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4. The Sac Evolution Imaging Follow-Up after EVAR: an international expert opinion-based Delphi consensus study

Author

Tinelli, G, D'Oria, M, Sica, S, Mani, K, Rancic, Z, Resch, T, Beccia, F, Azizzadeh, A, Da Volta Ferreira, M, Gargiulo, M, Lepidi, S, Tshomba, Y, Oderich, G, Haulon, S, Beck, A, Hertault, A, Savlania, A, Froio, A, Giaquinta, A, Zimmermann, A, Psyllas, A, Wanhainen, A, Marchetti, A, Queiroz, A, Kahlberg, A, Reyes-Valdivia, A, Schanzer, A, Tambyraja, A, Freyrie, A, Lorido, A, Millon, A, Ippoliti, A, Abai, B, Mees, B, Reutersberg, B, Maurel, B, Michel, B, Wahlgren, C, Cavazzini, C, Setacci, C, Lee, C, Ferrer, C, Bicknell, C, Raphael, C, Clair, D, Dawson, D, Arnaoutakis, D, Bockler, D, Kotelis, D, Mujagic, E, Chisci, E, Cieri, E, Gallitto, E, Marone, E, Ducasse, E, Verzini, F, Pecoraro, F, Serracino-Inglott, F, Benedetto, F, Speziale, F, Stilo, F, Alvarez-Marcos, F, Pagliariccio, G, Piffaretti, G, Lanza, G, Philipp, G, Geenberg, G, Jung, G, Melissano, G, Veraldi, G, Parlani, G, Faggioli, G, de Donato, G, Simonte, G, Colacchio, G, De Caridi, G, Pratesi, G, Spinella, G, Torsello, G, Leong Tan, G, Magee, G, Verhagen, H, Andrew, H, Koleilat, I, Ohman, J, de Vries, J, Budtz-Lilly, J, Black, J, Eldrup-Jorgensen, J, Hockley, J, Bath, J, Sobocinski, J, van Herwaarden, J, Reinhard, K, Orion, K, Amankwah, K, Bertoglio, L, di Marzo, L, Garriboli, L, Rizzo, L, Hakimi, M, Sheahan, M, Khashram, M, Schermerhorn, M, Lescan, M, Conrad, M, Davies, M, Czerny, M, Orrico, M, Eagleton, M, Smeds, M, Taurino, M, Wohlauer, M, Sharafuddin, M, Anna-Leonie, M, Reijnen, M, Antonello, M, Piazza, M, Settembre, N, Mouawad, N, Tsilimparis, N, Dias, N, Martinelli, O, Frigatti, P, Sirignano, P, Chong, P, Bevis, P, Dimuzio, P, Henke, P, Duppers, P, Holt, P, Helmio, P, Vriens, P, Pulli, R, Bellosta, R, Micheli, R, Veeraswamy, R, Cuff, R, Chiappa, R, Gattuso, R, Pini, R, Dalman, R, Milner, R, Scali, S, Bahia, S, Laukontaus, S, Trimarchi, S, Fernandez-Alonso, S, Deglise, S, Bellmunt-Montoya, S, Hofer, S, Yusuf, S, Ronchey, S, Bartoli, S, Bonvini, S, Camparini, S, Fazzini, S, Pirrelli, S, Horer, T, Bisdas, T, Vasudevan, T, Lattmann, T, Wyss, T, Maldonado, T, Pfammatter, T, Kolbel, T, Jakimowicz, T, Donati, T, Tracci, M, Bracale, U, Tolva, V, Riambau, V, Palazzo, V, Makaloski, V, Von Allmen, R, Dorigo, W, Mansour, W, Van den Eynde, W, Tinelli G., D'Oria M., Sica S., Mani K., Rancic Z., Resch T. A., Beccia F., Azizzadeh A., Da Volta Ferreira M. M., Gargiulo M., Lepidi S., Tshomba Y., Oderich G. S., Haulon S., Beck A. W., Hertault A., Savlania A., Froio A., Giaquinta A., Zimmermann A., Psyllas A., Wanhainen A., Marchetti A. A., Queiroz A. B., Kahlberg A., Reyes-Valdivia A., Schanzer A., Tambyraja A., Freyrie A., Lorido A., Millon A., Ippoliti A., Abai B., Mees B., Reutersberg B., Maurel B., Michel B., Wahlgren C. M., Cavazzini C., Setacci C., Lee C. J., Ferrer C., Bicknell C., Raphael C., Clair D., Dawson D. L., Arnaoutakis D. J., Bockler D., Kotelis D., Mujagic E., Chisci E., Cieri E., Gallitto E., Marone E. M., Ducasse E., Verzini F., Pecoraro F., Serracino-Inglott F., Benedetto F., Speziale F., Stilo F., Alvarez-Marcos F., Pagliariccio G., Piffaretti G., Lanza G., Philipp G., Geenberg G., Jung G., Melissano G., Veraldi G. F., Parlani G., Faggioli G., de Donato G., Simonte G., Colacchio G., De Caridi G., Pratesi G., Spinella G., Torsello G., Leong Tan G. W., Magee G. A., Verhagen H., Andrew H., Koleilat I., Ohman J. W., de Vries J. P. P. M., Budtz-Lilly J., Black J., Eldrup-Jorgensen J., Hockley J., Bath J., Sobocinski J., van Herwaarden J. A., Reinhard K., Orion K. C., Amankwah K., Bertoglio L., di Marzo L., Garriboli L., Rizzo L., Hakimi M., Sheahan M., Khashram M., Schermerhorn M., Lescan M., Conrad M., Davies M. G., Czerny M., Orrico M., Eagleton M. J., Smeds M. R., Taurino M., Wohlauer M., Sharafuddin M. J., Anna-Leonie M., Reijnen M., Antonello M., Piazza M., Settembre N., Mouawad N. J., Tsilimparis N., Dias N., Martinelli O., Frigatti P., Sirignano P., Chong P., Bevis P., DiMuzio P., Henke P., Duppers P., Holt P., Helmio P., Vriens P., Pulli R., Bellosta R., Micheli R., Veeraswamy R., Cuff R., Chiappa R., Gattuso R., Pini R., Dalman R. L., Milner R., Scali S. T., Bahia S., Laukontaus S., Trimarchi S., Fernandez-Alonso S., Deglise S., Bellmunt-Montoya S., Hofer S., Yusuf S. W., Ronchey S., Bartoli S., Bonvini S., Camparini S., Fazzini S., Pirrelli S., Horer T., Bisdas T., Vasudevan T., Lattmann T., Wyss T. R., Maldonado T., Pfammatter T., Kolbel T., Jakimowicz T., Donati T., Tracci M., Bracale U. M., Tolva V. S., Riambau V., Palazzo V., Makaloski V., Von Allmen R. S., Dorigo W., Mansour W., Van den Eynde W., Tinelli, G, D'Oria, M, Sica, S, Mani, K, Rancic, Z, Resch, T, Beccia, F, Azizzadeh, A, Da Volta Ferreira, M, Gargiulo, M, Lepidi, S, Tshomba, Y, Oderich, G, Haulon, S, Beck, A, Hertault, A, Savlania, A, Froio, A, Giaquinta, A, Zimmermann, A, Psyllas, A, Wanhainen, A, Marchetti, A, Queiroz, A, Kahlberg, A, Reyes-Valdivia, A, Schanzer, A, Tambyraja, A, Freyrie, A, Lorido, A, Millon, A, Ippoliti, A, Abai, B, Mees, B, Reutersberg, B, Maurel, B, Michel, B, Wahlgren, C, Cavazzini, C, Setacci, C, Lee, C, Ferrer, C, Bicknell, C, Raphael, C, Clair, D, Dawson, D, Arnaoutakis, D, Bockler, D, Kotelis, D, Mujagic, E, Chisci, E, Cieri, E, Gallitto, E, Marone, E, Ducasse, E, Verzini, F, Pecoraro, F, Serracino-Inglott, F, Benedetto, F, Speziale, F, Stilo, F, Alvarez-Marcos, F, Pagliariccio, G, Piffaretti, G, Lanza, G, Philipp, G, Geenberg, G, Jung, G, Melissano, G, Veraldi, G, Parlani, G, Faggioli, G, de Donato, G, Simonte, G, Colacchio, G, De Caridi, G, Pratesi, G, Spinella, G, Torsello, G, Leong Tan, G, Magee, G, Verhagen, H, Andrew, H, Koleilat, I, Ohman, J, de Vries, J, Budtz-Lilly, J, Black, J, Eldrup-Jorgensen, J, Hockley, J, Bath, J, Sobocinski, J, van Herwaarden, J, Reinhard, K, Orion, K, Amankwah, K, Bertoglio, L, di Marzo, L, Garriboli, L, Rizzo, L, Hakimi, M, Sheahan, M, Khashram, M, Schermerhorn, M, Lescan, M, Conrad, M, Davies, M, Czerny, M, Orrico, M, Eagleton, M, Smeds, M, Taurino, M, Wohlauer, M, Sharafuddin, M, Anna-Leonie, M, Reijnen, M, Antonello, M, Piazza, M, Settembre, N, Mouawad, N, Tsilimparis, N, Dias, N, Martinelli, O, Frigatti, P, Sirignano, P, Chong, P, Bevis, P, Dimuzio, P, Henke, P, Duppers, P, Holt, P, Helmio, P, Vriens, P, Pulli, R, Bellosta, R, Micheli, R, Veeraswamy, R, Cuff, R, Chiappa, R, Gattuso, R, Pini, R, Dalman, R, Milner, R, Scali, S, Bahia, S, Laukontaus, S, Trimarchi, S, Fernandez-Alonso, S, Deglise, S, Bellmunt-Montoya, S, Hofer, S, Yusuf, S, Ronchey, S, Bartoli, S, Bonvini, S, Camparini, S, Fazzini, S, Pirrelli, S, Horer, T, Bisdas, T, Vasudevan, T, Lattmann, T, Wyss, T, Maldonado, T, Pfammatter, T, Kolbel, T, Jakimowicz, T, Donati, T, Tracci, M, Bracale, U, Tolva, V, Riambau, V, Palazzo, V, Makaloski, V, Von Allmen, R, Dorigo, W, Mansour, W, Van den Eynde, W, Tinelli G., D'Oria M., Sica S., Mani K., Rancic Z., Resch T. A., Beccia F., Azizzadeh A., Da Volta Ferreira M. M., Gargiulo M., Lepidi S., Tshomba Y., Oderich G. S., Haulon S., Beck A. W., Hertault A., Savlania A., Froio A., Giaquinta A., Zimmermann A., Psyllas A., Wanhainen A., Marchetti A. A., Queiroz A. B., Kahlberg A., Reyes-Valdivia A., Schanzer A., Tambyraja A., Freyrie A., Lorido A., Millon A., Ippoliti A., Abai B., Mees B., Reutersberg B., Maurel B., Michel B., Wahlgren C. M., Cavazzini C., Setacci C., Lee C. J., Ferrer C., Bicknell C., Raphael C., Clair D., Dawson D. L., Arnaoutakis D. J., Bockler D., Kotelis D., Mujagic E., Chisci E., Cieri E., Gallitto E., Marone E. M., Ducasse E., Verzini F., Pecoraro F., Serracino-Inglott F., Benedetto F., Speziale F., Stilo F., Alvarez-Marcos F., Pagliariccio G., Piffaretti G., Lanza G., Philipp G., Geenberg G., Jung G., Melissano G., Veraldi G. F., Parlani G., Faggioli G., de Donato G., Simonte G., Colacchio G., De Caridi G., Pratesi G., Spinella G., Torsello G., Leong Tan G. W., Magee G. A., Verhagen H., Andrew H., Koleilat I., Ohman J. W., de Vries J. P. P. M., Budtz-Lilly J., Black J., Eldrup-Jorgensen J., Hockley J., Bath J., Sobocinski J., van Herwaarden J. A., Reinhard K., Orion K. C., Amankwah K., Bertoglio L., di Marzo L., Garriboli L., Rizzo L., Hakimi M., Sheahan M., Khashram M., Schermerhorn M., Lescan M., Conrad M., Davies M. G., Czerny M., Orrico M., Eagleton M. J., Smeds M. R., Taurino M., Wohlauer M., Sharafuddin M. J., Anna-Leonie M., Reijnen M., Antonello M., Piazza M., Settembre N., Mouawad N. J., Tsilimparis N., Dias N., Martinelli O., Frigatti P., Sirignano P., Chong P., Bevis P., DiMuzio P., Henke P., Duppers P., Holt P., Helmio P., Vriens P., Pulli R., Bellosta R., Micheli R., Veeraswamy R., Cuff R., Chiappa R., Gattuso R., Pini R., Dalman R. L., Milner R., Scali S. T., Bahia S., Laukontaus S., Trimarchi S., Fernandez-Alonso S., Deglise S., Bellmunt-Montoya S., Hofer S., Yusuf S. W., Ronchey S., Bartoli S., Bonvini S., Camparini S., Fazzini S., Pirrelli S., Horer T., Bisdas T., Vasudevan T., Lattmann T., Wyss T. R., Maldonado T., Pfammatter T., Kolbel T., Jakimowicz T., Donati T., Tracci M., Bracale U. M., Tolva V. S., Riambau V., Palazzo V., Makaloski V., Von Allmen R. S., Dorigo W., Mansour W., and Van den Eynde W.

Abstract

Objective: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. Methods: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. Results: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. Conclusions: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

Published
2024

5. Seismic Performance of a Bituminous-Faced Rockfill Dam

Author

Tretola, M., Zeolla, E., Sica, S., Ansal, Atilla, Series Editor, Bommer, Julian, Editorial Board Member, Bray, Jonathan D., Editorial Board Member, Pitilakis, Kyriazis, Editorial Board Member, Yasuda, Susumu, Editorial Board Member, Wang, Lanmin, editor, Zhang, Jian-Min, editor, and Wang, Rui, editor

Published
2022
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9. Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study

Author

Sirignano, P, Piffaretti, G, Ceruti, S, Orso, M, Picozzi, M, Ricci, G, Sirignano, A, Taurino, M, Giancarlo Accarino, M, Accrocca, F, Alba, G, Alberti, A, Alberti, V, Allevi, S, Aloisi, F, Amato, B, Amico, A, Andreoli, F, Angiletta, D, Antico, A, Antico, L, Antonello, M, Baccellieri, D, Badalamenti, G, Bafile, G, Baldi, C, Barillà, C, Barillà, D, Bartoli, S, Basile, G, Battaglia, G, Battocchio, C, Belloni, A, Bellosta, R, Benevento, D, Bernardini, G, Bertagna, G, Bertoglio, L, Bianchini Massoni, C, Bisacco, D, Bischetti, M, Boccalon, L, Bonanno, P, Bonardelli, S, Borioni, R, P Borrelli, M, Bozzani, A, M Bracale, U, Camparini, S, Canciglia, A, Canova, F, Capoccia, L, Cappelli, A, Cappiello, P, Carluccio, C, Casalino, A, Casella, F, Casilli, G, Castagno, C, Castelli, P, Castrucci, T, Cavallo, M, Cavazzini, C, Ceccanei, G, Cefalì, P, Celoria, G, Cevolani, M, Chiappa, R, Chisci, E, Comande, C, Compagna, R, Cumino, A, Cuozzo, S, Dalla Caneva, P, D'Alessio, I, D'Arrigo, G, DE Caridi, G, DE Donato, G, DE Donno, G, Desantis, C, DE Santis, F, DE Troia, A, Dezi, T, A Diaco, D, DI Domenico, R, DI Filippo, M, DI Girolamo, A, P Dionisi, C, Dinoto, E, DI Stefano, F, DI STEFANO, L, D'Oria, M, Esposito, A, Esposito, D, Ettore, L, F Fadda, G, Faggioli, G, T Fargion, A, Fazzini, S, Fermani, N, Ferrante, G, Ferrari, M, Ferraro, S, Ferrer, C, Ferretto, L, Ficarelli, I, Filippi, F, Fino, G, Forliti, E, Formiconi, M, Flora, L, Fresilli, M, Frigatti, P, Frigerio, D, Froio, A, Freyrie, A, Furgiuele, S, Gabrielli, R, Gaggiano, A, Galassi, L, Gallelli, G, Gallitto, E, Gallo, F, Galzerano, G, Gargiulo, M, Garriboli, L, G Genadiev, G, Gentile, L, Giaquinta, A, Gibello, L, Grande, R, Grassi, V, Ippoliti, A, Irsara, S, Kahlberg, A, Konstantinos, N, LA Corte, F, Lanza, G, Lauricella, A, Lazzeri, E, Lenti, M, Leopardi, M, Lepidi, S, Li Destri, A, Locatelli, F, Lomazzi, C, Lombardi, F, Lorido, A, Maggiore, C, Mansour, W, Marcucci, V, Mascia, D, Massara, M, Mastrangelo, G, Margheritini, C, Maritati, G, Martelli, E, Martinelli, O, Marzano, A, Mauri, F, Mazzacaro, D, Melloni, A, Mezzetti, R, Michelagnoli, S, Migliara, B, Migliari, M, Millarelli, M, Misuraca, M, Modugno, P, Moniaci, D, Montelione, N, Monti, A, Monzio-Compagnoni, N, Moro, M, Mortola, L, Mozzetta, G, Musilli, A, Nano, G, Occhiuto, M, M Oddi, F, Orellana, B, Orlando, P, Orrico, M, A Pacilè, M, Pagliariccio, G, Pallini, C, Palmieri, A, Palughi, M, Panagrasso, M, Panzano, C, Panzera, C, Pascucci, F, Pasqua, R, Pasquetti, L, Pasqui, E, Pecchio, A, Pecoraro, F, Peluttiero, I, F Pennetta, F, Perini, P, Piazza, M, Pini, R, Pipito, N, Pranteda, C, Praquin, B, Pratesi, C, F Porreca, C, Pulli, R, Reina, N, F Rinaldi, L, Rizzo, L, Romano, E, Ronchey, S, Ruggiero, F, Ruggiero, M, Sallustro, M, Saviane, G, Sbarigia, E, Scovazzi, P, M Segramor, V, Sena, G, Setacci, C, Setacci, F, E Setteducati, C, M Settembrini, A, Siani, A, Sica, S, Speziale, F, Squizzato, F, Stella, N, Stilo, F, Sufali, G, Tanda, E, Tinelli, G, Tomei, F, Tosti, F, Trimarchi, S, Troisi, N, Tshomba, Y, Turchino, D, Turriziani, V, Ucci, A, Veneto, V, Veraldi, G, Wiesel, P, Xodo, A, Zacà, S, Zaraca, F, Zenunaj, G, SIRIGNANO, Pasqualino, PIFFARETTI, Gabriele, CERUTI, Silvia, ORSO, Massimiliano, PICOZZI, Mario, RICCI, Giovanna, SIRIGNANO, Ascanio, TAURINO, Maurizio, Giancarlo Accarino, Maurizio, Accrocca, Federico, Alba, Giuseppe, Alberti, Antonino, Alberti, Vittorio, Allevi, Sara, Aloisi, Francesco, Amato, Bruno, Amico, Alessio, Andreoli, Francesco, Angiletta, Domenico, Antico, Antonio, Antico, Lorenzo, Antonello, Michele, Baccellieri, Domenico, Badalamenti, Giovanni, Bafile, Gennaro, Baldi, Claudio, Barillà, Chiara, Barillà, David, Bartoli, Stefano, Basile, Giusi, Battaglia, Giuseppe, Battocchio, Cesare, Belloni, Ailin, Bellosta, Raffello, Benevento, Domenico, Bernardini, Giulia, Bertagna, Giulia, Bertoglio, Luca, Bianchini Massoni, Claudio, Bisacco, Daniel, Bischetti, Michelangelo, Boccalon, Luca, Bonanno, Paolo, Bonardelli, Stefano, Borioni, Raul, P Borrelli, Maria, Bozzani, Antonio, M Bracale, Umberto, Camparini, Stefano, Canciglia, Aldo, Canova, Francesco, Capoccia, Laura, Cappelli, Alessandro, Cappiello, Pierlugi, Carluccio, Chiara, Casalino, Alfonso, Casella, Francesco, Casilli, Giulia, Castagno, Claudio, Castelli, Patrizio, Castrucci, Tommaso, Cavallo, Matteo, Cavazzini, Carlo, Ceccanei, Gianluca, Cefalì, Pietro, Celoria, Gianni, Cevolani, Mauro, Chiappa, Roberto, Chisci, Emiliano, Comande, Carlo, Compagna, Rita, Cumino, Andrea, Cuozzo, Simone, Dalla Caneva, Patrizia, D'Alessio, Ilaria, D'Arrigo, Giuseppe, DE Caridi, Giovanni, DE Donato, Gianmarco, DE Donno, Gabriele, Desantis, Claudio, DE Santis, Francesco, DE Troia, Alessandro, Dezi, Tommaso, A Diaco, Domenico, DI Domenico, Rossella, DI Filippo, Michele, DI Girolamo, Alessia, P Dionisi, Carlo, Dinoto, Ettore, DI Stefano, Francesco, DI STEFANO, Lucia, D'Oria, Mario, Esposito, Andrea, Esposito, Davide, Ettore, Ludovica, F Fadda, Gian, Faggioli, Gianluca, T Fargion, Aaron, Fazzini, Stefano, Fermani, Nicoletta, Ferrante, Giulia, Ferrari, Mauro, Ferraro, Stafanio, Ferrer, Ciro, Ferretto, Luca, Ficarelli, Ilaria, Filippi, Federico, Fino, Gianluigi, Forliti, Enzo, Formiconi, Martina, Flora, Loris, Fresilli, Mauro, Frigatti, Paolo, Frigerio, Dalmazio, Froio, Alberto, Freyrie, Antonio, Furgiuele, Sergio, Gabrielli, Roberto, Gaggiano, Andrea, Galassi, Luca, Gallelli, Giuseppe, Gallitto, Enrico, Gallo, Francesco, Galzerano, Giuseppe, Gargiulo, Mauro, Garriboli, Luca, G Genadiev, Genadi, Gentile, Lucia, Giaquinta, Alessia, Gibello, Lorenzo, Grande, Raffaele, Grassi, Viviana, Ippoliti, Arnaldo, Irsara, Sandro, Kahlberg, Andrea, Konstantinos, Nikolakopoulos, LA Corte, Francesco, Lanza, Gaetano, Lauricella, Antonio, Lazzeri, Elisa, Lenti, Massimo, Leopardi, Marco, Lepidi, Sandro, Li Destri, Andrea, Locatelli, Federica, Lomazzi, Chiara, Lombardi, Francesco, Lorido, Antonio, Maggiore, Claudia, Mansour, Wassim, Marcucci, Vittorio, Mascia, Daniele, Massara, Mafalda, Mastrangelo, Giovanni, Margheritini, Costanza, Maritati, Gabriele, Martelli, Eugenio, Martinelli, Ombretta, Marzano, Antonio, Mauri, Francesca, Mazzacaro, Daniela, Melloni, Andrea, Mezzetti, Roberto, Michelagnoli, Stefano, Migliara, Bruno, Migliari, Mattia, Millarelli, Massimiliano, Misuraca, Maria, Modugno, Pietro, Moniaci, Diego, Montelione, Nunzio, Monti, Andrea, Monzio-Compagnoni, Nicola, Moro, Mario, Mortola, Lorenzo, Mozzetta, Gaddiel, Musilli, Aldo, Nano, Giovanni, Occhiuto, Mariateresa, M Oddi, Fabio, Orellana, Bernardo, Orlando, Paola, Orrico, Matteo, A Pacilè, Maria, Pagliariccio, Gabriele, Pallini, Cristina, Palmieri, Armando, Palughi, Martina, Panagrasso, Marco, Panzano, Claudia, Panzera, Chiara, Pascucci, Francesco, Pasqua, Rocco, Pasquetti, Leonardo, Pasqui, Eduardo, Pecchio, Alberto, Pecoraro, Felice, Peluttiero, Ilaria, F Pennetta, Federico, Perini, Paolo, Piazza, Michele, Pini, Rodolfo, Pipito, Narayana, Pranteda, Chiara, Praquin, Barbara, Pratesi, Carlo, F Porreca, Carlo, Pulli, Raffaele, Reina, Nicola, F Rinaldi, Luigi, Rizzo, Luigi, Romano, Elisa, Ronchey, Sonia, Ruggiero, Federica, Ruggiero, Massimo, Sallustro, Marianna, Saviane, Gianna, Sbarigia, Enrico, Scovazzi, Paolo, M Segramor, Vittorio, Sena, Giuseppe, Setacci, Carlo, Setacci, Francesco, E Setteducati, Carmen, M Settembrini, Alberto, Siani, Andrea, Sica, Simona, Speziale, Francesco, Squizzato, Francesco, Stella, Nazzareno, Stilo, Francesco, Sufali, Gemmi, Tanda, Elisabetta, Tinelli, Giovanni, Tomei, Francesca, Tosti, Filomena, Trimarchi, Santi, Troisi, Nicola, Tshomba, Yamume, Turchino, Davide, Turriziani, Valerio, Ucci, Alessandro, Veneto, Vincenzo, Veraldi, Gianfranco, Wiesel, Paola, Xodo, Andrea, Zacà, Sergio, Zaraca, Francesco, Zenunaj, Glaudiol, Sirignano, P, Piffaretti, G, Ceruti, S, Orso, M, Picozzi, M, Ricci, G, Sirignano, A, Taurino, M, Giancarlo Accarino, M, Accrocca, F, Alba, G, Alberti, A, Alberti, V, Allevi, S, Aloisi, F, Amato, B, Amico, A, Andreoli, F, Angiletta, D, Antico, A, Antico, L, Antonello, M, Baccellieri, D, Badalamenti, G, Bafile, G, Baldi, C, Barillà, C, Barillà, D, Bartoli, S, Basile, G, Battaglia, G, Battocchio, C, Belloni, A, Bellosta, R, Benevento, D, Bernardini, G, Bertagna, G, Bertoglio, L, Bianchini Massoni, C, Bisacco, D, Bischetti, M, Boccalon, L, Bonanno, P, Bonardelli, S, Borioni, R, P Borrelli, M, Bozzani, A, M Bracale, U, Camparini, S, Canciglia, A, Canova, F, Capoccia, L, Cappelli, A, Cappiello, P, Carluccio, C, Casalino, A, Casella, F, Casilli, G, Castagno, C, Castelli, P, Castrucci, T, Cavallo, M, Cavazzini, C, Ceccanei, G, Cefalì, P, Celoria, G, Cevolani, M, Chiappa, R, Chisci, E, Comande, C, Compagna, R, Cumino, A, Cuozzo, S, Dalla Caneva, P, D'Alessio, I, D'Arrigo, G, DE Caridi, G, DE Donato, G, DE Donno, G, Desantis, C, DE Santis, F, DE Troia, A, Dezi, T, A Diaco, D, DI Domenico, R, DI Filippo, M, DI Girolamo, A, P Dionisi, C, Dinoto, E, DI Stefano, F, DI STEFANO, L, D'Oria, M, Esposito, A, Esposito, D, Ettore, L, F Fadda, G, Faggioli, G, T Fargion, A, Fazzini, S, Fermani, N, Ferrante, G, Ferrari, M, Ferraro, S, Ferrer, C, Ferretto, L, Ficarelli, I, Filippi, F, Fino, G, Forliti, E, Formiconi, M, Flora, L, Fresilli, M, Frigatti, P, Frigerio, D, Froio, A, Freyrie, A, Furgiuele, S, Gabrielli, R, Gaggiano, A, Galassi, L, Gallelli, G, Gallitto, E, Gallo, F, Galzerano, G, Gargiulo, M, Garriboli, L, G Genadiev, G, Gentile, L, Giaquinta, A, Gibello, L, Grande, R, Grassi, V, Ippoliti, A, Irsara, S, Kahlberg, A, Konstantinos, N, LA Corte, F, Lanza, G, Lauricella, A, Lazzeri, E, Lenti, M, Leopardi, M, Lepidi, S, Li Destri, A, Locatelli, F, Lomazzi, C, Lombardi, F, Lorido, A, Maggiore, C, Mansour, W, Marcucci, V, Mascia, D, Massara, M, Mastrangelo, G, Margheritini, C, Maritati, G, Martelli, E, Martinelli, O, Marzano, A, Mauri, F, Mazzacaro, D, Melloni, A, Mezzetti, R, Michelagnoli, S, Migliara, B, Migliari, M, Millarelli, M, Misuraca, M, Modugno, P, Moniaci, D, Montelione, N, Monti, A, Monzio-Compagnoni, N, Moro, M, Mortola, L, Mozzetta, G, Musilli, A, Nano, G, Occhiuto, M, M Oddi, F, Orellana, B, Orlando, P, Orrico, M, A Pacilè, M, Pagliariccio, G, Pallini, C, Palmieri, A, Palughi, M, Panagrasso, M, Panzano, C, Panzera, C, Pascucci, F, Pasqua, R, Pasquetti, L, Pasqui, E, Pecchio, A, Pecoraro, F, Peluttiero, I, F Pennetta, F, Perini, P, Piazza, M, Pini, R, Pipito, N, Pranteda, C, Praquin, B, Pratesi, C, F Porreca, C, Pulli, R, Reina, N, F Rinaldi, L, Rizzo, L, Romano, E, Ronchey, S, Ruggiero, F, Ruggiero, M, Sallustro, M, Saviane, G, Sbarigia, E, Scovazzi, P, M Segramor, V, Sena, G, Setacci, C, Setacci, F, E Setteducati, C, M Settembrini, A, Siani, A, Sica, S, Speziale, F, Squizzato, F, Stella, N, Stilo, F, Sufali, G, Tanda, E, Tinelli, G, Tomei, F, Tosti, F, Trimarchi, S, Troisi, N, Tshomba, Y, Turchino, D, Turriziani, V, Ucci, A, Veneto, V, Veraldi, G, Wiesel, P, Xodo, A, Zacà, S, Zaraca, F, Zenunaj, G, SIRIGNANO, Pasqualino, PIFFARETTI, Gabriele, CERUTI, Silvia, ORSO, Massimiliano, PICOZZI, Mario, RICCI, Giovanna, SIRIGNANO, Ascanio, TAURINO, Maurizio, Giancarlo Accarino, Maurizio, Accrocca, Federico, Alba, Giuseppe, Alberti, Antonino, Alberti, Vittorio, Allevi, Sara, Aloisi, Francesco, Amato, Bruno, Amico, Alessio, Andreoli, Francesco, Angiletta, Domenico, Antico, Antonio, Antico, Lorenzo, Antonello, Michele, Baccellieri, Domenico, Badalamenti, Giovanni, Bafile, Gennaro, Baldi, Claudio, Barillà, Chiara, Barillà, David, Bartoli, Stefano, Basile, Giusi, Battaglia, Giuseppe, Battocchio, Cesare, Belloni, Ailin, Bellosta, Raffello, Benevento, Domenico, Bernardini, Giulia, Bertagna, Giulia, Bertoglio, Luca, Bianchini Massoni, Claudio, Bisacco, Daniel, Bischetti, Michelangelo, Boccalon, Luca, Bonanno, Paolo, Bonardelli, Stefano, Borioni, Raul, P Borrelli, Maria, Bozzani, Antonio, M Bracale, Umberto, Camparini, Stefano, Canciglia, Aldo, Canova, Francesco, Capoccia, Laura, Cappelli, Alessandro, Cappiello, Pierlugi, Carluccio, Chiara, Casalino, Alfonso, Casella, Francesco, Casilli, Giulia, Castagno, Claudio, Castelli, Patrizio, Castrucci, Tommaso, Cavallo, Matteo, Cavazzini, Carlo, Ceccanei, Gianluca, Cefalì, Pietro, Celoria, Gianni, Cevolani, Mauro, Chiappa, Roberto, Chisci, Emiliano, Comande, Carlo, Compagna, Rita, Cumino, Andrea, Cuozzo, Simone, Dalla Caneva, Patrizia, D'Alessio, Ilaria, D'Arrigo, Giuseppe, DE Caridi, Giovanni, DE Donato, Gianmarco, DE Donno, Gabriele, Desantis, Claudio, DE Santis, Francesco, DE Troia, Alessandro, Dezi, Tommaso, A Diaco, Domenico, DI Domenico, Rossella, DI Filippo, Michele, DI Girolamo, Alessia, P Dionisi, Carlo, Dinoto, Ettore, DI Stefano, Francesco, DI STEFANO, Lucia, D'Oria, Mario, Esposito, Andrea, Esposito, Davide, Ettore, Ludovica, F Fadda, Gian, Faggioli, Gianluca, T Fargion, Aaron, Fazzini, Stefano, Fermani, Nicoletta, Ferrante, Giulia, Ferrari, Mauro, Ferraro, Stafanio, Ferrer, Ciro, Ferretto, Luca, Ficarelli, Ilaria, Filippi, Federico, Fino, Gianluigi, Forliti, Enzo, Formiconi, Martina, Flora, Loris, Fresilli, Mauro, Frigatti, Paolo, Frigerio, Dalmazio, Froio, Alberto, Freyrie, Antonio, Furgiuele, Sergio, Gabrielli, Roberto, Gaggiano, Andrea, Galassi, Luca, Gallelli, Giuseppe, Gallitto, Enrico, Gallo, Francesco, Galzerano, Giuseppe, Gargiulo, Mauro, Garriboli, Luca, G Genadiev, Genadi, Gentile, Lucia, Giaquinta, Alessia, Gibello, Lorenzo, Grande, Raffaele, Grassi, Viviana, Ippoliti, Arnaldo, Irsara, Sandro, Kahlberg, Andrea, Konstantinos, Nikolakopoulos, LA Corte, Francesco, Lanza, Gaetano, Lauricella, Antonio, Lazzeri, Elisa, Lenti, Massimo, Leopardi, Marco, Lepidi, Sandro, Li Destri, Andrea, Locatelli, Federica, Lomazzi, Chiara, Lombardi, Francesco, Lorido, Antonio, Maggiore, Claudia, Mansour, Wassim, Marcucci, Vittorio, Mascia, Daniele, Massara, Mafalda, Mastrangelo, Giovanni, Margheritini, Costanza, Maritati, Gabriele, Martelli, Eugenio, Martinelli, Ombretta, Marzano, Antonio, Mauri, Francesca, Mazzacaro, Daniela, Melloni, Andrea, Mezzetti, Roberto, Michelagnoli, Stefano, Migliara, Bruno, Migliari, Mattia, Millarelli, Massimiliano, Misuraca, Maria, Modugno, Pietro, Moniaci, Diego, Montelione, Nunzio, Monti, Andrea, Monzio-Compagnoni, Nicola, Moro, Mario, Mortola, Lorenzo, Mozzetta, Gaddiel, Musilli, Aldo, Nano, Giovanni, Occhiuto, Mariateresa, M Oddi, Fabio, Orellana, Bernardo, Orlando, Paola, Orrico, Matteo, A Pacilè, Maria, Pagliariccio, Gabriele, Pallini, Cristina, Palmieri, Armando, Palughi, Martina, Panagrasso, Marco, Panzano, Claudia, Panzera, Chiara, Pascucci, Francesco, Pasqua, Rocco, Pasquetti, Leonardo, Pasqui, Eduardo, Pecchio, Alberto, Pecoraro, Felice, Peluttiero, Ilaria, F Pennetta, Federico, Perini, Paolo, Piazza, Michele, Pini, Rodolfo, Pipito, Narayana, Pranteda, Chiara, Praquin, Barbara, Pratesi, Carlo, F Porreca, Carlo, Pulli, Raffaele, Reina, Nicola, F Rinaldi, Luigi, Rizzo, Luigi, Romano, Elisa, Ronchey, Sonia, Ruggiero, Federica, Ruggiero, Massimo, Sallustro, Marianna, Saviane, Gianna, Sbarigia, Enrico, Scovazzi, Paolo, M Segramor, Vittorio, Sena, Giuseppe, Setacci, Carlo, Setacci, Francesco, E Setteducati, Carmen, M Settembrini, Alberto, Siani, Andrea, Sica, Simona, Speziale, Francesco, Squizzato, Francesco, Stella, Nazzareno, Stilo, Francesco, Sufali, Gemmi, Tanda, Elisabetta, Tinelli, Giovanni, Tomei, Francesca, Tosti, Filomena, Trimarchi, Santi, Troisi, Nicola, Tshomba, Yamume, Turchino, Davide, Turriziani, Valerio, Ucci, Alessandro, Veneto, Vincenzo, Veraldi, Gianfranco, Wiesel, Paola, Xodo, Andrea, Zacà, Sergio, Zaraca, Francesco, and Zenunaj, Glaudiol

Abstract

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SI CVE). METHODS : A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline

Published
2024

10. Endothelial Activation and Stress Index (EASIX) to predict mortality after allogeneic stem cell transplantation: a prospective study

Author

Penack, O., Luft, T., Peczynski, C., Benner, A., Sica, S., Arat, M., Itäla-Remes, M., Corral, L.L., Schaap, N.P.M., Karas, M., Raida, L., Schroeder, T., Dreger, P., Metafuni, E., Ozcelik, T., Sandmaier, B.M., Kordelas, L., Moiseev, I., Schoemans, H., Koenecke, C., Basak, G.W., Peric, Z., Penack, O., Luft, T., Peczynski, C., Benner, A., Sica, S., Arat, M., Itäla-Remes, M., Corral, L.L., Schaap, N.P.M., Karas, M., Raida, L., Schroeder, T., Dreger, P., Metafuni, E., Ozcelik, T., Sandmaier, B.M., Kordelas, L., Moiseev, I., Schoemans, H., Koenecke, C., Basak, G.W., and Peric, Z.

Abstract

Contains fulltext : 304924.pdf (Publisher’s version ) (Open Access), BACKGROUND: We previously reported that the "Endothelial Activation and Stress Index" (EASIX; ((creatinine×lactate dehydrogenase)÷thrombocytes)) measured before start of conditioning predicts mortality after allogeneic hematopoietic stem cell transplantation (alloSCT) when used as continuous score. For broad clinical implementation, a prospectively validated EASIX-pre cut-off is needed that defines a high-risk cohort and is easy to use. METHOD: In the current study, we first performed a retrospective cohort analysis in n=2022 alloSCT recipients and identified an optimal cut-off for predicting non-relapse mortality (NRM) as EASIX-pre=3. For cut-off validation, we conducted a multicenter prospective study with inclusion of n=317 first alloSCTs from peripheral blood stem cell in adult patients with acute leukemia, lymphoma or myelodysplastic syndrome/myeloproliferative neoplasms in the European Society for Blood and Marrow Transplantation network. RESULTS: Twenty-three % (n=74) of alloSCT recipients had EASIX-pre ≥3 taken before conditioning. NRM at 2 years was 31.1% in the high EASIX group versus 11.5% in the low EASIX group (p<0.001). Patients with high EASIX-pre also had worse 2 years overall survival (51.6% vs 70.9%; p=0.002). We were able to validate the cut-off and found that EASIX ≥3 was associated with more than twofold increased risk for NRM in multivariate analysis (HR=2.18, 95% CI 1.2 to 3.94; p=0.01). No statistically significant difference could be observed for the incidence of relapse. CONCLUSIONS: The results of this study provide a prospectively validated standard laboratory biomarker index to estimate the transplant-related mortality risk after alloSCT. EASIX ≥3 taken before conditioning identifies a population of alloSCT recipients who have a more than twofold increased risk of treatment-related mortality.

Published
2024

11. What is the best treatment strategy before autologous peripheral blood stem cell transplantation in POEMS syndrome?

Author

Autore, Francesco, Bramanti, S., Lessi, F., Innocenti, Idanna, Galli, Eugenio, Rocchi, S., Ribolla, R., Derudas, D., Oliva, S., Stefanoni, P., Marcatti, M., Schenone, A., Nasa, G. L., Crippa, C., Zamagni, E., Riva, M., Mazza, R., Mannina, D., Sica, Simona, Bacigalupo, Andrea, Laurenti, Luca, Autore F., Innocenti I., Galli E., Sica S. (ORCID:0000-0003-2426-3465), Bacigalupo A. (ORCID:0000-0002-9119-567X), Laurenti L. (ORCID:0000-0002-8327-1396), Autore, Francesco, Bramanti, S., Lessi, F., Innocenti, Idanna, Galli, Eugenio, Rocchi, S., Ribolla, R., Derudas, D., Oliva, S., Stefanoni, P., Marcatti, M., Schenone, A., Nasa, G. L., Crippa, C., Zamagni, E., Riva, M., Mazza, R., Mannina, D., Sica, Simona, Bacigalupo, Andrea, Laurenti, Luca, Autore F., Innocenti I., Galli E., Sica S. (ORCID:0000-0003-2426-3465), Bacigalupo A. (ORCID:0000-0002-9119-567X), and Laurenti L. (ORCID:0000-0002-8327-1396)

Abstract

Autologous peripheral blood stem cell transplantation (aPBSCT) provides optimal outcomes in POEMS syndrome but the definition of the best treatment before aPBSCT remains to be defined because of the rarity of the disease and the heterogeneity of published case series. We collected clinical and laboratory data of patients with POEMS syndrome undergoing aPBSCT from 1998 to 2020 in ten Italian centers. The primary endpoint of the study was to evaluate the impact of prior therapies and mobilization regimen on outcome. We divided the patients into three groups: patients who did not receive any treatment before transplant (15 patients, group A: front-line), patients pre-treated with other agents (14 patients, group B) and patients treated with cyclophosphamide as their mobilizing regimen (16 patients, group C). The three groups did not show differences in terms of demographic and clinical characteristics. All 45 patients underwent aPBSCT after a high-dose melphalan conditioning regimen, with a median follow-up of 77 months (range, 37-169 months). The responses were not statistically different between the three groups (P=0.38). Progression-free and overall survival rates at 6 years were: 70% (95% confidence interval: 55-85%) and 91% (95% confidence interval: 82-99) 65%, respectively, and did not differ between the three groups. The cumulative incidence of transplant-related mortality and relapse was 4% and 36%, respectively. In conclusion, in a relatively large number of patients with POEMS syndrome, undergoing an autologous transplant, pre-treatment and disease status at transplant did not appear to have an impact on major transplant outcomes.

Published
2024

12. Risk factors for hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation in a letermovir-exposed CMV-free population receiving PTCy

Author

Galli, Eugenio, Metafuni, Elisabetta, Gandi, Carlo, Limongiello, M. A., Giammarco, S., Mattozzi, Andrea, Santangelo, Rosaria, Bacigalupo, Andrea, Sora', Federica, Chiusolo, Patrizia, Sica, Simona, Galli, E., Metafuni, E., Gandi, C., Mattozzi, A., Santangelo, R. (ORCID:0000-0002-8056-218X), Bacigalupo, A. (ORCID:0000-0002-9119-567X), Sora', F. (ORCID:0000-0002-9607-5298), Chiusolo, P. (ORCID:0000-0002-1355-1587), Sica, S. (ORCID:0000-0003-2426-3465), Galli, Eugenio, Metafuni, Elisabetta, Gandi, Carlo, Limongiello, M. A., Giammarco, S., Mattozzi, Andrea, Santangelo, Rosaria, Bacigalupo, Andrea, Sora', Federica, Chiusolo, Patrizia, Sica, Simona, Galli, E., Metafuni, E., Gandi, C., Mattozzi, A., Santangelo, R. (ORCID:0000-0002-8056-218X), Bacigalupo, A. (ORCID:0000-0002-9119-567X), Sora', F. (ORCID:0000-0002-9607-5298), Chiusolo, P. (ORCID:0000-0002-1355-1587), and Sica, S. (ORCID:0000-0003-2426-3465)

Abstract

Hemorrhagic cystitis (HC) is a highly impacting complication in allogeneic hematopoietic stem cell transplantation (HSCT), occurring in 12%–37% of patients. The impact of transplant- and patient-specific variables has been described, with a possible role for JCV and BKV, which may be cooperating with cytomegalovirus (CMV). Here, we analyze 134 letermovir-exposed, CMV-free patients, treated with the same cyclophosphamide-based graft-versus-host disease (GVHD) prophylaxis, describing risk factors for HC. The overall incidence of HC was 23%. Patients with HLA mismatched transplant, higher comorbidity score, and receiving three alkylating agents with TBF (thiotepa, busulfan, and fludarabine) conditioning regimen had a higher risk of HC in multivariate analysis (OR: 4.48, 6.32, and 1.32, respectively). A HC-score including male gender, TBF conditioning, and HLA-mismatch stratifies the risk of HC in the first 100 days after HSCT. The role of BKV and JCV was not highly impacting in those patients, suggesting a possible synergistic effect between CMV and JCV in causing HC. HC can be interpreted as the combination of patient-related factors, chemotherapy-related toxicities—especially due to alkylating agents—and immunological elements.

Published
2024

13. Unlocking Predictive Power: Quantitative Assessment of CAR-T Expansion with Digital Droplet Polymerase Chain Reaction (ddPCR)

Author

Galli, Eugenio, Viscovo, Marcello, Fosso, F., Pansini, Ilaria, Di Cesare, G., Iacovelli, C., Maiolo, E., Sora, F., Hohaus, Stefan, Sica, S., Bellesi, Silvia, Chiusolo, Patrizia, Galli E., Viscovo M., Pansini I., Hohaus S. (ORCID:0000-0002-5534-7197), Bellesi S., Chiusolo P. (ORCID:0000-0002-1355-1587), Galli, Eugenio, Viscovo, Marcello, Fosso, F., Pansini, Ilaria, Di Cesare, G., Iacovelli, C., Maiolo, E., Sora, F., Hohaus, Stefan, Sica, S., Bellesi, Silvia, Chiusolo, Patrizia, Galli E., Viscovo M., Pansini I., Hohaus S. (ORCID:0000-0002-5534-7197), Bellesi S., and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

Flow cytometry (FCM) and quantitative PCR (qPCR) are conventional methods for assessing CAR-T expansion, while digital droplet PCR (ddPCR) is emerging as a promising alternative. We monitored CAR-T transcript expansion in 40 B-NHL patients post-infusion of CAR-T products (axi-cel; tisa-cel; and brexu-cel) with both His-Tag FCM and ddPCR techniques. Sensitivity and predictive capacity for efficacy and safety outcomes of ddPCR were analyzed and compared with FCM. A significant correlation between CAR-T counts determined by FCM and CAR transcripts assessed by ddPCR (p < 0.001) was observed. FCM revealed median CD3+CAR+ cell counts at 7, 14, and 30 days post-infusion with no significant differences. In contrast, ddPCR-measured median copies of CAR-T transcripts demonstrated significant lower copy numbers in tisa-cel recipients compared to the other products at day 7 and day 14. Patients with a peak of CAR transcripts at day 7 exceeding 5000 copies/microg gDNA, termed “good CAR-T expanders”, were more likely to achieve a favorable response at 3 months (HR 10.79, 95% CI 1.16–100.42, p = 0.036). Good CAR-T expanders showed superior progression-free survival at 3, 6, and 12 months compared to poor CAR-T expanders (p = 0.088). Those reaching a peak higher than 5000 copies/microg gDNA were more likely to experience severe CRS and ICANS. DdPCR proves to be a practical method for monitoring CAR-T expansion, providing quantitative information that better predicts both treatment outcomes and toxicity.

Published
2024

17. Integrating biological HLA-DPB1 mismatch models to predict survival after unrelated hematopoietic cell transplantation

Author

Ruggeri, A, de Wreede, L, Muller, C, Crivello, P, Bonneville, E, Petersdorf, E, Socie, G, Dubois, V, Niittyvuopio, R, Perasaari, J, Yakoub-Agha, I, Cornelissen, J, Wieten, L, Gedde-Dahl, T, Forcade, E, Crawley, C, Marsh, S, Gandemer, V, Tholouli, E, Bulabois, C, Huynh, A, Choi, G, Deconinck, E, Itala-Remes, M, Lenhoff, S, Bengtsson, M, Johansson, J, van Gorkom, G, Hoogenboom, J, Vago, L, Rocha, V, Bonini, C, Chabannon, C, Fleischhauer, K, Clausen, J, Holter, W, Kalhs, P, Beguin, Y, Bron, D, Deeren, D, Lung, W, Kerre, T, Poire, X, Selleslag, D, Schroyens, W, Jindra, P, Mayer, J, Vydra, J, Zak, P, Nielsen, B, Sengeloev, H, Kaare, A, Partanen, A, Bay, J, Bertrand, Y, Blaise, D, Bourhis, J, Chevallier, P, Cluzeau, T, Damaj, G, Fegueux, N, Guyotat, D, Hunault-Berger, M, Labussiere-Wallet, H, Leleu, X, Lioure, B, Maury, S, Michel, G, Mohty, M, Rubio, M, Tilly, H, Turlure, P, Bethge, W, Casper, J, Einsele, H, Ganser, A, Kroger, N, Martin, S, Platzbecker, U, Reinhardt, C, Schafer-Eckart, K, Thurner, L, Valerius, T, Wulf, G, Karakasis, D, Spyridonidis, A, Hauser, P, Remenyi, P, Reykdal, S, Mousavi, A, Angelucci, E, Arcese, W, Benedetti, F, Bernasconi, P, Biondi, A, Bonifazi, F, Carella, A, Carluccio, P, Casini, M, Cavanna, L, Ciceri, F, Cimino, G, Corradini, P, Fanin, R, Galieni, P, Grillo, G, Iori, A, La Nasa, G, Locatelli, F, Marotta, G, Martino, M, Mazza, P, Mordini, N, Musso, M, Olivieri, A, Pavone, V, Pane, F, Petrini, M, Pioltelli, P, Rambaldi, A, Ruggeri, M, Saccardi, R, Santarone, S, Scime, R, Sica, S, Tarella, C, Velardi, A, Visani, G, Zecca, M, Tanase, A, Kulagin, A, Savchenko, V, Lopez, C, Amor, A, Lopez, J, Caballero, D, Duarte, R, Cascon, M, Porras, R, Perez-Simon, J, Rovira, M, Sanz, J, Carrete, J, Cammenga, J, Isaksson, C, Mielke, S, Chalandon, Y, Passweg, J, Schanz, U, Meijer, E, Kuball, J, Veelken, J, Apperley, J, Bloor, A, Byrne, J, Carpenter, B, Clark, A, Collin, M, Craddock, C, Gibson, B, Khan, A, Martin, M, Medd, P, Nicholson, E, Orchard, K, Patel, A, Peniket, A, Potter, V, Snowden, J, Wilson, K, Ruggeri A., de Wreede L. C., Muller C. R., Crivello P., Bonneville E. F., Petersdorf E. W., Socie G., Dubois V., Niittyvuopio R., Perasaari J., Yakoub-Agha I., Cornelissen J. J., Wieten L., Gedde-Dahl T., Forcade E., Crawley C. R., Marsh S. G. E., Gandemer V., Tholouli E., Bulabois C. -E., Huynh A., Choi G., Deconinck E., Itala-Remes M., Lenhoff S., Bengtsson M., Johansson J. -E., van Gorkom G., Hoogenboom J. D., Vago L., Rocha V., Bonini C., Chabannon C., Fleischhauer K., Clausen J., Holter W., Kalhs P., Beguin Y., Bron D., Deeren D., Lung W. K., Kerre T., Poire X., Selleslag D., Schroyens W., Jindra P., Mayer J., Vydra J., Zak P., Nielsen B., Sengeloev H., Kaare A., Partanen A., Bay J., Bertrand Y., Blaise D., Bourhis J. H., Chevallier P., Cluzeau T., Damaj G., Fegueux N., Guyotat D., Hunault-Berger M., Labussiere-Wallet H., Leleu X., Lioure B., Maury S., Michel G., Mohty M., Rubio M. T., Tilly H., Turlure P., Bethge W., Casper J., Einsele H., Ganser A., Kroger N., Martin S., Platzbecker U., Reinhardt C., Schafer-Eckart K., Thurner L., Valerius T., Wulf G. G., Karakasis D., Spyridonidis A., Hauser P., Remenyi P., Reykdal S., Mousavi A., Angelucci E., Arcese W., Benedetti F., Bernasconi P., Biondi A., Bonifazi F., Carella A. M., Carluccio P., Casini M., Cavanna L., Ciceri F., Cimino G., Corradini P., Fanin R., Galieni P., Grillo G., Iori A. P., La Nasa G., Locatelli F., Marotta G., Martino M., Mazza P., Mordini N., Musso M., Olivieri A., Pavone V., Pane F., Petrini M., Pioltelli P., Rambaldi A., Ruggeri M., Saccardi R., Santarone S., Scime R., Sica S., Tarella C., Velardi A., Visani G., Zecca M., Tanase A., Kulagin A., Savchenko V., Lopez C. A., Amor A. A., Lopez J. L. B., Caballero D., Duarte R., Cascon M. J. P., Porras R. P., Perez-Simon J. A., Rovira M., Sanz J., Carrete J. P. T., Cammenga J., Isaksson C., Mielke S., Chalandon Y., Passweg J., Schanz U., Meijer E., Kuball J., Veelken J. H., Apperley J., Bloor A., Byrne J., Carpenter B., Clark A., Collin M., Craddock C., Gibson B. E., Khan A., Martin M., Medd P., Nicholson E., Orchard K., Patel A., Peniket A., Potter V., Snowden J., Wilson K. M. O., Ruggeri, A, de Wreede, L, Muller, C, Crivello, P, Bonneville, E, Petersdorf, E, Socie, G, Dubois, V, Niittyvuopio, R, Perasaari, J, Yakoub-Agha, I, Cornelissen, J, Wieten, L, Gedde-Dahl, T, Forcade, E, Crawley, C, Marsh, S, Gandemer, V, Tholouli, E, Bulabois, C, Huynh, A, Choi, G, Deconinck, E, Itala-Remes, M, Lenhoff, S, Bengtsson, M, Johansson, J, van Gorkom, G, Hoogenboom, J, Vago, L, Rocha, V, Bonini, C, Chabannon, C, Fleischhauer, K, Clausen, J, Holter, W, Kalhs, P, Beguin, Y, Bron, D, Deeren, D, Lung, W, Kerre, T, Poire, X, Selleslag, D, Schroyens, W, Jindra, P, Mayer, J, Vydra, J, Zak, P, Nielsen, B, Sengeloev, H, Kaare, A, Partanen, A, Bay, J, Bertrand, Y, Blaise, D, Bourhis, J, Chevallier, P, Cluzeau, T, Damaj, G, Fegueux, N, Guyotat, D, Hunault-Berger, M, Labussiere-Wallet, H, Leleu, X, Lioure, B, Maury, S, Michel, G, Mohty, M, Rubio, M, Tilly, H, Turlure, P, Bethge, W, Casper, J, Einsele, H, Ganser, A, Kroger, N, Martin, S, Platzbecker, U, Reinhardt, C, Schafer-Eckart, K, Thurner, L, Valerius, T, Wulf, G, Karakasis, D, Spyridonidis, A, Hauser, P, Remenyi, P, Reykdal, S, Mousavi, A, Angelucci, E, Arcese, W, Benedetti, F, Bernasconi, P, Biondi, A, Bonifazi, F, Carella, A, Carluccio, P, Casini, M, Cavanna, L, Ciceri, F, Cimino, G, Corradini, P, Fanin, R, Galieni, P, Grillo, G, Iori, A, La Nasa, G, Locatelli, F, Marotta, G, Martino, M, Mazza, P, Mordini, N, Musso, M, Olivieri, A, Pavone, V, Pane, F, Petrini, M, Pioltelli, P, Rambaldi, A, Ruggeri, M, Saccardi, R, Santarone, S, Scime, R, Sica, S, Tarella, C, Velardi, A, Visani, G, Zecca, M, Tanase, A, Kulagin, A, Savchenko, V, Lopez, C, Amor, A, Lopez, J, Caballero, D, Duarte, R, Cascon, M, Porras, R, Perez-Simon, J, Rovira, M, Sanz, J, Carrete, J, Cammenga, J, Isaksson, C, Mielke, S, Chalandon, Y, Passweg, J, Schanz, U, Meijer, E, Kuball, J, Veelken, J, Apperley, J, Bloor, A, Byrne, J, Carpenter, B, Clark, A, Collin, M, Craddock, C, Gibson, B, Khan, A, Martin, M, Medd, P, Nicholson, E, Orchard, K, Patel, A, Peniket, A, Potter, V, Snowden, J, Wilson, K, Ruggeri A., de Wreede L. C., Muller C. R., Crivello P., Bonneville E. F., Petersdorf E. W., Socie G., Dubois V., Niittyvuopio R., Perasaari J., Yakoub-Agha I., Cornelissen J. J., Wieten L., Gedde-Dahl T., Forcade E., Crawley C. R., Marsh S. G. E., Gandemer V., Tholouli E., Bulabois C. -E., Huynh A., Choi G., Deconinck E., Itala-Remes M., Lenhoff S., Bengtsson M., Johansson J. -E., van Gorkom G., Hoogenboom J. D., Vago L., Rocha V., Bonini C., Chabannon C., Fleischhauer K., Clausen J., Holter W., Kalhs P., Beguin Y., Bron D., Deeren D., Lung W. K., Kerre T., Poire X., Selleslag D., Schroyens W., Jindra P., Mayer J., Vydra J., Zak P., Nielsen B., Sengeloev H., Kaare A., Partanen A., Bay J., Bertrand Y., Blaise D., Bourhis J. H., Chevallier P., Cluzeau T., Damaj G., Fegueux N., Guyotat D., Hunault-Berger M., Labussiere-Wallet H., Leleu X., Lioure B., Maury S., Michel G., Mohty M., Rubio M. T., Tilly H., Turlure P., Bethge W., Casper J., Einsele H., Ganser A., Kroger N., Martin S., Platzbecker U., Reinhardt C., Schafer-Eckart K., Thurner L., Valerius T., Wulf G. G., Karakasis D., Spyridonidis A., Hauser P., Remenyi P., Reykdal S., Mousavi A., Angelucci E., Arcese W., Benedetti F., Bernasconi P., Biondi A., Bonifazi F., Carella A. M., Carluccio P., Casini M., Cavanna L., Ciceri F., Cimino G., Corradini P., Fanin R., Galieni P., Grillo G., Iori A. P., La Nasa G., Locatelli F., Marotta G., Martino M., Mazza P., Mordini N., Musso M., Olivieri A., Pavone V., Pane F., Petrini M., Pioltelli P., Rambaldi A., Ruggeri M., Saccardi R., Santarone S., Scime R., Sica S., Tarella C., Velardi A., Visani G., Zecca M., Tanase A., Kulagin A., Savchenko V., Lopez C. A., Amor A. A., Lopez J. L. B., Caballero D., Duarte R., Cascon M. J. P., Porras R. P., Perez-Simon J. A., Rovira M., Sanz J., Carrete J. P. T., Cammenga J., Isaksson C., Mielke S., Chalandon Y., Passweg J., Schanz U., Meijer E., Kuball J., Veelken J. H., Apperley J., Bloor A., Byrne J., Carpenter B., Clark A., Collin M., Craddock C., Gibson B. E., Khan A., Martin M., Medd P., Nicholson E., Orchard K., Patel A., Peniket A., Potter V., Snowden J., and Wilson K. M. O.

Published
2023

19. Coagulopathy in Patients with Low/Intermediate Risk Acute Promyelocytic Leukemia treated with First Line Arsenic Trioxide in Combination with All-Trans Retinoic Acid: A Monocentric Experience

Author

Autore, Francesco, Chiusolo, Patrizia, Sora, F, Laurenti, Luca, Pagano, Livio, Bacigalupo, Andrea, De Stefano, Valerio, Sica, Simona, Autore, F, Chiusolo, P (ORCID:0000-0002-1355-1587), Laurenti, L (ORCID:0000-0002-8327-1396), Pagano, L (ORCID:0000-0001-8287-928X), Bacigalupo, A (ORCID:0000-0002-9119-567X), De Stefano, V (ORCID:0000-0002-5178-5827), Sica, S (ORCID:0000-0003-2426-3465), Autore, Francesco, Chiusolo, Patrizia, Sora, F, Laurenti, Luca, Pagano, Livio, Bacigalupo, Andrea, De Stefano, Valerio, Sica, Simona, Autore, F, Chiusolo, P (ORCID:0000-0002-1355-1587), Laurenti, L (ORCID:0000-0002-8327-1396), Pagano, L (ORCID:0000-0001-8287-928X), Bacigalupo, A (ORCID:0000-0002-9119-567X), De Stefano, V (ORCID:0000-0002-5178-5827), and Sica, S (ORCID:0000-0003-2426-3465)

Abstract

Patients with acute promyelocytic leukemia (APL) often show some clinical and/or laboratory features of coagulopathy. However, the evidence of alterations in blood clotting tests seems not to correspond to clinically significant thrombotic or hemorrhagic complications in low and intermediate risk APL patients. Presentation of patients with APL is often characterized by coagulopathy.1 At diagnosis, a percentage close to 76% of APL patients have some clinical and/or laboratory features of coagulopathy, from skin or soft tissue bleedings to intracranial hemorrhage.2–3 While physicians pay attention to bleeding-related complications in APL, it is also important to note that it is not uncommon to develop thrombotic events, particularly in patients on treatment.4 Lately, the introduction of new drugs such as all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) allowed for reducing complications: bleeding events were predominant rather than severe thrombotic events (29% vs. 12%).5

Published
2023

20. Donor cell-derived myelofibrosis relapse after allogeneic stem cell transplantation

Author

Chiusolo, Patrizia, Orlando, Nicoletta, Giammarco, S., Rossi, Monica, Metafuni, Elisabetta, Leotta, Salvatore Nuccio, Milone, G., Valentini, C. G., Bianchi, Maria, Frioni, Filippo, Pellegrino, Claudio, Sora', Federica, Larocca, Luigi Maria, Sica, Simona, Bacigalupo, Andrea, Teofili, Luciana, Chiusolo P. (ORCID:0000-0002-1355-1587), Orlando N., Rossi M., Metafuni E., Leotta S., Bianchi M., Frioni F., Pellegrino C., Sora F. (ORCID:0000-0002-9607-5298), Larocca L. M. (ORCID:0000-0003-1739-4758), Sica S. (ORCID:0000-0003-2426-3465), Bacigalupo A. (ORCID:0000-0002-9119-567X), Teofili L. (ORCID:0000-0002-7214-1561), Chiusolo, Patrizia, Orlando, Nicoletta, Giammarco, S., Rossi, Monica, Metafuni, Elisabetta, Leotta, Salvatore Nuccio, Milone, G., Valentini, C. G., Bianchi, Maria, Frioni, Filippo, Pellegrino, Claudio, Sora', Federica, Larocca, Luigi Maria, Sica, Simona, Bacigalupo, Andrea, Teofili, Luciana, Chiusolo P. (ORCID:0000-0002-1355-1587), Orlando N., Rossi M., Metafuni E., Leotta S., Bianchi M., Frioni F., Pellegrino C., Sora F. (ORCID:0000-0002-9607-5298), Larocca L. M. (ORCID:0000-0003-1739-4758), Sica S. (ORCID:0000-0003-2426-3465), Bacigalupo A. (ORCID:0000-0002-9119-567X), and Teofili L. (ORCID:0000-0002-7214-1561)

Abstract

Primary myelofibrosis (PMF) is a rare myeloproliferative neoplasm characterized by clonal proliferation of mature myeloid lineages derived from stem cells (erythrocytes, leukocytes and magakaryocytes) with variable megakaryocyte atypia associated with reticulin and / or collagen bone marrow (BM) fibrosis, osteosclerosis, ineffective erythropoiesis, angiogenesis, extramedullary hematopoiesis and abnormal expression of cytokines. Allogeneic hemopoietic stem cell transplantation (alloHSCT) is currently the only curative approach for patients with myelofibrosis, and for this reason the number of allografts for these indications have been growing over the past years. Unfortunately relapse of myelofibrosis (MF) after an alloHSCT occurs in 10-40% of cases: patients usually present with a declining donor chimerism, and a reappearance of driver mutations if present; BM biopsy is usually consistent with typical megakaryocyte abnormalities and stromal fibrosis. Ultimately BM cells exhibit progressive loss of donor chimerism, and the relapse is therefore of recipient origin. Here we report two allografted MF patients who relapsed in donor cells.

Published
2023

21. Integrating biological HLA-DPB1 mismatch models to predict survival after unrelated hematopoietic cell transplantation

Author

Ruggeri, A., de Wreede, L. C., Muller, C. R., Crivello, P., Bonneville, E. F., Petersdorf, E. W., Socie, G., Dubois, V., Niittyvuopio, R., Perasaari, J., Yakoub-Agha, I., Cornelissen, J. J., Wieten, L., Gedde-Dahl, T., Forcade, E., Crawley, C. R., Marsh, S. G. E., Gandemer, V., Tholouli, E., Bulabois, C. -E., Huynh, A., Choi, G., Deconinck, E., Itala-Remes, M., Lenhoff, S., Bengtsson, M., Johansson, J. -E., van Gorkom, G., Hoogenboom, J. D., Vago, L., Rocha, V., Bonini, C., Chabannon, C., Fleischhauer, K., Clausen, J., Holter, W., Kalhs, P., Beguin, Y., Bron, D., Deeren, D., Lung, W. K., Kerre, T., Poire, X., Selleslag, D., Schroyens, W., Jindra, P., Mayer, J., Vydra, J., Zak, P., Nielsen, B., Sengeloev, H., Kaare, A., Partanen, A., Bay, J., Bertrand, Y., Blaise, D., Bourhis, J. H., Chevallier, P., Cluzeau, T., Damaj, G., Fegueux, N., Guyotat, D., Hunault-Berger, M., Labussiere-Wallet, H., Leleu, X., Lioure, B., Maury, S., Michel, G., Mohty, M., Rubio, M. T., Tilly, H., Turlure, P., Bethge, W., Casper, J., Einsele, H., Ganser, A., Kroger, N., Martin, S., Platzbecker, U., Reinhardt, C., Schafer-Eckart, K., Thurner, L., Valerius, T., Wulf, G. G., Karakasis, D., Spyridonidis, A., Hauser, P., Remenyi, P., Reykdal, S., Mousavi, A., Angelucci, E., Arcese, W., Benedetti, F., Bernasconi, P., Biondi, A., Bonifazi, F., Carella, A. M., Carluccio, P., Casini, M., Cavanna, L., Ciceri, F., Cimino, G., Corradini, P., Fanin, R., Galieni, P., Grillo, G., Iori, A. P., La Nasa, G., Locatelli, Franco, Marotta, G., Martino, M., Mazza, P., Mordini, N., Musso, M., Olivieri, A., Pavone, V., Pane, F., Petrini, M., Pioltelli, P., Rambaldi, A., Ruggeri, M., Saccardi, R., Santarone, S., Scime, R., Sica, S., Tarella, C., Velardi, A., Visani, G., Zecca, M., Tanase, A., Kulagin, A., Savchenko, V., Lopez, C. A., Amor, A. A., Lopez, J. L. B., Caballero, D., Duarte, R., Cascon, M. J. P., Porras, R. P., Perez-Simon, J. A., Rovira, M., Sanz, J., Carrete, J. P. T., Cammenga, J., Isaksson, C., Mielke, S., Chalandon, Y., Passweg, J., Schanz, U., Meijer, E., Kuball, J., Veelken, J. H., Apperley, J., Bloor, A., Byrne, J., Carpenter, B., Clark, A., Collin, M., Craddock, C., Gibson, B. E., Khan, A., Martin, M., Medd, P., Nicholson, E., Orchard, K., Patel, A., Peniket, A., Potter, V., Snowden, J., Wilson, K. M. O., Locatelli F. (ORCID:0000-0002-7976-3654), Ruggeri, A., de Wreede, L. C., Muller, C. R., Crivello, P., Bonneville, E. F., Petersdorf, E. W., Socie, G., Dubois, V., Niittyvuopio, R., Perasaari, J., Yakoub-Agha, I., Cornelissen, J. J., Wieten, L., Gedde-Dahl, T., Forcade, E., Crawley, C. R., Marsh, S. G. E., Gandemer, V., Tholouli, E., Bulabois, C. -E., Huynh, A., Choi, G., Deconinck, E., Itala-Remes, M., Lenhoff, S., Bengtsson, M., Johansson, J. -E., van Gorkom, G., Hoogenboom, J. D., Vago, L., Rocha, V., Bonini, C., Chabannon, C., Fleischhauer, K., Clausen, J., Holter, W., Kalhs, P., Beguin, Y., Bron, D., Deeren, D., Lung, W. K., Kerre, T., Poire, X., Selleslag, D., Schroyens, W., Jindra, P., Mayer, J., Vydra, J., Zak, P., Nielsen, B., Sengeloev, H., Kaare, A., Partanen, A., Bay, J., Bertrand, Y., Blaise, D., Bourhis, J. H., Chevallier, P., Cluzeau, T., Damaj, G., Fegueux, N., Guyotat, D., Hunault-Berger, M., Labussiere-Wallet, H., Leleu, X., Lioure, B., Maury, S., Michel, G., Mohty, M., Rubio, M. T., Tilly, H., Turlure, P., Bethge, W., Casper, J., Einsele, H., Ganser, A., Kroger, N., Martin, S., Platzbecker, U., Reinhardt, C., Schafer-Eckart, K., Thurner, L., Valerius, T., Wulf, G. G., Karakasis, D., Spyridonidis, A., Hauser, P., Remenyi, P., Reykdal, S., Mousavi, A., Angelucci, E., Arcese, W., Benedetti, F., Bernasconi, P., Biondi, A., Bonifazi, F., Carella, A. M., Carluccio, P., Casini, M., Cavanna, L., Ciceri, F., Cimino, G., Corradini, P., Fanin, R., Galieni, P., Grillo, G., Iori, A. P., La Nasa, G., Locatelli, Franco, Marotta, G., Martino, M., Mazza, P., Mordini, N., Musso, M., Olivieri, A., Pavone, V., Pane, F., Petrini, M., Pioltelli, P., Rambaldi, A., Ruggeri, M., Saccardi, R., Santarone, S., Scime, R., Sica, S., Tarella, C., Velardi, A., Visani, G., Zecca, M., Tanase, A., Kulagin, A., Savchenko, V., Lopez, C. A., Amor, A. A., Lopez, J. L. B., Caballero, D., Duarte, R., Cascon, M. J. P., Porras, R. P., Perez-Simon, J. A., Rovira, M., Sanz, J., Carrete, J. P. T., Cammenga, J., Isaksson, C., Mielke, S., Chalandon, Y., Passweg, J., Schanz, U., Meijer, E., Kuball, J., Veelken, J. H., Apperley, J., Bloor, A., Byrne, J., Carpenter, B., Clark, A., Collin, M., Craddock, C., Gibson, B. E., Khan, A., Martin, M., Medd, P., Nicholson, E., Orchard, K., Patel, A., Peniket, A., Potter, V., Snowden, J., Wilson, K. M. O., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

NO ABSTRACT

Published
2023

22. “Redo” 2D–3D Fusion Technique during Endovascular Redo Aortic Repair

Author

Minelli, Fabrizio, Sica, Simona, Salman, Fadia, Donato, Federica, Dvir, M., Tshomba, Yamume, Tinelli, Giovanni, Minelli F., Sica S., Salman F., Donato F., Tshomba Y. (ORCID:0000-0001-7304-7553), Tinelli G. (ORCID:0000-0002-2212-3226), Minelli, Fabrizio, Sica, Simona, Salman, Fadia, Donato, Federica, Dvir, M., Tshomba, Yamume, Tinelli, Giovanni, Minelli F., Sica S., Salman F., Donato F., Tshomba Y. (ORCID:0000-0001-7304-7553), and Tinelli G. (ORCID:0000-0002-2212-3226)

Abstract

Purpose: The present study aims to describe a new 2D–3D fusion registration method in the case of endovascular redo aortic repair and compare the accuracy of the registration using the previously implanted devices vs. bones as landmarks. Materials and Methods: This single-center study prospectively analyzed all the patients that underwent elective endovascular re-interventions using the Redo Fusion technique between January 2016 and December 2021 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario A. Gemelli (FPUG)—IRCCS in Rome, Italy. The fusion overlay was performed twice, first using bone landmarks (bone fusion) and the second using radiopaque markers of a previous endovascular device (redo fusion). The pre-operative 3D model was fused with live fluoroscopy to create a roadmap. Longitudinal distances between the inferior margin of the target vessel in live fluoroscopy and the inferior margin of the target vessel in bone fusion and redo fusion were measured. Results: This single-center study prospectively analyzed 20 patients. There were 15 men and five women, with a median age of 69.7 (IQR 42) years. The median distance between the inferior margin of the target vessel ostium in digital subtraction angiography and the inferior margin of the target vessel ostium in bone fusion and redo fusion was 5.35 mm and 1.35 mm, respectively (p ≤ 0.0001). Conclusions: The redo fusion technique is accurate and allows the optimization of X-ray working views, supporting the endovascular navigation and vessel catheterization in case of endovascular redo aortic repair.

Published
2023

23. Discrepancy between recipient and donor rs4364254 heparanase single nucleotide polymorphism impacts graft-versus-host disease after allogeneic stem cell transplant

Author

Metafuni, Elisabetta, Giammarco, S., Bellesi, Silvia, Rossi, M., Minnella, Gessica, Limongiello, M. A., Valentini, C. G., Teofili, Luciana, Sica, S., Chiusolo, Patrizia, Metafuni E., Bellesi S., Minnella G., Teofili L. (ORCID:0000-0002-7214-1561), Chiusolo P. (ORCID:0000-0002-1355-1587), Metafuni, Elisabetta, Giammarco, S., Bellesi, Silvia, Rossi, M., Minnella, Gessica, Limongiello, M. A., Valentini, C. G., Teofili, Luciana, Sica, S., Chiusolo, Patrizia, Metafuni E., Bellesi S., Minnella G., Teofili L. (ORCID:0000-0002-7214-1561), and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

Introduction: The heparanase (HPSE) gene is highly polymorphic, but only a minority of its single nucleotide polymorphisms (SNPs) have been studied. Among these, rs4693608 and rs4364254 SNPs are closely associated with mRNA expression and HPSE protein levels in healthy subjects. Given the association between HPSE and inflammatory response, we aimed to evaluate whether HPSE rs4693608 and rs4364254 SNPs could have an impact on graft-versus-host disease after allogeneic stem cell transplants (HSCT). Methods: A total of 228 consecutive patients who underwent HSCT at our center between 2005 and 2018 were included. The rs4693608 SNP was identified by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) analysis, while the rs4364254 was detected by allele-specific amplification. Results: The recipient-donor discrepancy for rs4364254 HPSE SNP was significantly associated with grade II-IV aGvHD (HR 1.75, p = 0.03). Patients were stratified into risk groups as follows: low-risk group (LDR) including TT-TT, TT-CT, CT-TT, CC-CC; high-risk group (HDR) including CC-CT, CC-TT, CT-CC, CT–CT, TT-CC. Day 100 cumulative incidence of grade II-IV aGvHD was 23.4% in the LDR group and 41.4% in the HDR group (p = 0.01). One-year cumulative incidence of moderate/severe cGvHD was 42.6% in the LDR group and 58.6% in the HDR group (p = 0.04). Independent variables for moderate/severe cGvHD in patients who received myeloablative conditioning included donor rs4693608 SNP (GA/AA vs. GG: HR 6.86, p = 0.008), rs4693608-rs4364254 SNP combination in recipient (HR/MR vs. LR: HR 3.67, p = 0.01), and previous grade II-IV aGvHD (HR 3.28, p = 0.0005). Finally, donors with rs4364254 SNP CC conferred increased transplant-related mortality (TRM) (39.1% vs. 25%, p = 0.03) and decreased graft-relapse free survival (GRFS) (23.5% vs. 34.4%, p = 0.04) compared with CT or TT genotypes. Conclusion: The differences in incidence of GvHD according to recipient-donor genotype combinations sugge

Published
2023

24. Impact of Covid 19 pandemic on hematopoietic stem cell transplantation activities: Report from a single center

Author

Giammarco, S., Sica, Simona, Metafuni, Elisabetta, Limongiello, M. A., Valentini, C. G., Sora', Federica, Marra, John Donald, Bacigalupo, Andrea, Teofili, Luciana, Chiusolo, Patrizia, Sica S. (ORCID:0000-0003-2426-3465), Metafuni E., Sora' F. (ORCID:0000-0002-9607-5298), Marra J. D., Bacigalupo A. (ORCID:0000-0002-9119-567X), Teofili L. (ORCID:0000-0002-7214-1561), Chiusolo P. (ORCID:0000-0002-1355-1587), Giammarco, S., Sica, Simona, Metafuni, Elisabetta, Limongiello, M. A., Valentini, C. G., Sora', Federica, Marra, John Donald, Bacigalupo, Andrea, Teofili, Luciana, Chiusolo, Patrizia, Sica S. (ORCID:0000-0003-2426-3465), Metafuni E., Sora' F. (ORCID:0000-0002-9607-5298), Marra J. D., Bacigalupo A. (ORCID:0000-0002-9119-567X), Teofili L. (ORCID:0000-0002-7214-1561), and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

The current COVID-19 pandemic has placed unprecedented stress on the healthcare system, including HSCT. Several international organizations have created guidelines for managing different aspects of HSCT in the context of the pandemic. Comparing 2019 and 2020, our transplant center performed the same number of transplants. In both periods, transplants were mainly for patients with acute leukemia; thus, the urgency criteria was respected in light of pandemic restraints. Transplants by sibling donors and cord blood units remained the same, while transplants by unrelated donors were increased, in particular from European registries, and transplants by haploidentical donors were decreased. This change was made in light of the necessity of cryopreserving all apheresis products. We decided against cryopreserving bone marrow products due to the greater risk of drastic reduction in CD34 + cell count during the process. For urgent cases with only a haploidentical donor available, we opted for the use of PBSC following stimulation with G-CSF. GvHD prophylaxis was performed with PTCY on days + 3 + 5, cyclosporine with tapering from day + 100, and mycophenolic acid until day + 90 post-HSCT. Post-transplant outcomes such as graft failure, sepsis, and GVHD were not affected by the changes implemented. As a result of logistic difficulties, we halted our Car-T program from the start of the lockdown in March 2020 until September 2020. In accord with international guidelines, we were able to continue our HSCT program in the order to ensure a lifesaving treatment for patients with hematologic diseases for whom this procedure cannot be postponed.

Published
2023

25. Efficacy and safety of nilotinib as frontline treatment in elderly (> 65 years) chronic myeloid leukemia patients outside clinical trials

Author

Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

Here, we report real-world evidence on the safety and efficacy of nilotinib as a first-line treatment in elderly patients with chronic phase CML, treated in 18 Italian centers. Sixty patients aged > 65 years (median age 72 years (65–84)) were reported: 13 patients were older than 75 years. Comorbidities were recorded at baseline in 56/60 patients. At 3 months of treatment, all patients obtained complete hematological response (CHR), 43 (71.6%) an early molecular response (EMR), while 47 (78%) reached a complete cytogenetic response (CCyR). At last follow-up, 63.4% of patients still had a deep molecular response (MR4 or better), 21.6% reached MR3 as best response and 11.6% persisted without MR. Most patients (85%) started the treatment at the standard dose (300 mg BID), maintained at 3 months in 80% of patients and at 6 months in 89% of them. At the last median follow-up of 46.3 months, 15 patients discontinued definitively the treatment (8 due to side effects, 4 died for unrelated CML causes, 1 for failure, 2 were lost to follow-up). One patient entered in treatment-free remission. As to safety, 6 patients (10%) experienced cardiovascular events after a median time of 20.9 months from the start. Our data showed that nilotinib could be, as first-line treatment, effective and relatively safe even in elderly CML patients. In this setting, more data in the long term are needed about possible dose reduction to improve the tolerability, while maintaining the optimal molecular response.

Published
2023

27. Late HBV reactivation after hematopoietic stem cell transplantation, despite long-term prophylaxis

Author

Viscovo, Marcello, Metafuni, Elisabetta, Giammarco, S., Santopaolo, Francesco, Frioni, Filippo, Pellegrino, Claudio, Sica, S., Chiusolo, Patrizia, Pompili, Maurizio, Viscovo M., Metafuni E., Santopaolo F., Frioni F., Pellegrino C., Chiusolo P. (ORCID:0000-0002-1355-1587), Pompili M. (ORCID:0000-0001-6699-7980), Viscovo, Marcello, Metafuni, Elisabetta, Giammarco, S., Santopaolo, Francesco, Frioni, Filippo, Pellegrino, Claudio, Sica, S., Chiusolo, Patrizia, Pompili, Maurizio, Viscovo M., Metafuni E., Santopaolo F., Frioni F., Pellegrino C., Chiusolo P. (ORCID:0000-0002-1355-1587), and Pompili M. (ORCID:0000-0001-6699-7980)

Abstract

N/A

Published
2023

28. The Role of Fecal Microbiota Transplantation in the Allogeneic Stem Cell Transplant Setting

Author

Metafuni, Elisabetta, Di Marino, Luca, Giammarco, S., Bellesi, Silvia, Limongiello, M. A., Sora', Federica, Frioni, Filippo, Maggi, Roberto, Chiusolo, Patrizia, Sica, Simona, Metafuni E., Di Marino L., Bellesi S., Sora' F. (ORCID:0000-0002-9607-5298), Frioni F., Maggi R., Chiusolo P. (ORCID:0000-0002-1355-1587), Sica S. (ORCID:0000-0003-2426-3465), Metafuni, Elisabetta, Di Marino, Luca, Giammarco, S., Bellesi, Silvia, Limongiello, M. A., Sora', Federica, Frioni, Filippo, Maggi, Roberto, Chiusolo, Patrizia, Sica, Simona, Metafuni E., Di Marino L., Bellesi S., Sora' F. (ORCID:0000-0002-9607-5298), Frioni F., Maggi R., Chiusolo P. (ORCID:0000-0002-1355-1587), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

Microbiota changes during allogeneic hematopoietic stem cell transplantation has several known causes: conditioning chemotherapy and radiation, broad-spectrum antibiotic administration, modification in nutrition status and diet, and graft-versus-host disease. This article aims to review the current knowledge about the close link between microbiota and allogeneic stem cell transplantation setting. The PubMed search engine was used to perform this review. We analyzed data on microbiota dysbiosis related to the above-mentioned affecting factors. We also looked at treatments aimed at modifying gut dysbiosis and applications of fecal microbiota transplantation in the allogeneic stem cell transplant field, with particular interest in fecal microbiota transplantation for graft-versus-host disease (GvHD), multidrug-resistant and clostridium difficile infections, and microbiota restoration after chemotherapy and antibiotic therapy.

Published
2023

29. Impact of SARS-CoV-2 vaccination and passive prophylaxis with tixagevimab/cilgavimab on CAR-T patients: a three-year regional experience from the Italian covid pandemic

Author

Galli, Eugenio, Di Rocco, A., Pansini, Ilaria, Frondizi, Federico, Di Palma, Matteo, Metafuni, Elisabetta, Piccirillo, Nicola, Bianchi, Maria, Cingolani, Antonella, Torelli, G. F., Hohaus, Stefan, Chiusolo, Patrizia, Iori, A. P., Sica, Simona, Martelli, Maddalena, Sora', Federica, Galli E., Pansini I., Frondizi F., Di Palma M., Metafuni E., Piccirillo N. (ORCID:0000-0002-1688-1987), Bianchi M., Cingolani A. (ORCID:0000-0002-3793-2755), Hohaus S. (ORCID:0000-0002-5534-7197), Chiusolo P. (ORCID:0000-0002-1355-1587), Sica S. (ORCID:0000-0003-2426-3465), Martelli M., Sora' F. (ORCID:0000-0002-9607-5298), Galli, Eugenio, Di Rocco, A., Pansini, Ilaria, Frondizi, Federico, Di Palma, Matteo, Metafuni, Elisabetta, Piccirillo, Nicola, Bianchi, Maria, Cingolani, Antonella, Torelli, G. F., Hohaus, Stefan, Chiusolo, Patrizia, Iori, A. P., Sica, Simona, Martelli, Maddalena, Sora', Federica, Galli E., Pansini I., Frondizi F., Di Palma M., Metafuni E., Piccirillo N. (ORCID:0000-0002-1688-1987), Bianchi M., Cingolani A. (ORCID:0000-0002-3793-2755), Hohaus S. (ORCID:0000-0002-5534-7197), Chiusolo P. (ORCID:0000-0002-1355-1587), Sica S. (ORCID:0000-0003-2426-3465), Martelli M., and Sora' F. (ORCID:0000-0002-9607-5298)

Abstract

N/A

Published
2023

30. Effect of HLA mismatch on post-transplant infections in allogeneic hematopoietic stem cell transplantation with PTCy-based GvHD prophylaxis

Author

Marra, John Donald, Galli, Eugenio, Giammarco, S., Chiusolo, Patrizia, Metafuni, Elisabetta, Sora', Federica, Laurenti, Luca, Innocenti, Idanna, Autore, Francesco, Limongiello, M. A., Fresa, Alberto, Bacigalupo, Andrea, Sica, Simona, Marra J. D., Galli E., Chiusolo P. (ORCID:0000-0002-1355-1587), Metafuni E., Sora' F. (ORCID:0000-0002-9607-5298), Laurenti L. (ORCID:0000-0002-8327-1396), Innocenti I., Autore F., Fresa A., Bacigalupo A. (ORCID:0000-0002-9119-567X), Sica S. (ORCID:0000-0003-2426-3465), Marra, John Donald, Galli, Eugenio, Giammarco, S., Chiusolo, Patrizia, Metafuni, Elisabetta, Sora', Federica, Laurenti, Luca, Innocenti, Idanna, Autore, Francesco, Limongiello, M. A., Fresa, Alberto, Bacigalupo, Andrea, Sica, Simona, Marra J. D., Galli E., Chiusolo P. (ORCID:0000-0002-1355-1587), Metafuni E., Sora' F. (ORCID:0000-0002-9607-5298), Laurenti L. (ORCID:0000-0002-8327-1396), Innocenti I., Autore F., Fresa A., Bacigalupo A. (ORCID:0000-0002-9119-567X), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

N/A

Published
2023

31. Targeting the undruggable: menin inhibitors ante portas

Author

Dempke, W. C. M., Desole, M., Chiusolo, Patrizia, Sica, S., Schmidt-Hieber, M., Chiusolo P. (ORCID:0000-0002-1355-1587), Dempke, W. C. M., Desole, M., Chiusolo, Patrizia, Sica, S., Schmidt-Hieber, M., and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

Acute myeloid leukaemias harbouring a rearrangement of the mixed lineage leukaemia gene (MLL) are aggressive haematopoietic malignancies that relapse early and have a poor prognosis (event-free survival less than 50%). Menin is a tumour suppressor, however, in MLL-rearranged leukaemias it functions as a co-factor which is mandatory for the leukaemic transformation by interaction with the N-terminal part of MLL, which is maintained in all MLL-fusion proteins. Inhibition of menin blocks leukaemogenesis and leads to differentiation and, in turn, to apoptosis of leukaemic blasts. Furthermore, nucleophosmin 1 (NPM1) binds to specific chromatin targets, which are co-occupied by MLL, and menin inhibition has been shown to trigger degradation of mNPM1 resulting in a rapid decrease in gene expression and activating histone modifications. Therefore, disruption of the menin-MLL axis blocks leukaemias driven by NPM1 mutations for which the expression of menin-MLL target genes (e.g., MEIS1, HOX etc.) is essential. To date at least six different menin-MLL inhibitors are undergoing clinical evaluation as first- and second-line monotherapy in acute leukaemias: DS-1594, BMF-219, JNJ-75276617, DSP-5336, revumenib, and ziftomenib, however, only for revumenib and ziftomenib early clinical data have been reported. In the revumenib phase I/II AUGMENT-101 trial (N = 68) with very heavily pretreated AML patients the ORR was 53% with a CR rate of 20%. The ORR in patients harbouring MLL rearrangement of mNPM1 was 59%. Patients who achieved a response had a mOS of 7 months. Similar results have been reported for ziftomenib in the phase I/II COMET-001 trial. ORR was 40% and CRc was 35% in AML patients with mNPM1. However, outcome was worse in AML patients with a MLL rearrangement (ORR 16.7%, CRc 11%). Differentiation syndrome was a notable adverse event. The clinical development of novel menin-MLL inhibitors is well in line with the currently ongoing paradigm shift towards targeted therap

Published
2023

32. The CD4/CD8 ratio of infused CD19-CAR-T is a prognostic factor for efficacy and toxicity

Author

Galli, Eugenio, Bellesi, Silvia, Pansini, Ilaria, Di Cesare, G., Iacovelli, Camilla, Malafronte, Rosalia, Maiolo, Elena, Chiusolo, Patrizia, Sica, Simona, Sora', Federica, Hohaus, Stefan, Galli E., Bellesi S., Pansini I., Iacovelli C., Malafronte R., Maiolo E., Chiusolo P. (ORCID:0000-0002-1355-1587), Sica S. (ORCID:0000-0003-2426-3465), Sora' F. (ORCID:0000-0002-9607-5298), Hohaus S. (ORCID:0000-0002-5534-7197), Galli, Eugenio, Bellesi, Silvia, Pansini, Ilaria, Di Cesare, G., Iacovelli, Camilla, Malafronte, Rosalia, Maiolo, Elena, Chiusolo, Patrizia, Sica, Simona, Sora', Federica, Hohaus, Stefan, Galli E., Bellesi S., Pansini I., Iacovelli C., Malafronte R., Maiolo E., Chiusolo P. (ORCID:0000-0002-1355-1587), Sica S. (ORCID:0000-0003-2426-3465), Sora' F. (ORCID:0000-0002-9607-5298), and Hohaus S. (ORCID:0000-0002-5534-7197)

Abstract

CD4+ and CD8+ chimeric antigen receptor T cells (CAR-T) play different roles in the in vivo anti-tumour response, but the role of the CD4+/CD8+ ratio among infused CAR-T has not been clearly defined yet. We analysed leftovers from infused anti-CD19 CAR-T bags of 31 patients with aggressive B-cell lymphomas. The median ratio was 1.44, lower for brexu-cel compared to tisa-cel and axi-cel. The CAR+CD4+/CD8+ ratio was influenced by lactate dehydrogenase levels at apheresis, not by age, previous treatments or the CD4+/CD8+ ratio in peripheral blood. Patients with a response at 3 months after CAR-T (M3) had a lower CAR+CD4+/CD8+ ratio in the infused products compared to non-responders (ratio 0.74 vs. 2.47, p = 0.011). A CAR+CD4+/CD8+ ratio higher than the cut point of 1.12 was associated with an increased risk of treatment failure at M3 (OR 23.3, p = 0.012) and M6 (OR 10, p = 0.028). The median 6-month PFS was 76% for patients with a ratio lower than 1.12% vs. 31% for the others. The prognostic role of the CAR+CD4+/CD8+ ratio was independent of the costimulatory domain (CD28 vs. 4-1BB) of the product (OR 16.41, p = 0.041). Our data indicate a crucial role for CD8+ CAR-T and the CAR+CD4+/CD8+ ratio in predicting CAR-T efficacy.

Published
2023

33. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, S.F., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, A.M., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, E.M., Luppi, M., Marasca, R., Pogliani, E.M., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, M.C., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, A.M., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., D'Emilio, A., Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., and Rosti, G.

Published
2015
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34. Decision analysis of allogeneic hematopoietic stem cell transplantation for patients with myelodysplastic syndrome stratified according to the revised International Prognostic Scoring System

Author

Della Porta, M G, Jackson, C H, Alessandrino, E P, Rossi, M, Bacigalupo, A, van Lint, M T, Bernardi, M, Allione, B, Bosi, A, Guidi, S, Santini, V, Malcovati, L, Ubezio, M, Milanesi, C, Todisco, E, Voso, M T, Musto, P, Onida, F, Iori, A P, Cerretti, R, Grillo, G, Molteni, A, Pioltelli, P, Borin, L, Angelucci, E, Oldani, E, Sica, S, Pascutto, C, Ferretti, V, Santoro, A, Bonifazi, F, Cazzola, M, and Rambaldi, A

Published
2017
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38. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author

Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., and Elice F.

Abstract

The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.

Published
2021

39. Non-overt disseminated intravascular coagulopathy associated with the first obinutuzumab administration in patients with chronic lymphocytic leukemia

Author

Fresa, A., Autore, F., Innocenti, I., Piciocchi, A., Tomasso, A., Morelli, F., Sora, F., Sica, S., De Stefano, V., Laurenti, L., Fresa A., Autore F., Innocenti I., Tomasso A., Morelli F., Sora F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), De Stefano V. (ORCID:0000-0002-5178-5827), Laurenti L. (ORCID:0000-0002-8327-1396), Fresa, A., Autore, F., Innocenti, I., Piciocchi, A., Tomasso, A., Morelli, F., Sora, F., Sica, S., De Stefano, V., Laurenti, L., Fresa A., Autore F., Innocenti I., Tomasso A., Morelli F., Sora F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), De Stefano V. (ORCID:0000-0002-5178-5827), and Laurenti L. (ORCID:0000-0002-8327-1396)

Abstract

Infusion-related reactions are among the worst complications of obinutuzumab (G) administration and occur predominantly during the first infusion. We reported another adverse event related to the first G infusion, a subclinical coagulopathy. We retrospectively analyzed a cohort of 13 pts with chronic lymphocytic leukemia treated with a frontline G-chlorambucil regimen. Six pts developed non-overt disseminated intravascular coagulopathy (DIC) (46%) after the first administration of G. The coagulopathy was subclinical and self-limited in all pts, not requiring any intervention apart from the suspension of anticoagulant therapy in one pt. We observed a drop in the platelet count, an elevation of D-dimer levels, and an elongation of activated partial thromboplastin time. We found a significant difference in the platelet count between the pts with DIC and those withouts; in fact, all the six pts with non-overt DIC had a platelet count greater than 100 × 109/L, while in the other group only one (p = 0.019). A trend towards a lower lymphocyte count and a higher CD20 expression was found in the pts with DIC. No other correlation between the DIC complication and the clinical or laboratory characteristics of the patients was found. The pathogenesis of the G-related non-overt DIC could be related to the consumption of the platelets after the lysis of lymphocytes, probably triggered by the damage associated molecular patterns. Despite its limitations, this study describes a new adverse event and identifies a specific subgroup of patients whose clinical management at the time of the infusion of G may need to be refined.

Published
2021

40. List of Contributors

Author

Ahmed, S.O., primary, Aldawsari, G., additional, Aljurf, M.D., additional, Alzahrani, H., additional, Ayas, M., additional, Bacigalupo, A., additional, Ciceri, F., additional, Cooper, J.N., additional, Dalle, J.H., additional, Dufour, C., additional, Elmahdi, S., additional, Farruggia, P., additional, Fioredda, F., additional, Gandhi, S., additional, Giraudier, S., additional, Gluckman, E., additional, Grimaldi, F., additional, Höchsmann, B., additional, Hosokawa, K., additional, Kojima, S., additional, Leblanc, T., additional, Marsh, J.C.W., additional, Meyran, D., additional, Miano, M., additional, Mufti, G.J., additional, Passweg, J.R., additional, de Latour, R. Peffault, additional, Risitano, A.M., additional, Rovó, A., additional, Ruggeri, A., additional, Samarasinghe, S., additional, Scheinberg, P., additional, Schrezenmeier, H., additional, Sica, S., additional, Stanghellini, M.T.L., additional, Tichelli, A., additional, Van Lint, M.T., additional, Warren, A.J., additional, and Young, N.S., additional

Published
2017
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43. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author

Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo, D., Polverelli, N., Malagola, M., Farina, M., Leoni, A., Bernardi, S., Mammoliti, S., Sacchi, N., Martino, M., Ciceri, F., Zallio, F., Olivieri, A., Falcioni, S., Storti, G., Michieli, M., Carluccio, P., Grassi, A., Oldani, E., Bonifazi, F., Prete, A., Cavattoni, I. M., Maffeis, M., Pastore, D., Vacca, A., Caravelli, D., Mirabile, M., Mordini, N., Nozzoli, C., Faraci, M., Federico, V., Ronconi, S., Skert, C., Onida, F., Marcatti, M., Piemontese, S., Narni, F., Balduzzi, A., De Simone, G., Picardi, A., De Gobbi, M., Calore, E., Tringali, S., Zecca, M., Secondino, S., Guiducci, B., Pelosini, M., Zuffa, E., Facchini, L., Imola, M., Iori, A. P., Proia, A., Sica, S., Armiento, D., Carella, A. M., Dellacasa, C. M., Fagioli, F., Rabusin, M., Ferrario, A., and Elice, F.

Subjects
Homologous, Myeloid, medicine.medical_specialty, 2019-20 coronavirus outbreak, Bone marrow transplant, Coronavirus disease 2019 (COVID-19), Epidemiology, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Hematopoietic stem cell transplantation, Acute, Humans, Italy, Pandemics, RNA, Viral, SARS-CoV-2, Stem Cell Transplantation, Transplantation, Homologous, COVID-19, Hematopoietic Stem Cell Transplantation, Leukemia, Myeloid, Acute, Article, hematopoietic stem cell transplantation, covid-19, pandemic, Internal medicine, Pandemic, medicine, Viral, Acute leukemia, Transplantation, Leukemia, business.industry, Hematology, Stem-cell research, RNA, Stem cell, business
Abstract

The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.

Published
2021

44. S156: INTERNATIONAL, PROSPECTIVE STUDY COMPARING NILOTINIB VERSUS IMATINIB WITH EARLY SWITCH TO NILOTINIB TO OBTAIN SUSTAINED TREATMENT-FREE REMISSION IN PATIENTS WITH WITH CHRONIC MYELOID LEUKEMIA

Author

Pane, F., primary, Castagnetti, F., additional, Luciano, L., additional, Russo Rossi, A., additional, Abruzzese, E., additional, Bassan, R., additional, Binotto, G., additional, Caocci, G., additional, Cimino, G., additional, Fazi, P., additional, Gozzini, A., additional, Lunghi, M., additional, Marasca, R., additional, Martino, B., additional, Bonifacio, M., additional, Cavazzini, F., additional, Paoloni, F., additional, Saglio, G., additional, Sica, S., additional, Tafuri, A., additional, Vallisa, D., additional, Vignetti, M., additional, Westerweel, P., additional, Rosti, G., additional, and Breccia, M., additional

Published
2022
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45. P957: CARFILZOMIB, LENALIDOMIDE, DEXAMETHASONE FOLLOWED BY A SECOND AUTO-HCT IS AN EFFECTIVE STRATEGY IN FIRST RELAPSE MULTIPLE MYELOMA: A STUDY OF THE CHRONIC MALIGNANCIES WORKING PARTY OF EBMT

Author

Tilmont, R., primary, Yakoub-Agha, I., additional, Eikema, D.-J., additional, Zinger, N., additional, Haenel, M., additional, Schaap, N., additional, Herrera Arroyo, C., additional, Schuermans, C., additional, Bethge, W., additional, Engelhardt, M., additional, Kuball, J., additional, Michieli, M., additional, Schub, N., additional, Wilson, K. M. O., additional, Bourhis, J. H., additional, Mateos, M. V., additional, Robin, N., additional, Jost, E., additional, Kröger, N., additional, Moraleda, J. M., additional, Sica, S., additional, Hayden, P. J., additional, Beksac, M., additional, Schönland, S., additional, and Manier, S., additional

Published
2022
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46. P307: DEL(17)(Q11) IS TYPICAL MARKER OF IMMATURE T-ALL OF ADULTS, WITH NF1, UTP6, AND SUZ12 HAPLOINSUFFICIENCY, GENOME INSTABILITY, AND GENE DOWNREGULATION

Author

Bardelli, V., primary, Pierini, V., additional, Arniani, S., additional, Mvridou, E., additional, Matteucci, C., additional, Lema Fernandez, A. G., additional, Moretti, M., additional, Elia, L., additional, Giglio, F., additional, Forghieri, F., additional, Cerrano, M., additional, Fracchiolla, N., additional, Delia, M., additional, Sica, S., additional, Mecucci, C., additional, and La Starza, R., additional

Published
2022
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47. P470: NGS-BASED MINIMAL RESIDUAL DISEASE DETECTION IN PERIPHERAL BLOOD SHOWS GOOD PROGNOSTIC VALUE FOR OS AND EFS IN PATIENTS WITH ACUTE MYELOID LEUKEMIA RECRUITED IN THE UNIFY TRIAL

Author

Thiede, C., primary, Schuster, C., additional, Krippendorf, C., additional, Koenen, G., additional, Medts, T., additional, Marques Ramos, P., additional, Gou, L., additional, Montesinos, P., additional, Fiedler, W., additional, Müller, R., additional, Krauter, J., additional, Sica, S., additional, Westermann, J., additional, Levis, M., additional, Stone, R., additional, Sierra, J., additional, and Döhner, H., additional

Published
2022
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48. P830: CROVALIMAB MAINTAINS CLINICAL BENEFIT OVER LONG-TERM TREATMENT IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: RESULTS FROM THE COMPOSER TRIAL OPEN-LABEL EXTENSION

Author

Röth, A., primary, Egyed, M., additional, Ichikawa, S., additional, Ito, Y., additional, Kim, J. S., additional, Nagy, Z., additional, Obara, N., additional, Panse, J., additional, Schrezenmeier, H., additional, Sica, S., additional, Soret, J., additional, Usuki, K., additional, Yoon, S.-S., additional, Benkali, K., additional, Buri, M., additional, Lundberg, P., additional, Patel, H., additional, Shinomiya, K., additional, Sreckovic, S., additional, and Nishimura, J.-I., additional

Published
2022
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50. P1353: EFFICACY OF SARSCOV2 VACCINATION IN PATIENTS UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION. A MULTICENTER EXPERIENCE

Author

Stirparo, L., primary, Autore, F., additional, Innocenti, I., additional, Papa, E., additional, Marchesi, F., additional, Togni, C., additional, Mariani, S., additional, Torrieri, L., additional, Salvatori, M., additional, Fazio, F., additional, Metafuni, E., additional, Giammarco, S., additional, Sorà, F., additional, Falcucci, P., additional, Ferrari, A., additional, Trisolini, S. M., additional, Tafuri, A., additional, Chiusolo, P., additional, Sica, S., additional, and Laurenti, L., additional

Published
2022
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