conducted at an outpatient oncology clinic at large academic center., Patients: A total of 107 patients were reviewed, 39 HIV positive and 68 HIV negative. All of the patients underwent definitive chemoradiation for anal cancer., Main Outcome Measures: Data on patient characteristics, treatment, toxicity, and outcomes were collected. Overall survival, colostomy-free survival, local recurrence-free survival, and distant metastasis-free survival were analyzed., Results: Median follow-up was 15 months. HIV-positive patients were younger (median, 52 vs 64 years; p < 0.001) and predominantly men (82% men vs 49% men; p = 0.001). There were no significant differences in T, N, or stage groups. HIV-positive patients had a significantly longer duration from biopsy to start of chemoradiation (mean number of days, 82 vs 54; p = 0.042). There were no differences in rates of acute toxicities including diarrhea, fatigue, or dermatitis. HIV-positive patients had significantly higher rates of hospitalization (33% vs 15%; p = 0.024). The 3-year overall survival rate was 42% in HIV-positive and 76% in HIV-negative patients (p = 0.037; HR, 2.335 (95% CI, 1.032-5.283)). Three-year colostomy-free survival was 67% in HIV-positive and 88% in HIV-negative patients (p = 0.036; HR, 3.231 (95% CI, 1.014-10.299)). Differences in overall survival rates were not significant on multivariate analysis., Limitations: This study was limited by its retrospective design and small patient numbers., Conclusions: In this cohort, HIV-positive patients had significantly worse overall and colostomy-free survival rates than HIV-negative patients. However, differences in survival were not significant on multivariate analysis. Additional studies are necessary to establish the etiology of this difference.

Published
2015
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11. Different Cardiac Anomalies in Mother and Son with 4q-Syndrome.

Author

Marcì M, Guarina A, Castiglione MC, and Sanfilippo N

Abstract

We report a female patient with asymptomatic cor triatriatum sinister, associated with 4q34.3 deletion. Her child, carrying the same imbalance, suffers from tetralogy of Fallot. To the best of our knowledge, this is the first reported case of cor triatriatum associated with deletion of the long arm of the chromosome 4; furthermore, the majority of patients with chromosome 4 long arm syndrome have de novo deletions and only few familial cases have been reported so far.

Published
2015
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12. Effects of exercise on swallowing and tongue strength in patients with oral and oropharyngeal cancer treated with primary radiotherapy with or without chemotherapy.

Author

Lazarus CL, Husaini H, Falciglia D, DeLacure M, Branski RC, Kraus D, Lee N, Ho M, Ganz C, Smith B, and Sanfilippo N

Subjects
Aged, Combined Modality Therapy, Deglutition Disorders physiopathology, Female, Humans, Male, Middle Aged, Oropharyngeal Neoplasms drug therapy, Quality of Life, Surveys and Questionnaires, Tongue radiation effects, Treatment Outcome, Deglutition Disorders etiology, Deglutition Disorders rehabilitation, Exercise Therapy methods, Oropharyngeal Neoplasms radiotherapy, Tongue physiopathology
Abstract

Tongue strength is reduced in patients treated with chemoradiotherapy for oral/oropharyngeal cancer. Tongue strengthening protocols have resulted in improved lingual strength and swallowing in healthy individuals, as well as in patients following a neurological event. However, no studies have examined the efficacy of tongue strengthening exercises on tongue strength, swallowing, and quality of life (QOL; Head and Neck Cancer Inventory) in patients treated with chemoradiotherapy. A randomized clinical trial examined the effects of a tongue strengthening programme paired with traditional exercises vs. traditional exercises alone. Dependent variables included tongue strength, swallowing, and QOL in a group of patients with oral and oropharyngeal cancer treated with primary radiotherapy with or without chemotherapy. Differences with regard to tongue strength and oropharyngeal swallow efficiency (OPSE) were not observed within or between groups. QOL in the eating and speech domains improved following treatment in both groups. However, the experimental group demonstrated greater impairment in QOL in the social disruption domain following treatment, whereas the control group demonstrated a slight improvement in functioning. Tongue strengthening did not yield a statistically significant improvement in either tongue strength or swallowing measures in this patient cohort. Patient compliance and treatment timing may be factors underlying these outcomes., (Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.)

Published
2014
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13. Novel use of endoscopically placed fiducial markers for targeted radiation therapy of colonic lymphomas.

Author

Gurvits GE, Marsano J, Kobrinsky B, Shin S, Sanfilippo N, and Volkov D

Abstract

Non-Hodgkin's lymphomas (NHL) are an important variety of gastrointestinal tumors with increasing incidence and prevalence. Traditional management of NHL with chemotherapy is challenging and expanding evidence points to significant tumor response to radiation therapy (RT). However, there exists a wide range of radiation-related toxicities. Optimization of exact tumor marking coupled with minimization of the radius of radiation delivery is essential to increase patient's tolerance and decrease side effects of the treatment. We report our experience with mantle cell lymphoma of the colon treated with precision RT after endoscopic placement of resolution clips in a "shooting target" fashion in a patient who failed conventional chemotherapy. Fourteen months after completion of RT, the patient remains in complete remission.

Published
2014

14. Delayed diagnosis of Fabry disease presenting as myocardial ischaemia.

Author

Marcì M, Duro G, Tuttolomondo A, Pinto A, Cirrincione V, and Sanfilippo N

Subjects
Delayed Diagnosis, Fabry Disease complications, Humans, Myocardial Ischemia etiology, Fabry Disease diagnosis
Abstract

ERRATUM: Hellenic J Cardiol. 2012; 53: 77-79. At the request of the authors, the name of the third author of this Case Report has been changed from Bruno Tuttolomondo to Antonino Tuttolomondo.

Published
2012

15. Management of high-risk localized prostate cancer.

Author

Marciscano AE, Hardee ME, and Sanfilippo N

Abstract

Traditionally, patients with high-risk localized prostate cancer have been an extremely challenging group to manage due to a significant likelihood of treatment failure and prostate cancer-specific mortality (PCSM). The results of multiple large, prospective, randomized trials have demonstrated that men with high-risk features who are treated in a multimodal fashion at the time of initial diagnosis have improved overall survival. Advances in local treatments such as dose-escalated radiotherapy in conjunction with androgen suppression and postprostatectomy adjuvant radiotherapy have also demonstrated benefits to this subset of patients. However, therapeutic enhancement with the addition of chemotherapy to the primary treatment regimen may help achieve optimal disease control.

Published
2012
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16. Detection of early cardiac dysfunction in patients with Beta thalassemia by tissue Doppler echocardiography.

Author

Marcí M, Pitrolo L, Lo Pinto C, Sanfilippo N, and Malizia R

Subjects
Adult, Early Diagnosis, Female, Humans, Male, Reproducibility of Results, Sensitivity and Specificity, Echocardiography methods, Elasticity Imaging Techniques methods, Ventricular Dysfunction, Left diagnostic imaging, Ventricular Dysfunction, Left etiology, beta-Thalassemia complications, beta-Thalassemia diagnostic imaging
Abstract

Backgrounds: In this study we tried to evaluate the prognostic significance of several echocardiographic parameters on the occurrence of heart failure or arrhythmias in patients with beta thalassemia., Methods: We investigated possible differences in myocardial function between a population of 37 asymptomatic patients with beta thalassemia and 25 age-matched healthy controls, all of whom underwent an echocardiographic study, including tissue Doppler imaging (TDI), moreover plasmatic levels of N-terminal pro-BNP (NT-pro BNP) were measured in all patients. We followed the patients for 22 ± 8 months to evaluate adverse cardiac events., Results: Conventional echocardiographic parameters of left ventricle were comparable in both groups. Whereas TDI peak systolic velocity (Sm) and diastolic parameter (E/Em ratio) were significantly abnormal in patients with thalassemia. Moreover eleven adverse cardiac events were observed during follow-up. Baseline systolic velocity (Sm) <7.9 cm/s was significantly associated with cardiac complications (P < 0.05). We also demonstrated that systolic velocity is inversely related to NT-proBNP plasmatic levels (P < 0.001)., Conclusions: Our study suggests that mitral annular systolic velocity <7.9 cm/s is associated to the onset of adverse cardiac events., (© 2010, Wiley Periodicals, Inc.)

Published
2011
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17. Review of chemoradiotherapy for high-risk prostate cancer.

Author

Sanfilippo N, Hardee ME, and Wallach J

Subjects
Humans, Male, Radiotherapy, Adjuvant, Risk Factors, Treatment Outcome, Antineoplastic Agents therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms radiotherapy
Abstract

While most newly-diagnosed prostate cancers are well-differentiated tumors that have high probability of cure, there is a subset of patients that present with aggressive malignancies that have significant potential for recurrence and metastasis. Single-modality treatment approaches have demonstrated relatively high failure rates, and multimodality therapy (radiation therapy and hormonal ablation therapy) has become standard of care for these patients. These treatments are not without toxicity, and a significant percentage of patients will become refractory to hormonal therapy. Historically, radiation therapy of prostate cancer was associated with significant genitourinary and gastrointestinal morbidity. With advances in radiation therapy techniques and delivery, the potential for safe dose-escalation has emerged. Further, there is an opportunity for chemotherapeutic agents to play an important syngergistic role in radiosensitizing the tumor cells at the primary site while also addressing micrometastatic disease. Concurrent chemoradiation therapy has become standard treatment for many types of locally advanced tumors, including lung, cervical, esophageal, rectal, and anal malignancies. We present a review of clinical trials examining the role of chemoradiation therapy in high-risk prostate cancer.

Published
2011
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18. Malignant melanoma metastatic to the larynx: treatment and functional outcome.

Author

Lanson BG, Sanfilippo N, Wang B, Grew D, and DeLacure MD

Abstract

The review considers management strategies for malignant melanoma metastatic to the larynx. This rare clinical entity lacks clear treatment recommendations because extirpative surgery can often result in severe functional debilitation in patients with limited life expectancy. Here, we report a case of melanoma metastatic to the larynx in a patient with a prior history of Hodgkin lymphoma. The patient was treated with partial laryngectomy and local radiation therapy. The rationale for treatment decisions and for surgical and radiotherapeutic techniques and the associated literature are discussed.

Published
2010
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19. Technical aspects and perspectives of the vaginal mold applicator for brachytherapy of gynecologic malignancies.

Author

Magné N, Chargari C, SanFilippo N, Messai T, Gerbaulet A, and Haie-Meder C

Subjects
Equipment Design, Female, Humans, Brachytherapy instrumentation, Uterine Cervical Neoplasms radiotherapy, Vagina
Abstract

Purpose: The importance of the quality of cervical cancer brachytherapy applicators has been reported, suggesting a direct influence of competent technical implant performance on outcome. In our institute, an original brachytherapy technique based on the use of a molded applicator for genital tract brachytherapy has been applied routinely in clinical practice. Here, we report the technical aspects of this customized applicator and perspectives on its use., Technical Aspects: The first step consists of a vaginal impression that accurately shows the topography and extension of the tumor as well as the anatomy of the vagina and cervix. From this impression, an acrylic applicator is made. Then, the intended positions of the vaginal catheters are drawn on the surface of the mold by the radiation oncologist. Two plastic vaginal catheters are introduced and fixed on the internal surface of the molded applicator. A hole for the cervical os is made through which the uterine probe will be positioned., Perspectives: This method allows for high specificity within the framework of a modern brachytherapy procedure, integrating the tumor topography, anatomy of the patient, and internal movements of target and critical volumes. This technique has been successfully extended to other tumor locations, such as genital tract rhabdomyosarcoma in children and postoperative endocavitary brachytherapy in patients with endometrial cancer., Conclusion: Customization of a vaginal brachytherapy applicator allows for the maintenance of morphologic optimization throughout the treatment course, which better takes into account a fourth dimension: internal organ motion during the course of brachytherapy., ((c) 2010. Published by Elsevier Inc.)

Published
2010
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20. Head and neck radiotherapy compliance in an underserved patient population.

Author

Sethi RA, Stamell EF, Price L, DeLacure M, and Sanfilippo N

Subjects
Humans, New York City, Social Class, Head and Neck Neoplasms radiotherapy, Patient Compliance
Abstract

Objectives/hypothesis: Compliance to intensive multiweek radiation therapy (RT) regimens in head and neck cancer (HNC) patients is challenging, particularly among medically underserved patients with fewer financial and social resources. Treatment prolongation reduces local control and overall survival rates, making adherence to treatment a key factor in optimal outcome. We evaluated factors affecting compliance in medically underserved patients who received RT for HNC in a large municipal hospital setting in New York City., Study Design: Retrospective review., Methods: Treatment records of patients treated between July 2004 and August 2008 were reviewed. Number of and reasons for missed treatments were identified. Several demographic, toxicity, and treatment variables were analyzed for impact on compliance., Results: Eighty consecutive HNC patients who underwent RT with a 5- to 7-week regimen were identified. Thirty-two patients (40%) missed no treatments, 36 (45%) missed one to six treatments, six (8%) missed seven to 14 treatments, two (3%) missed more than 14 treatments, and four (5%) did not complete treatment. Reasons for missed treatments were hospitalization (31% of events) and toxicity (20%). Patients with percutaneous endoscopic gastrostomy tube were more likely to miss treatments (P = .01, chi(2) test). No other variable showed a significant association with missed treatments (chi(2) test)., Conclusions: Intensive RT for HNC can be delivered with very good adherence within a medically underserved population. Eighty-five percent of patients completed treatment with 0 to 6 days of interruption. Efforts to further improve adherence in this population are ongoing.

Published
2010
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21. Acute cardiac injury after subarachnoid haemorrhage: two case reports.

Author

Marcì M, Savatteri P, Pizzuto A, Giammona G, Renda B, Lojacono F, and Sanfilippo N

Abstract

It is well known that cardiopulmonary complications are often associated to subarachnoid haemorrhage. For appropriate therapeutic managing it is very important to distinguish acute coronary syndrome from neurogenic myocardial injury, which is a reversible condition. Furthermore, because the hearts of brain dead patients may be utilized for therapeutic purpose, it has became of importance to rule out erroneous diagnosis of cardiac ischemia in order to avoid rejection of hearts potential suitable for transplantation.We present a report of two female patients affected by cardiac complications caused by aneurismal subarachnoid haemorrhage admitted to our neurosurgical intensive care department.

Published
2009
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22. Long-term results of brachytherapy for carcinoma of the penis confined to the glans (N- or NX).

Author

de Crevoisier R, Slimane K, Sanfilippo N, Bossi A, Albano M, Dumas I, Wibault P, Fizazi K, Gerbaulet A, and Haie-Meder C

Subjects
Adult, Aged, Aged, 80 and over, Brachytherapy adverse effects, Brachytherapy instrumentation, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell secondary, Carcinoma, Squamous Cell surgery, Circumcision, Male, Follow-Up Studies, Humans, Inguinal Canal, Lymph Node Excision, Male, Middle Aged, Neoplasm Recurrence, Local surgery, Penile Neoplasms mortality, Penile Neoplasms pathology, Penile Neoplasms surgery, Penis pathology, Penis surgery, Prognosis, Radiotherapy Dosage, Salvage Therapy, Survival Rate, Treatment Outcome, Brachytherapy methods, Carcinoma, Squamous Cell radiotherapy, Iridium Radioisotopes therapeutic use, Penile Neoplasms radiotherapy
Abstract

Purpose: To analyze the results of exclusive interstitial low-dose-rate brachytherapy (BT) for squamous cell carcinoma (SCC) of the penis, strictly confined to the glans., Methods and Materials: A total of 144 patients with SSC of the glans penis were treated with BT. Inguinal nodal dissection was performed in 19% of patients (all N-). After circumcision, BT was performed using the hypodermic needle technique. Median iridium length per patients was 24 cm (range, 4-108) and median dose was 65 Gy (range, 37-75). Median treated volume was 22 cm(3) (range, 5-110) and median reference isodose rate was 0.4 Gy/h (range, 0.2-1.2)., Results: Median follow-up was 5.7 years (range, 0.5-29). The 10-year penile recurrence, inguinal lymph node recurrence, and inguinal nodal metastasis rates were: 20% (CI 95%, 11-29), 11% (CI 95%, 5-17), and 6% (CI 95%, 2-10), respectively. After salvage treatment, 86% patients with local failure were in a complete remission at last follow-up. The 10-year probability of avoiding penile surgery (for complication or local recurrence) was 72% (CI 95%, 62-82). The 10-year cancer-specific survival rate was 92% (CI 95%, 87-97). Diameter of tumor significantly increased the risk of recurrence (p = 0.02). The 10-year painful ulceration and stenosis risk rates were: 26% (CI 95%, 17-35) and 29% (CI 95%, 18-40), respectively. Seven patients required excision for necrosis. Treated volume and reference isodose rate significantly increased the risk of complications., Conclusion: BT is an effective conservative treatment for SCC confined to the glans. Salvage local treatment is effective. Dose rate should be limited to decrease toxicity.

Published
2009
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24. High-grade hyperinvasive sarcomatoid urothelial bladder carcinoma demonstrating complete response to bladder-preserving chemoradiation.

Author

Wallach JB, Wang B, and Sanfilippo N

Abstract

The standard treatment for locally advanced urothelial bladder carcinoma is radical cystectomy or chemoradiation. Sarcomatoid urothelial carcinoma, a rare tumour, is treated with radical cystectomy because the response to radiation therapy alone is poor in other sarcomas. We report a case of high-grade hyperinvasive urothelial bladder carcinoma with sarcomatoid differentiation. The patient refused cystectomy, and so a chemoradiation regimen was devised for her treatment. She completed the regimen and has since demonstrated a complete response to chemoradiation therapy clinically and pathologically by biopsy. The patient has therefore been able to attain a complete response while preserving a functional bladder.

Published
2009
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26. Six-month depot formulation of leuprorelin acetate in the treatment of prostate cancer.

Author

Sethi R and Sanfilippo N

Subjects
Antineoplastic Agents, Hormonal pharmacology, Delayed-Action Preparations, Dose-Response Relationship, Drug, Humans, Leuprolide pharmacology, Male, United States, Antineoplastic Agents, Hormonal administration & dosage, Leuprolide administration & dosage, Prostatic Neoplasms drug therapy
Abstract

Hormonal deprivation therapy is well established for the treatment of locally advanced and metastatic prostate cancer, as well as the adjuvant treatment of some patients with localized disease. Long-acting gonadotropin releasing hormone (GnRH) agonists have become a mainstay of androgen deprivation therapy, due to their efficacy, tolerability, and convenience of use. One-month, 3-month, and 4-month depot leuprorelin formulations are well established and widely used to this end. Recently, a 6-month depot leuprorelin has been approved for use in advanced and metastatic prostate cancer patients. With similar efficacy and side effect profiles to earlier formulations, 6-month depot leuprorelin is a convenient treatment option for these patients. This review will highlight the role of GnRH agonists in the treatment of prostate cancer with a focus on the clinical efficacy, pharmacology, and patient-focused outcomes of the newer 6-month 45 mg depot leuprorelin formulation in comparison to available shorter-acting products.

Published
2009
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27. Exclusive radiotherapy for primary squamous cell carcinoma of the vagina.

Author

de Crevoisier R, Sanfilippo N, Gerbaulet A, Morice P, Pomel C, Castaigne D, Pautier P, Lhomme C, Duvillard P, and Haie-meder C

Subjects
Adult, Aged, Aged, 80 and over, Carcinoma, Squamous Cell mortality, Female, Humans, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Radiotherapy adverse effects, Radiotherapy Dosage, Retrospective Studies, Survival Rate, Vaginal Neoplasms mortality, Brachytherapy methods, Carcinoma, Squamous Cell radiotherapy, Vaginal Neoplasms radiotherapy
Abstract

Purpose: To retrospectively analyze results of external beam therapy (EBT) with brachytherapy (BT) for primary vaginal squamous cell carcinoma (PVSCC)., Materials and Methods: From 1970 to 2001, 91 patients were included. FIGO stages were: I (29%), II (38%), III (29%) and IVa (4%). EBT delivered a median total dose of 50 Gy to the pelvis. BT was performed with a customized intra-vaginal applicator and in 36% of applications combined endocavitary and interstitial BT. ICRU Report 38 parameters were reported., Results: The 5-year cause specific survival (CSS) rates were: 83% for stage I, 76% for stage II, 52% for stage III, and 2 of the 4 stage IVa patients died 9 and 36 months after treatment. The 5-year pelvis control rates were: 79% for stage I and II and 62% for stage III. Recurrences as a first event were local only in 68% of cases, nodal only in 10%, metastatic only in 13% and combined in 9%. In multivariate analysis: stage (I and II versus II and IV), response to EBT (evaluated at BT), and the number of BT applications were statistically significant for CSS. Grade 2-3 toxicities were as follows (Franco-Italian Glossary): rectum (n=3), sigmoid colon and small bowel (n=8), bladder (n=5), ureter (n=4) and vagina (n=13). Anterior location of the tumor increased bladder toxicity (p=0.01) and total reference air kerma was higher in patients who experienced grade 2-3 urinary or digestive toxicity (p=0.03)., Conclusion: EBT with BT is an effective treatment for patients with stage I-II PVSCC. The incidence and severity of late toxicity were relatively low. Recent advances in the treatment of cervix carcinoma emphasize the need for concomitant radio-chemotherapy in stages III-IV and the use of MRI for treatment planning.

Published
2007
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28. Chromosomal aberrations induced by chemotherapy and radiotherapy in lymphocytes from patients with breast carcinoma.

Author

Légal JD, De Crevoisier R, Lartigau E, Morsli K, Dossou J, Chavaudra N, Sanfilippo N, Bourhis J, Eschwège F, and Parmentier C

Subjects
Adult, Aged, Aged, 80 and over, Breast radiation effects, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Combined Modality Therapy, Dose-Response Relationship, Drug, Dose-Response Relationship, Radiation, Female, Humans, In Situ Hybridization, Fluorescence, Lymph Nodes radiation effects, Lymphocytes drug effects, Middle Aged, Prospective Studies, Breast Neoplasms radiotherapy, Chromosome Aberrations, Lymphocytes radiation effects
Abstract

Purpose: Stable chromosomal aberrations (SCAs) have been found in circulating lymphocytes from patients treated for breast carcinoma. Therefore, we tried to define their incidence in such patients, to determine an in vitro dose-effect relationship, and to correlate these data with clinical parameters., Methods and Materials: This prospective study included 25 patients who, after surgery, underwent either radiotherapy (RT) alone (n = 15) or RT combined with chemotherapy (n = 10). SCAs were scored using the fluorescent in situ hybridization technique before RT and 4 and 12 months after RT. Dose-effect curves were established by in vitro irradiation of blood samples with 2 and 4 Gy, before and after treatment., Results: In all patients, the rate of SCAs increased significantly after external irradiation. No significant decrease in SCAs was observed during the first year after RT. RT and chemotherapy had no effect on the lymphocyte in vitro dose-effect relationship. No relationship was found in the distribution of patients between the yield of SCAs scored after external irradiation and after in vitro irradiation. SCAs after RT or in vitro irradiation did not correlate with family history of breast carcinoma or acute toxicity of treatment. More significantly, the yield of SCA after external irradiation was strongly related to the irradiation of the internal mammary chain and the supraclavicular lymph node area, suggesting that the volume of irradiated blood vessels was an essential parameter in determining the rate of SCAs., Conclusion: A high and stable yield of SCAs persisted at least 1 year after external irradiation. The nature of the volume irradiated containing large blood vessels was the major determinant of the observed biologic dose.

Published
2002
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29. Elective groin irradiation is not indicated for patients with adenocarcinoma of the rectum extending to the anal canal.

Author

Taylor N, Crane C, Skibber J, Feig B, Ellis L, Vauthey JN, Hamilton S, Cleary K, Dubrow R, Brown T, Wolff R, Hoff P, Sanfilippo N, and Janjan N

Subjects
Adenocarcinoma drug therapy, Adenocarcinoma pathology, Adult, Aged, Aged, 80 and over, Anus Neoplasms drug therapy, Anus Neoplasms pathology, Anus Neoplasms radiotherapy, Female, Follow-Up Studies, Groin, Humans, Male, Middle Aged, Rectal Neoplasms drug therapy, Rectal Neoplasms pathology, Retrospective Studies, Survival Analysis, Adenocarcinoma radiotherapy, Lymphatic Irradiation, Rectal Neoplasms radiotherapy, Salvage Therapy
Abstract

Purpose: To evaluate the inguinal nodal failure rate in patients with locally advanced rectal cancer with anal canal involvement (ACI) treated with pelvic chemoradiation without elective inguinal irradiation., Methods and Materials: From 1990 and 1998, 536 patients received preoperative or postoperative chemoradiation for rectal cancer with curative intent; 186 patients had ACI (<4 cm from the anal verge on rigid proctoscopy). Two patients had positive inguinal nodes at presentation. Chemoradiation was delivered preoperatively (45 Gy in 25 fraction) or postoperatively (53 Gy in 29 fractions) with concurrent continuous infusion of 5-fluorouracil (300 mg/m2/d). The inguinal region was specifically irradiated in only 2 patients who had documented inguinal nodal disease., Results: The median follow-up was 50 months. Only 6 of 184 ACI patients who had clinically negative inguinal nodes at presentation developed inguinal nodal recurrence (5-year actuarial rate 4%); 4 of the 6 cases were isolated. Two patients underwent successful salvage. Only 1 died of uncontrolled groin disease. Local control was achieved in both patients with inguinal nodal disease at presentation, but both died of metastatic disease. Only 3 patients with tumors >4 cm from the verge developed inguinal recurrence (5-year actuarial rate <1%)., Conclusions: Inguinal nodal failure in rectal cancer patients with ACI treated with neoadjuvant or adjuvant chemoradiation is not high enough to justify routine elective groin irradiation.

Published
2001
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