Search

Your search keyword '"Spadafora S"' showing total 89 results
Start Over Author "Spadafora S"
89 results on '"Spadafora S"'

2. Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies

Author

Leung KM, Goeree RA, Dolovich LR, Straus SE, Ciaschini PM, Woods CR, Zimmerman GM, Majumdar SR, Spadafora S, Fera LA, and Lee HN

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted community-based care program aimed at optimizing the evidence-based management of falls and fractures in patients at risk. Design 6-month randomised controlled study. Methods This population-based study was completed in the Algoma District of Ontario, Canada a geographically vast area with Sault Ste Marie (population 78 000) as its main city. Eligible patients were allocated to an immediate intervention protocol (IP) group, or a delayed intervention protocol (DP) group. The DP group received usual care for 6 months and then was crossed over to receive the interventions. Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada, and falls risk assessment and treatment. Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management. Secondary outcomes included quality of life and the number of falls, fractures, and hospital admissions over a twelve-month period. The patient is the unit of allocation and analysis. Analyses will be performed on an intention to treat basis. Discussion This paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387)

Published
2008
Full Text
View/download PDF

4. Latent tuberculosis infection in patients with chronic plaque psoriasis: evidence from the Italian Psocare Registry*

Author

Gisondi, P., Cazzaniga, S., Chimenti, S., Maccarone, M., Picardo, M., Girolomoni, G., Naldi, L., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnù, B., Spaziani, G., Cusano, F., Iannazzone, Saletta S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Balestri, R., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Grilli, Cilioni E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., di Luzio, Scotto G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., dʼAmico, D., Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Domaneschi, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., DʼOria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., González Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavò, S., Manfrè, C., Borgia, F., Guerra, Puglisi A., Sedona, P., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Mozzillo, R., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Aricò, M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M.G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvarà, M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., Amerio, P., De Simone, C., DʼAgostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigò, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappalà, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Fornasa, Veller C., and Trevisan, G. P.

Published
2015
Full Text
View/download PDF

9. LBA87 A pragmatic cluster-randomized trial of ambulatory toxicity management in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer (AToM)

Author

Krzyzanowska, M.K., primary, Julian, J., additional, Gu, C-S., additional, Powis, M., additional, Li, Q., additional, Enright, K.A., additional, Howell, D., additional, Earle, C., additional, Gandhi, S., additional, Rask, S., additional, Brezden-Masley, C., additional, Dent, S.F., additional, Hajra, L., additional, Freedman, O., additional, Spadafora, S., additional, Hamm, C., additional, Califaretti, N., additional, Trudeau, M., additional, Levine, M., additional, and Grunfeld, E., additional

Published
2020
Full Text
View/download PDF

10. Pruritus characteristics in a large Italian cohort of psoriatic patients

Author

Damiani, G., Cazzaniga, S., Conic, R. R. Z., Naldi, L., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnu, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto di Luzio, G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., Amico, Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D'Oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., Gonzalez Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavo, S., Manfre, C., Borgia, F., Puglisi Guerra, A., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Arico, M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M. G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvara, M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D'Agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigo, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappala, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Girolomoni, G., Gisondi, P., Veller Fornasa, C., Trevisan, G. P., Damiani G., Cazzaniga S., Conic R.R.Z., Naldi L., Griseta V., Miracapillo A., Azzini M., Mocci L., Michelini M., Offidani A., Bernardini L., Campanati A., Ricotti G., Giacchetti A., Norat M., Gualco F., Castelli A., Cuccia A., Diana A., Roncarolo G., Belli M.A., Baldassarre M.A., Santoro G., Vena G.A., Lo Console F., Filotico R., Mastrandrea V., Brunetti B., Musumeci F., Carrabba E., Dal Mas P., Annicchiarico F., Benvegnu B., Spaziani G., Cusano F., Saletta Iannazzone S., Galluccio A., Pezza M., Marchesi L., Imberti G., Reseghetti A., Barbera C., Reggiani M., Lanzoni A., Patrizi A., Bardazzi F., Antonucci A., De Tommaso S., Wallnofer W., Ingannamorte F., Calzavara-Pinton P., Iannazzi S., Zane C., Capezzera R., Bassisi S., Rossi M.T., Altamura V., Vigl W., Nobile C., Aste N., Murgia S., Mugheddu C., Scuderi G., Baglieri F., Di Dio C., Cilioni Grilli E., Mastronardi C., Agnusdei C.P., Antrilli A., Aulisa L., Raimondo U., Scotto di Luzio G., Battarra V.C., Farro P., Plaitano R., Micali G., Musumeci M.L., Massimino D., Li Calzi M., La Greca S., Pettinato M., Sapienza G., Valenti G., De Giacomo P.F., Amico, Arcangeli F., Brunelli D., Ghetti E., Tulli A., Assi G., Amerio P., Laria G., Prestinari F., Spadafora S., Coppola M., Caresana G., Pezzarossa E., Felisi C., Donato L., Bertero M., Musso L., Pa lazzini S., Bruscino P., Agozzino U.C., Ottaviani M., Simoncini C., Virgili A., Osti F., Fabbri P., Volpi W., Caproni M., Lotti T., Prignano F., Buggiani G., Troiano M., Fenizi G., Altobella A., Amoruso A., Condello M., Goffredo A., Righini M.G., Alessandrini F., Satolli F., Zampetti M., Bertani E., Fossati S., Parodi A., Burlando M., Fiorucci C., Nigro A., Ghigliotti G., Massone L., Moise G.M., Serrai M., Cannata G., Campagnoli A.M., Daly M., Leporati C., Peila R., Filosa G., Bugatti L., Nicolini M., Nazzari G., Cestari R., Anastasio F., Larussa F.M., Pollice N., De Francesco F., Mazzocchetti G., Peris K., Fargnoli M.C., Di Cesare A., De Angelis L., Flati G., Biamonte A.S., Quarta G., Congedo M., Carcaterra A., Strippoli D., Fideli D., Marsili F., Celli M., Ceccarini M., Bachini L., D'Oria M., Schirripa V., De Filippi C., Martini P., Lapucci E., Mazzatenta C., Ghilardi A., Simonacci M., Bettacchi A., Gasco R., Zanca A., Battistini S., Dattola S., Vernaci R., Postorino F., Zampieri P.F., Padovan C., Gonzalez Intchaurraga M.A., Ladurner J., Guarneri B., Cannavo S., Manfre C., Borgia F., Puglisi Guerra A., Cattaneo A., Carrera C., Fracchiolla C., Mozzanica N., Prezzemolo L., Menni S., Lodi A., Martino P., Monti M., Mancini L., Sacrini F., Altomare G.F., Taglioni M., Lovati C., Mercuri S.R., Schiesari G., Giannetti A., Conti A., Lasagni C., Greco M., Ronsini G., Schianchi S., Fiorentini C., Niglietta S., Maglietta R., Padalino C., Crippa D., Pini M., Rossi E., Tosi D., Armas M., Ruocco V., Ayala F., Balato N., Gaudiello F., Cimmino G.F., Monfrecola G., Gallo L., Argenziano G., Fulgione E., Berruti G., Ceparano S., De Michele I., Giorgiano D., Leigheb G., Deledda S., Peserico A., Alaibac M., Piaserico S., Schiesari L., Dan G., Mattei I., Oro E., Arico M., Bongiorno M.R., Angileri R., Amato S., Todaro F., Milioto M., Bellastro R., Di Nuzzo S., De Panfilis G., Zanni M., Borroni G., Cananzi R., Brazzelli V., Lisi P., Stingeni L., Hansel K., Pierfelice V., Donelli S., Rastelli D., Gasperini M., Barachini P., Cecchi R., Bartoli L., Pavesi M., De Paola S., Corradin M.T., Ricciuti F., Piccirillo A., Viola L., Tataranni M., Mautone M.G., Lo Scocco G., Niccoli M.C., Brunasso Vernetti A.M.G., Gaddoni G., Resta F., Casadio M.C., Arcidiaco M.C., Luvara M.C., Albertini G., Di Lernia V., Guareschi E., Catrani S., Morri M., De Simone C., D'Agostino M., Agostino I., Calvieri S., Cantoresi F., Richetta A., Sorgi P., Carnevale C., Nicolucci F., Berardesca E., Ardigo M., De Felice C., Gubinelli E., Talamonti M., Camplone G., Cruciani G., Riccardi F., Barbati R., Zumiani G., Pagani W., Malagoli P.G., Pellicano R., Donadio D., Di Vito C., Cottoni F., Montesu M.A., Pirodda C., Addis G., Marongiu P., Farris A., Cacciapuoti M., Verrini A., Desirello G., Gnone M., Fimiani M., Pellegrino M., Castelli G., Zappala L., Sesana G., Ingordo V., Vozza E., Di Giuseppe D., Fasciocco D., Nespoli P., Papini M., Cicoletti M., Bernengo M.G., Ortoncelli M., Bonvicino A., Capella G., Doveil G.C., Forte M., Peroni A., Salomone B., Savoia P., Pippione M., Zichichi L., Frazzitta M., De Luca G., Tasin L., Simonetto D., Ros S., Trevisan G., Patamia M., Miertusova S., Patrone P., Frattasio A., Piccirillo F., La Spina S., Di Gaetano L., Marzocchi V., Motolese A., Venturi C., Gai F., Pasquinucci S., Bellazzi R.M., Silvestri T., Girolomoni G., Gisondi P., Veller Fornasa C., and Trevisan G.P.

Subjects
Male, Cross-sectional study, Severity of Illness Index, Cohort Studies, 030207 dermatology & venereal diseases, 0302 clinical medicine, Risk Factors, education, itch, pruritus, psoriasis, pustular psoriasis, treatment, Adolescent, Adult, Cross-Sectional Studies, Educational Status, Facial Dermatoses, Female, Foot Dermatoses, Genitalia, Hand Dermatoses, Humans, Italy, Middle Aged, Pruritus, Psoriasis, Registries, Sex Factors, Young Adult, Epidemiology, Young adult, skin and connective tissue diseases, Settore MED/33 - MALATTIE APPARATO LOCOMOTORE, Infectious Diseases, 030220 oncology & carcinogenesis, Cohort, PRURITIS EPIDEMIOLOGY, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Cohort study, medicine.medical_specialty, PSORIAS, Dermatology, Article, 03 medical and health sciences, Pharmacotherapy, Settore MED/35, Severity of illness, medicine, business.industry, medicine.disease, Pruritus,Itch sensation, business
Abstract

Background: Psoriasis (Ps) is a chronic systemic autoimmune disease associated with pruritus in 64–98% of patients. However, few modestly sized studies assess factors associated with psoriatic pruritus. Objective: To investigate factors associated with Ps pruritus intensity. Methods: Psoriasis patients 18years or older seen in one of 155 centres in Italy between September 2005 and 2009 were identified from the Italian PsoCare registry. Patients without cutaneous psoriasis and those with missed information on pruritus were excluded. Results: We identified 10802 patients, with a mean age 48.8±14.3years. Mild itch was present in 33.2% of patients, moderate in 34.4%, severe in 18.7% and very severe in 13.7%. Higher itch intensity was associated with female gender, lower educational attainment compared to university degree, pustular psoriasis, psoriasis on the head, face, palmoplantar areas, folds and genitalia, more severe disease, disease duration

Published
2019

11. Abstracts

Author

Hurtado, Cristina, Bradley, John, Burns, Andrew R., Bradley, John, Karkouti, Keyvan, Hurtado, Cristina, Burns, Andrew R., Bradley, John, Anderson, Rob, Abrahamson, Simon D., Mazer, C. David, Hung, O. R., Comeau, L., Fisher, Joseph A., Tessler, Janet, Rucker, Joshua, Mathicu, Alix, Murray-Foster, Sara, Tz-Chong Chou, Chi-Yuan Li, Tsuda, Takako, Tabuchi, Akihiko, Sasano, Hiroshi, Kiriyama, Masanobu, Okada, Akinori, Hayano, Junichiro, Takeuchi, Akinori, Katsuya, Hirotada, Tousignant, Claude P., Mazer, C. David, Tousignant, Claude P., Mazer, C. David, Ling, Elizabeth, Arellano, Ramiro, Dowd, N., Karski, J., Cheng, D., Carroll-Munro, J., Rose, D. K., Mazer, C. O., Cohen, M. M., Wigglesworth, D., McKay, William P. S., Teskey, Robert J., Militzer, Julio, Kember, Guy, Blanchet, Travis, Gregson, Peter H., Howells, Steven R., Robblee, James A., Breen, Terrance W., Dierenfield, Laura, McNeil, Tacie, Breen, Terrance W., McNeil, Tacie, Dierenfield, Laura, Nicholson, Donna J., Kowalski, Stephen E., Hamilton, G. Andrew, Meyers, Michael P., Serrette, Carl, Duke, Peter C., Custeau, Ingrid, Martin, Rend, Larabée, Sonia, Pirlet, Martine, Pilote, Madeleine, Tetrault, Jean-Pierre, Tsui, Ban C. H., Gupta, Sunil, Finucane, Brendan, Weisbrod, Mitchell J., Chan, Vincent W. S., Kaszas, Z., Dragomir, C., Cohen, M. R., Gandhi, M., Clanachan, A. S., Finegan, B. A., Isaac, Lisa, Splinter, William M., Hall, L. A., Gould, H. M., Rhine, E. J., Bergeron, Lyne, Girard, Michel, Drolet, Pierre, Truong, Hong Hanh Le, Boucher, Carl, Vézina, Daniel, Lessard, Martin R., Gourdeau, Marie, Trépanier, Claude A., Yang, Theresa, Breen, Terrance W., Macarthur, Alison, Chouinard, P., Fugère, F., Ruel, M., Tarkkila, Pekka, Silvasti, Marja, Tuominen, Marjatta, Svartling, Nils, Rosenberg, Per H., Bond, David M., Rudan, John F., Adams, Michael A., Tsang, Brian K., Keahey, Wanda, Gagliese, Lucia, Jackson, Marla, Ritvo, Paul, Wowk, Adarose, Sandler, Alan N., Katz, Joel, Laffey, J. G., Boylan, J. F., Badner, Neal H., Komar, Wendy E., Bond, David M., Cherry, R. A., Spadafora, S. M., Butler, R. J., McHardy, Fiona, Fortier, Joanne, Chung, Frances, Marshall, Scott, Krishnathas, Ananthan, Wong, Jean, Chung, Frances, Ritchie, Ewan, McHardy, Fiona, Marshall, Scott, Fortier, Joanne, Meikle, Andrew, Avery, Nicole, van Vlymen, Janet, Parlow, Joel L., Sinclair, David, Chung, Frances, Mezei, Gabor, Jin, Fengling, Chung, Frances, Norris, Andrew, Ganeshram, Tharini, MacLeod, Bernard A., Azmudéh, Aliréza, Franciosi, Luigi G., Ries, Craig R., Schwarz, Stephan K. W., McKay, William PS, Gregson, Peter H., McKay, Benjamin W. S., Blanchet, Travis, Meuret, Pascal, Bonhomme, Vincent, Plourde, Gilles, Fiset, Pierre, Backman, Stevens B., Vesely, Alex, Takeuchi, Akinori, Sommer, Leeor, Rucker, Joshua, Greenwald, Joel, Lavine, Elana, Iscoe, Steve, Volgyesi, George, Fedorko, Ludwik, Fisher, Joseph, Lobato, Emilio B., Sulek, Cheri A., Davies, Laurie K., Gearen, Peter F., Bellemare, François, Donati, François, Couture, Jacques, Joo, Hwan S., Rose, D. K., Kapoor, Sunil, Shayan, Shahriar, Karkouti, Keyvan, LeDez, Kenneth M., Au, Jim, Tucker, John H., Redmond, Edwin B., Gadag, V., Penney, Catherine, Hare, Gregory M. T., Lee, Timothy D. G., Hirsch, Gregory M., Yang, Fan, Troncy, Eric, Blaise, Gilbert, Naito, Yoshiyuki, Arisawa, Shoji, Ide, Masahiro, Nakano, Susumu, Yamazaki, Kazuo, Kawamura, Takae, Nara, Noriko, Wakusawa, Reiji, Inada, Katsuya, Hudson, Robert J., Singh, Karanbir, Harding, Gary A., Henderson, Blair T., Thomson, Ian R., Harding, Gary A., Hudson, Robert J., Thomson, Ian R., Thomson, Ian R., Singh, Karanbir, Hudson, Robert J., Wherrett, Christopher G., Miller, Donald R., Giachino, Alan A., Turek, Michelle A., Rody, Kelly, Vaghadia, H., Chan, V., Ganapathy, S., Lui, A., McKenna, J., Zimmer, K., Schwarz, Stephan K. W., MacLeod, Bernard A., Ries, Craig R., Franciosi, Luigi G., Regan, William D., Davidson, Ross G., Nevin, Krista, Escobedo, Sergio, Mitmaker, E., Tessler, M. J., Kardash, K., Kleiman, S. J., Rossignol, M., Kahn, L., Baxter, F., Dauphin, A., Goldsmith, C., Jackson, P., McChesney, J., Miller, J., Takeuchi, L., Young, E., Klubien, Kristine, Bandi, Edith, Carli, Franco, Dattilo, Kathleen, Tong, Doris, Bhandari, Mohit, Carli, Franco, Klubien, Kristine, Mazza, Louise, Wykes, Linda, Sommer, L. Z., Rucker, J., Veseley, A., Levene, E., Greenwald, Y., Volgyesi, G., Fedorko, L., Iscoe, S., Fisher, J. A., Tian, Guo-Feng, Baker, Andrew J., Reinders, F. X., Baker, A. J., Moulton, R. J., Brown, J. I. M., Schlichter, L., Troncy, Eric, Van Tulder, Laurence, Carignan, Stéphane, Prénovault, Julie, Collet, Jean-Paul, Shapiro, Stan, Guimond, Jean-Gilles, Blait, Louis, Ducruet, Thierry, Francœur, Martin, Charbonneau, Marc, Cousineau, Guy, Blaise, Gilbert, Wong, Daniel R., McCall, Michele, Walsh, Fergus, Kurian, Regina, Keith, Mary, Sole, Michael J., Jeejeebhoy, Kursheed N., Mazer, C. David, Whitten, E., Norman, P. H., Aucar, J. A., Coveler, L. A., Solgonick, Rodney M., Bastien, Y., Mazer, Bruce, Lihara, Koji, Orser, Beverley A., Tymianski, Michael, Finucane, Brendan T., Zaman, Nuzhat, Kashkari, Ibrahim, Tawfik, Soheir, Tarn, Yun K., Slinger, Peter D., McRae, Karen, Winton, Timothy, Sandier, Alan N., Zamora, J. E., Salpeter, Mary Jane, Bai, Donglin, MacDonald, John F., Orser, Beverley A., Mayson, Kelly, Gofton, Ed, Chambers, Keith, Belo, Susan E., Kay, J. Colin, Mazer, C. David, Hall, Sean R. R., Wang, Louie, Milne, Brian, Loomis, Chris, Tsang, Brian K., He, Zhi, Wougchanapai, Wichai, Ho, Ing K., Eichhorn, John H., Tsang, Brian K., Ma, Tangeng, Wongchanapai, Wichai, He, Zhi, Ho, Ing K., Eicnhorn, John H., Tsang, Brian K., Wongchanapai, Wichai, He, Zhi, Ho, Ing K., Eichhorn, John H., Murphy, Damian B., Murphy, M. B., Bonhomme, Vincent, Meuret, Pascal, Backman, Steven B., Plourde, Gilles, Fiset, Pierre, Stein, Reuben D., Backman, Steven B., Collier, Brian, Polosa, Canio, Li, Chi-Yuan, Chou, Tz-Chong, Wang, Jia-Yi, Fuller, John, Butler, Ronald, Spadafora, Salvatore, Donen, Neil, Brownell, Laurence, Donen, Neil, Brownell, Laurence, Shysh, Sandy, Carter, Keith, Eagle, Chris, Devito, Isabella, Halpern, Stephen, Devitt, J. Hugh, Yee, Doreen A., deLacy, John L., Oxorn, Donald C., Morris, Gary F., Yip, Raymond W., Gregoret-Quinn, M. G., Seal, R. F., Smith, LJ., Jones, A. B., Tang, C., Clanachan, A. S., Gallant, B. J., Nadwidny, L. A., Goresky, Gerald V., Cowtan, Tara, Bridge, Hilary S., Montgomery, Carolyne J., Kennedy, Ross A., Merrick, Pamela M., Yamashita, M., Wada, K., LeMay, Sylvie, Hardy, Jean-François, Morgan, Pamela, Halpern, Steven, Evers, Jana, Ronaldson, P., Rose, D. K., Dexter, F., Cohen, M. M., Wigglesworth, D., Writer, Desmond, Muir, Holly, Shukla, Romesh, Nunn, Rob, Scovil, John, Pridham, Jeremy, Rosaeg, Ola, Sandier, Allan, Morley-Foster, Patricia, Lucy, Simon, Crone, Lesley-Ann, Zimmer, Karen, Wilson, Deborah J., Heid, Robert, Douglas, M. Joanne, Rurak, Dan W., Fabrizi, Anna, Crochetière, Chantal T., Roy, Louise, Villeneuve, Edith, Lortie, Louise, Katsiris, Sandra, Leighton, Barbara, Halpern, Stephen, Wilson, Donna, Kronberg, Jean, Swica, Leszek, Midgley, Janet, Nunn, Robert, Muir, Holly, Shukla, Romesh, Smith, Bruce, Rooney, Michael E., Campbell, David C., Riben, Celina M., Crone, Lesley-Ann, Yip, Ray W., Halpern, Stephen, Halpern, Stephen, MacDonell, Jo, Levine, Tracey, and Wilson, Donna

Published
1998
Full Text
View/download PDF

13. Abstracts

Author

Kavanagh, Brian P., Ngo, Cuong, Raymer, Karen, Yang, Homer, Alhashemi, Jamal A., Lui, Anne C. P., Reid, Dennis, Cicutti, Nicholas, Krepski, Barbra, Wood, Gordon, Heyland, Daren K., Badner, Neal H., Murkin, John M., Mohr, Jim, McKenzie, F. Neil, van der Starre, Peter J. A., van Rooyen-Butijn, W. T., Wilson-Yang, Kristine, Teoh, Kevin, Lee, R. M. K. W., Hossain, Imtiaz, Cheng, Davy, Karski, Jacek, Asokumar, Buvanendran, Sandier, Alan, St-Amand, Marc A., Murkin, John M., Menkis, Alan H., Downey, Donal B., Nantau, William, Adams, Sandy, Dowd, Noreen, Cheng, Davy, Wong, David, Carroll-Munro, Jo, Trachuk, Clare, Cregg, N., Cheng, D. C. H., Williams, W. G., Karski, J. M., Siu, S., Webb, G., Cheng, Davy C. H., Wong, David T., Kustra, Rafal, Karski, Jacek, Tibshirani, Robert J., Côté, Dany L., Lacey, David E., LeDez, Kenneth M., Smith, Julia A., Crosby, Edward T., Orkin, Fredrick K., Fisher, A., Volgyesi, G., Silverman, J., Edelstein, S., Rucker, J., Sommer, L., Dunington, S., Roy, L., Crochetière, C., Arsenault, M. -Y., Villeneuve, E., Lortie, L., Grange, Caroline S., Douglas, M. Joanne, Adams, Timothy J., Merrick, Pamela M., Lucas, S. Brian, Morgan, Pamela J., Halpern, Stephen, Lo, Jason, Giesinger, Carolyn L., Halpern, Stephen H., Breen, Terrance W., Vishnubala, Srigowri, Shetty, Geeta R., De Kock, M., Lagmiche, A., Scholtes, J. L., Grodecki, Wlodzimierz, Duffy, Peter J., Hull, Kathryn A., Hawboldt, Geoffrey S., Clark, Alexander J., Smith, J. Bruce, Norman, Richard W., Beattie, W. Scott, Sandier, A., Jewett, M., Valiquette, L., Katz, J., Fradet, Y., Redelmeier, D., Sampson, H., Cole, Jeff, Chedore, Todd, Snedden, Walter, Green, Robert G., Sosis, Mitchel B., Robles, Philip I., Lazar, Edward R., Jolly, Donald T., Tarn, Yun K., Tawfik, Soheir R., Clanachan, Alexander S., Milne, Avaleigh, Beamish, Travis, Cuillerier, D. J., Sharpe, M. D., Lee, J. K., Basta, M., Krahn, A. D., Klein, G. J., Yee, R., Vakharia, Narendra, Francis, Heather, Scheepers, Louis, Vaghadia, Himat, Carrier, Joanne, Martin, René, Pirlet, Marline, Claprood, Yves, Tétrault, Jean-Pierre, Wong, T. D., Ryner, L., Kozlowski, P., Scarth, G., Warrian, R. K., Lefevre, G., Thiessen, D., Girling, L., Doiron, L., McCudden, C., Saunders, J., Mutch, W. A. C., Duffy, Peter J., Langevin, Stéphan, Lessard, Martin R., Trépanier, Claude A., Hare, Gregory M. T., Ngan, Johnson C. S., Viskari, Dan, Berrill, A., Jodoin, Christian, Couture, Jacques, Bellemare, François, Farmer, Stephen, Muir, Holly, Money, Phyllis, Milne, Brian, Parlow, Joel, Raymond, Jennifer, Williams, Julie M., Craen, Rosemary A., Novick, Teresa, Komar, Wendy, Frenette, Luc, Cox, Jerry, Lockhart, B., McArdle, P., Eckhoff, D., Bynon, S., Dobkowski, Wojciech B., Grant, David R., Wall, William J., Chedrawy, Edgar G., Hall, Richard I., Nedelcu, Vivian, Parlow, Joel, Viale, Jean-Paul, Bégou, Gérard, Sagnard, Pierre, Hughson, Richard, Quintin, Luc, Troncy, Éric, Collet, Jean-Paul, Shapiro, Stan, Guimond, Jean-Gilles, Blair, Louis, Ducruet, Thiérry, Francœur, Martin, Charbonneau, Marc, Blaise, Gilbert, Snedden, W., Bernadska, E., Manson, H. I., Kutt, Juditli L., Mezon, Beruie Y., Nishida, Osamu, Arellano, Ramiro, Boylen, Patty, DeMajo, Wilfred, Archer, David P., Roth, Sheldon H., Raman, Sitaram, Manninen, Pirjo, Boyle, Kevin, Cenic, Aleksa, Lee, Ting-Yim, Gelb, Adrian W., Reinders, F. X., Brown, J. I. M., Baker, A. J., Moulton, R. J., Schlichtert, L., Schwarz, Stephan K. W., Puil, Ernest, Finegan, Barry A., Finucane, Brendan T., Kurrek, Matt M., Devitt, J. Hugh, Morgan, Pamela J., Cleave-Hogg, Doreen, Bradley, John, Byrick, Robert, Spadafora, Salvatore M., Fuller, John G., Gelula, Mark H., Mayson, Kelly, Forster, Bruce, Byrick, R. J., McKnight, D. J., Kurrek, M., Kolton, M., Cleave-Hogg, D., Haughton, J., Halpern, S., Kronberg, J., Shysh, Sandy, Eagle, Chris, Dagnone, A. Joel, Parlow, Joel L., Blaise, G., Yang, F., Nguyen, H., Troncy, E., Czaika, G., Wachowski, Ireneusz, Basta, M., Krahn, A. D., Yee, R., Deladrière, Hervé, Cambier, Chantal, Pendeville, Philippe, Hung, O. R., Coonan, E., Whynot, S. C., Mezei, M., Coonan, E., Whynot, S. C., Ho, Anthony M. -H., Luchsinger, Ingrid S., Ling, Elizabeth, Mashava, Doreen, Chinyanga, Herbert M., Cohen, Marsha M., Shaw, Melissa, Robblee J. A., Labow R. S., Rubens F. D., Diemunsch, A. M., Gervais, R., Rose, D. K., Cohen, M. M., O’Brien-Pallas, L., Copplestone, C., Rose, D. K., Karkouti, K., Sykora, K., Cheung, Shirley L. W., Booker, Peter D., Franks, Roger, Pozzi, Marco, Guard, Beverley, Sikich, Nancy, Lerman, Jerrold, Levine, Mark, Swan, Hilton, Cox, Peter, Montgomery, Carolyne, Dunn, Gillian, Bourne, Russell, Kinahan, Anna, McCormack, James, Dunn, Gillian S., Reimer, Eleanor J., Sanderson, Peter, Sanderson, Peter M., Montgomery, Carolyne J., Betts, Terri A., Orlay, Guy R., Wong, David H., Cohen, Marsha, Al-Kaisy, A. A., Chan, V., Peng, P., Perlas, A., Miniad, A., Cushing, Edward V., Mills, Keith R., El-Beheiry, Hossam, Jahromi, Shokrollah S., Weaver, John, Morris, Mary, Carien, Peter L., Cowan, Robert McTaggart, Manninen, Pirjo, Richards, Jonathan, Robblee, J. A., Labow, R. S., Rubens, F. D., Menkis, Alan H., Adams, Sandy, Henderson, Blair T., Hudson, Robert J., Thomson, Ian R., Moon, Michael, Peterson, Mark D., Rosenbloom, Morley, Davison, Patrick J., Ali, Mohamed, Ali, Naheed S., Searle, Norman R., Thomson, Ian, Roy, Micheline, Gagnon, Line, Lye, A., Walsh, F., Middleton, W., Wong, D., Langer, A., Errett, L., Mazer, C. D., Karski, Jacek, Tibshirani, Robert J., Williamson, Karin M., Smith, Graham, Gnanendran, Kandiah P., Bignell, S. J., Jones, S., Sleigh, J., Arnell, M., Schultz, Jan-Ake I., Fear, David W., Ganapathy, S., Moote, C., Wassermann, R., Watson, J., Armstrong, K., Calikyan, Aznif Ozsolak, Yilmaz, Oya, Kose, Yildiz, Peng, Philip, Chan, Vincent, Chung, Frances, Claxton, Andrew R., Krishnathas, Ananthan, Mezei, Gabor, Badner, Neal H., Paul, Terri L., Doyle, Jacqueline A., Mehta, Mahesh, DeLima, Luiz G. R., Silva, Lucia E. O., May, Warren L., Maliakkal, Roy J., Mehta, Mahesh, Kolesar, Richard, Arellano, Ramiro, Rafuse, Sara, Fletcher, Mary, Dunn, Geoffrey, Curran, Michael, Bragg, Paul, Chamberlain, Wayne, Crossan, MaryLou, Ganapathy, S., Sandhu, H., Spadafora, S., Mian, R., Evans, B., Hurst, L., and Katsiris, S.

Published
1997
Full Text
View/download PDF

15. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author

Vergote, I. Scambia, G. O'Malley, D.M. Van Calster, B. Park, S.-Y. del Campo, J.M. Meier, W. Bamias, A. Colombo, N. Wenham, R.M. Covens, A. Marth, C. Raza Mirza, M. Kroep, J.R. Ma, H. Pickett, C.A. Monk, B.J. Park, S.Y. Song, Y.S. Makarova, Y. Trinidad, J. Ngan, H.Y.S. Aravantinos, G. Nam, J.-H. Gorbunova, V. Krikunova, L. Bae, D.-S. Arija, J.A.A. Mirza, M.R. Zamagni, C. Papandreou, C. Raspagliesi, F. Lisyanskaya, A. Benzaquen, A.O. Tognon, G. Ortega, E. Herraez, A.C. Buscema, J. Green, A. Burger, R. Sakaeva, D. Sanchez, A.R. Ghamande, S. King, L. Petru, E. Peen, U. Takeuchi, S. Ushijima, K. Martin, A.G. Kamelle, S. Carney, M. Forget, F. Bentley, J. Sehouli, J. Zola, P. Kato, H. Fadeeva, N. Gotovkin, E. Vladimirov, V. Marin, M.R. Alia, E.G. Shahin, M. Bhoola, S. Tewari, K. Anderson, D. Honhon, B. Pelgrims, J.G. Oza, A. Jimenez, J.G.-D. Hansen, V. Benjamin, I. Renard, V. Van den Bulck, H. Haenle, C. Koumakis, G. Yokota, H. Popov, V. Bradley, W. Wenham, R. Reid, R. McNamara, D. Friedman, R. Barlin, J. Spirtos, N. Chapman, J. Sevelda, P. Huizing, M. Lamot, C. Goffin, F. Hondt, L.D. Covens, A. Spadafora, S. Rautenberg, B. Reimer, T. Möbus, V. Hilpert, F. Gropp-Meier, M. Savarese, A. Pignata, S. Verderame, F. Mizuno, M. Takano, H. Ottevanger, P. Velasco, A.P. Palacio-Vazquez, I. Law, A. McIntyre, K. Teneriello, M. Fields, A. Lentz, S. Street, D. Schwartz, B. Mannel, R. Lim, P. Pulaski, H. Janni, W. Zorr, A. Karck, U. Cheng, A.C.K. Sorio, R. Gridelli, C. Aoki, D. Oishi, T. Hirashima, Y. Boere, I. Ferrer, E.F. Braly, P. Wilks, S. Lee, C. Schilder, J. Veljovich, D. Secord, A. Davis, K. Rojas-Espaillat, L. Lele, S. DePasquale, S. Squatrito, R. Schauer, C. Dirix, L. Vuylsteke, P. Joosens, E. Provencher, D. Lueck, H.-J. Hein, A. Burges, A. Canzler, U. Park-Simon, T.-W. Griesinger, F. Gadducci, A. Alabiso, O. Okamoto, A. Sawasaki, T. Saito, T. Ibañez, A.H. Calomeni, C. Spillman, M. Choksi, J. Taylor, N. Muller, C. Moore, D. DiSilvestro, P. Cunningham, M. Rose, P. Oppelt, P. Verhoeven, D. Graas, M.-P. Ghatage, P. Tonkin, K. Kurzeder, C. Schnappauf, B. Müller, V. Schmalzrie, H. Kalofonos, H. Bruzzone, M. Kroep, J. Diaz, C.C. Garcia, J.M. Polo, S.H. Garrison, M. Rocconi, R. Andrews, S. Bristow, R. McHale, M. Basil, J. Houck III, W. Bell, M. Cosin, J. Modesitt, S. Kendrick, J. Wade III, J. Wong, C. Evans, A. Buekers, T. Vanderkwaak, T. Ferriss, J. Darus, C. DAndre, S. Higgins, R. Monk, B. Bakkum-Gamez, J. DeMars, L. Van Le, L. Puls, L. Trehan, S. LaPolla, J. Michelson, E.D. Merchant, J. Peterson, C. Reid, G. Seago, D. Zweizig, S. Gajewski, W. Panwalkar, A. Leikermoser, R. Bogner, G. Debruyne, P. D'hondt, R. Berteloot, P. Kerger, J. Biagi, J. Castonguay, V. Welch, S. Muhic, A. Heubner, M. Grischke, E.-M. Rack, B. Fleisch, M. Lordick, F. Pectasides, D. Ho, W.M. Selvaggi, L. Vasquez, F.M. Villanueva, W.O.B. Alavez, A.M. Kessels, L. Bertran, A.S. Fernandez, C.M. Fabregat, M.B. Del Prete, S. Elkas, J. Cecchi, G. Kumar, P. Huh, W. Messing, M. Karimi, M. Kelley, A. Edraki, B. Mutch, D. Leiserowitz, G. Anderson, J. Lentz, S. Chambers, S. Morris, R. Waggoner, S. Gordon, A. Method, M. Johnson, P. Lord, R. Drake, J. Sivarajan, K. Midathada, M. Rice, K. Wadsworth, T. Pavelka, J. Edwards, R. Miller, D.S. Ford, P.L. Hurteau, J. Bender, D. Schimp, V. Creasman, W. Lerner, R. Chamberlain, D. Kueck, A. McDonald, J. Malad, S. Robinson-Bennett, B. Davidson, S. Krivak, T. Lestingi, T. Arango, H. Berard, P. Finkelstein, K. Gaur, R. Krasner, C. Ueland, F. Talmage, L. Yamada, S. Sutton, G. Potkul, R. Prasad-Hayes, M. Osborne, J. Celano, P. Thigpen, J. Sharma, S. Schilder, R. Tammela, J. Kemeny, M. Brown, A. Eisenhauer, E. Williams, J. Rowland, K. Nahum, K. Burke, J. Dar, Z. Fleming, N. Gibb, R. Guirguis, A. Herzog, T. John, V. Kumar, S. Kamat, A. Kassar, M. Leitao, M. Levine, L. Mendez, L. Patel, D. Berry, E. Warshal, D. Wolf, J. Zarwan, C. Collins, Y. Spitzer, G. Miller, B. Einstein, M. TRINOVA-3/ENGOT-ov2/GOG-3001 investigators

Abstract

Background: Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial. Methods: TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres)in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO)stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1)using a permuted block method (block size of six patients)to receive six cycles of paclitaxel (175 mg/m2)and carboplatin (area under the serum concentration-time curve 5 or 6)every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete. Findings: Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7–34·2), 626 patients had progression-free survival events (405 [60%]of 678 in the trebananib group and 221 [66%]of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0–17·6])and the placebo group (15·0 months [12·6–16·1])groups (hazard ratio 0·93 [95% CI 0·79–1·09]; p=0·36). 512 (76%)of 675 patients in the trebananib group and 237 (71%)of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%]vs placebo 126 [38%])anaemia (76 [11%]vs 40 [12%]), and leucopenia (81 [12%]vs 35 [10%]). 269 (40%)patients in the trebananib group and 104 (31%)in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group. Interpretation: Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population. Funding: Amgen. © 2019 Elsevier Ltd

Published
2019

16. Latent tubercolosis infection in patients with cronic plaque psoriasis: evidence from the Italian Psocare Registry

Author

Gisondi, P, Cazzaniga, S, Chimenti, S, Maccarone, M, Picardo, M, Girolomoni, G, Naldi, L, Griseta V, Psocare Study Group., Miracapillo, A, Azzini, M, Mocci, L, Michelini, M, Offidani, A, Bernardini, L, Campanati, A, Ricotti, G, Giacchetti, Alessandro, Norat, M, Gualco, F, Castelli, A, Cuccia, A, Diana, A, Roncarolo, G, Belli, Ma, Baldassarre, Ma, Santoro, G, Vena, Ga, Lo Console, F, Filotico, R, Mastrandrea, V, Brunetti, B, Musumeci, F, Carrabba, E, Dal Mas, P, Annicchiarico, F, Benvegnù, B, Spaziani, G, Cusano, F, Saletta Iannazzone, S, Galluccio, A, Pezza, M, Marchesi, L, Imberti, G, Reseghetti, A, Barbera, Claudia, Reggiani, Matteo, Lanzoni, A, Patrizi, A, Bardazzi, F, Antonucci, A, De Tommaso, S, Balestri, R, Wallnofer, W, Ingannamorte, F, Calzavara-Pinton, P, Iannazzi, S, Zane, C, Capezzera, R, Bassisi, S, Rossi, Mt, Altamura, V, Vigl, W, SCHETTINO NOBILE, Carla, Aste, N, Murgia, S, Mugheddu, C, Scuderi, G, Baglieri, F, Di Dio, C, Cilioni Grilli, E, Mastronardi, C, Agnusdei, Cp, Antrilli, A, Aulisa, L, Raimondo, U, Scotto di Luzio, G, Battarra, Vc, Farro, P, Plaitano, R, Micali, G, Musumeci, Ml, D'Armiento, Massimino, Li Calzi, M, LA GRECA, SEBASTIANO VITTORIO, Pettinato, Cristiana Maria, Sapienza, G, Valenti, G, De Giacomo PF, D'Amico, D, Arcangeli, Federica, Brunelli, D, Ghetti, E, Tulli, Augusta, Assi, G, Amerio, P, Laria, G, Prestinari, F, Spadafora, S, Coppola, M, Caresana, G, Pezzarossa, E, Domaneschi, E, Felisi, C, Donato, L, Bertero, M, Musso, L, Pa Lazzini, S, Bruscino, P, Agozzino, Uc, Ottaviani, M, Simoncini, Cristiana, Virgili, A, Osti, F, Fabbri, P, Volpi, Walter, Caproni, M, Lotti, T, Prignano, F, Buggiani, G, Troiano, M, Fenizi, G, Altobella, A, Amoruso, A, Condello, M, Goffredo, A, Righini, Mg, Alessandrini, F, Satolli, F, Zampetti, M, Bertani, E, Fossati, S, Parodi, A, Burlando, M, Fiorucci, C, Nigro, A, Ghigliotti, G, Massone, L, Moise, Gm, Serrai, M, Cannata, G, Campagnoli, Am, Daly, M, Leporati, C, Peila, R, Filosa, Giovanna, Bugatti, L, Nicolini, M, Nazzari, G, Cestari, R, Anastasio, Fabio, Larussa, Fm, Pollice, N, De Francesco, F, Mazzocchetti, G, Peris, K, Fargnoli, Mc, Di Cesare, A, De Angelis, L, Flati, G, Biamonte, As, Quarta, Giovanni, Congedo, M, Carcaterra, A, Strippoli, D, Fideli, D, Marsili, Filippo, Celli, M, Ceccarini, M, Bachini, L, D ORIA, MARIA FEDERICA, Schirripa, V, De Filippi, C, Martini, P, Lapucci, E, Mazzatenta, C, Ghilardi, A, Simonacci, M, Bettacchi, A, Gasco, R, Zanca, A, Battistini, Simone, Dattola, S, Vernaci, R, Postorino, F, Zampieri, Pf, Padovan, MARIA CRISTINA, González Intchaurraga MA, Ladurner, J, Guarneri, B, Cannavo', Serena, Manfrè, C, Borgia, F, Puglisi Guerra, A, Sedona, P, Cattaneo, A, Carrera, C, Fracchiolla, C, Mozzanica, N, Prezzemolo, L, Menni, S, Lodi, A, Martino, P, Monti, M, Mancini, L, Sacrini, F, Altomare, Gf, Taglioni, M, Lovati, C, Mercuri, Sr, Schiesari, G, Giannetti, A, Conti, A, Lasagni, C, Greco, M, Ronsini, G, Schianchi, S, Fiorentini, C, Niglietta, S, Miglietta, R, Padalino, C, Crippa, D, Pini, M, Rossi, E, Tosi, D, Armas, M, Ruocco, V, Ayala, F, Balato, N, Gaudiello, F, Cimmino, Gf, Monfrecola, G, Gallo, L, Argenziano, G, Fulgione, E, Berruti, G, Mozzillo, R, Ceparano, S, De Michele, I, Giorgiano, D, Leigheb, G, Deledda, S, Peserico, A, Alaibac, M, Piaserico, S, Schiesari, L, Dan, G, Mattei, I, Oro, E, Aricò, M, Bongiorno, Mr, Angileri, Rosalia, Amato, S, Todaro, F, Milioto, M, Bellastro, R, Di Nuzzo, S, De Panfilis, G, Zanni, M, Borroni, G, Cananzi, R, Brazzelli, V, Lisi, P, Stingeni, L, Hansel, K, Pierfelice, V, Donelli, S, Rastelli, D, Gasperini, M, Barachini, P, Cecchi, R, Bartoli, L, Pavesi, Maria Gabriella, De Paola, S, Corradin, Mt, Ricciuti, F, Piccirillo, Alessandro, Viola, L, Tataranni, M, Mautone, Mg, Lo Scocco, G, Niccoli, Mc, Brunasso Vernetti AM, Gaddoni, G, DI RESTA, Fabio, Casadio, Mc, Arcidiaco, Mc, Luvarà, Mc, ALBERTINI PETRONI, Guglielmo, DI LERNIA, Valerio, Guareschi, E, Catrani, S, Morri, M, De Simone, C, D'Agostino, M, Agostino, I, Calvieri, S, Cantoresi, F, Richetta, A, Sorgi, Paola, Carnevale, C, Nicolucci, F, Berardesca, E, Ardigò, M, De Felice, C, Gubinelli, E, Talamonti, Marina, Camplone, G, Cruciani, Giulio, Riccardi, F, Barbati, R, Zumiani, G, Pagani, W, Malagoli, Pg, Pellicano, R, Donadio, Diego, Di Vito, C, Cottoni, F, Montesu, Ma, Pirodda, C, Addis, G, Marongiu, P, Farris, A, Cacciapuoti, Anna Maria, Verrini, A, Desirello, G, Gnone, M, Fimiani, M, Pellegrino, M, Castelli, G, Zappalà, L, Sesana, G, Ingordo, V, Vozza, E, Di Giuseppe, D, Fasciocco, D, Nespoli, P, Papini, M, Cicoletti, M, Bernengo, Mg, Ortoncelli, M, Bonvicino, A, Capella, G, Doveil, Gc, Forte, M, Peroni, A, Salomone, B, Savoia, P, Pippione, M, Zichichi, Ludovica, Frazzitta, M, De Luca, G, Tasin, L, Simonetto, D, Ros, S, Trevisan, G, Patamia, M, Miertusova, S, Patrone, Pietro, Frattasio, A, Piccirillo, Fabiola, La Spina, S, Di Gaetano, L, Marzocchi, V, Motolese, A, Venturi, Caterina, Gai, Francesco, Pasquinucci, S, Bellazzi, Rm, Silvestri, Tommaso, Veller Fornasa, C, Trevisan, Gp., Gisondi, P, Cazzaniga, S, Chimenti, S, Maccarone, M, Picardo, M, Girolomoni, G, Naldi, L, the Psocare Study Group [.., Annalisa Patrizi, ], Trevisan, Giusto, Girolomoni, G., Maccarone, Sergio, Naldi, L., Gisondi, P., Cazzaniga, S., Chimenti, S., Maccarone, M., Picardo, M., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M.A., Baldassarre, M.A., Santoro, G., Vena, G.A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnù, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Balestri, R., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M.T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C.P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto Di Luzio, G., Battarra, V.C., Farro, P., Plaitano, R., Micali, G., Musumeci, M.L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P.F., D'Amico, D., Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Domaneschi, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa Lazzini, S., Bruscino, P., Agozzino, U.C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M.G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G.M., Serrai, M., Cannata, G., Campagnoli, A.M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F.M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M.C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A.S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D'Oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P.F., Padovan, C., González Intchaurraga, M.A., Ladurner, J., Guarneri, B., Cannavò, S.P., Manfrè, C., Borgia, F., Puglisi Guerra, A., Sedona, P., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G.F., Taglioni, M., Lovati, C., Mercuri, S.R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G.F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Mozzillo, R., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Aricò, M., Bongiorno, M.R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M.T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M.G., Lo Scocco, G., Niccoli, M.C., Brunasso Vernetti, A.M.G., Gaddoni, G., Resta, F., Casadio, M.C., Arcidiaco, M.C., Luvarà, M.C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D'Agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigò, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P.G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M.A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappalà, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M.G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G.C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R.M., Silvestri, T., Veller Fornasa, C., and Trevisan, G.P.

Subjects
Registrie, Male, taiwan, Antitubercular Agents, Biological Factor, quantiferon-tb-gold, Antitubercular Agent, Biological Factors, experience, Residence Characteristics, 80 and over, Prevalence, Registries, Young adult, risk, Aged, 80 and over, Latent Tuberculosi, Latent tuberculosis, psoriasis, Middle Aged, Italy, Female, tubercolosis, tubercolosi, Adolescent, Adult, Age Distribution, Aged, Chronic Disease, Humans, Latent Tuberculosis, PUVA Therapy, Psoriasis, Sex Distribution, Tuberculin Test, Young Adult, 2708, Human, medicine.drug, medicine.medical_specialty, chronic plaque psoriasis, Tuberculin, consensus statement, Dermatology, tuberculosis infection, Settore MED/35, Internal medicine, medicine, Adalimumab, factor antagonists, necrosis-factor blockers, systemic treatment, therapy, assay, Psoriasi, History of tuberculosis, tuberculosis infection, chronic plaque psoriasis,Italian Psocare Registry, business.industry, Odds ratio, medicine.disease, bacterial infections and mycoses, Confidence interval, Surgery, Residence Characteristic, Italian Psocare Registry, business
Abstract

SummaryBackground The nationwide prevalence of latent tuberculosis infection (LTBI) in Italian patients with psoriasis has never been investigated. Objectives To estimate the nationwide prevalence of LTBI in Italian patients with psoriasis who are candidates for systemic treatment. Methods Data were obtained from the Psocare Registry on those patients (n = 4946) with age > 18 years, systemic treatment at entry specified and tuberculin skin test (TST) performed according to the Mantoux method. LTBI diagnosis was based on a positive TST result in the absence of any clinical, radiological or microbiological evidence of active tuberculosis. Results Latent tuberculosis infection was diagnosed in 8·3% of patients with psoriasis (409 of 4946). The prevalence of LTBI was lower in patients on biologics than in those on conventional systemic treatments, ranging from 4·3% (19 of 444) of patients on adalimumab to 31% (eight of 26) of those on psoralen–ultraviolet A (P

Published
2015

17. Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry

Author

Piaserico, Stefano, Cazzaniga, Simone, Chimenti, Sergio, Giannetti, Alberto, Maccarone, Mara, Picardo, Mauro, Peserico, Andrea, Naldi, Luigi, Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnã¹, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Balestri, R., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto di Luzio, G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., D’amico, D., Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Domaneschi, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D’oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., González Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavo', S., Manfrã, C., Borgia, F., Puglisi Guerra, A., Sedona, P., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Aricã², M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M. G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvarã , M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D’agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigã², M., De Felice, C., Gubinelli, E., Chimenti, S., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappalã , L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Girolomoni, G., Gisondi, P., Veller Fornasa, C., Trevisan, G. P., Piaserico S, Cazzaniga S, Chimenti S, Giannetti A, Maccarone M, Picardo M, Peserico A, Naldi L, Psocare Study Group [.., Patrizi A, ], Piaserico, S, Cazzaniga, S, Chimenti, S, Giannetti, A, Maccarone, M, Picardo, M, Peserico, A, Naldi, L, Bongiorno, MR, Psocare Study Group, Monfrecola, Giuseppe, and Trevisan, Giusto

Subjects
Male, primary inefficacy, 75% improvement in the Psoriasis Area Severity Index score, PASI, PASI 75, Psoriasis Area Severity Index, TNF, biologics, efficacy, psoriasis, secondary loss of efficacy, switching, tumor necrosis factor, tumor necrosis factor-alfa inhibitors, Adult, Analysis of Variance, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Cohort Studies, Confidence Intervals, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Immunoglobulin G, Italy, Middle Aged, Multivariate Analysis, Predictive Value of Tests, Proportional Hazards Models, Psoriasis, Receptors, Tumor Necrosis Factor, Registries, Retrospective Studies, Risk Assessment, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor-alpha, Young Adult, SWITHCES, psoriasis arthritis, pharmachological treatment, Etanercept, Monoclonal, Receptors, Settore MED/35 - Malattie Cutanee E Veneree, Humanized, Hazard ratio, Predictive value of tests, Drug, biologic, TNF-alpha, medicine.medical_specialty, Dermatology, Antibodies, Dose-Response Relationship, Settore MED/35, Internal medicine, Severity of illness, medicine, Adverse effect, psoriasi, Adalimumab, Infliximab, 2708, Proportional hazards model, business.industry, tumor necrosis factor-alfa inhibitor, Retrospective cohort study, medicine.disease, Confidence interval, Surgery, ANTI-TNFA, business
Abstract

Background: Some studies have shown that switching patients from one tumor necrosis factor (TNF)-alfa inhibitor to another may be beneficial when they have an inadequate response or an adverse event. Objective: We sought to assess the variables predicting the efficacy of the second TNF-alfa inhibitor in patients discontinuing the first TNF-alfa inhibitor. Methods: Data from all 5423 consecutive patients starting TNF-alfa inhibitor therapy for psoriasis between September 2005 and September 2010 who were included in the Italian Psocare registry were analyzed. Results: In 105 patients who switched to a second TNF-alfa inhibitor who had complete follow-up data, 75% improvement in the Psoriasis Area Severity Index score (PASI 75) was reached by 29% after 16 weeks and by 45.6% after 24 weeks. Patients who switched because of secondary loss of efficacy (loss of initial PASI 75 response) or adverse events/intolerance were more likely to reach PASI 75 than those who switched as a result of primary inefficacy (PASI 75 never achieved) (hazard ratio 2.7, 95% confidence interval 1.3-5.5 vs hazard ratio 2.0, 95% confidence interval 1.0-3.9 and 1, respectively). Limitations: There was a small number of patients with complete follow-up data. Conclusion: PASI 75 response in patients who switched from one antie-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first antie-TNF-alfa.

Published
2014

19. Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: Evidence from the Italian Psocare Registry

Author

Gisondi, P., Cazzaniga, S., Chimenti, S., Giannetti, A., Maccarone, M, Picardo, M., Girolomoni, G., Naldi, L., Griseta, V, Miracapillo, A, Azzini, M, Mocci, L, Michelini, M, Offidani, A, Bernardini, L, Campanati, A, Ricotti, G, Giacchetti, A, Norat, M, Gualco, F, Castelli, A, Cuccia, A, Diana, A, Roncarolo, G, Belli, Ma, Baldassarre, Ma, Santoro, G, Vena, Ga, Lo Console, F, Filotico, R, Mastrandrea, V, Brunetti, B, Musumeci, F, Carrabba, E, Dal Mas, P, Annicchiarico, F, Benvegnù, B, Spaziani, G, Cusano, F, Saletta Iannazzone, S, Galluccio, A, Pezza, M, Marchesi, L, Imberti, G, Reseghetti, A, Barbera, C, Reggiani, M, Lanzoni, A, Patrizi, A, Bardazzi, F, Antonucci, A, De Tommaso, S, Balestri, R, Wallnofer, W, Ingannamorte, F, Calzavara-Pinton, P, Iannazzi, S, Zane, C, Capezzera, R, Bassisi, S, Rossi, Mt, Altamura, V, Vigl, W, Nobile, C, Aste, N, Murgia, S, Mugheddu, C, Scuderi, G, Baglieri, F, Di Dio, C, Cilioni Grilli, E, Mastronardi, C, Agnusdei, Cp, Antrilli, A, Aulisa, L, Raimondo, U, Scotto di Luzio, G, Battarra, Vc, Farro, P, Plaitano, R, Micali, G, Musumeci, Ml, Massimino, D, Li Calzi, M, La Greca, S, Pettinato, M, Sapienza, G, Valenti, G, De Giacomo PF, D'Amico, D, Arcangeli, F, Brunelli, D, Ghetti, E, Tulli, A, Assi, G, Amerio, P, Laria, G, Prestinari, F, Spadafora, S, Coppola, M, Caresana, G, Pezzarossa, E, Domaneschi, E, Felisi, C, Donato, L, Bertero, M, Musso, L, Pa lazzini, S, Bruscino, P, Agozzino, Uc, Ottaviani, M, Simoncini, C, Virgili, A, Osti, F, Fabbri, P, Volpi, W, Caproni, M, Lotti, T, Prignano, F, Buggiani, G, Troiano, M, Fenizi, G, Altobella, A, Amoruso, A, Condello, M, Goffredo, A, Righini, Mg, Alessandrini, F, Satolli, F, Zampetti, M, Bertani, E, Fossati, S, Parodi, A, Burlando, M, Fiorucci, C, Nigro, A, Ghigliotti, G, Massone, L, Moise, Gm, Serrai, M, Cannata, G, Campagnoli, Am, Daly, M, Leporati, C, Peila, R, Filosa, G, Bugatti, L, Nicolini, M, Nazzari, G, Cestari, R, Anastasio, F, Larussa, Fm, Pollice, N, De Francesco, F, Mazzocchetti, G, Peris, K, Fargnoli, Mc, Di Cesare, A, De Angelis, L, Flati, G, Biamonte, As, Quarta, G, Congedo, M, Carcaterra, A, Strippoli, D, Fideli, D, Marsili, F, Celli, M, Ceccarini, M, Bachini, L, D'Oria, M, Schirripa, V, De Filippi, C, Martini, P, Lapucci, E, Mazzatenta, C, Ghilardi, A, Simonacci, M, Bettacchi, A, Gasco, R, Zanca, A, Battistini, S, Dattola, S, Vernaci, R, Postorino, F, Zampieri, Pf, Padovan, C, González Intchaurraga MA, Ladurner, J, Guarneri, B, Cannavò, S, Manfrè, C, Borgia, F, Puglisi Guerra, A, Sedona, P, Cattaneo, A, Carrera, C, Fracchiolla, C, Mozzanica, N, Prezzemolo, L, Menni, S, Lodi, A, Martino, P, Monti, M, Mancini, L, Sacrini, F, Altomare, F, Taglioni, M, Lovati, C, Mercuri, Sr, Schiesari, G, Giannetti, A, Conti, A, Lasagni, C, Greco, M, Ronsini, G, Schianchi, S, Fiorentini, C, Niglietta, S, Maglietta, R, Padalino, C, Crippa, D, Pini, M, Rossi, E, Tosi, D, Armas, M, Ruocco, V, Ayala, F, Balato, N, Gaudiello, F, Cimmino, Gf, Monfrecola, G, Gallo, L, Argenziano, G, Fulgione, E, Berruti, G, Ceparano, I, De Michele, I, Giorgiano, D, Leigheb, G, Deledda, S, Peserico, A, Alaibac, M, Piaserico, S, Schiesari, L, Dan, G, Mattei, I, Oro, E, Aricò, M, Bongiorno, Mr, Angileri, R, Amato, S, Todaro, F, Milioto, M, Bellastro, R, Di Nuzzo, S, De Panfilis, G, Zanni, M, Borroni, G, Cananzi, R, Brazzelli, V, Lisi, P, Stingeni, L, Hansel, K, Pierfelice, V, Donelli, S, Rastelli, D, Gasperini, M, Barachini, P, Cecchi, R, Bartoli, L, Pavesi, M, De Paola, S, Corradin, Mt, Ricciuti, F, Piccirillo, A, Viola, L, Tataranni, M, Mautone, Mg, Lo Scocco, G, Niccoli, Mc, Brunasso Vernetti AM, Gaddoni, G, Resta, F, Casadio, Mc, Arcidiaco, Mc, Luvarà, Mc, Albertini, G, Di Lernia, V, Guareschi, E, Catrani, S, Morri, M, De Simone, C, D'Agostino, M, Agostino, I, Calvieri, S, Cantoresi, F, Richetta, A, Sorgi, P, Carnevale, C, Nicolucci, F, Berardesca, E, Gubinelli, E, Chimenti, S, Talamonti, M, Camplone, G, Cruciani, G, Riccardi, F, Barbati, R, Zumiani, G, Pagani, W, Malagoli, Pg, Pellicano, R, Donadio, D, Di Vito, C, Cottoni, F, Montesu, Ma, Pirodda, C, Addis, G, Marongiu, P, Farris, A, Cacciapuoti, M, Verrini, A, Desirello, G, Gnone, M, Fimiani, M, Pellegrino, M, Castelli, G, Zappalà, L, Sesana, G, Ingordo, V, Vozza, Dg, Di Giuseppe, D, Fasciocco, D, Nespoli, P, Papini, M, Cicoletti, M, Bernengo, Mg, Ortoncelli, M, Bonvicino, A, Capella, G, Doveil, Gc, Forte, M, Peroni, A, Salomone, B, Savoia, P, Pippione, M, Zichichi, L, Frazzitta, M, De Luca, G, Tasin, L, Simonetto, S, Ros, S, Trevisan, G, Patamia, M, Miertusova, S, Patrone, A, Frattasio, A, Piccirillo, F, La Spina, S, Di Gaetano, L, Udine, Marzocchi, V, Motolese, A, Venturi, C, Gai, F, Pasquinucci, S, Bellazzi, Rm, Silvestri, T, Girolomoni, G, Gisondi, P, Veller Fornasa, C, Trevisan, Gp., Gisondi, P, Cazzaniga, S, Chimenti, S, Giannetti, A, Maccarone, M, Picardo, M, Girolomoni, G, Naldi, L, Monfrecola, Giuseppe, Psocare Study, G. r. o. u. p., P., Gisondi, S., Cazzaniga, S., Chimenti, A., Giannetti, M., Maccarone, M., Picardo, G., Girolimoni, L., Naldi, Trevisan, Giusto, Psocare Study Group: [.., M. Reggiani, A. Lanzoni, A. Patrizi, F. Bardazzi, A. Antonucci, S. De Tommaso, R. Balestri, and ]

Subjects
Adult, Male, arterial hypertension, Adolescent, Antineoplastic Agents, Risk Assessment, Severity of Illness Index, Antibodies, Drug Administration Schedule, Cohort Studies, Dose-Response Relationship, Young Adult, Settore MED/35, Age Distribution, Metabolic Diseases, Monoclonal, metabolic disorders, Humans, Psoriasis, Prospective Studies, Registries, Sex Distribution, Antibodies, Monoclonal, Dose-Response Relationship, Drug, Evidence-Based Medicine, Female, Immunosuppressive Agents, Incidence, Italy, Treatment Outcome, 2708, Infectious Diseases, METABOLIC SYNDROME, psoriasis, metabolic abnormalities, Treatment, therapy, Metabolic abnormalitie, metabolic comorbidities, Metabolic abnormalities, Drug
Abstract

OBJECTIVE: To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to 16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees. DESIGN: Prospective cohort study. SETTING: Italian public referral centres for psoriasis treatment. PATIENTS: First-time recipients (n = 10,539) of continuous systemic psoriasis treatment for at least 16 weeks. MAIN OUTCOME MEASURE: Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinically meaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartate amino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of new diagnoses of diabetes mellitus and arterial hypertension. RESULTS: Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin or cyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Mean transaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levels increased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treated patients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34) and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated with risk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanine amino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension and diabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88). CONCLUSION: Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed.

Published
2013

20. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Author

Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology

Subjects
Nephrology, Oncology, Male, Cancer Research, mTOR inhibitor, Settore MED/06 - Oncologia Medica, Medizin, Advanced kidney cancer, RAD001, REACT, 0302 clinical medicine, Renal cell carcinoma, Receptors, 80 and over, Treatment Failure, Neoplasm Metastasis, Aged, 80 and over, 0303 health sciences, Vascular Endothelial Growth Factor, Sirolimus, Young Adult, Antineoplastic Agents, Humans, Aged, Immunosuppressive Agents, Protein Kinase Inhibitors, Receptors, Vascular Endothelial Growth Factor, Kidney Neoplasms, Adult, Carcinoma, Renal Cell, Middle Aged, Female, 3. Good health, 030220 oncology & carcinogenesis, Safety, medicine.drug, medicine.medical_specialty, SECOND LINE THERPAY, Second-line therapy, Everolimus, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, 030304 developmental biology, business.industry, Carcinoma, Renal Cell, medicine.disease, Surgery, Clinical trial, Expanded access, business, Kidney cancer
Abstract

BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.

Published
2012

21. Disability, anxiety and depression associated with medication-overuse headache can be considerably reduced by detoxification and prophylactic treatment.:Results from a multicentre, multinational study (COMOESTAS project)

Author

Bendtsen, L, Munksgaard, Sb, Tassorelli, C, Nappi, G, Katsarava, Z, Lainez, M, Leston, Ja, Fadic, R, Spadafora, S, Stoppini, A, Jensen, Rigmor Højland, Bendtsen, L, Munksgaard, Sb, Tassorelli, C, Nappi, G, Katsarava, Z, Lainez, M, Leston, Ja, Fadic, R, Spadafora, S, Stoppini, A, and Jensen, Rigmor Højland

Abstract

OBJECTIVE: The objective of this article is to investigate whether headache-related disability, depression and anxiety can be reduced by detoxification and prophylactic treatment in patients with medication-overuse headache (MOH).METHODS: Patients with MOH were included from six centres in Europe and Latin America in a seven-month cohort study. Before and six months after treatment, the degree of disability was measured by the Migraine Disability Assessment (MIDAS) questionnaire, while anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS).RESULTS: A total of 694 patients with MOH were included, of whom 492 completed the study. Headache days were reduced by 58.4% from 23.6 to 9.8 days per month at six months ( P < 0.001). The MIDAS score was reduced by 57.1% from baseline 59.9 to 25.7 ( P < 0.001). Number of patients with depression was reduced by 50.7% from 195 to 96 and number of those with anxiety was reduced by 27.1% from 284 to 207 (both P < 0.001).CONCLUSIONS: Disability, depression and anxiety were considerably reduced in patients with MOH by detoxification and prophylactic treatment. This emphasises the urgent need for increased awareness about avoiding overuse of headache medications and demonstrates that not only headache frequency but also disability are remarkably improved by adequate intervention.

Published
2014

31. The Effects of MIL-R-81294 Paint Stripper on AS/3501-6 Graphite/Epoxy Composite Systems.

Author

NAVAL AIR DEVELOPMENT CENTER WARMINSTER PA AIRCRAFT AND CREW SYSTEMS TECHNOLOGY DIRECTORATE, Spadafora,S J, NAVAL AIR DEVELOPMENT CENTER WARMINSTER PA AIRCRAFT AND CREW SYSTEMS TECHNOLOGY DIRECTORATE, and Spadafora,S J

Abstract

The use of resin matrix composites for structural applications on naval aircraft has dramatically increased over the past decade. Nine percent of the F-18 Hornet is AS/3501-6 graphite/epoxy composite material. This composite material is predominantly surface structure and is coated with the standard paint scheme (MIL-P-23777 epoxy primer and MIL-C-83286 polyurethane topcoat). During general aircraft rework operations, the coating system of an aircraft is chemically stripped, which would result in the case of the F-18 to exposure of composite material to paint stripper. Previous studies have shown that the standard paint stripper MIL-R-81294 has an adverse effect on the epoxy matrix of these composite systems under total immersion exposure conditions. NAVAIRDEVCEN was tasked to evaluate the effects of MIL-R-81294 paint stripper on AS/3501-6 graphite/epoxy composites under simulated rework conditions. Results of this study show that MIL-R-81294 causes a statistically significant decrease in the physical properties of AS/3501-6 composite materials under simulated rework conditions. This deleterious effect was concentrated at the composite surface directly exposed to the paint stripper. AS/3501-6 graphite/epoxy composite structures should not be exposed to MIL-R-81294 paint stripper. (Author)

Published
1984

32. Investigation of Coating Systems and Removers for Graphite/Epoxy Composite Surfaces.

Author

NAVAL AIR DEVELOPMENT CENTER WARMINSTER PA, Clark, K. G., Spadafora, S. J., NAVAL AIR DEVELOPMENT CENTER WARMINSTER PA, Clark, K. G., and Spadafora, S. J.

Abstract

Permanent primer coating systems and strippable coating systems were investigated for use on both graphite/epoxy composite and aluminum surfaces. While the so-called permanent primer systems did not exhibit sufficient chemical resistance to be useful, two strippable systems were identified. One coating system, based on a nitrocellulose lacquer release coat, was suitable for graphite/epoxy surfaces but not aluminum. A compatible chemical remover was developed for this system using methylene chloride as the solvent base. The second strippable system, based on a polysulfide release coat, can be used on both surfaces and requires a polysulfide remover. Two methods were developed to determine compatibility of chemical removers with graphite/epoxy composites.

Published
1984

35. CONSENS-Latin American Consensus for the Internationalization in Postgraduate Education. Project evolution, communication objectives, web and social networks,CONSENS. Consenso latinoamericano para la internacionalización de la educación de posgrado. Evolución del proyecto, objetivos de comunicación, web y redes sociales,Consens. Consenso latinoamericano per l’internazionalizzazione nell’istruzione post-laurea. Evoluzione del progetto, obiettivi di comunicazione, web e social network

Author

Spadafora, S. G., Gomez, F., Franco LUCCHESE, and Nappi, G.

36. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy

Author

Cutsem, E., Siena, S., Humblet, Y., J-L, Canon, Maurel, J., Bajetta, E., Bart Neyns, Kotasek, D., Alberto Santoro, Sheithauer, W., Spadafora, S., Amado, R. G., Hogan, N., and Laboratory of Molecular and Medical Oncology

Subjects
EGFR, metastatic colorectal cancer, Panitumumab, Extension study, Crossover, Fully human antibody
Abstract

BACKGROUND: A phase 3 study demonstrated that panitumumab, a human monoclonal anti-epidermal growth factor receptor antibody, significantly prolonged progression-free survival versus best supportive care (BSC) in patients with chemorefractory metastatic colorectal cancer. PATIENTS AND METHODS: This open-label extension study evaluated panitumumab monotherapy in BSC patients with radiographically documented disease progression in the phase 3 study. Patients received panitumumab 6 mg/kg every 2 weeks. The primary end point was safety; efficacy was also evaluated. RESULTS: One hundred and seventy-six patients were randomly assigned to the BSC arm of the phase 3 study received >/=1 panitumumab dose in this extension study. Panitumumab was well tolerated. The most frequent treatment-related adverse events were skin toxic effects. Three (2%) patients had a grade 4 treatment-related adverse event. There were no infusion reactions. One (0.6%) patient had a complete response; 19 (11%) patients had a partial response; and 58 (33%) patients had stable disease. Median progression-free survival time was 9.4 [95% confidence interval (CI): 8.0-13.4) weeks. Median overall survival time was 6.3 (95% CI: 5.1-6.8) months. Anti-panitumumab antibodies were detected in 3 (4.2%) of 71 patients with a post-baseline sample. CONCLUSIONS: These findings are comparable to those from the phase 3 study and support panitumumab monotherapy for chemorefractory colorectal cancer.

37. Community based intervention to optimize osteoporosis management: randomized controlled trial

Author

Ciaschini Patricia M, Straus Sharon E, Dolovich Lisa R, Goeree Ron A, Leung Karen M, Woods Carol R, Zimmerman Greg M, Majumdar Sumit R, Spadafora Silvana, Fera Luke A, and Lee Hui N

Subjects
Geriatrics, RC952-954.6
Abstract

Abstract Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene) for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40). More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12) and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65). Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387)

Published
2010
Full Text
View/download PDF

38. A consensus protocol for the management of medication-overuse headache: Evaluation in a multicentric, multinational study.

Author

Tassorelli, C, Jensen, R, Allena, M, De Icco, R, Sances, G, Katsarava, Z, Lainez, M, Leston, JA, Fadic, R, Spadafora, S, Pagani, M, Nappi, G, and the COMOESTAS Consortium

Subjects
*HEADACHE, *HEAD diseases, *DRUGS, *MIGRAINE, *DETOXIFICATION (Substance abuse treatment)
Abstract

Introduction: The management of medication-overuse headache (MOH) is often difficult and no specific guidelines are available as regards the most practical and effective approaches. In this study we defined and tested a consensus protocol for the management of MOH on a large population of patients distributed in different countries.Subjects and Methods: The protocol was based on evidence from the literature and on consolidated expertise of the members of the consensus group. The study was conducted according to a multicentric interventional design with the enrolment of 376 MOH subjects in four centres from Europe and two centres in Latin America. The majority of patients were treated according to an outpatient detoxification programme. The post-detoxification follow-up lasted six months.Results: At the final evaluation, two-thirds of the subjects were no longer overusers and in 46.5% of subjects headache had reverted back to an episodic pattern of headache. When comparing the subjects who underwent out-patient detoxification vs those treated with in-patient detoxification, both regimens proved effective, although the drop-out rate was higher in the out-patient approach.Conclusions: The present findings support the effectiveness and usability of the proposed consensus protocol in different countries with different health care modalities. [ABSTRACT FROM AUTHOR]

Published
2014
Full Text
View/download PDF

39. Disability, anxiety and depression associated with medication-overuse headache can be considerably reduced by detoxification and prophylactic treatment. Results from a multicentre, multinational study (COMOESTAS project).

Author

Bendtsen, L, Munksgaard, SB, Tassorelli, C, Nappi, G, Katsarava, Z, Lainez, M, Leston, JA, Fadic, R, Spadafora, S, Stoppini, A, and Jensen, R

Subjects
*HEADACHE, *ANXIETY, *DRUG overdose, *MIGRAINE
Abstract

Objective: The objective of this article is to investigate whether headache-related disability, depression and anxiety can be reduced by detoxification and prophylactic treatment in patients with medication-overuse headache (MOH). Methods: Patients with MOH were included from six centres in Europe and Latin America in a seven-month cohort study. Before and six months after treatment, the degree of disability was measured by the Migraine Disability Assessment (MIDAS) questionnaire, while anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS). Results: A total of 694 patients with MOH were included, of whom 492 completed the study. Headache days were reduced by 58.4% from 23.6 to 9.8 days per month at six months (p<0.001). The MIDAS score was reduced by 57.1% from baseline 59.9 to 25.7 (p<0.001). Number of patients with depression was reduced by 50.7% from 195 to 96 and number of those with anxiety was reduced by 27.1% from 284 to 207 (both p<0.001). Conclusions: Disability, depression and anxiety were considerably reduced in patients with MOH by detoxification and prophylactic treatment. This emphasises the urgent need for increased awareness about avoiding overuse of headache medications and demonstrates that not only headache frequency but also disability are remarkably improved by adequate intervention [ABSTRACT FROM AUTHOR]

Published
2014
Full Text
View/download PDF

40. Correlation of CTCAE and patient-reported breast radiation dermatitis symptom scores.

Author

Rajeswaran T, Gojsevic M, Zhang L, Kennedy SKF, Karam I, Ding K, Herst P, Wong H, Kwan JYY, Safavi AH, Lam J, Spadafora S, Walde N, Carothers K, Gallant F, Behroozian T, Lam E, and Chow E

Subjects
Humans, Female, Middle Aged, Patient Reported Outcome Measures, Aged, Adult, Radiodermatitis etiology, Radiodermatitis diagnosis, Breast Neoplasms radiotherapy, Severity of Illness Index
Abstract

Background and Purpose: Clinicians use the CTCAE scale to grade radiation dermatitis (RD) based on edema, erythema, and desquamation. The purpose of this study was to correlate the CTCAE scores with the severity of patient-reported symptoms using a skin symptom assessment (SSA) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS)., Materials and Methods: This is a secondary analysis of a randomized controlled trial involving 376 patients receiving Mepitel Film or standard-of-care for RD prophylaxis. The highest symptom categories for SSA and patient-component RISRAS assessments were selected from all time points, and a summary analysis and Spearman correlation coefficient was calculated for patients with CTCAE Grades 0, 1, 2, 3, and Grade 2/3, respectively. Analyses were conducted across all patients, within each treatment arm, and between arms in patients with only Grade 2 or 3 toxicity., Results: Weak correlations between CTCAE scores and all patient-reported skin symptoms were found across the entire cohort and each treatment arm (p < 0.05). Patients with Grade 2 (n = 72) and Grade 3 RD (n = 24) reported similar rates of patient-reported moderate-to-severe skin symptoms (11-72% vs 14-79%), with no significant difference in rates of individual moderate-to-severe symptom between these cohorts (p > 0.05). Between treatment arms, rates of patient-reported moderate-to-severe scores were similar for most symptoms., Conclusion: CTCAE RD scores are weakly correlated with patient-reported skin symptoms and cannot distinguish between patients with severe patient-reported outcomes. Clinicians should consider the limitations of CTCAE grading and incorporate patient-reported outcomes within clinical practice., Competing Interests: Declarations Ethics approval This research was conducted in accordance with the Declaration of Helsinki. Human ethics and consent to participate declarations were not applicable. Competing Interests The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2024
Full Text
View/download PDF

41. Concordance of patient- and clinician-reported outcomes of acute radiation dermatitis in breast cancer.

Author

Gojsevic M, Rajeswaran T, Zhang L, Kennedy SKF, Karam I, Ding K, Herst P, Wong H, Kwan JYY, Safavi AH, Lam J, Spadafora S, Walde N, Carothers K, Gallant F, Behroozian T, Lam E, and Chow E

Subjects
Humans, Female, Middle Aged, Aged, Logistic Models, Adult, Radiotherapy, Adjuvant adverse effects, Radiotherapy, Adjuvant methods, Acute Disease, Severity of Illness Index, Breast Neoplasms radiotherapy, Radiodermatitis etiology, Patient Reported Outcome Measures
Abstract

Background and Purpose: The study evaluated the concordance between patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) of acute radiation dermatitis (RD) symptoms following adjuvant radiotherapy for early-stage and locally advanced breast cancer., Material and Methods: This is a secondary analysis of a multi-center randomized phase 3 trial (376 patients). Ordinal logistic regression analysis was used to compare the Skin Symptom Assessment (SSA) independently reported by both patients and clinicians. Concordance between patient- and clinician-reported SSAs for RD symptoms was measured by percent concordance, concordance index (C-statistic), and Cohen's Kappa. Analyses were performed across all patients in the original modified intention-to-treat analysis and those with only grade 2-3 (CTCAE) RD., Results: PROs were significantly more severe than CROs across all RD symptoms (Odds Ratio [OR] > 1; p < 0.0001). Pigmentation (OR 5.4), blistering/peeling (OR 4.0), and pain/soreness (OR 3.9) were the most differentially reported symptoms. Poor-to-low concordance was noted between patient- and clinician-reported SSAs for all RD symptoms for the entire cohort (percent concordance < 50%, C-statistic 0.52-0.63, Cohen's Kappa 13.9-23.4%) and those with grade 2-3 RD (percent concordance < 50%, C-statistic 0.56-0.66, Cohen's Kappa 2.0-24.5%). Similarly, poor-to-low concordance was noted in both Mepitel film and standard-of-care arms., Conclusion: PROs and CROs have poor concordance in breast RD, and patients report worse outcomes than clinicians, regardless of RD severity or prophylaxis. PROs must be further integrated into routine clinical practice and clinical trial design to reduce the risk of underreporting symptoms., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2024
Full Text
View/download PDF

42. Adjunctive Statistical Standardization of Adjuvant Estrogen Receptor and Progesterone Receptor in Canadian Cancer Trials Group MA.27 Postmenopausal Breast Cancer Trial of Exemestane Versus Anastrozole.

Author

Chapman JW, Bayani J, SenGupta S, Bartlett JMS, Piper T, Quintayo MA, Virk S, Goss PE, Ingle JN, Ellis MJ, Sledge GW, Budd GT, Rabaglio M, Ansari RH, Tozer R, D'Souza DP, Chalchal H, Spadafora S, Stearns V, Perez EA, Gelmon KA, Whelan TJ, Elliott C, Shepherd LE, Chen BE, and Taylor KJ

Subjects
Humans, Female, Middle Aged, Aged, Canada, Chemotherapy, Adjuvant, Disease-Free Survival, Anastrozole therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Breast Neoplasms mortality, Receptors, Progesterone metabolism, Receptors, Progesterone analysis, Receptors, Estrogen metabolism, Receptors, Estrogen analysis, Postmenopause, Androstadienes therapeutic use, Androstadienes administration & dosage
Abstract

Purpose: ASCO/College of American Pathologists guidelines recommend reporting estrogen receptor (ER) and progesterone receptor (PgR) as positive with (1%-100%) staining. Statistically standardized quantitated positivity could indicate differential associations of positivity with breast cancer outcomes., Methods: MA.27 (ClinicalTrials.gov identifier: NCT00066573) was a phase III adjuvant trial of exemestane versus anastrozole in postmenopausal women with early-stage breast cancer. Immunochemistry ER and PgR HSCORE and % positivity (%+) were centrally assessed by machine image quantitation and statistically standardized to mean 0 and standard deviation (SD) 1 after Box-Cox variance stabilization transformations of square for ER; for PgR, (1) natural logarithm (0.1 added to 0 HSCOREs and 0%+) and (2) square root. Our primary end point was MA.27 distant disease-free survival (DDFS) at a median 4.1-year follow-up, and secondary end point was event-free survival (EFS). Univariate survival with cut points at SDs about a mean of 0 (≤-1; (-1, 0]; (0, 1]; >1) was described with Kaplan-Meier plots and examined with Wilcoxon (Peto-Prentice) test statistic. Adjusted Cox multivariable regressions had two-sided Wald tests and nominal significance P < .05., Results: Of 7,576 women accrued, 3,048 women's tumors had machine-quantitated image analysis results: 2,900 (95%) for ER, 2,726 (89%) for PgR, and 2,582 (85% of 3,048) with both ER and PgR. Higher statistically standardized ER and PgR HSCORE and %+ were associated with better univariate DDFS and EFS ( P < .001). In multivariable assessments, ER HSCORE and %+ were not significantly associated ( P = .52-.88) with DDFS in models with PgR, whereas higher PgR HSCORE and %+ were significantly associated with better DDFS ( P = .001) in models with ER., Conclusion: Adjunctive statistical standardization differentiated quantitated levels of ER and PgR. Patients with higher ER- and PgR-standardized units had superior DDFS compared with those with HSCOREs and %+ ≤-1.

Published
2024
Full Text
View/download PDF

43. New Anticancer Drugs: Reliably Assessing "Value" While Addressing High Prices.

Author

Stewart DJ, Bradford JP, Sehdev S, Ramsay T, Navani V, Rawson NSB, Jiang DM, Gotfrit J, Wheatley-Price P, Liu G, Kaplan A, Spadafora S, Goodman SG, Auer RAC, and Batist G

Subjects
Humans, Canada, Quality-Adjusted Life Years, Drug Costs, COVID-19, Neoplasms drug therapy, Neoplasms economics, SARS-CoV-2, Antineoplastic Agents therapeutic use, Antineoplastic Agents economics, Cost-Benefit Analysis methods
Abstract

Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. We need system-wide reform that will enable less expensive, faster drug development. The speed with which COVID-19 vaccines and AIDS therapies were developed indicates this is possible if governments prioritize it. Countries also differ in how they value drugs, and generally, those willing to pay more have better, faster access. Canada is used as an example to illustrate how "incremental cost-effectiveness ratios" (ICERs) based on measures such as gains in "quality-adjusted life-years" (QALYs) may be used to determine a drug's value but are often problematic, imprecise assessments. Generally, ICER/QALY estimates inadequately consider the impact of patient crossover or long post-progression survival, therapy benefits in distinct subpopulations, positive impacts of the therapy on other healthcare or societal costs, how much governments willingly might pay for other things, etc. Furthermore, a QALY value should be higher for a lethal or uncommon disease than for a common, nonlethal disease. Compared to international comparators, Canada is particularly ineffective in initiating public funding for essential new medications. Addressing these disparities demands urgent reform.

Published
2024
Full Text
View/download PDF

44. Access to Oncology Medicines in Canada: Consensus Forum for Recommendations for Improvement.

Author

Sehdev SR, Rawson NSB, Aseyev OI, Buick CJ, Butler MO, Edwards S, Gill S, Gotfrit JM, Hsia CC, Juergens RA, Manna M, McCarthy JS, Mukherjee SD, Snow SL, Spadafora S, Stewart DJ, Wentzell JR, Wong RPW, and Zalewski PG

Subjects
Humans, Canada, Antineoplastic Agents therapeutic use, Consensus, Medical Oncology standards, Neoplasms drug therapy, Health Services Accessibility
Abstract

Patient access to new oncology drugs in Canada is only possible after navigating multiple sequential systemic checkpoints for national regulatory approval, health technology assessment (HTA) and collective government price negotiation. These steps delay access and prevent health care providers from being able to prescribe optimal therapy. Eighteen Canadian oncology clinicians from the medicine, nursing and pharmacy professions met to develop consensus recommendations for defining reasonable government performance standards around process and timeliness to improve Canadian cancer patients' access to best care. A modified Delphi methodology was used to identify consensus on 30 questions involving five themes: accountability, disparities, endpoints, timeliness, and cost-effectiveness. It was agreed that greater transparency is required across regulatory and HTA processes. Health professionals in oncology are frustrated for their patients because they are unable to deliver the modern guideline-supported therapies they want to provide due to delays in approval or funding. Canadian health care providers request improvements in timely access to life-saving therapeutics in line with other comparator countries. Clinicians expect urgent improvements in Canadian health systems to give our patients their best chance of survival.

Published
2024
Full Text
View/download PDF

45. Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial.

Author

Behroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C, Walde N, Lam E, Wong G, McKenzie E, Ariello K, Kennedy S, Shariati S, Carothers K, Gonzales G, Kagan Y, and Chow E

Subjects
Humans, Female, Mastectomy adverse effects, Silicones, Randomized Controlled Trials as Topic, Breast Neoplasms radiotherapy, Breast Neoplasms surgery, Breast Neoplasms complications, Radiodermatitis etiology, Radiodermatitis prevention & control
Abstract

Purpose: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD., Methods: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes., Results: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores ( P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1)., Conclusion: MF significantly reduces RD in patients undergoing breast radiotherapy.

Published
2023
Full Text
View/download PDF

46. Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial.

Author

Auer RC, Ott M, Karanicolas P, Brackstone MR, Ashamalla S, Weaver J, Tagalakis V, Boutros M, Stotland P, Marulanda AC, Moloo H, Jayaraman S, Patel S, Le Gal G, Spadafora S, MacLellan S, Trottier D, Jonker D, Asmis T, Mallick R, Pecarskie A, Ramsay T, and Carrier M

Subjects
Adolescent, Adult, Anticoagulants adverse effects, Disease-Free Survival, Heparin, Low-Molecular-Weight adverse effects, Humans, Neoplasm Recurrence, Local, Ontario, Postoperative Complications prevention & control, Postoperative Hemorrhage, Tinzaparin, Colorectal Neoplasms surgery, Venous Thromboembolism etiology
Abstract

Objective: To determine the efficacy and safety of extended duration perioperative thromboprophylaxis by low molecular weight heparin when assessing disease-free survival in patients undergoing resection for colorectal cancer., Design: Multicentre, open label, randomised controlled trial., Settings: 12 hospitals in Quebec and Ontario, Canada, between 25 October 2011 and 31 December 2020., Participants: 614 adults (age ≥18 years) were eligible with pathologically confirmed invasive adenocarcinoma of the colon or rectum, no evidence of metastatic disease, a haemoglobin concentration of ≥8 g/dL, and were scheduled to undergo surgical resection., Interventions: Random assignment to extended duration thromboprophylaxis using daily subcutaneous tinzaparin at 4500 IU, beginning at decision to operate and continuing for 56 days postoperatively, compared with in-patient postoperative thromboprophylaxis only., Main Outcome Measures: Primary outcome was disease-free survival at three years, defined as survival without locoregional recurrence, distant metastases, second primary (same cancer), second primary (other cancer), or death. Secondary outcomes included venous thromboembolism, postoperative major bleeding complications, and five year overall survival. Analyses were done in the intention-to-treat population., Results: The trial stopped recruitment prematurely after the interim analysis for futility. The primary outcome occurred in 235 (77%) of 307 patients in the extended duration group and in 243 (79%) of 307 patients in the in-hospital thromboprophylaxis group (hazard ratio 1.1, 95% confidence interval 0.90 to 1.33; P=0.4). Postoperative venous thromboembolism occurred in five patients (2%) in the extended duration group and in four patients (1%) in the in-hospital thromboprophylaxis group (P=0.8). Major surgery related bleeding in the first postoperative week was reported in one person (<1%) in the extended duration and in six people (2%) in the in-hospital thromboprophylaxis group (P=0.1). No difference was noted for overall survival at five years in 272 (89%) patients in the extended duration group and 280 (91%) patients in the in-hospital thromboprophylaxis group (hazard ratio 1.12; 95% confidence interval 0.72 to 1.76; P=0.1)., Conclusions: Extended duration to perioperative anticoagulation with tinzaparin did not improve disease-free survival or overall survival in patients with colorectal cancer undergoing surgical resection compared with in-patient postoperative thromboprophylaxis alone. The incidences of venous thromboembolism and postoperative major bleeding were low and similar between groups., Trial Registration: ClinicalTrials.gov NCT01455831., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Canadian Institute of Health Research, Ottawa Hospital Academic Medical Organisation, and Leo Pharma, as well as through generous patient donations through the Ottawa Hospital Foundation for the submitted work. MC has received research funding from BMS, Pfizer, and Leo Pharma, and honorariums from Bayer, Pfizer, BMS, Servier, and Leo Pharma. VT received consulting honorariums from Pfizer-BMS and Daiichi-Sankyo and has received research funding from Sanofi. MB received consulting honorariums from Johnson and Johnson. ACM received consulting honorariums from Johnson and Johnson. MO received consulting honorariums from Johnson and Johnson Ethicon. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
Full Text
View/download PDF

47. Access Denied? The Unintended Consequences of Pending Drug Pricing Rules.

Author

Kaplan A, Stewart DJ, Batist G, Spadafora S, Sehdev S, and Goodman SG

Subjects
Canada, Costs and Cost Analysis, Humans, Drug Costs
Abstract

The government of Canada now plans to bring into force new federal drug pricing regulations on 1 July 2022. We do not take issue with the goal of medication affordability, which is vital in healthcare the world over. Our concern is that the new guidelines are being implemented without due consideration for three major unintended consequences: regulatory changes will lower the number of clinical trials for new medications in Canada, fewer clinical trials will mean lower research and development investments, and changes will reduce patients' access to new medications. Access to effective medications is a cornerstone of healthcare for Canadian patients. As physicians, our duty to patient care demands that we tell the government to protect the right of Canadians to timely access to life-changing medicines.

Published
2022
Full Text
View/download PDF

48. Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial.

Author

Krzyzanowska MK, Julian JA, Gu CS, Powis M, Li Q, Enright K, Howell D, Earle CC, Gandhi S, Rask S, Brezden-Masley C, Dent S, Hajra L, Freeman O, Spadafora S, Hamm C, Califaretti N, Trudeau M, Levine MN, Amir E, Bordeleau L, Chiarotto JA, Elser C, Husain J, Laferriere N, Rahim Y, Robinson AG, Vandenberg T, and Grunfeld E

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms psychology, COVID-19, Chemotherapy, Adjuvant adverse effects, Drug-Related Side Effects and Adverse Reactions, Emergency Service, Hospital statistics & numerical data, Female, Humans, Middle Aged, Ontario, Pandemics, Quality of Life, SARS-CoV-2, Surveys and Questionnaires, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Breast Neoplasms drug therapy, Monitoring, Ambulatory methods, Outpatients, Telemedicine, Telephone
Abstract

Objective: To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer., Design: Pragmatic, cluster randomised trial., Setting: 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care., Participants: All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires., Interventions: Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle., Main Outcome Measures: The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life., Results: Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively., Conclusions: Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant., Trial Registration: ClinicalTrials.gov NCT02485678., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Ontario Institute for Cancer Research (OICR) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; CCE and EG hold appointments at the OICR Health Services Research Programme; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
Full Text
View/download PDF

49. The Operation of Canada's Only Virtually Operated Radiation Oncology Service During the COVID-19 Pandemic.

Author

Romani C, Conlon M, Oliver M, Leszczynski K, Hunter M, Lam K, Spadafora S, and Pearce A

Abstract

Purpose: Our institution operates a remote radiation oncology service in Northern Ontario, Canada. Since the start of the coronavirus disease 2019 pandemic, this center has operated without radiation oncologists on site owing to safety precautions, and this study seeks to understand the effect of this shift., Methods and Materials: Departmental level data reports were used to investigate differences in metrics between April to May of 2019 and April to May 2020. These metrics include the total number of referrals received, average wait time from referral to consult, the number of cases that underwent peer review before beginning treatment, the total number of fractions given over each period, patient-reported outcomes, and patient satisfaction. We also examined the importance of physical examinations and the use of SABR treatment., Results: There was an observed decrease in the number of referrals received, total number of fractions administered, and number of patients providing patient-reported outcomes. We observed no change in patient wait times, cases undergoing peer review before commencing treatment, or overall patient satisfaction. Challenges were identified in the collection of patient- reported outcomes and the conduction of physical examinations., Conclusions: This paper provides proof of concept that a radiation clinic can function entirely virtually in the short term without sacrificing patient satisfaction, efficiency, or safety., (© 2020 The Authors.)

Published
2020
Full Text
View/download PDF

50. Oncology education for family medicine residents: a national needs assessment survey.

Author

Yip SM, Meyers DE, Sisler J, Wycliffe-Jones K, Kucharski E, Elser C, Temple-Oberle C, Spadafora S, Ingledew PA, Giuliani M, Kuruvilla S, Sumar N, and Tam VC

Subjects
Canada, Education, Medical, Graduate, Female, Humans, Needs Assessment, Surveys and Questionnaires, Family Practice, Internship and Residency
Abstract

Background: This study aimed to determine the current state of oncology education in Canadian family medicine postgraduate medical education programs (FM PGME) and examine opinions regarding optimal oncology education in these programs., Methods: A survey was designed to evaluate ideal and current oncology teaching, educational topics, objectives, and competencies in FM PGMEs. The survey was sent to Canadian family medicine (FM) residents and program directors (PDs)., Results: In total, 150 residents and 17 PDs affiliated with 16 of 17 Canadian medical schools completed the survey. The majority indicated their programs do not have a mandatory clinical rotation in oncology (79% residents, 88% PDs). Low rates of residents (7%) and PDs (13%) reported FM residents being adequately prepared for their role in caring for cancer patients (p = 0.03). Residents and PDs believed the most optimal method of teaching oncology is through clinical exposure (65% residents, 80% PDs). Residents and PDs agreed the most important topics to learn (rated ≥4.7 on 5-point Likert scale) were: performing pap smears, cancer screening/prevention, breaking bad news, and approach to patient with increased cancer risk. According to residents, other important topics such as appropriate cancer patient referrals, managing cancer complications and post-treatment surveillance were only taught at frequencies of 52, 40 and 36%, respectively., Conclusions: Current FM PGME oncology education is suboptimal, although the degree differs in the opinion of residents and PDs. This study identified topics and methods of education which could be focussed upon to improve FM oncology education.

Published
2020
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results