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5. Immune-inflammatory biomarkers as prognostic factors for immunotherapy in pretreated advanced urinary tract cancer patients: an analysis of the Italian SAUL cohort

Author

Fornarini, G., Rebuzzi, S.E., Banna, G.L., Calabrò, F., Scandurra, G., De Giorgi, U., Masini, C., Baldessari, C., Naglieri, E., Caserta, C., Manacorda, S., Maruzzo, M., Milella, M., Buttigliero, C., Tambaro, R., Ermacora, P., Morelli, F., Nolè, F., Astolfi, C., and Sternberg, C.N.

Published
2021
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9. PROSTATIC ARTERY EMBOLIZATION IN PATIENTS WITH INDWELLING BLADDER CATHETER.

Author

Secco, S, primary, Campobasso, D, additional, Guarino, G, additional, Maggiorelli, S, additional, Brambillasca, P, additional, De Cinque, A, additional, Paladini, I, additional, Andreone, A, additional, Morelli, F, additional, Olivero, A, additional, Favali, M, additional, Zagnoli, A, additional, Dell’Oglio, P, additional, Ferretti, S, additional, Di Chiacchio, G, additional, Ziglioli, F, additional, Patera, A, additional, Slawitz, M, additional, Di Marco, G, additional, Puliatti, S, additional, Micali, S, additional, Bocciardi, A, additional, Rampoldi, A, additional, Maestroni, U, additional, and Galfano, A, additional

Published
2023
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16. Efficacy of prostate artery embolization in patients with indwelling bladder catheter

Author

Secco, S., primary, Brambillasca, P., additional, Morelli, M., additional, Sampogna, G., additional, Alfonsi, A., additional, Morelli, F., additional, Solcia, M., additional, Dell’Oglio, P., additional, Olivero, A., additional, Palagonia, E., additional, Spinelli, M., additional, Bocciardi, A., additional, Rampoldi, A., additional, and Galfano, A., additional

Published
2022
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18. Trauma quality indicators: internationally approved core factors for trauma management quality evaluation

Author

Coccolini, F., Kluger, Y., Moore, E. E., Maier, R. V., Coimbra, R., Ordonez, C., Ivatury, R., Kirkpatrick, A. W., Biffl, W., Sartelli, M., Hecker, A., Ansaloni, L., Leppaniemi, A., Reva, V., Civil, I., Vega, F., Chiarugi, M., Chichom-Mefire, A., Sakakushev, B., Peitzman, A., Chiara, O., Abu-Zidan, F., Maegele, M., Miccoli, M., Chirica, M., Khokha, V., Sugrue, M., Fraga, G. P., Otomo, Y., Baiocchi, G. L., Catena, F., Kuliesius, Z., Conti, L., Dogjani, A., Lee, J. G., Consani, H., Russello, D., Bortul, M., Maurel, T. G., Kaf, H. S., Adamou, H., Alin, V., Robustelli, U., Sato, N., Seretis, C., Quiodettis, M., Gomes, C. A., Kong, V., Zakaria, A. D., Guner, A., Gachabayov, M., Chowdhury, S., Pata, F., Garcia, A., Rems, M., Das, K., Riedel, J. G., Lasithiotakis, K., Sydorchuk, R., Sydorchuk, L., Lostoridis, E., Buia, A., Mcfarlane, M., Ciani, R., Munoz-Cruzado, V. M. D., Tartaglia, D., Ioannidis, O., Muhrbeck, M., Reicher, M., Roscio, F., Ceresoli, M., Tsiftsis, D., Kavalakat, A., Pintar, T., Georgiou, G., Ricci, G., Mohan, R., Saar, S., Di Carlo, I., Isik, A., Ahmed, A. Y. Y. M., Gonsaga, R. A. T., Sammartano, F., Tallon-Aguilar, L., Shoko, T., Hsu, J., Kobe, Y., Romeo, C. G. L., Podda, M., Mingoli, A., Delgado, R. C., Ekwen, G., Aude, V., Olona, C., Boati, P., Magnone, S., Capaldi, M., Bala, M., Picetti, E., Negoi, I., Kok, K. Y. Y., Jusoh, A. C., Amato, B., Nita, G. E., de Beaux, A., Demetrashvili, Z., Davies, R. J., Kim, J. I., Pereira, A., Fattori, L., Paolillo, C., Ghannam, W., Rodriguez, F. M., Berardi, L., Florio, M. G., Hecker, M., Dubuisson, V., O'Connor, D. B., De'Angelis, N., Dobric, I., Massalou, D., Ortenwall, P., Pikoulis, E., Ugarte-Sierra, B., Zuidema, W. P., Kechagias, A., Marwah, S., Litvin, A., Nikolopoulos, I., Pesce, A., Uranues, S., Luppi, D., Flohe, S., Martinez-Perez, A., Lorenzo, M., Vergano, L. B., Manca, M., Malacarne, P., Kurihara, H., Widder, S., Pucciarelli, M., Monzani, F., Brambillasca, P., Corbella, D., Agresta, F., Moore, L., Buonomo, L. A., Adeleye, A. O., Kim, D., Veroux, M., Hardcastle, T. C., Di Saverio, S., Recordare, A., Rubio-Perez, I., Shlyapnikov, S., Rahim, R., Vega, G. M. M., Boris, K., Sawyer, R., Baraket, O., Soreide, K., Weber, C., Seak, C. -J., Herman, S., Gamberini, E., Costa, S., Mazzocconi, G., Lozada, E., Manatakis, D., Lohsiriwat, V., Ahmed, A., Elbery, B., Tiberio, G. A. M., Santini, M., Mellace, L., Enoksen, C. H., Major, P., Parini, D., Improta, M., Fugazzola, P., Pini, S., Liberti, G., Martino, C., Cobianchi, L., Canzi, G., Cicuttin, E., Kenig, J., Zago, M., Giannessi, S., Scaglione, M., Orsitto, E., Cioni, R., Ghiadoni, L., Menichetti, F., Agnoletti, V., Sganga, G., Prosperi, P., Roviello, F., De Paolis, P., Gordini, G., Forfori, F., Ruscelli, P., Gabrielli, F., Puglisi, A., Bertolucci, A., Marchi, S., Bellini, M., Casagli, S., De Simone, B., Carmassi, F., Marchetti, S., Accorsini, M., Cremonini, C., Morelli, F., Romeo, L., Coccolini F., Kluger Y., Moore E.E., Maier R.V., Coimbra R., Ordonez C., Ivatury R., Kirkpatrick A.W., Biffl W., Sartelli M., Hecker A., Ansaloni L., Leppaniemi A., Reva V., Civil I., Vega F., Chiarugi M., Chichom-Mefire A., Sakakushev B., Peitzman A., Chiara O., Abu-Zidan F., Maegele M., Miccoli M., Chirica M., Khokha V., Sugrue M., Fraga G.P., Otomo Y., Baiocchi G.L., Catena F., Kuliesius Z., Conti L., Dogjani A., Lee J.G., Consani H., Russello D., Bortul M., Maurel T.G., Kaf H.S., Adamou H., Alin V., Robustelli U., Sato N., Seretis C., Quiodettis M., Gomes C.A., Kong V., Zakaria A.D., Guner A., Gachabayov M., Chowdhury S., Pata F., Garcia A., Rems M., Das K., Riedel J.G., Lasithiotakis K., Sydorchuk R., Sydorchuk L., Lostoridis E., Buia A., McFarlane M., Ciani R., Munoz-Cruzado V.M.D., Tartaglia D., Ioannidis O., Muhrbeck M., Reicher M., Roscio F., Ceresoli M., Tsiftsis D., Kavalakat A., Pintar T., Georgiou G., Ricci G., Mohan R., Saar S., Di Carlo I., Isik A., Ahmed A.Y.Y.M., Gonsaga R.A.T., Sammartano F., Tallon-Aguilar L., Shoko T., Hsu J., Kobe Y., Romeo C.G.L., Podda M., Mingoli A., Delgado R.C., Ekwen G., Aude V., Olona C., Boati P., Magnone S., Capaldi M., Bala M., Picetti E., Negoi I., Kok K.Y.Y., Jusoh A.C., Amato B., Nita G.E., de Beaux A., Demetrashvili Z., Davies R.J., Kim J.I., Pereira A., Fattori L., Paolillo C., Ghannam W., Rodriguez F.M., Berardi L., Florio M.G., Hecker M., Dubuisson V., O'Connor D.B., De'Angelis N., Dobric I., Massalou D., Ortenwall P., Pikoulis E., Ugarte-Sierra B., Zuidema W.P., Kechagias A., Marwah S., Litvin A., Nikolopoulos I., Pesce A., Uranues S., Luppi D., Flohe S., Martinez-Perez A., Lorenzo M., Vergano L.B., Manca M., Malacarne P., Kurihara H., Widder S., Pucciarelli M., Monzani F., Brambillasca P., Corbella D., Agresta F., Moore L., Buonomo L.A., Adeleye A.O., Kim D., Veroux M., Hardcastle T.C., Di Saverio S., Recordare A., Rubio-Perez I., Shlyapnikov S., Rahim R., Vega G.M.M., Boris K., Sawyer R., Baraket O., Soreide K., Weber C., Seak C.-J., Herman S., Gamberini E., Costa S., Mazzocconi G., Lozada E., Manatakis D., Lohsiriwat V., Ahmed A., Elbery B., Tiberio G.A.M., Santini M., Mellace L., Enoksen C.H., Major P., Parini D., Improta M., Fugazzola P., Pini S., Liberti G., Martino C., Cobianchi L., Canzi G., Cicuttin E., Kenig J., Zago M., Giannessi S., Scaglione M., Orsitto E., Cioni R., Ghiadoni L., Menichetti F., Agnoletti V., Sganga G., Prosperi P., Roviello F., De Paolis P., Gordini G., Forfori F., Ruscelli P., Gabrielli F., Puglisi A., Bertolucci A., Marchi S., Bellini M., Casagli S., De Simone B., Carmassi F., Marchetti S., Accorsini M., Cremonini C., Morelli F., Romeo L., Coccolini, F, Kluger, Y, Moore, E, Maier, R, Coimbra, R, Ordonez, C, Ivatury, R, Kirkpatrick, A, Biffl, W, Sartelli, M, Hecker, A, Ansaloni, L, Leppaniemi, A, Reva, V, Civil, I, Vega, F, Chiarugi, M, Chichom-Mefire, A, Sakakushev, B, Peitzman, A, Chiara, O, Abu-Zidan, F, Maegele, M, Miccoli, M, Chirica, M, Khokha, V, Sugrue, M, Fraga, G, Otomo, Y, Baiocchi, G, Catena, F, Kuliesius, Z, Conti, L, Dogjani, A, Lee, J, Consani, H, Russello, D, Bortul, M, Maurel, T, Kaf, H, Adamou, H, Alin, V, Robustelli, U, Sato, N, Seretis, C, Quiodettis, M, Gomes, C, Kong, V, Zakaria, A, Guner, A, Gachabayov, M, Chowdhury, S, Pata, F, Garcia, A, Rems, M, Das, K, Riedel, J, Lasithiotakis, K, Sydorchuk, R, Sydorchuk, L, Lostoridis, E, Buia, A, Mcfarlane, M, Ciani, R, Munoz-Cruzado, V, Tartaglia, D, Ioannidis, O, Muhrbeck, M, Reicher, M, Roscio, F, Ceresoli, M, Tsiftsis, D, Kavalakat, A, Pintar, T, Georgiou, G, Ricci, G, Mohan, R, Saar, S, Di Carlo, I, Isik, A, Ahmed, A, Gonsaga, R, Sammartano, F, Tallon-Aguilar, L, Shoko, T, Hsu, J, Kobe, Y, Romeo, C, Podda, M, Mingoli, A, Delgado, R, Ekwen, G, Aude, V, Olona, C, Boati, P, Magnone, S, Capaldi, M, Bala, M, Picetti, E, Negoi, I, Kok, K, Jusoh, A, Amato, B, Nita, G, de Beaux, A, Demetrashvili, Z, Davies, R, Kim, J, Pereira, A, Fattori, L, Paolillo, C, Ghannam, W, Rodriguez, F, Berardi, L, Florio, M, Hecker, M, Dubuisson, V, O'Connor, D, De'Angelis, N, Dobric, I, Massalou, D, Ortenwall, P, Pikoulis, E, Ugarte-Sierra, B, Zuidema, W, Kechagias, A, Marwah, S, Litvin, A, Nikolopoulos, I, Pesce, A, Uranues, S, Luppi, D, Flohe, S, Martinez-Perez, A, Lorenzo, M, Vergano, L, Manca, M, Malacarne, P, Kurihara, H, Widder, S, Pucciarelli, M, Monzani, F, Brambillasca, P, Corbella, D, Agresta, F, Moore, L, Buonomo, L, Adeleye, A, Kim, D, Veroux, M, Hardcastle, T, Di Saverio, S, Recordare, A, Rubio-Perez, I, Shlyapnikov, S, Rahim, R, Vega, G, Boris, K, Sawyer, R, Baraket, O, Soreide, K, Weber, C, Seak, C, Herman, S, Gamberini, E, Costa, S, Mazzocconi, G, Lozada, E, Manatakis, D, Lohsiriwat, V, Elbery, B, Tiberio, G, Santini, M, Mellace, L, Enoksen, C, Major, P, Parini, D, Improta, M, Fugazzola, P, Pini, S, Liberti, G, Martino, C, Cobianchi, L, Canzi, G, Cicuttin, E, Kenig, J, Zago, M, Giannessi, S, Scaglione, M, Orsitto, E, Cioni, R, Ghiadoni, L, Menichetti, F, Agnoletti, V, Sganga, G, Prosperi, P, Roviello, F, De Paolis, P, Gordini, G, Forfori, F, Ruscelli, P, Gabrielli, F, Puglisi, A, Bertolucci, A, Marchi, S, Bellini, M, Casagli, S, De Simone, B, Carmassi, F, Marchetti, S, Accorsini, M, Cremonini, C, Morelli, F, Romeo, L, and HUS Abdominal Center

Subjects
System, Consensus, Internationality, Delphi Technique, Accrual, Process (engineering), media_common.quotation_subject, Performance, education, lcsh:Surgery, 030230 surgery, Analysis, Data, Morbidity, Mortality, Outcome, Planning, Product, World, 03 medical and health sciences, 0302 clinical medicine, Trauma management, Health care, Medicine, Humans, Operations management, Quality (business), Product (category theory), media_common, Quality Indicators, Health Care, Core set, business.industry, lcsh:Medical emergencies. Critical care. Intensive care. First aid, Analysi, lcsh:RD1-811, lcsh:RC86-88.9, CARE, 3126 Surgery, anesthesiology, intensive care, radiology, Core (game theory), Traumatology, Emergency Medicine, Surgery, business, Research Article
Abstract

Introduction Quality in medical care must be measured in order to be improved. Trauma management is part of health care, and by definition, it must be checked constantly. The only way to measure quality and outcomes is to systematically accrue data and analyze them. Material and methods A systematic revision of the literature about quality indicators in trauma associated to an international consensus conference Results An internationally approved base core set of 82 trauma quality indicators was obtained: Indicators were divided into 6 fields: prevention, structure, process, outcome, post-traumatic management, and society integrational effects. Conclusion Present trauma quality indicator core set represents the result of an international effort aiming to provide a useful tool in quality evaluation and improvement. Further improvement may only be possible through international trauma registry development. This will allow for huge international data accrual permitting to evaluate results and compare outcomes.

Published
2021

19. Redefining the zoning of active and capable faults in urban areas: the case of the Mt. Marine fault across the Barete and Pizzoli towns (Central Apennines, Italy)

Author

Iezzi, F., Boncio, P., Pizzi, A., Piacentini, T., Pace, B., Francescone, M., Morelli, F., Puliti, I., Salvatore, N., Blumetti, A., Di Manna, P., Papasodaro, F., Moro, M., Falcucci, E., Gori, S., Saroli, M., Nicolosi, I., D’Ajello Caracciolo, F., Chiappini, M., Sapia, V., Materni, V., Urbini, S., Caciagli, M., Di Giulio, G., Vassallo, M., Milana, G., Minarelli, L., Pischiutta, M., Cara, F., Sepe, V., and Doglioni, C.

Published
2022

20. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II–III trial

Author

Ghi, M. G., Paccagnella, A., Ferrari, D., Foa, P., Alterio, D., Codecà, C., Nolè, F., Verri, E., Orecchia, R., Morelli, F., Parisi, S., Mastromauro, C., Mione, C. A., Rossetto, C., Polsinelli, M., Koussis, H., Loreggian, L., Bonetti, A., Campostrini, F., Azzarello, G., D’Ambrosio, C., Bertoni, F., Casanova, C., Emiliani, E., Guaraldi, M., Bunkheila, F., Bidoli, P., Niespolo, R. M., Gava, A., Massa, E., Frattegiani, A., Valduga, F., Pieri, G., Cipani, T., Da Corte, D., Chiappa, F., and Rulli, E.

Published
2017
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23. Apomorphine-induced reorganization of striato-frontal connectivity in patients with tremor-dominant Parkinson's disease

Author

Salvatore Nigro* a, Cécile Bordier* b, i, Antonio Cerasa c, Rita Nisticò c, Giuseppe Olivadese c, Basilio Vescio d, Maria Giovanna Bianco e, Antonino Fiorillo e, Gaetano Barbagallo f, Marianna Crasà c, Andrea Quattrone f, Maurizio Morelli f, Gennarina Arabia f, Antonio Augimeri d, Carlo Nicolini b, Angelo Bifone b, g, Aldo Quattrone c, and h

Subjects
Male, 0301 basic medicine, Levodopa, Parkinson's disease, Apomorphine, Dopamine agonist, Resting-state, 03 medical and health sciences, fMRI Graph theory, 0302 clinical medicine, Neural Pathways, Tremor, Basal ganglia, medicine, Humans, Single-Blind Method, Resting-state fMRI, Aged, Tremor-dominant Parkinson's disease, Neural correlates of consciousness, Community detection, Graph theory, Resting state fMRI, medicine.diagnostic_test, Electromyography, business.industry, Functional Neuroimaging, Parkinson Disease, Magnetic resonance imaging, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Frontal Lobe, 3. Good health, Neostriatum, 030104 developmental biology, Neurology, Dopamine Agonists, Female, Neurology (clinical), Geriatrics and Gerontology, business, Neuroscience, 030217 neurology & neurosurgery, medicine.drug
Abstract

Introduction Apomorphine is a dopamine agonist used in Parkinson's disease (PD), which matches levodopa in terms of the magnitude of effect on the cardinal motor features, such as tremor and bradykinesia. The beneficial effect of this treatment on PD patients with tremor-dominant has widely been demonstrated, although the underlying neural correlates are unknown. We sought to examine the effects of apomorphine on topological characteristics of resting-state functional connectivity networks in tremor-dominant PD (tdPD) patients. Methods Sixteen tdPD patients were examined using a combined electromyography-functional magnetic resonance imaging approach. Patients were scanned twice following either placebo (subcutaneous injection of 1 mL saline solution) or 1 mg of apomorphine injection. Graph analysis methods were employed to investigate the modular organization of functional connectivity networks before and after drug treatment. Results After injection of apomorphine, evident reduction of tremor symptoms was mirrored by a significant increase in overall connectivity strength and reorganization of the modular structure of the basal ganglia and of the fronto-striatal module. Moreover, we found an increase in the centrality of motor and premotor regions. No differences were found between pre- and post-placebo sessions. Conclusion These results provide new evidence about the effects of apomorphine at a large-scale neural network level showing that drug treatment modifies the brain functional organization of tdPD, increasing the overall resting-state functional connectivity strength, the segregation of striato-frontal regions and the integrative role of motor areas.

Published
2019

25. Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis

Author

Bracarda, S., Iacovelli, R., Boni, L., Rizzo, M., Derosa, L., Rossi, M., Galli, L., Procopio, G., Sisani, M., Longo, F., Santoni, M., Morelli, F., Di Lorenzo, G., Altavilla, A., Porta, C., Camerini, A., Escudier, B., Martignetti, Angelo, Ricotta, Riccardo, Gasparro, Donatello, Sabbatini, Roberto, Ceresoli, Giovanni Luca, Mosca, Alessandra, Santini, Daniele, Caserta, Claudia, Cavanna, Luigi, Massari, Francesco, Sava, Teodoro, Boni, Corrado, Verzoni, Elena, Cartenì, Giacomo, and Hamzaj, Alketa

Published
2015
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30. Multi-level approach for the assessment of bridges and viaducts within road networks

Author

Braga, F., Buratti, G., Cosentino, A., Dall'Asta, A., De Matteis, G., Gigliotti, R., Mezzina, M., Morelli, F., Ristori, C., Salvatore, W., Franco Braga, Andrea Dall'Asta, Fabrizio Gara, Braga, F., Buratti, G., Cosentino, A., Dall'Asta, A., De Matteis, G., Gigliotti, R., Mezzina, M., Morelli, F., Ristori, C., and Salvatore, W.

Published
2019

31. Radical metastasectomy followed by sorafenib versus observation in patients withclear cell renal cell carcinoma: extended follow -up of efficacy results from the randomized phase II RESORT trial

Author

Mennitto, A., primary, Verzoni, E., additional, Cognetti, F., additional, Miceli, R., additional, Milella, M., additional, Mosca, A., additional, Chiuri, V. E., additional, Bearz, A., additional, Morelli, F., additional, Ortega, C., additional, Atzori, F., additional, Donini, M., additional, Claps, M., additional, Guadalupi, V., additional, Sepe, P., additional, Cappelletti, V., additional, de Braud, F. G., additional, and Procopio, G., additional

Published
2021
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32. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Powles, T. van der Heijden, M.S. Castellano, D. Galsky, M.D. Loriot, Y. Petrylak, D.P. Ogawa, O. Park, S.H. Lee, J.-L. De Giorgi, U. Bögemann, M. Bamias, A. Eigl, B.J. Gurney, H. Mukherjee, S.D. Fradet, Y. Skoneczna, I. Tsiatas, M. Novikov, A. Suárez, C. Fay, A.P. Duran, I. Necchi, A. Wildsmith, S. He, P. Angra, N. Gupta, A.K. Levin, W. Bellmunt, J. van der Heijden, M.S. Lee, J.L. Eigl, B.J. Mukherjee, S.D. Suarez, C. Westgeest, H. Flechon, A. Ou, Y.-C. Park, I. Matveev, V. Pérez-Valderrama, B. Cheng, S. Frank, S. Anido, U. Hamzaj, A. Retz, M. Sridhar, S. Scagliotti, G.V. Voortman, J. Alekseev, B. Alyasova, A. Komyakov, B. Dumez, H. Pavic, M. Kimura, G. Mizokami, A. Osanto, S. Arranz, J.A. Piersma, D. Shin, S.J. Karyakin, O. Delgado, I. Gonzalez, J.L. Pang, S.-T. Tran, A. Lipatov, O. Su, W.-P. Flaig, T. Alva, A. Park Kyong, H. Kopyltsov, E. Almagro, E. Domenech, M. Chang, Y.-H. Sautois, B. Ravaux, A. Aravantinos, G. Georgoulias, V. Mulder, S. Kim, Y.J. Kater, F. Chevreau, C. Tagawa, S. Zalewski, P. Joly, F. Hatiboglu, G. Gianni, L. Morelli, F. Tambaro, R. Hashimoto, Y. Nosov, A. Font, A. Rodriguez-Vida, A.M. Jones, R. Vasudev, N. Srinivas, S. Zhang, J. Gil, T. Finch, D. Grimm, M.-O. Su, Y.-L. Chowdhury, S. Hocking, C. Plas, E. North, S. Jensen, N.V. Theodore, C. Imkamp, F. Peer, A. Kobayashi, T. Sakai, H. Sassa, N. Yoshimura, K. Aarts, M. Ferreira Castro, A. Topuzov, M. Rodriguez, J.F. Vazquez, F.J. Tsai, Y.-C. Crabb, S. Hussain, S. Bendell, J. Gross-Goupil, M. Gwenaelle, G. Berger, R. Statsenko, G. Evans, L. Drakaki, A. Somer, B. Davis, I. Lynam, J. Borges, G. Dettino, A. Fay, A.P. Martins, G. Zucca, L.E. Agerbaek, M. Kalofonos, H. Rosenbaum, E. Enokida, H. Kikukawa, H. Nishimura, K. Tamada, S. Uemura, M. Lopez, Y. Gietema, J. Slojewski, M. Fernandes, I. Smolin, A. Mazhar, D. Kalebasty, A.R. Carthon, B. Loidl, W. Franke, F. Girotto, G. Alimohamed, N. Macfarlane, R. Pappot, H. Niegisch, G. Mavroudis, D. Sella, A. Porta, C. Ebara, S. Nakamura, M. Obara, W. Okuno, N. Shinohara, N. Sugimoto, M. Suzuki, A. Tokuda, N. Uemura, H. Yamaguchi, A. Ramirez, F. Rozanowski, P. Wiechno, P. Keam, B. Kislov, N. Plaksin, D. Cicin, I. Kumar, S. Galsky, M.D. Petrylak, D.P. Rosales, J. Vaishampayan, U. Culine, S. Papandreou, C. Nara, T. Erman, M. Kreiger, L. Janoski, J. Rosa, D. Siqueira, M. Canil, C. Sengelov, L. Tourani, J.-M. Arai, G. Hashine, K. Kawakita, M. Nakaigawa, N. Nomi, H. Shiina, H. Suzuki, H. Yonese, J. Kuri, R. Macedo, E. Rivera, S. Villalobos Prieto, A. Polakiewicz-Gilowska, A. Zaucha, R. Lopes, F. Ponomarev, R. Pomerantz, M. Shariat, S. Luk, C. Lesniewski-Kmak, K.

Abstract

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma. Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24. Findings: Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9–43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4–17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4–15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71–1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1–18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9–14·0) in the chemotherapy group (0·85, 95% CI 0·72–1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (

Published
2020

34. Treatment of chronic lymphocytic leukemia in the new drugs era: the state of art in the Italian landscape

Author

Morelli, F, Innocenti, I, Autore, F, Fresa, F, Tomasso, A, Piciocchi, A, Frustaci, Am, Trentin, L, Mauro, Fr, Schiattone, L, Visentin, A, Del Poeta, G, Reda, G, Rigolin, Gm, Ibatici, A, Ciolli, S, Vitale, C, Sportoletti, P, Murru, R, Levato, L, Gentile, M, D’Arena, G, Coscia, M, Villa, Mr, Fontana, R, Efremov, D, Tedeschi, A, Scarfò, L, Cuneo, A, Foà, R, and Laurenti, L

Published
2020

36. Evaluation of the efficacy of prostatic artery embolization (PAE) in patients with benign outlet obstruction (BOO) due to intravesical prostatic protrusion: clinical findings and computerized assessments of volumetric data achieved from prostatic mpMRI

Author

Secco, S., primary, Brambillasca, P.M., additional, Dell’Oglio, P., additional, Barbosa, F., additional, Charalambous, S., additional, Galfano, A., additional, Alfonsi, A., additional, Morelli, F., additional, Vercelli, R., additional, Solcia, M., additional, Nichelatti, M., additional, Spinelli, M., additional, Bocciardi, A.M., additional, and Rampoldi, A.G., additional

Published
2020
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39. 2-18fluoro-deoxy-D-glucose positron emission tomography (FDG-PET) for postchemotherapy seminoma residual lesions: a retrospective validation of the SEMPET trial

Author

Bachner, M., Loriot, Y., Gross-Goupil, M., Zucali, P. A., Horwich, A., Germa-Lluch, J.-R., Kollmannsberger, C., Stoiber, F., Fléchon, A., Oechsle, K., Gillessen, S., Oldenburg, J., Cohn-Cedermark, G., Daugaard, G., Morelli, F., Sella, A., Harland, S., Kerst, M., Gampe, J., Dittrich, C., Fizazi, K., and De Santis, M.

Published
2012
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40. 767P Neutrophil-to-lymphocyte ratio (NLR) and systemic inflammation index (SII) as prognostic factors in advanced urinary tract carcinoma patients treated with atezolizumab: Subanalysis of the Italian population of the SAUL study

Author

Rebuzzi, S.E., primary, Sternberg, C.N., additional, Banna, G.L., additional, Ermacora, P., additional, Morelli, F., additional, Nolè, F., additional, Marandino, L., additional, Panni, S., additional, Massari, F., additional, Hamzaj, A., additional, Milesi, L., additional, Santini, D., additional, De Tursi, M., additional, Scartozzi, M., additional, Astolfi, C., additional, and Fornarini, G., additional

Published
2020
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41. 736P Updated data on patients (pts) with metastatic renal cell carcinoma (mRCC) treated with sorafenib (SOR) vs observation (obs) after radical metastasectomy in the RESORT trial

Author

Procopio, G., primary, Cognetti, F., additional, Miceli, R., additional, Milella, M., additional, Mosca, A., additional, Chiuri, V.E., additional, Bearz, A., additional, Morelli, F., additional, Ortega, C., additional, Atzori, F., additional, Donini, M., additional, Passalacqua, R., additional, Mennitto, A., additional, Sepe, P., additional, Martinetti, A., additional, Montone, R., additional, Apollonio, G., additional, Guadalupi, V., additional, Verzoni, E., additional, and Claps, M., additional

Published
2020
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42. Clinical outcome after radical metastasectomy in renal cell carcinoma: Results from a randomized phase 2 study

Author

Procopio, G., primary, Apollonio, G., additional, Cognetti, F., additional, Miceli, R., additional, Milella, M., additional, Mosca, A., additional, Chiuri, V.E., additional, Bearz, A., additional, Morelli, F., additional, Ortega, C., additional, Atzori, F., additional, Donini, M., additional, Ratta, R., additional, Raimondi, A., additional, Claps, M., additional, Martinetti, A., additional, Capitanio, U., additional, De Braud, F.G., additional, Cappelletti, V., additional, and Verzoni, E., additional

Published
2019
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43. First results of safety profile of nivolumab (NIVO) in combination with stereotactic body radiotherapy (SBRT) in II and III line of patients (pts) with metastatic renal cell carcinoma (mRCC) in NIVES study

Author

Masini, C., primary, Ciammella, P., additional, Timon, G., additional, Gnoni, R., additional, De Giorgi, U.F.F., additional, Bellia, S.R., additional, Buti, S., additional, Salaroli, F., additional, Milella, M., additional, Mazzarotto, R., additional, Mucciarini, C., additional, Vitale, M.G., additional, Bruni, A., additional, Procopio, G., additional, Kinspergher, S., additional, Nole, F., additional, Morelli, F., additional, Pappagallo, G., additional, buttigliero, C., additional, and Pinto, C., additional

Published
2019
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44. A single-arm, open-label, multicenter, phase IIIb clinical trial with nivolumab in subjects with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck

Author

Bossi, P., primary, Merlano, M.C., additional, Ghi, M.G., additional, Rinaldi, G., additional, Caponigro, F., additional, Morelli, F., additional, Airoldi, M., additional, Farnesi, A., additional, Cassano, A., additional, Ferrari, D., additional, Mirabile, A., additional, Tosoni, A., additional, Galizia, D., additional, Moretti, G., additional, Sponghini, A.P., additional, Calareso, G., additional, Vingiani, A., additional, Perrone, F., additional, Falletta, A., additional, and Licitra, L.F., additional

Published
2019
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