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1. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., and Marcellini V.

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

4. Cardioprotection beyond the guidelines: the SAFE trial results

Author

Barletta, G, primary, Meattini, I, additional, Del Bene, M R, additional, Martella, F, additional, Becherini, C, additional, Pilato, G, additional, Visani, L, additional, Salvestrini, V, additional, Airoldi, M, additional, Amoroso, D, additional, Coltelli, L, additional, Parisi, F, additional, Saieva, C, additional, and Livi, L, additional

Published
2023
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5. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, Stefania, Fusco, Francesco M, Milleri, Stefano, Borrè, Silvio, Carbonara, Sergio, Lo Caputo, Sergio, Leone, Sebastiano, Gori, Giovanni, Maggi, Paolo, Cascio, Antonio, Lichtner, Miriam, Cauda, Roberto, Dal Zoppo, Sarah, Cossu, Maria V, Gori, Andrea, Roda, Silvia, Confalonieri, Paola, Bonora, Stefano, Missale, Gabriele, Codeluppi, Mauro, Mezzaroma, Ivano, Capici, Serena, Pontali, Emanuele, Libanore, Marco, Diani, Augusta, Lanini, Simone, Battella, Simone, Contino, Alessandra M, Piano Mortari, Eva, Genova, Francesco, Parente, Gessica, Dragonetti, Rosella, Colloca, Stefano, Visani, Luigi, Iannacone, Claudio, Carsetti, Rita, Folgori, Antonella, Camerini, Roberto, Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, and Marcellini, V

Subjects
immunological memory, phase 2 clinical trial, safety, Sars-CoV-2 vaccine, COVID-19, CD8, T cell response, simian adenoviral vector, General Biochemistry, Genetics and Molecular Biology, CD4, neutralizing antibodie
Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific Tcell response peaks after the first dose and is characterized by high frequencies of CD8s. Tcells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

6. 259TiP Treatment of oligometastatic breast cancer (OMBC): A randomised phase III trial comparing stereotactic ablative radiotherapy (SABR) and systemic treatment with systemic treatment alone as first-line treatment - TAORMINA

Author

Linderholm, B.K., primary, Valachis, A., additional, Flote, V. Gordon, additional, Poortmans, P., additional, Person, O. Kaidar, additional, Niligal-Yam, E., additional, O'Reilly, S., additional, Duane, F., additional, Marinko, T., additional, Ekholm, M., additional, Andersson, A., additional, Bergqvist, J., additional, Foukakis, T., additional, Kadum, M., additional, Kulbacka-Ortiz, K., additional, Nilsson-Ek, A., additional, Visani, L., additional, Lundstedt, D., additional, and Meattini, I., additional

Published
2023
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7. P106 De-escalation of radiation therapy after primary systemic therapy in non-metastatic breast cancer: patterns of recurrence from a real-world single-centre cohort of patients

Author

Banini, M., primary, Valzano, M., additional, Becherini, C., additional, Visani, L., additional, Scoccimarro, E., additional, Salvestrini, V., additional, Lorenzetti, V., additional, Frosini, G., additional, Peruzzi, A., additional, Orzalesi, L., additional, Nori, J., additional, Bianchi, S., additional, Livi, L., additional, and Meattini, I., additional

Published
2023
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8. 231P Safety of CDK4/6 inhibitors and concomitant radiation therapy in patients affected by metastatic breast cancer

Author

Visani, L., primary, Becherini, C., additional, Scoccimarro, E., additional, Valzano, M., additional, Saieva, C., additional, Ratosa, I., additional, Ribnikar, D., additional, Orazem, M., additional, Marinko, T., additional, Desideri, I., additional, Scotti, V., additional, Morandi, A., additional, Lambertini, M., additional, Meattini, I., additional, and Livi, L., additional

Published
2022
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9. 242P Impact of metastases directed radiation therapy on CDK4/6 inhibitors treatment for metastatic breast cancer

Author

Meattini, I., primary, Visani, L., additional, Ratosa, I., additional, Saieva, C., additional, Ribnikar, D., additional, Scoccimarro, E., additional, Becherini, C., additional, Orazem, M., additional, Stocchi, G., additional, Bellini, C., additional, Lorenzetti, V., additional, Orsatti, C., additional, Angelini, L., additional, Desideri, I., additional, Scotti, V., additional, Morandi, A., additional, Marinko, T., additional, and Livi, L., additional

Published
2021
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11. 1369P Biochemical outcomes from ARTO trial (NCT03449719) a phase II randomized trial testing association between abiraterone acetate and stereotactic body radiation therapy in castrate-resistant prostate cancer patients

Author

Francolini, G., Detti, B., Di Cataldo, V., Caini, S., Alitto, A.R., S. Parisi, Demofonti, C., Bruni, A., Ingrosso, G., Timon, G., Allegra, A.G., Burchini, L., Salvestrini, V., Frosini, G., Cerbai, C., Visani, L., Becherini, C., Desideri, I., Meattini, I., and Livi, L.

Published
2022
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12. 1029 Anthracycline and trastuzumab-induced subclinical cardiac damage and its prevention in the SAFE trial. Myocardial strain imaging and 3D echo interim analysis data

Author

Barletta, G, primary, Livi, L, additional, Martella, F, additional, Desideri, I, additional, Venditti, F, additional, Scotti, V, additional, Pilato, G, additional, Argiro", A, additional, Becherini, C, additional, Bacci, C, additional, Terziani, F, additional, Visani, L, additional, Salvestrini, V, additional, Meattini, I, additional, and Del Bene, M R, additional

Published
2020
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13. EP1.04-02 Predictors of Lung Toxicity in First Line Pembrolizumb for Advanced NSCLC: An Interim Analysis of PRELUTOX Study

Author

Bonti, V., primary, Teriaca, M.A., additional, Lavacchi, D., additional, Perna, M., additional, Caini, S., additional, Mazzoni, F., additional, Maragna, V., additional, Rosi, E., additional, Giannelli, F., additional, Cozzi, D., additional, Visani, L., additional, Calabrò, A., additional, Bartolucci, M., additional, Ciccone, L.P., additional, Mariotti, M., additional, Flego, N., additional, Comin, C.E., additional, Pezzulla, D., additional, Moroni, C., additional, Cavigli, E., additional, Bindi, A., additional, Caramia, G., additional, Meacci, F., additional, Miele, V., additional, Lavorini, F., additional, Voltolini, L., additional, Livi, L., additional, Scotti, V., additional, and Ferrari, K., additional

Published
2019
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15. PV-0256 European survey on electronic patientreported outcomes by the EORTC young Radiation Oncology Group

Author

Thieme, A.H., primary, Eller, Y.G., additional, del Campo, E. Rivin, additional, Abrunhosa-Branquinho, A., additional, Adebahr, S., additional, Desideri, I., additional, Fiore, M., additional, Hafeez, S., additional, Hoeben, B., additional, Kaidar-Person, O., additional, Kindts, I., additional, Meattini, I., additional, Mercier, C., additional, Mehrhof, F., additional, Nevens, D., additional, Ollivier, L., additional, Suppli, M.H., additional, Visani, L., additional, Baumert, B.G., additional, and Ostheimer, C., additional

Published
2019
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19. Abstract P3-12-07: Conservative breast reconstruction: Outcomes of 146 consecutive cases of prepectoral, subcutaneous implant-based breast reconstruction in a single-Institution series

Author

Meattini, I, primary, Bernini, M, additional, Saieva, C, additional, Desideri, I, additional, Scotti, V, additional, Salvestrini, V, additional, Visani, L, additional, Mariotti, M, additional, Delli Paoli, C, additional, Olmetto, E, additional, Maragna, V, additional, Orzalesi, L, additional, Sanchez, L, additional, Nori, J, additional, Bianchi, S, additional, and Livi, L, additional

Published
2019
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20. Abstract P4-16-04: Oral ibandronate for osteopenic breast cancer patients receiving adjuvant aromatase inhibitors: secondary 5-year survival outcomes analysis of the single-center phase 2 BONADIUV trial

Author

Meattini, I, primary, Scotti, V, additional, Desideri, I, additional, Saieva, C, additional, Visani, L, additional, Salvestrini, V, additional, Cecchini, S, additional, De Feo, ML, additional, Mariotti, M, additional, Olmetto, E, additional, Delli Paoli, C, additional, Francolini, G, additional, Bernini, M, additional, Orzalesi, L, additional, Sanchez, L, additional, Nori, J, additional, Bianchi, S, additional, and Livi, L, additional

Published
2019
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23. EP-1127: Dose to hippocampus in brain metastases radiosurgery: need for an hippocampal sparing approach

Author

Scoccianti, S., primary, Greto, D., additional, Calusi, S., additional, Poggesi, L., additional, Arilli, C., additional, Casati, M., additional, Compagnucci, A., additional, Becherini, C., additional, Carta, G.A., additional, Desideri, I., additional, Baki, M., additional, Visani, L., additional, Simontacchi, G., additional, Bonomo, P., additional, Bordi, L., additional, Bono, P., additional, Pallotta, S., additional, and Livi, L., additional

Published
2017
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24. MEDICAL SCIENCE. GISSI-2: A factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12 490 patients with acute myocardial infarction

Author

Feruglio, G. A., Lotto, A., Rovelli, F., Solinas, P., Tavazzi, L., Tognoni, G., De Vita, C., Franzosi, M. G., Maggiom, A. P., Mauri, F., Volpi, A., Selvini, A., Donato, L., Garattmi, S., Loi, U., Sirchia, G., Ambrosioni, E., Camerini, F., Campolo, L., Donati, M. B., Ferrari, M., Farchi, G., Geraci, E., Mannucci, P. M., Marubini, E., Neri Semeri, G. G., Peto, R., Prati, P. L., Specchia, G., Vecchio, C., Visani, L., Yusuf, S., Mezzanotte, G., Santoro, E., Bruno, M., Cappello, T., Coppini, A., Fincati, F., Mantovani, G., Pangrazzi, J., Pogna, M., Turazza, F. M., Ansehni, M., Barbonaglia, L., Bigi, R., Cavalli, A., Frigerio, M., Giordano, A., Gualtierotti, C., Torta, D., Vinci, P., Bossi, M., Furlanello, F., Braito, E., Giulia, V., Palmieri, M., Majoimo, P., Pinelli, G., Papi, L., Nardelli, A., Capestro, F., Rossi, A., Ricci, D., Mininni, N., Bianco, G., Barbuzzi, S., Plastina, F., Di Giovanna, F., Mereu, D., Giordano, F., Barlotti, R., Loparco, G., Boscarino, S., Ruggeri, G., Anastasi, R., Paciaroni, E., Tomassini, P. F., Purcaro, A., Francesconi, M., Figliolia, S., Tesse, S., Devoti, G., Giometti, R., Teoni, P., Burali, A., Zucconelli, V., Iervoglini, A., Amabili, S., Caratti, C. A., Zola, G., Ferraguto, P., Sagci, G., Rotiroti, D., Genovese, M., Da€TMamato, N., Taurino, L., Colonna, L., Bovenzi, F., Messina, D., Sarcina, G., Compostella, L., Cucchini, F., Malacrida, R., Gradel, C., Bridda, A., Pellegrini, P., Acone, L., Bruno, A., Tespili, M., Guaghurrii, G., Casari, A., Bobba, F., Scaramuzzino, G., Berardi, C., De Castro, U., Fulvi, M., Lintner, W., Erlicher, A., Pitscheider, W., Scola Gagliardi, R., Bonizzato, G., Roggero, C., Perrini, A., Tsialtas, D., Straneo, U., Storelli, A., Verrienti, A., Albonico, B., Corradi, L., De Petra, V., Villani, C., Maxia, P., Bianco, A., Crabu, E., Centamore, G., Di Stefano, G., Vancheri, F., Amico, C., Baldini, F., Santopuoli, G., Pantaleoni, A., Contessotto, F., Terlizzi, R., Turchi, E., Teglio, V., Pignatti, F., Aletto, C., Gozzelino, G., Pettinati, G., De Santis, F., Correale, E., Romano, S., Perrotta, R., Tritto, C., May, L., Achilli, G., Suzzi, G., Cemetti, C., Longobardi, R., Somma, G., Palumbo, C., Gallone, P., Sorrentino, F., Dato, A., Della Monica, R., Pagano, L., Alberti, A., Orselli, L., Negrini, M., De Ponti, C., Acito, P., Capelletti, D., Bortolini, F., Coppola, V., Ciglia, C., De Cesare, M., De Lio, U., Maiolino, P., Giannini, R., Niccolini, A., Marinoni, C., Guasconi, C., Sonnino, S., Pagliei, M., Ferrari, G., Politi, A., Galli, M., De Rinaldis, G., Calcagnile, A., Bendinelli, S., Lusetti, L., Mollaioli, M., Cosmi, F., Venneri, N., Feraco, E., Lauro, A., Catelli, P., Poluzzi, C., Distante, S., Pedroni, P., Zampaglione, G., Lumare, R., Bruna, C., De Benedictis, N., Ziacchi, V., Lomanto, B., Riva, D., Bertocchi, P., Tirella, G., Tessitori, M., Bini, A., Peruzzi, F., Maresta, A., Pirazzini, L., Gaggi, S., Frausini, G., Malacame, C., Codeca, L., Cappato, R., Andreoli, L., Bastoni, L. A., Pucci, P., Sarro, F., Vergassola, R., Barchielli, M., De Matteis, D., Carrone, M., Liberati, R., Meniconi, L., Radogna, M., Tallone, M., Ieri, A., Ferreri, A., Guidali, P., Canziani, R., Mariello, F., Minelli, C., Muzio, L., Rota Baldini, M., Lupi, G., Cecchi, A., Giuliano, G., Bellotti, S., Livi, S., Corti, E., Rossi, P., Delfino, R., Iannetti, M., Pastorini, C., Pennesi, A., Di Giacinto, N., Bertolo, L., Slomp, L., Cresti, A., Svetoni, N., Distefano, S., Veneri, L., Moretti, S., Palermo, R., Giovanelli, N., Parchi, C., Dethomads, M., Paparella, N., Carrino, C., Aquaro, G., Idone, P., Marsili, P., Sideri, F., Valerio, A., Tullio, D., Ragazzini, G., Gramenzi, S., De Pasquale, B., Gelfo, P. G., Rosselli, P., De Marchi, E., Greco, M. R., Fazio, A. M., Savoia, M. T., Gerosa, C., Barbiero, M., Barbaresi, F., Volta, G., Da€TMurbano, M., Passoni, F., Parola, G., Lanzini, A., Baldini, U., Del Bene, P., Orlandi, M., Oddone, A., Lazzari, M., Ballerini, B., Bozzi, L., Moccetti, T., Bemasconi, E., Sanguinetti, M., Tognoli, T., Bardelli, G., Maggi, A., Turato, R., Piva, M., Izzo, A., Tantalo, L., Rizzi, A., Scilabra, G., Varvaro, F., Colombo, G., Grieco, A., Dovico, E., Belluzzi, F., Casellato, F., Lecchi, G., Maugeri Sacci, C., Consolo, A., Piccolo, E., Zuin, G., Zappa, C., Sanna, G. P., Dossena, M. G., Corsini, C., Lettino, M., Marconi, M., Mafrici, A., Leonardi, G., Moreo, A., Seregni, R., Pastine, I., Casazza, F., Regalia, F., Maggiolini, S., Benenati, P. M., Rigo, R., Pascotto, P., Zanocco, A., Artusi, L., Cappelli, C., Bernardi, C., Pahnieri, M., Zilio, G., Sandri, R., Neri, G., Valagussa, F., Osculati, G., Cira, A., Da€TManiello, L., Piantadosi, F. R., Improta, M., Severino, S., Bisconti, C., Mostacci, M., Randon, L., Boschello, M., Allegri, M., Freggiaro, V., Mureddu, V., Soro, F., Marras, E., Marchi, S. M., De Luca, C., Manetta, M., Dalla Volta, S., Maddalena, F., Donzelli, M., Vitrano, M. G., Canonico, A., Ledda, A., Bellomare, D., Carrubba, A., Da€TMantonio, E., Scardulla, C., Raineri, A., Traina, M., La Calce, C., Cirincione, V., Montanar, F., Strizzolo, L., Di Gregorio, D., Mantini, L., Chiriatti, G., Gazzola, U., Rosi, A., Mellini, M., Piazza, R., Micheli, G., Bechi, S., Martines, C., Marchese, D., Bigalli, A., Davini, P., Boem, A., Del Citerna, F., Giomi, A., Codeluppi, P., Negrelli, M., Brieda, M., Charmet, P. A., Petrella, A., Bardazzi, L., Bianco, G. A., Marco, A., Licitra, R., Lettica, G. V., Tumiotto, G., Bosi, S., Spitali, G., Casali, G., Bottoni, N., Parenti, G. F., Triulzi, E., Brighi, F., Benati, A., De Sanctis, A., Mene, A., Pesaresi, A., Bologna, F., Lumia, F., Barbato, G., Milazzotto, F., Proietti, F., Angrisani, G., Azzolini, P., Coppola, E., Trani, Carlo, Masini, V., Rocchi, M., Borgia, M. C., Luciani, C., Vitucci, N. C., Giuliani, P., Tugnoli, F., Vetta, C., Altieri, T., Gimigliano, F., Striano, U., Salituri, S., Zanazzi, G., Zonzin, P., Bugatti, U., Ravera, B., Allemano, P., Reynaud, S., Sanson, A., Milani, L., De Simone, M. V., Villella, A., Grazzini, M., Amidei, S., Ansehni, L., Benza, G., Tagliamonte, A., Messina, V., Etro, M. D., Vivaldi, F., Cortese, R., Ibba, G. V., Sannia, L., Pedrazzini, F., Gazzotti, G. L., Pizzuti, A., Antonielli, E., Becchi, G., Filice, A., Salmoiraghi, A., Caramanno, G., Caporicci, D., Brun, M., Ferrario, G., Giani, P., Ronconi, G., Douglas, S., Bianchi, C., Cucchi, G., Marieni, M., Marcellini, G., Speca, G., Beato, E., Serabni, N., Bazzucchi, M., Coronelli, R., Rossi, L., Basso, G., Presbitero, P., Bevilacqua, R., Pallisco, O., Di Leo, M., Golzio, P. G., Parigi, A., Belli, R., Trinchero, R., Gaschino, G., Barenghi, M., Poggio, G. L., Braschi, G. B., Sciacca, R., Sammartano, A., Braito, G., Cuzzato, V., Frigo, G., Perissinono, F., Galati, A., Accogli, M., Morgera, T., Barbieri, L., Slavich, G. A., Fresco, C., Cuda, A., Liguori, A., Cozzi, A., Caico, S., Alberio, M., Di Marco, G., De Vito, G., Valente, S., Zagatti, G., Zardini, P., Nidasio, G. P., Girardi, P., Mazzini, C., Nava, S., Achilli, A., Bisogno, A., Pasotti, C., Ballestra, A. M., Giustarini, C., Trani C. (ORCID:0000-0001-9777-013X), Feruglio, G. A., Lotto, A., Rovelli, F., Solinas, P., Tavazzi, L., Tognoni, G., De Vita, C., Franzosi, M. G., Maggiom, A. P., Mauri, F., Volpi, A., Selvini, A., Donato, L., Garattmi, S., Loi, U., Sirchia, G., Ambrosioni, E., Camerini, F., Campolo, L., Donati, M. B., Ferrari, M., Farchi, G., Geraci, E., Mannucci, P. M., Marubini, E., Neri Semeri, G. G., Peto, R., Prati, P. L., Specchia, G., Vecchio, C., Visani, L., Yusuf, S., Mezzanotte, G., Santoro, E., Bruno, M., Cappello, T., Coppini, A., Fincati, F., Mantovani, G., Pangrazzi, J., Pogna, M., Turazza, F. M., Ansehni, M., Barbonaglia, L., Bigi, R., Cavalli, A., Frigerio, M., Giordano, A., Gualtierotti, C., Torta, D., Vinci, P., Bossi, M., Furlanello, F., Braito, E., Giulia, V., Palmieri, M., Majoimo, P., Pinelli, G., Papi, L., Nardelli, A., Capestro, F., Rossi, A., Ricci, D., Mininni, N., Bianco, G., Barbuzzi, S., Plastina, F., Di Giovanna, F., Mereu, D., Giordano, F., Barlotti, R., Loparco, G., Boscarino, S., Ruggeri, G., Anastasi, R., Paciaroni, E., Tomassini, P. F., Purcaro, A., Francesconi, M., Figliolia, S., Tesse, S., Devoti, G., Giometti, R., Teoni, P., Burali, A., Zucconelli, V., Iervoglini, A., Amabili, S., Caratti, C. A., Zola, G., Ferraguto, P., Sagci, G., Rotiroti, D., Genovese, M., Da€TMamato, N., Taurino, L., Colonna, L., Bovenzi, F., Messina, D., Sarcina, G., Compostella, L., Cucchini, F., Malacrida, R., Gradel, C., Bridda, A., Pellegrini, P., Acone, L., Bruno, A., Tespili, M., Guaghurrii, G., Casari, A., Bobba, F., Scaramuzzino, G., Berardi, C., De Castro, U., Fulvi, M., Lintner, W., Erlicher, A., Pitscheider, W., Scola Gagliardi, R., Bonizzato, G., Roggero, C., Perrini, A., Tsialtas, D., Straneo, U., Storelli, A., Verrienti, A., Albonico, B., Corradi, L., De Petra, V., Villani, C., Maxia, P., Bianco, A., Crabu, E., Centamore, G., Di Stefano, G., Vancheri, F., Amico, C., Baldini, F., Santopuoli, G., Pantaleoni, A., Contessotto, F., Terlizzi, R., Turchi, E., Teglio, V., Pignatti, F., Aletto, C., Gozzelino, G., Pettinati, G., De Santis, F., Correale, E., Romano, S., Perrotta, R., Tritto, C., May, L., Achilli, G., Suzzi, G., Cemetti, C., Longobardi, R., Somma, G., Palumbo, C., Gallone, P., Sorrentino, F., Dato, A., Della Monica, R., Pagano, L., Alberti, A., Orselli, L., Negrini, M., De Ponti, C., Acito, P., Capelletti, D., Bortolini, F., Coppola, V., Ciglia, C., De Cesare, M., De Lio, U., Maiolino, P., Giannini, R., Niccolini, A., Marinoni, C., Guasconi, C., Sonnino, S., Pagliei, M., Ferrari, G., Politi, A., Galli, M., De Rinaldis, G., Calcagnile, A., Bendinelli, S., Lusetti, L., Mollaioli, M., Cosmi, F., Venneri, N., Feraco, E., Lauro, A., Catelli, P., Poluzzi, C., Distante, S., Pedroni, P., Zampaglione, G., Lumare, R., Bruna, C., De Benedictis, N., Ziacchi, V., Lomanto, B., Riva, D., Bertocchi, P., Tirella, G., Tessitori, M., Bini, A., Peruzzi, F., Maresta, A., Pirazzini, L., Gaggi, S., Frausini, G., Malacame, C., Codeca, L., Cappato, R., Andreoli, L., Bastoni, L. A., Pucci, P., Sarro, F., Vergassola, R., Barchielli, M., De Matteis, D., Carrone, M., Liberati, R., Meniconi, L., Radogna, M., Tallone, M., Ieri, A., Ferreri, A., Guidali, P., Canziani, R., Mariello, F., Minelli, C., Muzio, L., Rota Baldini, M., Lupi, G., Cecchi, A., Giuliano, G., Bellotti, S., Livi, S., Corti, E., Rossi, P., Delfino, R., Iannetti, M., Pastorini, C., Pennesi, A., Di Giacinto, N., Bertolo, L., Slomp, L., Cresti, A., Svetoni, N., Distefano, S., Veneri, L., Moretti, S., Palermo, R., Giovanelli, N., Parchi, C., Dethomads, M., Paparella, N., Carrino, C., Aquaro, G., Idone, P., Marsili, P., Sideri, F., Valerio, A., Tullio, D., Ragazzini, G., Gramenzi, S., De Pasquale, B., Gelfo, P. G., Rosselli, P., De Marchi, E., Greco, M. R., Fazio, A. M., Savoia, M. T., Gerosa, C., Barbiero, M., Barbaresi, F., Volta, G., Da€TMurbano, M., Passoni, F., Parola, G., Lanzini, A., Baldini, U., Del Bene, P., Orlandi, M., Oddone, A., Lazzari, M., Ballerini, B., Bozzi, L., Moccetti, T., Bemasconi, E., Sanguinetti, M., Tognoli, T., Bardelli, G., Maggi, A., Turato, R., Piva, M., Izzo, A., Tantalo, L., Rizzi, A., Scilabra, G., Varvaro, F., Colombo, G., Grieco, A., Dovico, E., Belluzzi, F., Casellato, F., Lecchi, G., Maugeri Sacci, C., Consolo, A., Piccolo, E., Zuin, G., Zappa, C., Sanna, G. P., Dossena, M. G., Corsini, C., Lettino, M., Marconi, M., Mafrici, A., Leonardi, G., Moreo, A., Seregni, R., Pastine, I., Casazza, F., Regalia, F., Maggiolini, S., Benenati, P. M., Rigo, R., Pascotto, P., Zanocco, A., Artusi, L., Cappelli, C., Bernardi, C., Pahnieri, M., Zilio, G., Sandri, R., Neri, G., Valagussa, F., Osculati, G., Cira, A., Da€TManiello, L., Piantadosi, F. R., Improta, M., Severino, S., Bisconti, C., Mostacci, M., Randon, L., Boschello, M., Allegri, M., Freggiaro, V., Mureddu, V., Soro, F., Marras, E., Marchi, S. M., De Luca, C., Manetta, M., Dalla Volta, S., Maddalena, F., Donzelli, M., Vitrano, M. G., Canonico, A., Ledda, A., Bellomare, D., Carrubba, A., Da€TMantonio, E., Scardulla, C., Raineri, A., Traina, M., La Calce, C., Cirincione, V., Montanar, F., Strizzolo, L., Di Gregorio, D., Mantini, L., Chiriatti, G., Gazzola, U., Rosi, A., Mellini, M., Piazza, R., Micheli, G., Bechi, S., Martines, C., Marchese, D., Bigalli, A., Davini, P., Boem, A., Del Citerna, F., Giomi, A., Codeluppi, P., Negrelli, M., Brieda, M., Charmet, P. A., Petrella, A., Bardazzi, L., Bianco, G. A., Marco, A., Licitra, R., Lettica, G. V., Tumiotto, G., Bosi, S., Spitali, G., Casali, G., Bottoni, N., Parenti, G. F., Triulzi, E., Brighi, F., Benati, A., De Sanctis, A., Mene, A., Pesaresi, A., Bologna, F., Lumia, F., Barbato, G., Milazzotto, F., Proietti, F., Angrisani, G., Azzolini, P., Coppola, E., Trani, Carlo, Masini, V., Rocchi, M., Borgia, M. C., Luciani, C., Vitucci, N. C., Giuliani, P., Tugnoli, F., Vetta, C., Altieri, T., Gimigliano, F., Striano, U., Salituri, S., Zanazzi, G., Zonzin, P., Bugatti, U., Ravera, B., Allemano, P., Reynaud, S., Sanson, A., Milani, L., De Simone, M. V., Villella, A., Grazzini, M., Amidei, S., Ansehni, L., Benza, G., Tagliamonte, A., Messina, V., Etro, M. D., Vivaldi, F., Cortese, R., Ibba, G. V., Sannia, L., Pedrazzini, F., Gazzotti, G. L., Pizzuti, A., Antonielli, E., Becchi, G., Filice, A., Salmoiraghi, A., Caramanno, G., Caporicci, D., Brun, M., Ferrario, G., Giani, P., Ronconi, G., Douglas, S., Bianchi, C., Cucchi, G., Marieni, M., Marcellini, G., Speca, G., Beato, E., Serabni, N., Bazzucchi, M., Coronelli, R., Rossi, L., Basso, G., Presbitero, P., Bevilacqua, R., Pallisco, O., Di Leo, M., Golzio, P. G., Parigi, A., Belli, R., Trinchero, R., Gaschino, G., Barenghi, M., Poggio, G. L., Braschi, G. B., Sciacca, R., Sammartano, A., Braito, G., Cuzzato, V., Frigo, G., Perissinono, F., Galati, A., Accogli, M., Morgera, T., Barbieri, L., Slavich, G. A., Fresco, C., Cuda, A., Liguori, A., Cozzi, A., Caico, S., Alberio, M., Di Marco, G., De Vito, G., Valente, S., Zagatti, G., Zardini, P., Nidasio, G. P., Girardi, P., Mazzini, C., Nava, S., Achilli, A., Bisogno, A., Pasotti, C., Ballestra, A. M., Giustarini, C., and Trani C. (ORCID:0000-0001-9777-013X)

Abstract

A multicentre, randomised, open trial with a 2 x 2 factorial design was conducted to compare the benefits and risks of two thrombolytic agents, streptokinase (SK, 1·5 MU infused intravenously over 30-60 min) and alteplase (tPA, 100 mg infused intravenously over 3 h) in patients with acute myocardial infarction admitted to coronary care units within 6 h from onset of symptoms. The patients were also randomised to receive heparin (12 500 U subcutaneously twice daily until discharge from hospital, starting 12 h after beginning the tPA or SK infusion) or usual therapy. All patients without specific contraindications were given atenolol (5-10 mg iv) and aspirin (300-325 mg a day). The end-point of the study was the combined estimate of death plus severe left ventricular damage. 12 490 patients were randomised to four treatment groups (SK alone, SK plus heparin, tPA alone, tPA plus heparin). No specific differences between the two thrombolytic agents were detected as regards the combined end-point (tPA 23·1%; SK 22·5%; relative risk 1·04, 95% Cl 0·95-1·13), nor after the addition of heparin to the aspirin treatment (hep 22·7%, no hep 22·9%; RR 0·99, 95% Cl 0·91-1·08). The outcome of patients allocated to the four treatment groups was similar with respect to baseline risk factors such as age, Killip class, hours from onset of symptoms, and site and type of infarct. The rates of major in-hospital cardiac complications (reinfarction, post-infarction angina) were also similar. The incidence of major bleeds was significantly higher in SK and heparin treated patients (respectively, tPA 0·5%, SK 1·0%, RR 0·57, 95% Cl 0·38-0·85; hep 1·0%, no hep 0·6%, RR 1·64, 95% Cl 1·09-2·45), whereas the overall incidence of stroke was similar in all groups. SK and tPA appear equally effective and safe for use in routine conditions of care, in all infarct patients who have no contraindications, with or without post-thrombolytic heparin treatment. The 8·8% hospital mortality of the study popula

Published
1990

25. Nuclear medicine and radiotherapy in the clinical management of glioblastoma patients

Author

Valerio Nardone, Isacco Desideri, Luca D’Ambrosio, Ilaria Morelli, Luca Visani, Eugenio Di Giorgio, Cesare Guida, Alfredo Clemente, Maria Paola Belfiore, Fabrizio Cioce, Marco Spadafora, Claudia Vinciguerra, Luigi Mansi, Alfonso Reginelli, Salvatore Cappabianca, Nardone, V., Desideri, I., D'Ambrosio, L., Morelli, I., Visani, L., Di Giorgio, E., Guida, C., Clemente, A., Belfiore, M. P., Cioce, F., Spadafora, M., Vinciguerra, C., Mansi, L., Reginelli, A., and Cappabianca, S.

Subjects
Oncology, Radiotherapy, PET/CT, Nuclear medicine, Precision medicine, Radiology, Nuclear Medicine and imaging, Glioblastoma
Abstract

Introduction The aim of the narrative review was to analyse the applications of nuclear medicine (NM) techniques such as PET/CT with different tracers in combination with radiotherapy for the clinical management of glioblastoma patients. Materials and methods Key references were derived from a PubMed query. Hand searching and clinicaltrials.gov were also used. Results This paper contains a narrative report and a critical discussion of NM approaches in combination with radiotherapy in glioma patients. Conclusions NM can provide the Radiation Oncologist several aids that can be useful in the clinical management of glioblastoma patients. At the same, these results need to be validated in prospective and multicenter trials.

Published
2022
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26. Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study.

Author

Krasniqi E, Filomeno L, Arcuri T, Di Lisa FS, Astone A, Cutigni C, Foglietta J, Nunzi M, Rossi R, Minelli M, Meattini I, Visani L, Scialino J, Livi L, Moscetti L, Marchetti P, Botticelli A, Paris I, Pavese F, D'Angelo T, Sini V, Stani S, Valerio MR, Grassadonia A, Tinari N, Mazzotta M, Vergati M, D'Auria G, Gamucci T, D'Onofrio L, Gasparro S, Roselli A, Fulvi A, Ferretti G, Torchia A, Giordano M, Greco F, Pantano F, Tonini G, Fabbri A, Bria E, Garufi G, Fiorio E, Raffaele M, Pistelli M, Berardi R, Saltarelli R, Kayal R, Ferranti FR, Cannita K, Irelli A, D'Ostilio N, De Rossi C, Palumbo R, Cariello A, Sanguineti G, Calabrò F, Pizzuti L, Barba M, Botti C, Pelle F, Cappelli S, Cavicchi F, Puccica I, Villanucci A, Sperduti I, Ciliberto G, and Vici P

Abstract

Background/objectives: HER2-positive breast cancer (HER2 + BC) is an aggressive subtype, with neoadjuvant treatment (NAT) aiming to achieve a pathological complete response (pCR) to improve long-term outcomes. Trastuzumab emtansine (T-DM1) has been established as the standard of care in the adjuvant setting for HER2 + BC patients who do not obtain pCR. The ATD study aimed to evaluate the real-world tolerability of T-DM1 in this setting. The secondary objective was to assess the effectiveness., Methods: This was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2 + BC treated with adjuvant T-DM1 following a lack of pCR after NAT. Patient characteristics, NAT regimens, and surgical outcomes were recorded. Tolerability was assessed by documenting adverse events (AEs) according to the CTCAE (v5.0). Preliminary effectiveness was evaluated in terms of relapse-free survival (RFS) and overall survival (OS)., Results: Overall, 228 patients (55.6%) experienced at least one AE related to T-DM1, with 4.9% experiencing grade 3 or higher AEs. The most common AEs were hepatotoxicity (18.5%) and thrombocytopenia (17.6%). T-DM1 was discontinued in 10.0% of patients due to toxicity. After a median follow-up of 25 months, 31 relapse events (7.6%) and 22 deaths (5.4%) were reported. The preliminary incidence of RFS and OS events was similar between patients who completed the T-DM1 course and those who discontinued it early., Conclusions: T-DM1 demonstrated a manageable safety profile, and the adverse events were consistent with those reported in randomized trials. The data are not yet sufficient to allow for a formal analysis of RFS and OS, and long-term follow-up is required.

Published
2024
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27. Pre-pectoral breast reconstruction with tissue expander entirely covered by acellular dermal matrix: feasibility, safety and histological features resulting from the first 64 procedures.

Author

Bernini M, Gigliucci G, Cassetti D, Tommasi C, Gaggelli I, Arlia L, Becherini C, Salvestrini V, Visani L, Nori Cucchiari J, De Benedetto D, Di Naro F, Bicchierai G, Bellini C, Bianchi S, Orzalesi L, Livi L, and Meattini I

Abstract

Background: Reconstructive options that can be used following conservative mastectomy, skin-, nipple-sparing and skin-reducing mastectomies, allow a remarkable variety of safe methods to restore the natural shape and aesthetics of the breast mound. In case of two-stage breast reconstruction, tissue expanders (TEs) are usually placed in a subpectoral position. The purpose of this retrospective cohort study is to evaluate the feasibility and safety of two-step reconstruction with TE in pre-pectoral position covered by acellular dermal matrix (ADM)., Methods: Between March 2021 and May 2023, at the Azienda Ospedaliero Universitaria Careggi, University of Florence, 55 patients with BRCA 1/2 mutations or early breast cancer underwent conservative mastectomy with immediate pre-pectoral reconstruction using TE covered with ADM, followed by a second surgery with replacement of the expander with definitive prosthesis. Demographic, oncological, and histological data along with surgical complications were recorded., Results: A total of 64 conservative mastectomies were performed. In 2 patients (3.1%) complications were found that required reintervention and, in both cases, the TE had to be removed. Two patients developed hematoma and one patient developed seroma. Two patients showed wound dehiscence, both healed after conservative treatment and without implant exposure. No case of necrosis of the skin or nipple-areola complex has been observed, neither of capsular contracture. Capsule formed around TE was populated with cells and blood vessels and showed a thin area of synovial metaplasia., Conclusions: In selected cases it may be more cautious to perform a two-stage breast reconstruction after radical breast surgery by means of TEs. The placement of TEs in pre-pectoral position combines the excellent aesthetic and functional results of the pre-pectoral philosophy with a quite safer and more prudent two-step approach. Our experience reports optimistic results: the ADM covering the TE is seen successfully integrating during tissue expansion and becoming a vascularised new self-tissue. Complications rates are low and such ADM-assisted two-stage pre-pectoral reconstructive technique is a safe, practical, and reproducible method., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-23-432/coif). The authors have no conflicts of interest to declare., (2024 Gland Surgery. All rights reserved.)

Published
2024
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28. Cancer Treatment-Related Complications in Patients With Hypertrophic Cardiomyopathy.

Author

Zampieri M, Schoonvelde SAC, Vinci M, Meattini I, Visani L, Fornaro A, Coppini R, Romei A, Marchi A, Morelli I, van Slegtenhorst MA, Palinkas ED, Livi L, Michels M, and Olivotto I

Subjects
Humans, Retrospective Studies, Cardiotoxicity, Death, Sudden, Cardiac, Risk Factors, Cardiomyopathy, Hypertrophic complications, Cardiomyopathy, Hypertrophic therapy, Cardiomyopathy, Hypertrophic diagnosis, Ventricular Dysfunction, Left, Neoplasms complications
Abstract

Objective: To describe the potential clinical cardiotoxicity of oncological treatments in a cohort of consecutive patients with hypertrophic cardiomyopathy (HCM), systematically followed-up at two national referral centers for HCM. Cardiotoxicity relates to the direct effects of cancer-related treatment on heart function, commonly presenting as left ventricular contractile dysfunction. However, limited data are available regarding cardiotoxic effects on HCM as most studies have not specifically analyzed the effects of oncological treatment in HCM populations. This gap in knowledge may lead to unjustified restriction of HCM patients from receiving curative cancer treatments., Methods: We retrospectively analyzed clinical and instrumental data of all consecutive HCM patients who underwent oncological treatment between January 2000 and December 2020 collected in a centralized database., Results: Of 3256 HCM patients, 121 (3.7%) had cancer; 110 (90.9%) underwent oncological surgery, 45 (37.2%) received chemotherapy, and 22 (18.2%) received chest radiation therapy (cRT). After a median follow-up of 5.2 years (Q1-Q3: 2-13 years) from oncological diagnosis, 32 patients died. The cumulative survival at 5 years was 79.9%. The cause of death was mainly attributed to the oncological condition, whereas four patients died of sudden cardiac death without receiving previous chemotherapy or cRT. No patient interrupted or reduced the dose of oncological treatment due to cardiac dysfunction. No sustained ventricular tachyarrhythmia was induced by chemotherapy or radiation therapy., Conclusion: Cancer treatment was well tolerated in HCM patients. In our consecutive series, none died of cardiovascular complications induced by chemotherapy or cRT and they did not require interruption or substantial treatment tapering due to cardiovascular toxic effects. Although a multidisciplinary evaluation is necessary and regimens must be tailored individually, the diagnosis of HCM per se should not be considered a contraindication to receive optimal curative cancer treatment., (Copyright © 2023 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Published
2024
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29. Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients.

Author

Valachis A, Biganzoli L, Christopoulou A, Fjermeros K, Fountzila E, Geisler J, Gomez-Bravo R, Karihtala P, Kosmidis P, Koutras A, Linardou H, Lindman H, Martínez-Ballestero I, Rodríguez AB, Meattini I, Munoz-Mateu M, Othman M, Psyrri A, Risi E, Schiza A, Spathas N, Utriainen M, Visani L, Ballesteros S, Basdekis I, Hay SD, Fotis T, Fricker S, de Graaf G, Jenset M, Kanters T, Lampropoulos K, Markou C, Mastoraki K, Nanou C, Reales Aviles JM, Santaholma M, and Kosmidis T

Subjects
Aged, Aged, 80 and over, Female, Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Receptor, ErbB-2 antagonists & inhibitors, Receptor, ErbB-2 metabolism, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Cyclin-Dependent Kinase 4 antagonists & inhibitors, Cyclin-Dependent Kinase 6 antagonists & inhibitors, Geriatric Assessment, Protein Kinase Inhibitors therapeutic use, Protein Kinase Inhibitors administration & dosage, Protein Kinase Inhibitors adverse effects
Abstract

Current evidence from both randomized trials and real-world studies suggests that older patients with advanced hormone receptor-positive/HER2-negative (HR+/HER2) breast cancer derive clinical benefit from the addition of CDK4/6 inhibitors to endocrine therapy. However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at lower dose in clinical practice, though without evidence. The aim of the IMPORTANT-trial, a pragmatic, multinational, open-label, partly decentralized randomized trial is to investigate whether lower starting dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older (≥70 years old) patients with advanced HR+/HER2- breast cancer who are assessed as vulnerable or frail based on comprehensive geriatric assessment. Clinical Trial Registration: NCT06044623 (ClinicalTrials.gov); Registration date: 13 September 2023.

Published
2024
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30. Quality of life after definitive treatment for bladder cancer: A systematic review and meta-analysis.

Author

Francolini G, Ghoshal A, Caini S, Piazzini T, Becherini C, Detti B, Di Cataldo V, Valzano M, Visani L, Salvestrini V, Olmetto E, Desideri I, Meattini I, and Livi L

Subjects
Humans, Retrospective Studies, Prospective Studies, Cystectomy, Quality of Life, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms pathology
Abstract

Radical cystectomy (RC) is considered the standard treatment for muscle invasive bladder cancer (MIBC). However, RC is often burdened by significant impact on quality of life (QoL); Continence preserving methods (e.g., continent cutaneous urinary diversion and orthotopic neobladder-ONB), have been proposed as alternatives to improve postoperative QoL. Trimodal therapy (TMT) emerged as alternative to surgery. To assess the impact of these treatments from the patients' perspective, we undertook a systematic review and meta-analysis of literature, focusing on studies reporting QoL data about each of the abovementioned approaches. A systematic review was carried out including all prospective and retrospective studies enrolling patientstreated with radical intent for non-metastatic MIBC from 1999 to 2021 (either RC or TMT). All studies included specifically reported QoL for one of the main treatment approaches explored (RC followed by ileal conduit urinary diversion-ICUD, ONB or TMT). Pooled analysis for EORTC QLQ-C30 and BLM-30 questionnaires showed that ONB yielded a significant advantage only for Physical Functioning (pooled mean standardized difference -0.73 SD, p-value 0.019, I 2 = 93 %) and for Emotional Functioning (pooled mean standardized difference -0.16 SD, p-value 0.029, I 2 = 0 %). A trend in favour of higher mean reported values after TMT for Global Health Score, Physical Functioning and Role Functioning was found, if compared to both RC approaches. Significant benefit for ONB if compared to ICUD was detected only for specific subdomains of QoL questionnaires. No direct comparison with TMT is available, but data suggest advantage of this approach when compared to both reconstructive scenarios., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Conflict of Interest IM received a small fee for occasional attendance at the advisory board supported by Lilly, Novartis, Pfizer, Seagen, Accuray which is not related to the contents of this manuscript., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Published
2024
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31. Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: A systematic review and meta-analysis.

Author

Salvestrini V, Kim K, Caini S, Alkner S, Ekholm M, Skyttä T, Becherini C, Coles CE, Kaidar-Person O, Offersen B, de Azambuja E, Visani L, Cortes J, Harbeck N, Rugo HS, Isacke CM, Marangoni E, Morandi A, Lambertini M, Poortmans P, Livi L, and Meattini I

Subjects
Humans, Female, Ado-Trastuzumab Emtansine adverse effects, Trastuzumab adverse effects, Receptor, ErbB-2 analysis, Receptor, ErbB-2 therapeutic use, Antibodies, Monoclonal, Humanized, Treatment Outcome, Maytansine adverse effects, Breast Neoplasms drug therapy, Breast Neoplasms pathology
Abstract

Background and Purpose: In recent years, the treatment landscape for breast cancer has undergone significant advancements, with the introduction of several new anticancer agents. One such agent is trastuzumab emtansine (T-DM1), an antibody drug conjugate that has shown improved outcomes in both early and advanced breast cancer. However, there is currently a lack of comprehensive evidence regarding the safety profile of combining T-DM1 with radiation therapy (RT). In this study, we aim to provide a summary of the available data on the safety of combining RT with T-DM1 in both early and metastatic breast cancer settings., Materials and Methods: This systematic review and meta-analysis project is part of the consensus recommendations by the European Society for Radiotherapy and Oncology (ESTRO) Guidelines Committee on integrating RT with targeted treatments for breast cancer. A thorough literature search was conducted using the PUBMED/MedLine, Embase, and Cochrane databases to identify original studies focusing on the safety profile of combining T-DM1 with RT., Results: After applying eligibility criteria, nine articles were included in the meta-analysis. Pooled data from these studies revealed a high incidence of grade 3 + radionecrosis (17%), while the rates of grade 3 + radiation-related pneumonitis (<1%) and skin toxicity (1%) were found to be very low., Conclusion: Although there is some concern regarding a slight increase in pneumonitis when combining T-DM1 with postoperative RT, the safety profile of this combination was deemed acceptable for locoregional treatment in non-metastatic breast cancer. However, caution is advised when irradiating intracranial sites concurrently with T-DM1. There is a pressing need for international consensus guidelines regarding the safety considerations of combining T-DM1 and RT for breast cancer., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2023
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32. De-escalating postoperative radiation therapy after primary systemic therapy in cT1-2N1 breast cancer: lesson from the RAPCHEM/BOOG 2010-03 trial.

Author

Banini M, Visani L, Livi L, and Meattini I

Abstract

Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-23-1051/coif). IM disclosed occasional fees for advisory board supported by Novartis, Eli Lilly, Pfizer, Seagen, Gilead, and Accuray. The other authors have no conflicts of interests to disclose.

Published
2023
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33. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial.

Author

Capone S, Fusco FM, Milleri S, Borrè S, Carbonara S, Lo Caputo S, Leone S, Gori G, Maggi P, Cascio A, Lichtner M, Cauda R, Dal Zoppo S, Cossu MV, Gori A, Roda S, Confalonieri P, Bonora S, Missale G, Codeluppi M, Mezzaroma I, Capici S, Pontali E, Libanore M, Diani A, Lanini S, Battella S, Contino AM, Piano Mortari E, Genova F, Parente G, Dragonetti R, Colloca S, Visani L, Iannacone C, Carsetti R, Folgori A, and Camerini R

Subjects
Humans, SARS-CoV-2, COVID-19 Vaccines, Immunity, Cellular, COVID-19 prevention & control, Vaccines
Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed., Competing Interests: Declaration of interests S. Capone, R. Camerini, R.D., F.G., S. Battella, A.M.C., G.P., S. Colloca, and A.F. are full employees of ReiThera Srl. S. Colloca and A.F. are founders and shareholders of Keires AG. S. Colloca is named inventor of the patent application no. 20183515.4 titled “GORILLA ADENOVIRUS NUCLEIC ACID- AND AMINO ACID-SEQUENCES, VECTORS CONTAINING SAME, AND USES THEREOF.” L.V. is full employee of Exom, the CRO in charge of the COVITAR study management. S.L.C. received honoraria from Gilead, ViiV, GSK, Janssen, and MSD, has participated on the advisory boards of Gilead, ViiV, GSK, Janssen, and MSD, and has received support for attending meetings from Gilead. M. Lichtner received honoraria and support for attending meetings from Gilead, MSD, and ViiV, participated on the advisory boards of ViiV, Abbvie, and MSD, and received grants through the institution from Gilead and Abbvie. R. Carsetti was a member of the COVITAR study steering committee. C.I. received financial support from Exom for statistical analysis of the COVITAR study., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2023
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34. Ventilatory Parameters in Obstetric Patients With COVID-19 and Impact of Delivery: A Multicenter Prospective Cohort Study.

Author

Vasquez DN, Giannoni R, Salvatierra A, Cisneros K, Lafosse D, Escobar MF, Montenegro M, Juárez P, Visani L, Mandich V, Barrozo E, Kirschbaum M, Das Neves AV, Valenti MF, Canseco MC, Romero I, Macharé P, Marquez AK, Rodriguez E, Palacio C, Rapela L, Amillategui Scenna JM, Nuñez R, Torres S, González MA, Franconieri L, Nasner D, Okurzaty P, Plotnikow GA, and Intile AD

Subjects
Female, Infant, Newborn, Humans, Prospective Studies, Cohort Studies, Retrospective Studies, Respiration, Artificial, COVID-19
Abstract

Background: Current evidence on obstetric patients requiring advanced ventilatory support and impact of delivery on ventilatory parameters is retrospective, scarce, and controversial., Research Question: What are the ventilatory parameters for obstetric patients with COVID-19 and how does delivery impact them? What are the risk factors for invasive mechanical ventilation (IMV) and for maternal, fetal, and neonatal mortality?, Study Design and Methods: Prospective, multicenter, cohort study including pregnant and postpartum patients with COVID-19 requiring advanced ventilatory support in the ICU., Results: Ninety-one patients were admitted to 21 ICUs at 29.2 ± 4.9 weeks; 63 patients (69%) delivered in ICU. Maximal ventilatory support was as follows: IMV, 69 patients (76%); high-flow nasal cannula, 20 patients (22%); and noninvasive mechanical ventilation, 2 patients (2%). Sequential Organ Failure Assessment during the first 24 h (SOFA 24 ) score was the only risk factor for IMV (OR, 1.97; 95% CI, 1.29-2.99; P = .001). Respiratory parameters at IMV onset for pregnant patients were: mean ± SD plateau pressure (PP), 24.3 ± 4.5 cm H 2 O; mean ± SD driving pressure (DP), 12.5 ± 3.3 cm H 2 O; median static compliance (SC), 31 mL/cm H 2 O (interquartile range [IQR], 26-40 mL/cm H 2 O); and median Pao 2 to Fio 2 ratio, 142 (IQR, 110-176). Respiratory parameters before (< 2 h) and after (≤ 2 h and 24 h) delivery were, respectively: mean ± SD PP, 25.6 ± 6.6 cm H 2 O, 24 ± 6.7 cm H 2 O, and 24.6 ± 5.2 cm H 2 O (P = .59); mean ± SD DP, 13.6 ± 4.2 cm H 2 O, 12.9 ± 3.9 cm H 2 O, and 13 ± 4.4 cm H 2 O (P = .69); median SC, 28 mL/cm H 2 O (IQR, 22.5-39 mL/cm H 2 O), 30 mL/cm H 2 O (IQR, 24.5-44 mL/cm H 2 O), and 30 mL/cm H 2 O (IQR, 24.5-44 mL/cm H 2 O; P = .058); and Pao 2 to Fio 2 ratio, 134 (IQR, 100-230), 168 (IQR, 136-185), and 192 (IQR, 132-232.5; P = .022). Reasons for induced delivery were as follows: maternal, 43 of 71 patients (60.5%); maternal and fetal, 21 of 71 patients (29.5%); and fetal, 7 of 71 patients (9.9%). Fourteen patients (22.2%) continued pregnancy after ICU discharge. Risk factors for maternal mortality were BMI (OR, 1.10; 95% CI, 1.006-1.204; P = .037) and comorbidities (OR, 4.15; 95% CI, 1.212-14.20; P = .023). Risk factors for fetal or neonatal mortality were gestational age at delivery (OR, 0.67; 95% CI, 0.52-0.86; P = .002) and SOFA 24 score (OR, 1.53; 95% CI, 1.13-2.08; P = .006)., Interpretation: Contrary to expectations, pregnant patient lung mechanics were similar to those of the general population with COVID-19 in the ICU. Delivery was induced mainly for maternal reasons, but did not change ventilatory parameters other than Pao 2 to Fio 2 ratio. SOFA 24 score was the only risk factor for IMV. Maternal mortality was associated independently with BMI and comorbidities. Risk factors for fetal and neonatal mortality were SOFA 24 score and gestational age at delivery., (Copyright © 2022 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Published
2023
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35. Three Months' PSA and Toxicity from a Prospective Trial Investigating STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence after Prostatectomy-STARR (NCT05455736).

Author

Francolini G, Garlatti P, Di Cataldo V, Detti B, Loi M, Greto D, Simontacchi G, Morelli I, Burchini L, Allegra AG, Frosini G, Ganovelli M, Salvestrini V, Olmetto E, Visani L, Becherini C, Valzano M, Carnevale MG, Roghi M, Serni S, Mattioli C, Desideri I, and Livi L

Abstract

Biochemical recurrences after radical prostatectomy (RP) can be managed with curative purpose through salvage radiation therapy (SRT). RT dose escalation, such as stereotactic RT (SSRT), may improve relapse-free survival in this setting. STARR trial (NCT05455736) is a prospective multicenter study including patients affected by macroscopic recurrence within the prostate bed after RP treated with SSRT. Recurrence was detected with a Choline or PSMA CT-PET. In the current analysis, the early biochemical response (BR) rate and toxicity profile after three months of follow-up were assessed. Twenty-five patients were enrolled, and data about BR and toxicity at three months after treatment were available for 19 cases. Overall, BR was detected after three months in 58% of cases. Four G1-G2 adverse events were recorded; no G ≥ 3 adverse events were detected. SSRT appears feasible and safe, with more than half of patients experiencing BR and an encouraging toxicity profile. The STARR trial is one of the few prospective studies aimed at implementing this promising treatment strategy in this scenario.

Published
2023
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36. Preoperative robotic radiosurgery for early breast cancer: Results of the phase II ROCK trial (NCT03520894).

Author

Meattini I, Francolini G, Di Cataldo V, Visani L, Becherini C, Scoccimarro E, Salvestrini V, Bellini C, Masi L, Doro R, Di Naro F, Loi M, Salvatore G, Simontacchi G, Greto D, Bernini M, Nori J, Orzalesi L, Bianchi S, Mangoni M, and Livi L

Abstract

Background and Purpose: Preoperative partial breast irradiation (PBI) has got the advantage of treating a well-defined target. We report the results of the phase II ROCK trial (NCT03520894), enrolling early breast cancer (BC) patients treated with preoperative robotic radiosurgery (prRS), in terms of acute and early late toxicity, disease control, and cosmesis., Material and Methods: The study recruited between 2018 and 2021 at our Radiation Oncology Unit. Eligible patients were 50 + years old BC, hormonal receptors positive/human epidermal growth factor receptor 2 negative (HR+/HER2-), sized up to 25 mm. The study aimed to prospectively assess the toxicity and feasibility of a robotic single 21 Gy-fraction prRS in preoperative setting., Results: A total of 70 patients were recruited and 22 patients were successfully treated with pRS. Overall, three G1 adverse events (13.6 %) were recorded within 7 days from prRS. Three events (13.6 %) were recorded between 7 and 30 days, one G2 breast oedema and two G1 breast pain. No acute toxicity greater than G2 was recorded. Five patients experienced early late G1 toxicity. One patient reported G2 breast induration. No early late toxicity greater than G2 was observed. At a median follow up of 18 months (range 6-29.8), cosmetic results were scored excellent/good and fair in 14 and 5 patients, respectively, while 3 patients experienced a poor cosmetic outcome., Conclusions: ROCK trial showed that a single 21 Gy dose prRS represents a feasible technique for selected patients affected by early BC, showing an acceptable preliminary toxicity profile., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Icro Meattini reports occasional speaker honoraria supported by Eli Lilly, Novartis, Pfizer, Accuray, and Seagen, outside the submitted work. No other competing interests declared., (© 2022 The Author(s).)

Published
2022
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37. Efficacy and Tolerability of CyberKnife Stereotactic Robotic Radiotherapy for Primary or Secondary Orbital Lesions: A Single-Center Retrospective Experience.

Author

Desideri I, Francolini G, Carta GA, Di Cataldo V, Masi L, Meattini I, Bonomo P, Loi M, Greto D, Visani L, Lo Russo M, Grassi R, Teriaca MA, Garlatti P, Nardi C, and Livi L

Subjects
Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasms pathology, Orbital Neoplasms secondary, Prognosis, Radiotherapy Dosage, Retrospective Studies, Neoplasms surgery, Orbital Neoplasms surgery, Quality of Life, Radiosurgery methods, Robotic Surgical Procedures methods
Abstract

Introduction: Orbital lesions are rare, but are likely to become symptomatic and can impact on patients' quality of life. Local control is often difficult to obtain, because of proximity to critical structures. CyberKnife stereotactic robotic radiotherapy could represent a viable treatment option., Materials and Methods: Data on patients treated for intraorbital lesions from solid malignancies were retrospectively collected. All patients underwent treatment with CyberKnife system. We analyzed local control, response rate, symptoms control, progression-free survival and overall survival, acute and late toxicity., Results: From January 2012 to May 2017, 20 treatments on 19 patients were performed, with dose ranging from 24 to 35 Gy in 1 to 5 fractions, prescribed at an average isodose line of 79.5% (range: 78-81). After a mean follow-up of 14.26 months (range: 0-58), overall response rate was 75%, with 2 and 4 patients presenting a partial and complete response, respectively. Mean time to best measured response was 15.16 months (range: 2-58). Thirteen patients were alive, with a local control rate of 79%. Mean time to local progression was 5 months (range: 3-7). Three patients reported improvement in symptoms after treatment. Mean planning target volume dose coverage was 97.2% (range: 93.5-99.7). Mean maximum dose (D max) to eye globe, optic nerve, optic chiasm, and lens was 2380.8 cGy (range: 290-3921), 1982.82 cGy (range: 777.3-2897.8), 713.14 cGy (range: 219.5-2273), and 867.9 cGy (range: 38-3118.5). Four patients presented acute toxicity., Conclusion: This current retrospective series demonstrated that CyberKnife robotic stereotactic radiotherapy is a feasible and tolerable approach for intraorbital lesions.

Published
2019
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38. Re-irradiation as salvage treatment in recurrent glioblastoma: A comprehensive literature review to provide practical answers to frequently asked questions.

Author

Scoccianti S, Francolini G, Carta GA, Greto D, Detti B, Simontacchi G, Visani L, Baki M, Poggesi L, Bonomo P, Mangoni M, Desideri I, Pallotta S, and Livi L

Subjects
Brain Neoplasms epidemiology, Brain Neoplasms pathology, Dose Fractionation, Radiation, Glioblastoma epidemiology, Glioblastoma pathology, Humans, Neoplasm Recurrence, Local epidemiology, Practice Patterns, Physicians' statistics & numerical data, Prospective Studies, Radiosurgery adverse effects, Salvage Therapy statistics & numerical data, Brain Neoplasms radiotherapy, Glioblastoma radiotherapy, Neoplasm Recurrence, Local radiotherapy, Re-Irradiation methods, Re-Irradiation statistics & numerical data, Salvage Therapy methods
Abstract

The primary aim of this review is to provide practical recommendations in terms of fractionation, dose, constraints and selection criteria to be used in the daily clinical routine. Based on the analysis of the literature reviewed, in order to keep the risk of severe side effects ≤3,5%, patients should be stratified according to the target volume. Thus, patients should be treated with different fractionation and total EQD2 (<12.5 ml: EQD2 < 65 Gy with radiosurgery; >12.5 ml and <35 ml: EQD2 < 50 Gy with hypofractionated stereotactic radiotherapy; >35 ml and <50 ml: EQD2 < 36 Gy with conventionally fractionated radiotherapy). Concurrent approaches with temozolomide or bevacizumab do not seem to improve the outcomes of reirradiation and may lead to a higher risk of toxicity but these findings need to be confirmed in prospective series., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Published
2018
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