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1. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids

Author

Monfredo, M., Mistretta, R., di Salemi, P.O., Zecca, E., Cartoni, C., Brunetti, G.A., Tassinari, D., Drudi, F., Rizzi, F., Pizzuto, M., Formaglio, F., Luzi, M., Narducci, F., Boscolo, G., Mangiapia, M., Artioli, F., Lazzari, M., Dauri, M., Diodati, M., Cupaiolo, A., Mameli, S., Preti, P., Ferrari, P., Vasini, G., Roy, M.T., Piva, L., Nardi, L.F., Montanari, L., Reina, V., Fusco, F., Orsi, L., Molinari, E., Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M.T., Caraceni, A., Kaasa, S., Dragani, T.A., Azzarello, G., Luzzani, M., Cavanna, L., Bandieri, E., Gamucci, T., Lipari, G., Di Gregorio, R., Valenti, D., Reale, C., Pavesi, L., Iorno, V., Crispino, C., Pacchioni, M., and Apolone, G.

Published
2016
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2. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids

Author

Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M. T., Caraceni, A., Kaasa, S., Dragani, T. A., Azzarello, G., Luzzani, M., Cavanna, L., Bandieri, E., Gamucci, T., Lipari, G., Di Gregorio, R., Valenti, D., Reale, C., Pavesi, L., Iorno, V., Crispino, C., Pacchioni, M., Apolone, G., Monfredo, M., Mistretta, R., di Salemi, P.O., Zecca, E., Cartoni, C., Brunetti, G.A., Tassinari, D., Drudi, F., Rizzi, F., Pizzuto, M., Formaglio, F., Luzi, M., Narducci, F., Boscolo, G., Mangiapia, M., Artioli, F., Lazzari, M., Dauri, M., Diodati, M., Cupaiolo, A., Mameli, S., Preti, P., Ferrari, P., Vasini, G., Roy, M.T., Piva, L., Nardi, L.F., Montanari, L., Reina, V., Fusco, F., Orsi, L., and Molinari, E.

Published
2016
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3. Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator

Author

Burri H, da Costa A, Quesada A, Ricci R, Favale S, Clementy N, Boscolo G, Segura Villalobos F, Stefano L, Sharma V, Boriani G, and MORE-CARE Investigators

Subjects
virus diseases
Abstract

Aims Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P < 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P < 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P < 0.001). The negative predictive value of low or medium HFRS for these admissions was >= 98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients.

Published
2018

4. 37th International Symposium on Intensive Care and Emergency Medicine (part 1 of 3)

Author

Karavana, V., Smith, I., Kanellis, G., Sigala, I., Kinsella, T., Zakynthinos, S., Liu, L., Chen, J., Zhang, X., Liu, A., Guo, F., Liu, S., Yang, Y., Qiu, H., Grimaldi, D. G., Kaya, E., Acicbe, O., Kayaalp, I., Asar, S., Dogan, M., Eren, G., Hergunsel, O., Pavelescu, D., Grintescu, I., Mirea, L., Guanziroli, M., Gotti, M., Marino, A., Cressoni, M., Vergani, G., Chiurazzi, C., Chiumello, D., Gattinoni, L., Spano, S., Massaro, F., Moustakas, A., Johansson, S., Larsson, A., Perchiazzi, G., Zhang, X. W., Guo, F. M., Chen, J. X., Xue, M., Qiu, H. B., Yang, L., Fister, M., Knafelj, R., Suzer, M. A., Kavlak, M. E., Atalan, H. K., Gucyetmez, B., Cakar, N., Weller, D., Grootendorst, A. F., Dijkstra, A., Kuijper, T. M., Cleffken, B. I., Regli, A., De Keulenaer, B., Van Heerden, P., Hadfield, D., Hopkins, P. A., Penhaligon, B., Reid, F., Hart, N., Rafferty, G. F., Grasselli, G., Mauri, T., Lazzeri, M., Carlesso, E., Cambiaghi, B., Eronia, N., Maffezzini, E., Bronco, A., Abbruzzese, C., Rossi, N., Foti, G., Bellani, G., Pesenti, A., Bassi, G. Li, Panigada, M., Ranzani, O., Kolobow, T., Zanella, A., Berra, L., Parrini, V., Kandil, H., Salati, G., Livigni, S., Amatu, A., Girardis, M., Barbagallo, M., Moise, G., Mercurio, G., Costa, A., Vezzani, A., Lindau, S., Babel, J., Cavana, M., Torres, A., Ranzani, O. T., Umbrello, M., Taverna, M., Formenti, P., Mistraletti, G., Vetrone, F., Baisi, A., Garnero, A. G., Novotni, D. N., Arnal, J. A., Urner, M., Fan, E., Dres, M., Vorona, S., Brochard, L., Ferguson, N. D., Goligher, E. C., Leung, C., Joynt, G., Wong, W., Lee, A., Gomersall, C., Poels, S., Casaer, M., Schetz, M., Van den Berghe, G., Meyfroidt, G., Holzgraefe, B., Von Kobyletzki, L. B., Cianchi, G., Becherucci, F., Batacchi, S., Cozzolino, M., Franchi, F., Di Valvasone, S., Ferraro, M. C., Peris, A., Phiphitthanaban, H., Wacharasint, P., Wongsrichanalai, V., Lertamornpong, A., Pengpinij, O., Wattanathum, A., Oer-areemitr, N., Boddi, M., Cappellini, E., Ciapetti, M., Di Lascio, G., Bonizzoli, M., Lazzeri, C., Katsin, M. L., Hurava, M. Y., Dzyadzko, A. M., Hermann, A., Schellongowski, P., Bojic, A., Riss, K., Robak, O., Lamm, W., Sperr, W., Staudinger, T., Buoninsegni, L. Tadini, Parodo, J., Ottaviano, A., Cecci, L., Corsi, E., Ricca, V., de Garibay, A. Perez Ruiz, Ende-Schneider, B., Schreiber, C., Kreymann, B., Turani, F., Resta, M., Niro, D., Castaldi, P., Boscolo, G., Gonsales, G., Martini, S., Belli, A., Zamidei, L., Falco, M., Lamas, T., Mendes, J., Galazzi, A., Benco, B., Binda, F., Masciopinto, L., Lissoni, A., Adamini, I., Thamjamrassri, T., Watcharotayangul, J., Numthavaj, P., Kongsareepong, S., Higuera, J., Cabestrero, D., Rey, L., Narváez, G., Blandino, A., Aroca, M., Saéz, S., De Pablo, R., Mohamed, A., Sklar, M., Munshi, L., Alban, L., Turrini, C., Taccone, P., Marenghi, C., Spadaro, S., Volta, C., Alonso, D. Cabestrero, González, L. Rey, Franci, A., Stocchi, G., Cappuccini, G., Socci, F., Guetti, C., Rastrelli, P., Nestorowicz, A., Glapinski, J., Fijalkowska-Nestorowicz, A., Wosko, J., Duprez, F., Bonus, T., Cuvelier, G., Mashayekhi, S., Ollieuz, S., Reychler, G., Kuchyn, I., Bielka, K., Sergienko, A., Jones, H., Day, C., Park, S. C., Yeom, S. R., Myatra, S. N., Gupta, S., Rajnala, V., Divatia, J., Silva, J. Villalobos, Olvera, O. Aguilera, Schulte, R. Cavazos, Bermudez, M. Castañeda, Zorrilla, L. Pariente, Ferretis, H. Lopez, García, K. Trejo, Balciuniene, N., Ramsaite, J., Kriukelyte, O., Krikscionaitiene, A., Tamosuitis, T., Terragni, P., Brazzi, L., Falco, D., Pistidda, L., Magni, G., Bartoletti, L., Mascia, L., Filippini, C., Ranieri, V., Kyriakoudi, A., Rovina, N., Koltsida, O., Konstantellou, E., Kardara, M., Kostakou, E., Gavriilidis, G., Vasileiadis, I., Koulouris, N., Koutsoukou, A., Van Snippenburg, W., Kröner, A., Flim, M., Buise, M., Hemler, R., Spronk, P., Noffsinger, B., Singh, B., Hockings, L., Spina, C., Magni, F., Di Giambattista, C., Vargiolu, A., Citerio, G., Scaramuzzo, G., Waldmann, A. D., Böhm, S. H., Ragazzi, R., Volta, C. A., Heines, S. J., Strauch, U., Van de Poll, M. C., Roekaerts, P. M., Bergmans, D. C., Sosio, S., Gatti, S., Punzi, V., Asta, A., Mroczka, J., Yaroshetskiy, A. I, Rezepov, N. A., Mandel, I. A., Gelfand, B. R., Ozen, E., Karakoc, E., Ayyildiz, A., Kara, S., Ekemen, S., Yelken, B. Buyukkidan, Saasouh, W., Freeman, J., Turan, A., Hajjej, Z., Sellami, W., Bousselmi, M., Samoud, W., Gharsallah, H., Labbene, I., Ferjani, M., Vetrugno, L., Barbariol, F., Forfori, F., Regeni, I., Della Rocca, G., Jansen, D., Jonkman, A., Doorduin, J., Roesthuis, L., Van der Hoeven, J., Heunks, L., Marocco, S. Arrigoni, Bottiroli, M., Pinciroli, R., Galanti, V., Calini, A., Gagliardone, M., Fumagalli, R., Ippolito, D., Sala, V. L., Meroni, V., Elbanna, M., Nassar, Y., Abdelmohsen, A., Yahia, M., Mongodi, S., Mojoli, F., Via, G., Tavazzi, G., Fava, F., Pozzi, M., Iotti, G. A., Bouhemad, B., Ruiz-Ferron, F., Simón, J. Serrano, Gordillo-Resina, M., Chica-Saez, V., Garcia, M. Ruiz, Vela-Colmenero, R., Redondo-Orts, M., Gontijo-Coutinho, C., Ozahata, T., Nocera, P., Franci, D., Santos, T., Carvalho-Filho, M., Fochi, O., Nacoti, M., Signori, D., Bonacina, D., Bonanomi, E., Bonvecchio, E., Stella, A., Roldi, E., Orlando, A., Luperto, M., Trunfio, D., Licitra, G., Martinelli, R., Vannini, D., Giuliano, G., Näslund, E., Lindberg, L. G., Lund, I., Frithiof, R., Nichols, A., Pentakota, S., Kodali, B., Pranskunas, A., Kiudulaite, I., Simkiene, J., Damanskyte, D., Pranskuniene, Z., Arstikyte, J., Vaitkaitis, D., Pilvinis, V., Brazaitis, M., Pool, R., Haugaa, H., Botero, A., Escobar, D., Maberry, D., Tønnessen, T., Zuckerbraun, B., Pinsky, M., Gomez, H., Lyons, H., Trimmings, A., Domizi, R., Scorcella, C., Damiani, E., Pierantozzi, S., Tondi, S., Monaldi, V., Carletti, A., Zuccari, S., Adrario, E., Pelaia, P., Donati, A., Kazune, S., Grabovskis, A., Volceka, K., Rubins, U., Bol, M., Suverein, M., Delnoij, T., Driessen, R., Heines, S., Delhaas, T., Vd Poll, M., Sels, J., Jozwiak, M., Chambaz, M., Sentenac, P., Richard, C., Monnet, X., Teboul, J. L., Bitar, Z., Maadarani, O., Al Hamdan, R., Huber, W., Malbrain, M., Chew, M., Mallat, J., Tagami, T., Hundeshagen, S., Wolf, S., Mair, S., Schmid, R., Aron, J., Adlam, M., Dua, G., Mu, L., Chen, L., Yoon, J., Clermont, G., Dubrawski, A., Duhailib, Z., Al Assas, K., Shafquat, A., Salahuddin, N., Donaghy, J., Morgan, P., Valeanu, L., Stefan, M., Provenchere, S., Longrois, D., Shaw, A., Mythen, M. G., Shook, D., Hayashida, D., Munson, S. H., Sawyer, A., Mariyaselvam, M., Blunt, M., Young, P., Nakwan, N., Khwannimit, B., Checharoen, P., Berger, D., Moller, P., Bloechlinger, S., Bloch, A., Jakob, S., Takala, J., Van den Brule, J. M., Stolk, R., Vinke, E., Van Loon, L. M., Pickkers, P., Van der Hoeven, J. G., Kox, M., Hoedemaekers, C. W., Werner-Moller, P., Bertini, P., Guarracino, F., Colosimo, D., Gonnella, S., Brizzi, G., Mancino, G., Baldassarri, R., Pinsky, M. R., Amitrano, D., Goslar, T., Stajer, D., Radsel, P., De Vos, R., Dijk, N. Bussink-van, Stringari, G., Cogo, G., Devigili, A., Graziadei, M. Ceola, Bresadola, E., Lubli, P., Amella, S., Marani, F., Polati, E., Gottin, L., Colinas, L., Hernández, G., Vicho, R., Serna, M., Canabal, A., Cuena, R., Gimenez, J., Mercado, P., Depret, F., Sassi, K., Herner, A., Abded, N., Elghonemi, M., Monir, A., Nikhilesh, J., Apurv, T., Uber, A. U., Grossestreuer, A., Moskowitz, A., Patel, P., Holmberg, M. J., Donnino, M. W., Graham, C. A., Hung, K., Lo, R., Leung, L. Y., Lee, K. H., Yeung, C. Y., Chan, S. Y., Trembach, N., Zabolotskikh, I., Caldas, J., Panerai, R., Camara, L., Ferreira, G., Almeida, J., de Oliveira, G. Queiroz, Jardim, J., Bor-Seng-Shu, E., Lima, M., Nogueira, R., Jatene, F., Zeferino, S., Galas, F., Robinson, T., Hajjar, L. A., Oliveira, M., Norgueira, R., Groehs, R., Ferreira-Santos, L., Oliveira, G., Hajjar, L., Ribeiro, J., Gaiotto, F., Lisboa, L., Fukushima, J., Rizk, S., Osawa, E., Franco, R., Kalil, R., Chlabicz, M., Sobkowicz, B., Kaminski, K., Kazimierczyk, R., Musial, W., Tycińska, A., Siranovic, M., Gopcevic, A., Gavranovic, Z. G., Horvat, A. H., Krolo, H., Rode, B., Videc, L., Trifi, A., Abdellatif, S., Ismail, K. Ben, Bouattour, A., Daly, F., Nasri, R., Lakhal, S. Ben, Beurton, A., Girotto, V., Galarza, L., Guedj, T., Iliæ, M. Karaman, Sakic, L., NN, V., Stojcic, L., Alphonsine, J., Lai, C., Tapanwong, N., Chuntupama, P., Hoellthaler, J., Lahmer, T., Latham, H., Bengtson, C. D., Satterwhite, L., Stites, M., Simpson, S. Q., Skladzien, T., Cicio, M., Garlicki, J., Serednicki, W., Wordliczek, J., Vargas, P., Salazar, A., Espinoza, M., Graf, J., Kongpolprom, N., Sanguanwong, N., Jonnada, S., Gerrard, C., Jones, N., Morley, T., Thorburn, P. T., Musaeva, T., Horst, S., Lipcsey, M., Kawati, R., Pikwer, A., Rasmusson, J., Castegren, M., Shilova, A., Yafarova, A., Gilyarov, M., Stojiljkovic, D. L. Loncar, Ulici, A., Reidt, S., Lam, T., Jancik, J., Ragab, D., Taema, K., Farouk, W., Saad, M., Liu, X., Uber, A., Montissol, S., Donnino, M., Andersen, L. W., Perlikos, F., Lagiou, M., Papalois, A., Kroupis, C., Toumpoulis, I., Carter, D., Sardo, S., Landoni, G., Kongsayreepong, S., Sungsiri, R., Wongsripunetit, P., Marchio, P., Guerra-Ojeda, S., Gimeno-Raga, M., Mauricio, M. D., Valles, S. L., Aldasoro, C., Jorda, A., Aldasoro, M., Vila, J. M., Borg, U. B., Neitenbach, A. M., García, M., González, P. Guijo, Romero, M. Gracia, Orduña, P. Saludes, Cano, A. Gil, Rhodes, A., Grounds, R. M., Cecconi, M., Lee, C., Hatib, F., Jian, Z., Rinehart, J., De Los Santos, J., Canales, C., Cannesson, M., García, M. I. Monge, Scheeren, T., Chantziara, V., Vassi, A., Michaloudis, G., Sanidas, E., Golemati, S., Bateman, R. M., Mokhtar, A., Omar, W., Aziz, K. Abdel, El Azizy, H., Nielsen, D. L. Lykke, Holler, J. G., Lassen, A., Eriksson, M., Strandberg, G., Capoletto, C., Nakamura, R., Risk, S., Park, C., Dias, F., D’Arrigo, N., Fortuna, F., Redaelli, S., Zerman, L., Becker, L., Serrano, T., Cotes, L., Ramos, F., Fadel, L., Coelho, F., Mendes, C., Real, J., Pedron, B., Kuroki, M., Costa, E., and Azevedo, L.

Subjects
Critical Care and Intensive Care Medicine, Meeting Abstracts
Published
2017

5. Clinical prognostic factors in patients (pts) with recurrent and/or metastatic (RM) head and neck carcinoma (HNC) treated with cetuximab plus chemotherapy

Author

Bossi, P., primary, Depenni, R., additional, cossu rocca, M., additional, Ferrari, D., additional, Azzarello, G., additional, Alù, M., additional, Nolè, F., additional, Codecà, C., additional, Boscolo, G., additional, Piccininni, M., additional, Cavalieri, S., additional, Pugliese, G., additional, and Licitra, L.F., additional

Published
2018
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10. Paratesticular rhabdomyosarcoma: a comparison of two Italian studies

Author

Boscolo, G, Bisogno, G, Cecchetto, G, Dalligna, P, Zanetti, I, DE BERNARDI, B, CORDERO DI MONTEZEMOLO, Luca, Mancini, A, Indolfi, P, Donfrancesco, A, Tamaro, P, DI CATALDO, A, Tamburini, A, Riccardi, R, Gallismi, D, Arrighini, A, Santoro, N, and Carli, M.

Subjects
Paratesticular rhabdomyosarcoma, retroperitoneal, lymphadenectomy, primary re-excision
Published
2002

15. Management of alert messages in the remote monitoring of implantable cardioverter defibrillators and pacemakers: an Italian single-region study

Author

Folino, A. F., primary, Chiusso, F., additional, Zanotto, G., additional, Vaccari, D., additional, Gasparini, G., additional, Megna, A., additional, Marras, E., additional, Mantovan, R., additional, Vaglio, A., additional, Boscolo, G., additional, Biancalana, G., additional, Leoni, L., additional, Iliceto, S., additional, and Buja, G., additional

Published
2011
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16. Initial Panitumumab Plus Fluorouracil, Leucovorin, and Oxaliplatin or Plus Fluorouracil and Leucovorin in Elderly Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The PANDA Trial by the GONO Foundation.

Author

Lonardi S, Rasola C, Lobefaro R, Rossini D, Formica V, Scartozzi M, Frassineti GL, Boscolo G, Cinieri S, Di Donato S, Pella N, Bergamo F, Raimondi A, Arnoldi E, Antonuzzo L, Granetto C, Zustovich F, Ronzoni M, Leo S, Morano F, Loupakis F, Buggin F, Zagonel V, Fassan M, Cremolini C, Boni L, and Pietrantonio F

Subjects
Humans, Aged, Panitumumab, Oxaliplatin, Proto-Oncogene Proteins B-raf genetics, Leucovorin, Fluorouracil, Antineoplastic Combined Chemotherapy Protocols adverse effects, Colorectal Neoplasms drug therapy, Colorectal Neoplasms genetics, Colonic Neoplasms drug therapy, Rectal Neoplasms drug therapy
Abstract

Purpose: To verify whether both doublet chemotherapy with a modified schedule of fluorouracil, leucovorin, and oxaliplatin (mFOLFOX) and monochemotherapy with fluorouracil plus leucovorin (5-FU + LV) achieve satisfactory efficacy when both regimens are combined with panitumumab (PAN) as initial treatment of elderly patients with RAS / BRAF wild-type metastatic colorectal cancer (mCRC)., Patients and Methods: PANDA (ClinicalTrials.gov identifier: NCT02904031) was an open-label, randomized phase II noncomparative trial in previously untreated patients age 70 years and older with unresectable RAS / BRAF wild-type mCRC. Patients were randomly assigned 1:1 to mFOLFOX + PAN (arm A) or 5-FU + LV + PAN (arm B) for up to 12 cycles, followed by PAN maintenance. The primary end point was progression-free survival (PFS). In each arm, assuming a null hypothesis of median PFS time ≤ 6 months and target PFS ≥9.65, 90 patients per arm were needed to achieve 90% power and 5% type I error (one-sided Brookmeyer-Crowley test)., Results: Between July 2016 and April 2019, 91 patients were randomly assigned to arm A and 92 to arm B. At a median follow-up of 50.0 months (IQR, 45.6-56.4), median PFS was 9.6 and 9.0 months for arm A and B, respectively ( P < .001 in each arm). Overall response rate was 69% and 52%, whereas median overall survival was 23.5 and 22.0 months in arm A and B, respectively. The overall rate of grade >2 chemotherapy-related adverse events was 60% and 37%, respectively. Baseline G8 and Chemotherapy Risk Assessment Scale for High-Age Patients scores were prognostic, but they were not associated with efficacy and safety of the two arms., Conclusion: Both mFOLFOX and 5-FU + LV + PAN are reasonable options as initial therapy of elderly patients with RAS / BRAF wild-type mCRC. 5-FU + LV + PAN is associated with a better safety profile.

Published
2023
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17. Negative hyperselection of elderly patients with RAS and BRAF wild-type metastatic colorectal cancer receiving initial panitumumab plus FOLFOX or 5-FU/LV.

Author

Pietrantonio F, Bergamo F, Rossini D, Ghelardi F, De Grandis MC, Germani MM, Barsotti G, Formica V, Frassineti GL, Boscolo G, Cinieri S, Di Donato S, Antonuzzo L, Antoniotti C, Ambrosini M, Piva VM, Nichetti F, Fassan M, Cremolini C, and Lonardi S

Subjects
Aged, Humans, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal pharmacology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, ErbB Receptors, Fluorouracil therapeutic use, Panitumumab therapeutic use, Protein-Tyrosine Kinases metabolism, Proto-Oncogene Proteins genetics, Proto-Oncogene Proteins B-raf genetics, Colonic Neoplasms, Colorectal Neoplasms drug therapy, Colorectal Neoplasms genetics, Colorectal Neoplasms pathology, Rectal Neoplasms
Abstract

Background: Upfront anti-EGFR therapy represents the standard of care for patients with left-sided, MSS/pMMR, RAS and BRAF wild-type mCRC. Molecular 'hyperselection' may optimize EGFR inhibition by detecting additional resistance alterations., Materials and Methods: We used comprehensive genomic profiling on archival samples of elderly patients enrolled in the PANDA trial to detect: HER2 amplification/mutations; MET amplification; NTRK/ROS1/ALK/RET rearrangements; PIK3CA exon 20 mutations; PTEN alterations; AKT1 mutations; MAP2K1 mutations. We defined 'Gene Altered' (GA) patients whose tumour harboured at least one alteration, and 'Hyperselected' (HS) those without. Survival and tumour response outcomes were correlated to hyperselection status alone or combined with primary tumour sidedness or treatment arm., Results: Genomic alterations were detected in 41/147 patients (27.9%). PFS, OS and ORR were inferior in GA versus HS (median PFS: 7.6 versus 12.8 months, HR = 2.08, 95% CI: 1.43-3.03, p < 0.001; median OS: 20.0 versus 29.5 months, HR = 1.82, 95% CI:1.23-2.69, p = 0.002; ORR: 51% versus 71%; OR = 0.43, 95% CI: 0.21-0.91, p = 0.02). In the multivariable models, the impact of hyperselection on PFS and OS was confirmed. Lower ORR was observed with 5-FU/LV/panitumumab in GA (40% versus 62%), but not in HS (70% versus 72%). GA was associated with worse survival and response regardless of primary tumour sidedness, whereas in the HS subgroup, right-and left sided tumours had similar outcomes., Conclusions: Molecular hyperselection and comprehensive genomic profiling have a potential usefulness in elderly patients with RAS/BRAF wild-type, pMMR/MSS mCRC, eligible for upfront EGFR inhibition., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: F.P. received honoraria from Amgen, Bayer, Servier, Merck-Serono, MSD, BMS, Takeda, Astellas, Pierre-Fabre and received research grants for academic studies from Bristol-Myers Squibb, AstraZeneca, Agenus, Incyte, Amgen. F.B. received personal honoraria as invited speaker from Eli-Lilly, MSD, EISAI, BMS; participation in advisory board for Servier, AAA Novartis. D.R. received honoraria from Amgen, MSD and Takeda. V.F. received personal honoraria as invited speaker from Merck Serono, Pierre Fabre, Amgen, MSD, Servier. G.L.F. received personal honoraria as invited speaker from: Servier, Merck Serono; participation in advisory board for Servier, Novartis, Merck Sharp & Dohme. S.D.D received personal honoraria as invited speaker from Roche, Servier, Merck Serono, Pierre Fabre, Amgen, Merck Sharp & Dohme, iNCYTE, Bayer; participation in advisory board for Amgen, Merck Serono, Servier, Bayer. L.A. received research funding (to institution) from Novartis, Merck Serono, Bristol Myers Squibb, Astra Zeneca; personal honoraria as invited speaker from Roche, Bristol Myers Squibb, Servier, AstraZeneca, Amgen, MSD; participation in advisory board for Amgen, Merk Serono, Ely Lilly, AstraZeneca, Incite, Bristol Myers Squibb, Servier, MSD. C.A. received speaker fees from Merck; Honoraria from Merck and Nordic Pharma. M.F. received research funding (to Institution) from QED, Macrophage pharma, Diaceutics, Astellas; personal honoraria as invited speaker from Roche, Eli Lilly, Bristol Myers Squibb, MSD, Pierre Fabre, GlaxoSmithKline, Amgen, Astellas, AstraZeneca. C.A. received speaker fees from Merck; Honoraria from Merck and Nordic Pharma. M.F. received research funding (to Institution) from QED, Macrophage pharma, Diaceutics, Astellas; personal honoraria as invited speaker from Roche, Eli Lilly, Bristol Myers Squibb, MSD, Pierre Fabre, GlaxoSmithKline, Amgen, Astellas, AstraZeneca. C.C. received research funding from Merck, Bayer, Servier; Honoraria from Amgen, Bayer, Merck, MSD, Pierre Fabre, Roche and Servier; Consulting or advisory role: Amgen, Bayer, MSD, Nordic Pharma, Roche. S.L. received research funding (to Institution) from Amgen,Merck Serono, Bayer, Roche, Eli Lilly, AstraZeneca, Bristol Myers Squibb; personal honoraria as invited speaker from Roche, Eli Lilly, Bristol Myers Squibb, Servier, Merck Serono, Pierre Fabre, GlaxoSmithKline, Amgen; participation in advisory board for Amgen, Merck Serono, Eli Lilly, AstraZeneca, Incyte, Daiichi-Sankyo, Bristol Myers Squibb, Servier, Merck Sharp & Dohme, Astellas, Takeda. FG, MCDG, MMG, GBa, GBo, SC, MA, VMP and FN declare no competing interests., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2023
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18. Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients.

Author

Testoni I, Ronconi L, Lampis F, Iacona E, Zammarrelli J, Pompele S, Valle R, Boscolo G, and De Leo D

Abstract

Informed consent practices in healthcare represent a fundamental element of patient-centred care; however, the traditional use of a written, paper-based description of the medical procedure to obtain informed consent presents many limitations. This research aimed to evaluate the effects of an alternative modality of obtaining informed consent using a brief informative video for patients waiting to undergo a coronary angiography procedure in Italy. The study involved 40 participants-28 males and 12 females (mean age: 68.55, SD = 13.03)-divided equally into two groups: one group received the video-based informed consent and the other received a traditional paper-based form. Each group was asked to fill in two questionnaires; one was created by the researchers to measure the patient's level of understanding of the given information and the perception of usefulness of the informed consent, and the other was the Depression Anxiety Stress Scales-21 (DASS-21), which evaluates levels of anxiety, depression and stress. A comparison of the results of the two groups showed that video-based informed consent allowed participants to better understand the given information, to feel more confident concerning their subjective comprehension of it and to perceive the video-based informed consent as more useful than the traditional one. The video-based informed consent did not lead to higher levels of anxiety, depression or stress among the participants. It can be hypothesized that video-based formats may represent a more useful, understandable and safe alternative to traditional paper-based informed consent in healthcare.

Published
2023
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19. Combined Renal-Pulmonary Extracorporeal Support with Low Blood Flow Techniques: A Retrospective Observational Study (CICERO Study).

Author

Consales G, Zamidei L, Turani F, Atzeni D, Isoni P, Boscolo G, Saggioro D, Resta MV, and Ronco C

Subjects
Humans, Kidney, Lung, Respiration, Artificial, Carbon Dioxide, Respiratory Distress Syndrome therapy
Abstract

Background: Critically ill patients with acute respiratory failure frequently present concomitant lung and kidney injury, within a multiorgan failure condition due to local and systemic mediators. To face this issue, extracorporeal carbon dioxide removal (ECCO2R) systems have been integrated into continuous renal replacement therapy (CRRT) platforms to provide a combined organ support, with efficient clearance of CO2 with very low extracorporeal blood flows (<400 mL/min)., Objectives: To evaluate efficacy and safety of combined ECCO2R-CRRT support with PrismaLung®-Prismaflex® in patients affected by hypercapnic respiratory acidosis associated with AKI in a second level intensive care unit., Methods: We carried out a retrospective observational study enrolling patients submitted to PrismaLung®-Prismaflex® due to mild to moderate acute respiratory distress syndrome (ARDS) or acute exacerbation of chronic obstructive pulmonary disease (aeCOPD). The primary endpoints were the shift to protective ventilation and extubation of mechanically ventilated patients and the shift to invasive mechanical ventilation of patients receiving noninvasive ventilation (NIV). Clinical-laboratoristic data and operational characteristics of ECCO2R-CRRT were recorded., Results: Overall, 12/17 patients on mechanical ventilation shifted to protective ventilation, CO2 clearance was satisfactorily maintained during the whole observational period, and pH was rapidly corrected. Treatment prevented NIV failure in 4 out of 5 patients. No treatment-related complications were recorded., Conclusion: ECCO2R-CRRT was effective and safe in patients with aeCOPD and ARDS associated with AKI., (© 2021 S. Karger AG, Basel.)

Published
2022
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20. Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation in relation to the Patients' Age: Results from a Large Real-World Multicenter Observational Project.

Author

Sciarra L, Iacopino S, Arena G, Tondo C, Pieragnoli P, Molon G, Manfrin M, Curnis A, Russo AD, Rovaris G, Stabile G, Calò L, Boscolo G, and Verlato R

Abstract

Background: The real-world efficacy and safety of atrial fibrillation (AF) ablation in particularly young and elderly patients are still under debate. The aim of the analysis was to investigate the effect of age on the efficacy and safety of cryoballoon ablation (CBA)., Methods: 2,534 patients underwent pulmonary vein isolation (PVI) by way of CBA for paroxysmal or persistent drug-resistant and symptomatic AF. The population was divided into age quartiles for evaluation, including (1) <53 years, (2) ≥53 and <61 years, (3) ≥61 and <67 years, and (4) ≥67 years. Furthermore, outcomes were analyzed in patients <41 years, ≥41 and ≤74, and >74 years old. Procedural data and complications were collected, and atrial fibrillation recurrences were evaluated during follow-up., Results: Procedural-related complications (4.1%) were similar in the four subgroups according to age. At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% ( p =0.21), respectively (with increasing age). At 24-month follow-up, similar incidences of AF recurrence were observed in the four subgroups. When the sample was arbitrarily divided into the three age groups, a higher rate of recurrence was observed in older patients with regard to long-term follow-up (freedom from AF recurrence was 71.8% and 40.9%, respectively, at 12 and 24-month follow-up). In the univariate and multivariate analysis, age did not result in a significant predictor of AF recurrence during follow-up; however, a trend toward higher AF recurrences rates in patients ≥67 years was observed., Conclusion: The data demonstrated a high degree of safety during CBA across all patient ages. Procedural performance and complications were similar between different ages; AF recurrences seem to be more frequent in patients over 74 years., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2021 Luigi Sciarra et al.)

Published
2021
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21. Clinical outcomes and prognostic factors in recurrent and/or metastatic head and neck cancer patients treated with chemotherapy plus cetuximab as first-line therapy in a real-world setting.

Author

Depenni R, Cossu Rocca M, Ferrari D, Azzarello G, Baldessari C, Alù M, Nolé F, Codecà C, Boscolo G, Piccininni M, Cavalieri S, and Bossi P

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cetuximab adverse effects, Disease Progression, Female, Head and Neck Neoplasms mortality, Head and Neck Neoplasms pathology, Humans, Italy, Longitudinal Studies, Male, Middle Aged, Neoplasm Metastasis, Progression-Free Survival, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Antineoplastic Agents, Immunological administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cetuximab administration & dosage, Head and Neck Neoplasms drug therapy, Neoplasm Recurrence, Local
Abstract

Aim: The aims of the study are to evaluate the clinical outcomes of first-line treatment with platinum-based chemotherapy and cetuximab in patients with relapsing/metastatic head and neck cancer (RM HNC) and to identify predictors of treatment response., Methods: This is a retrospective, observational, longitudinal, real-world study involving 6 oncology centres in Italy. All consecutive patients with RM HNC treated between January 2007 and December 2016 with a first-line therapy consisting of a platinum-based chemotherapy regimen plus cetuximab were included. The primary objective of the study was to assess overall survival (OS) and progression-free survival (PFS). Secondary objectives included the identification of predictors of treatment response., Results: Overall, 297 patients were identified. Median OS was 10.8 months (95% confidence interval [CI] 9.3-12.2), whereas median PFS was 4.8 months (95% CI 4.3-5.5). On multivariable analysis, independent unfavourable prognostic factors for OS were performance status (PS) Eastern Cooperative Oncology Group (ECOG) >0, presence of residual tumour at primary site, platinum resistance and lack of objective response. Unfavourable predictors for PFS included cancer primary site (paranasal sinuses, hypopharynx), PS ECOG >0, presence of residual tumour at primary site, platinum resistance and lack of objective response. Independent unfavourable predictors of objective response were tumour site (oral cavity, larynx-hypopharynx), residual tumour at primary site and prior chemotherapy., Conclusions: The availability of new treatment modalities and epidemiological changes make the periodic reassessment of prognostic factors of great relevance to guide clinical practice and the design of future randomised clinical trials., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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22. The PANDA study: a randomized phase II study of first-line FOLFOX plus panitumumab versus 5FU plus panitumumab in RAS and BRAF wild-type elderly metastatic colorectal cancer patients.

Author

Battaglin F, Schirripa M, Buggin F, Pietrantonio F, Morano F, Boscolo G, Tonini G, Lutrino ES, Lucchetti J, Salvatore L, Passardi A, Cremolini C, Arnoldi E, Scartozzi M, Pella N, Boni L, Bergamo F, Zagonel V, Loupakis F, and Lonardi S

Subjects
Colorectal Neoplasms genetics, Colorectal Neoplasms pathology, Disease-Free Survival, ErbB Receptors antagonists & inhibitors, ErbB Receptors genetics, Fluorouracil administration & dosage, Humans, Leucovorin administration & dosage, Mutation, Organoplatinum Compounds administration & dosage, Panitumumab, Prognosis, Proto-Oncogene Proteins B-raf genetics, Treatment Outcome, ras Proteins genetics, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Colorectal Neoplasms drug therapy
Abstract

Background: Few data are available regarding the treatment of metastatic colorectal cancer elderly patients with anti-EGFR agents in combination with chemotherapy. FOLFOX plus panitumumab is a standard first-line option for RAS wild-type metastatic colorectal cancer. Slight adjustments in chemo-dosage are commonly applied in clinical practice to elderly patients, but those modified schedules have never been prospectively tested. Clinical definition of elderly (≥70 years old) patients that may deserve a more or less intensive combination therapy is still debated. Several geriatric screening tools have been developed to predict survival and risk of toxicity from treatment. Among those, the G8 screening tool has been tested in cancer patients showing the strongest prognostic value for overall survival, while the CRASH score can stratify patients according to an estimated risk of treatment-related toxicities., Methods: The PANDA study is a prospective, open-label, multicenter, randomized phase II trial of first-line therapy with panitumumab in combination with dose-adjusted FOLFOX or with 5-fluorouracil monotherapy, in previously untreated elderly patients (≥70 years) with RAS and BRAF wild-type unresectable metastatic colorectal cancer. RAS and BRAF analyses are centralized. Geriatric assessment by means of G8 and CRASH score is planned at baseline and G8 will be re-evaluated at disease progression. The primary endpoint is duration of progression-free survival in both arms. Secondary endpoints include prospective evaluation of the prognostic role of G8 score and the correlation of CRASH risk categories with toxicity., Discussion: The PANDA study aims at exploring safety and efficacy of panitumumab in combination with FOLFOX or with 5FU/LV in elderly patients affected by RAS and BRAF wild-type metastatic colorectal cancer, to identify the most promising treatment strategy in this setting. Additionally, this is the first trial in which the prognostic role of the G8 score will be prospectively evaluated. Results of this study will drive further experimental developments for one or both combinations., Trial Registration: PANDA is registered at Clinicaltrials.gov : NCT02904031 , July 11, 2016. PANDA is registered at EudraCT-No.: 2015-003888-10, September 3, 2015.

Published
2018
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23. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

Author

Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S Stefano L, and Burri H

Subjects
Aged, Cardiovascular Diseases, Female, Humans, Male, Middle Aged, Prospective Studies, Aftercare methods, Cardiac Resynchronization Therapy, Cardiac Resynchronization Therapy Devices, Emergency Service, Hospital statistics & numerical data, Heart Failure therapy, Hospitalization statistics & numerical data, Monitoring, Ambulatory, Mortality, Telemedicine methods
Abstract

Aims: The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics., Methods and Results: The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits., Conclusions: In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety., Trial Registration: NCT00885677., (© 2016 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Published
2017
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24. FOLFOX4 in advanced colorectal cancer: a monoinstitutional experience.

Author

Boscolo G, Pasetto LM, Jirillo A, and Monfardini S

Subjects
Adult, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Colorectal Neoplasms pathology, Disease-Free Survival, Drug Administration Schedule, Female, Fluorouracil administration & dosage, Humans, Leucovorin administration & dosage, Male, Middle Aged, Organoplatinum Compounds administration & dosage, Retrospective Studies, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Colorectal Neoplasms drug therapy
Abstract

Aims and Background: Patients included in clinical trials are "selected", and they usually differ from those commonly treated., Methods: From 1999 to 2004, in the Medical Oncology Department of Padua (Italy), 70 metastatic colorectal cancers were treated with FOLFOX4., Results: Our results, compared with those of the registration trial (response rate, duration of response and progression-free survival) appeared lower; overall survival was improved., Conclusions: The number of therapeutic regimens more than their type influenced the results.

Published
2006
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25. Complete remission of poorly differentiated squamous liver carcinoma after systemic chemotherapy and surgery. A case report.

Author

Boscolo G, Jirillo A, and Da Pian P

Subjects
Carcinoma, Squamous Cell pathology, Cisplatin administration & dosage, Fluorouracil administration & dosage, Humans, Liver Neoplasms pathology, Male, Middle Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell surgery, Liver Neoplasms drug therapy, Liver Neoplasms surgery
Abstract

We report the case of a 64-year-old male patient diagnosed as having inoperable poorly differentiated liver carcinoma that could be completely resected after systemic chemotherapy with cisplatin and 5-fluorouracil.

Published
2005
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26. Hypertension in acute ischemic stroke: a compensatory mechanism or an additional damaging factor?

Author

Semplicini A, Maresca A, Boscolo G, Sartori M, Rocchi R, Giantin V, Forte PL, and Pessina AC

Subjects
Aged, Aged, 80 and over, Female, Glasgow Coma Scale, Humans, Male, Middle Aged, Risk Factors, Blood Pressure, Brain Ischemia physiopathology, Stroke physiopathology
Abstract

Background: In acute ischemic stroke, a transient blood pressure (BP) elevation is common, but the best management is still unknown. Therefore, we investigated retrospectively the relationship between BP after ischemic stroke and neurological outcome (evaluated by means of the National Institutes of Health Stroke Scale score at day 7)., Methods: The medical records of 92 consecutive patients with acute ischemic stroke, aged 47 to 96 years, were examined. Blood pressure was measured on admission, 4 times during the first 24 hours, 3 times daily for the first 4 days, and twice daily on day 7 (or at discharge). Antihypertensive treatment was given according to American Heart Association guidelines., Results: The region damaged by the stroke was total anterior in 16 patients (17%), partial anterior in 30 (33%), lacunar in 34 (37%), and posterior circulation in 12 (13%). Stroke pathogenesis was cardioembolic in 28 (30%), atherothrombotic in 29 (32%), and lacunar in 34 (37%). The systolic BP range was 140 to 220 mm Hg; diastolic BP, 70 to 110 mm Hg. Initial BP was higher in the group with lacunar infarction than in the other groups (P<.05). The patients with the best outcome had the highest BP during the first 24 hours. The neurological outcome was strongly influenced by baseline stroke severity (NIH Scale score) and admission BP. Better initial neurological conditions and higher initial BP resulted in better neurological outcomes., Conclusions: The outcome of stroke is influenced by the type of stroke and initial BP. Lacunar stroke and the highest BP on admission carry the best prognosis, whereas the reverse is true for posterior circulation infarction and low BP. We found no evidence that, within the present BP range, hypertension is harmful and that its lowering is beneficial.

Published
2003
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27. Cognition in action: testing a model of limb apraxia.

Author

Cubelli R, Marchetti C, Boscolo G, and Della Sala S

Subjects
Aged, Brain diagnostic imaging, Female, Functional Laterality physiology, Humans, Male, Middle Aged, Neuropsychological Tests, Radiography, Severity of Illness Index, Stroke complications, Stroke diagnostic imaging, Apraxias etiology, Apraxias physiopathology, Arm, Brain physiopathology, Cognition Disorders diagnosis, Cognition Disorders etiology, Stroke physiopathology
Abstract

Assessment of limb apraxia is still suffering from Liepmann's legacy and performance in gesture-processing tests is generally rendered by classifying patients' profile according to the classic clinical labels of ideomotor and ideational apraxia. At odds with other cognitive functions, interpretation of apraxia has suffered from a lack of a reliable model which does justice to its complexity. Recently such a model has been proposed (Rothi et al., 1991, 1997). In this article a modified version of this model is presented and predictions are made according to its functional architecture. Five different patterns of impairment of gesture processing are postulated. To validate the predicted performance profiles, 19 left-hemisphere-damaged patients were assessed by means of an ad hoc battery of four praxis tests. Four of the five predicted apraxia patterns were observed, the fifth being more equivocal. These results support the need to overcome the simplistic dichotomous view of apraxia and confirm the fruitfulness of a model of normal gesture processing in order to understand dissociations in apraxia., (Copyright 2000 Academic Press.)

Published
2000
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