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1. Durability of INI-containing regimens after switching from PI-containing regimens: a single-centre cohort of drug-experienced HIV-infected subjects

Author

Giacomelli A, Ranzani A, Oreni L, Gervasi E, Lupo A, Ridolfo AL, Galli M, and Rusconi S

Subjects
HIV, protease inhibitors, integrase inhibitors, dolutegravir, lipids, Framingham, Therapeutics. Pharmacology, RM1-950
Abstract

Andrea Giacomelli, Alice Ranzani, Letizia Oreni, Elena Gervasi, Angelica Lupo, Anna Lisa Ridolfo, Massimo Galli, Stefano RusconiIII Infectious Disease Unit, Department of Biomedical and Clinical Sciences "L. Sacco", University of Milan, Milan, ItalyPurpose: Integrase inhibitor (INI)-containing regimens are increasingly replacing protease inhibitor(PI)-containing regimens in clinical practice. The aim of this study was to evaluate the determinants of the durability of INI-containing regimens after the switch.Patients and methods: We retrospectively analysed all of the people with HIV infection attending the University of Milan’s Infectious Diseases Unit at Luigi Sacco Hospital who were switched from a PI- to an INI-containing regimen between April 2008 and March 2017. The probability of remaining on an INI-containing regimen was estimated using Kaplan-Meier curves, and the baseline clinical predictors of INI-containing regimen durability were assessed using a multivariable Cox proportional hazard regression model.Results: Three hundred and twelve patients were included in the analysis. The median time of observation was 21 months (interquartile range 10–36 months). The main reasons for switching from a PI-containing regimen to an INI-containing regimen were toxicities (31.4%) and simplification (31.1%). Univariate analysis revealed no difference in the probability of INI discontinuation between the patients treated with raltegravir, dolutegravir or elvitegravir (p=0.060), but the multivariable Cox regression model showed that the patients treated with dolutegravir were at less risk of discontinuation than those treated with raltegravir (adjusted hazard ratio 0.49, 95% confidence interval 0.26–0.95; p=0.034).Conclusion: Switching from a PI- to an INI-containing regimen may be an option for patients under virological control. The patients switched to dolutegravir were less likely to discontinue the INI than those switched to raltegravir. Our findings support this therapeutic strategy and highlight the durability and efficacy of dolutegravir containing-regimens after switching from a PI-containing regimen.Keywords: HIV, protease inhibitors, integrase inhibitors, dolutegravir, lipids, Framingham

Published
2019

3. Open Latarjet Procedure

Author

Gervasi, E., Castricini, R., Galasso, O., Brzóska, Roman, editor, Milano, Giuseppe, editor, Randelli, Pietro S., editor, and Kovačič, Ladislav, editor

Published
2020
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4. Symptomatic neurocognitive impairmentassociated to CNS viral escape in an HIV-1 infected patient: a case report.

Author

Mezzadri, L, Bana, N, Gervasi, E, Gallizzi, N, Bonfanti, P, Ripamonti, D, Mezzadri Luca, Bana Nicholas Brian, Gervasi Elena, Gallizzi Nadia, Bonfanti Paolo, Ripamonti Diego, Mezzadri, L, Bana, N, Gervasi, E, Gallizzi, N, Bonfanti, P, Ripamonti, D, Mezzadri Luca, Bana Nicholas Brian, Gervasi Elena, Gallizzi Nadia, Bonfanti Paolo, and Ripamonti Diego

Abstract

Despite the significant reduction in overall mortality among individuals with HIV in the era of combination antiretroviral therapy (cART), chronic HIV infection remains associated with a broad spectrum of neurocognitive disorders. This correlation is attributed to the pronounced neurotropism of the virus, which infects the central nervous system (CNS) from the early stages of primary infection. However, other contributing factors include comorbidities, accelerated ageing, various forms of dementia, psychiatric disorders, and CNS viral escape. The latter, characterized by detectable levels of HIV-RNA in cerebrospinal fluid despite undetectable or lower levels in plasma, poses a significant challenge in HIV management. We herein describe the case of a man with HIV infection whose adherence to therapy was suboptimal. The patient presented to medical attention with cognitive impairment, ultimately attributed to a case of viral escape. Management was particularly challenging due to the necessity of selecting a cART regimen with enhanced CSF penetration, given his history of multiple virologic failures, previously detected resistance-associated mutations, and poor treatment compliance.

Published
2024

6. Anthracycline-induced cardiotoxicity: A multicenter randomised trial comparing two strategies for guiding prevention with enalapril: The International CardioOncology Society-one trial

Author

Cipolla, C.M., Cardinale, D., Ciceri, F., Latini, R., Sandri, M.T., Maggioni, A.P., Labianca, R., Tettamanti, M., Senni, M., Finzi, A., Grosso, F., Vago, T., Civelli, M., Gramenzi, S., Masson, S., Balconi, G., Bernasconi, R., Salvatici, M., Nicolis, E., Barlera, S., Magnoli, M., Buratti, M.G., Ojeda Fernandez, M.L., Franzosi, M.G., Staszewsky, L., Vasamì, A., Malossi, A., Sicuro, M., Thiebat, B., Barè, C., Corzani, A., Coccolo, F., Colecchia, S., Pellegrini, C., Bregni, M., Appio, L., Caico, I., G.Rossetti, Mesenzani, O., Campana, C., Giordano, M., Gilardoni, M., Scognamiglio, G., Corrado, G., Battagin, D., De Rosa, F., Carpino, C., Palazzo, S., Monopoli, A., Milandri, C., Giannessi, P.G., Zipoli, G., Ghisoni, F., Rizzo, A., Pastori, P., Callegari, S., Sesenna, C., Colombo, A., G.Curigliano, Fodor, C., Mangiavacchi, M., Cavina, R., Guiducci, D., Mazza, R., Turazza, F.M., Vallerio, P., Marbello, L., Sala, E., Fragasso, G., Trinca, S., Aquilina, M., Rocca, A., Farolfi, A., Andreis, D., Gori, S., Barbieri, E., Lanzoni, L., Marchetti, F., Falci, C., Bianchi, A., Mioranza, E., Banzato, A., Re, F., Gaibazzi, N., Gullo, M., Turina, M.C., Gervasi, E., Giaroli, F., Nassiacos, D., Verusio, C., Barco, B., Bertolini, A., Cucchi, G., Menatti, E., Sinagra, G., Aleksova, A., Guglielmi, A., Pinotti, G., Gueli, R., Mongiardi, C., Vallini, I., Cardinale, Daniela, Ciceri, Fabio, Latini, Roberto, Franzosi, Maria Grazia, Sandri, Maria Teresa, Civelli, Maurizio, Cucchi, GianFranco, Menatti, Elisabetta, Mangiavacchi, Maurizio, Cavina, Raffaele, Barbieri, Enrico, Gori, Stefania, Colombo, Alessandro, Curigliano, Giuseppe, Salvatici, Michela, Rizzo, Antonio, Ghisoni, Francesco, Bianchi, Alessandra, Falci, Cristina, Aquilina, Michele, Rocca, Andrea, Monopoli, Anna, Milandri, Carlo, Rossetti, Giuseppe, Bregni, Marco, Sicuro, Marco, Malossi, Alessandra, Nassiacos, Daniele, Verusio, Claudio, Giordano, Monica, Staszewsky, Lidia, Barlera, Simona, Nicolis, Enrico B., Magnoli, Michela, Masson, Serge, and Cipolla, Carlo M.

Published
2018
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7. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Alù, M., Ancona, C., Andreis, D., Bajardi, E., Benedetto, C., Berardi, R., Bordin, E., Butti, C., Capri, G., Cicchiello, F., Cocciolone, V., Dester, M., D'Onofrio, L., Febbraro, A., Ferrarini, I., Fotia, V., Gervasi, E., Guaitoli, G., Licata, L., Liscia, N., Mentuccia, L., Miraglio, E., Nicolini, M., Paternò, E., Pedani, F., Pellegrini, D., Petrucelli, L., De Laurentiis, M., Pizzuti, L., Pogliani, C., Riva, F., Cazzaniga, M.E., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G.V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M.C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M.R., Vici, P., Zambelli, A., Clivio, L., and Torri, V.

Published
2017
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13. The Italian Consensus Conference on FAI Syndrome in Athletes (Cotignola Agreement)

Author

Zini, R., Panasci, M., Santori, N., Potestio, D., Di Pietto, F., Milano, G., Gervasi, E., Falez, F., Castelli, C., Aprato, A., Auci, A., Baffoni, L., Benelli, P., Bianchi, L., Bigoni, M., Bisciotti, A., Bona, S., Carraro, A., Carulli, C., Cassaghi, G., Catani, F., Cerulli, S., Conati, M., Corsini, A., Costantini, A., Dallari, D., Dall'Oca, C., Della Rocca, F., De Nardo, P., Di Benedetto, P., Di Muzio, F., Fabris, T., Fiorentino, G., Fioruzzi, A., Foglia, A., Fogli, M., Fontana, A., Gallo, E., Via, A. G., Giammattei, C., Giuliani, P., Grano, G., Guglielmi, A., Longo, G. U., Mazzoni, G., Moretti, B., Moretti, L., Munegato, D., Nanni, G., Occhialini, M., Papalia, R., Parra, M. F., Ruiz, M. T. P., Pierannunzii, L., Pirani, P., Ponzetto, G., Randelli, F., Sabetta, E., Serafini, S., Stagni, C., Tombari, E., Trento, F. M., Volpi, P., and Bisciotti, G. N.

Subjects
return to play, Pincer-FAI, surgical treatment, Cam-FAI, rehabilitation, Orthopedics and Sports Medicine
Published
2023

15. Propensity Score and Desirability of Outcome Ranking Analysis of Ertapenem for Treatment of Nonsevere Bacteremic Urinary Tract Infections Due to Extended-Spectrum-Beta-Lactamase-Producing Enterobacterales in Kidney Transplant Recipients

Author

Gutierrez-Gutierrez, B., Perez-Nadales, E., Perez-Galera, S., Fernandez-Ruiz, M., Carratala, J., Oriol, I., Cordero, E., Lepe, J. A., Tan, B. H., Corbella, L., Paul, M., Natera, A. M., David, M. D., Montejo, M., Iyer, R. N., Pierrotti, L. C., Merino, E., Steinke, S. M., Rana, M. M., Munoz, P., Mularoni, A., van Delden, C., Grossi, P. A., Seminari, E. M., Gunseren, F., Lease, E. D., Roilides, E., Fortun, J., Arslan, H., Coussement, J., Tufan, Z. K., Pilmis, B., Rizzi, M., Loeches, B., Eriksson, B. M., Abdala, E., Soldani, F., Lowman, W., Clemente, W. T., Bodro, M., Farinas, M. C., Kazak, E., Martinez-Martinez, L., Aguado, J. M., Torre-Cisneros, J., Pascual, A., Rodriguez-Bano, J., Sabe, N., Camoez, M., Martin-Gandul, C., Bernal, G., Kee, T. Y. S., Lopez-Medrano, F., Juan, R. S., Koppel, F., Bar-Sinai, N., Caston, J. J., Cano, A., Gracia-Ahufinger, I., Rodriguez, R., Lopez-Soria, L., Azurmendi, M., Pinheiro, M., Freire, M., Banks, I., Lopes, F., David-Neto, E., Balibrea, N., Franco, A., Avery, R., Ostrander, D., Minero, M. V., Carrillo, C. S., Rodriguez-Ferrero, M. L., Monaco, F., Campanella, M., Mueller, N. J., Manuel, O., Khanna, N., Rovelli, C., Balsamo, M. L., Colombo, A., Leoni, C., Pyrpasopoulou, A., Mouloudi, E., Iosifidis, E., Martin-Davila, P., Gioia, F., Escudero, R., Demirkaya, M. H., Dewispelaere, L., Kalem, A. K., Hasanoglu, I., Guner, R., Lortholary, O., Scemla, A., Calvi, E. G., Gervasi, E., Binda, F., Oliva, M. L., Dimopoulos, N., Magalhaes, M. R., Song, A. T. W., D'Albuquerque, L. A. C., Chiesi, S., Salerno, N. D., Mourao, P. H. O., Moreno, A., Linares, L., Almela, M., Rico, C. G., Rodrigo, E., Martinez, M. F., Falcone, M., Tumbarello, M., Strabelli, T. M. V., Instituto de Salud Carlos III, Ministerio de Ciencia, Innovación y Universidades (España), Red Española de Investigación en Patología Infecciosa, European Commission, Sociedad Andaluza de Trasplante de Órganos y Tejidos, and Ministerio de Ciencia e Innovación (España)

Subjects
Ertapenem, medicine.medical_specialty, Urinary system, UTI, Bacteremia, Bloodstream infection, BSI, Logistic regression, Extended-spectrum-b-lactamase-producing Enterobacterales, Meropenem, beta-Lactamases, Cohort Studies, chemistry.chemical_compound, Internal medicine, polycyclic compounds, medicine, Humans, Pharmacology (medical), Propensity Score, Kidney transplant, Retrospective Studies, Pharmacology, Urinary tract infection, business.industry, ESBL-E, Anti-Bacterial Agents, Kidney Transplantation, Urinary Tract Infections, bacterial infections and mycoses, medicine.disease, Infectious Diseases, chemistry, Propensity score matching, Cohort, business, medicine.drug, Cohort study
Abstract

REIPI/ESGICH/ESGBIS/INCREMENT-SOT Group., There are scarce data on the efficacy of ertapenem in the treatment of bacteremia due to extended-spectrum-beta-lactamase (ESBL)-producing Enterobacterales (ESBL-E) in kidney transplant (KT) recipients. We evaluated the association between treatment with ertapenem or meropenem and clinical cure in KT recipients with nonsevere bacteremic urinary tract infections (B-UTI) caused by ESBL-E. We performed a registered, retrospective, international (29 centers in 14 countries) cohort study (INCREMENT-SOT, NCT02852902). The association between targeted therapy with ertapenem versus meropenem and clinical cure at day 14 (the principal outcome) was studied by logistic regression. Propensity score matching and desirability of outcome ranking (DOOR) analyses were also performed. A total of 201 patients were included; only 1 patient (treated with meropenem) in the cohort died. Clinical cure at day 14 was reached in 45/100 (45%) and 51/101 (50.5%) of patients treated with ertapenem and meropenem, respectively (adjusted OR 1.29; 95% CI 0.51 to 3.22; P = 0.76); the propensity score-matched cohort included 55 pairs (adjusted OR for clinical cure at day 14, 1.18; 95% CI 0.43 to 3.29; P = 0.74). In this cohort, the proportion of cases treated with ertapenem with better DOOR than with meropenem was 49.7% (95% CI, 40.4 to 59.1%) when hospital stay was considered. It ranged from 59 to 67% in different scenarios of a modified (weights-based) DOOR sensitivity analysis when potential ecological advantage or cost was considered in addition to outcome. In conclusion, targeted therapy with ertapenem appears as effective as meropenem to treat nonsevere B-UTI due to ESBL-E in KT recipients and may have some advantages., This work was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III (ISCIII), Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001, RD16/0016/0002, RD16/0016/0008; RD16/0016/00010) and was cofinanced by the European Development Regional Fund “A way to achieve Europe,” Operative program Intelligent Growth 2014‐2020; ESCMID Study Group for Infections in Compromised Hosts (ESGICH grant to J.M.A.); Sociedad Andaluza de Trasplante de Órgano Sólido (SATOT grant to L.M.-M.); ESCMID Study Group for Bloodstream Infections and Sepsis (ESGBIS); and ESCMID Study Group for Antimicrobial Resistance Surveillance (ESGARS). B.G.-G. (PI 18/01849) and E.P.-N. (PI 16/01631) have received research funds from the Spanish Ministry of Science and Innovation, ISCIII; M.F.-R. holds a research contract “Miguel Servet” (CP 18/00073) from the Spanish Ministry of Science and Innovation, ISCIII.

Published
2021

17. ROS1 rearrangements are uncommon in biliary tract cancers

Author

Mazzoni F., Petreni P., Vasile E., Panebianco M., Casadei Gardini A., Negri F., Lunghi A., Pillozzi S., Vivaldi C., Gervasi E., Frassineti G. L., Messerini L., Jocolle G., Bisagni A., Antonuzzo L., Rossi G., Mazzoni, F., Petreni, P., Vasile, E., Panebianco, M., Casadei Gardini, A., Negri, F., Lunghi, A., Pillozzi, S., Vivaldi, C., Gervasi, E., Frassineti, G. L., Messerini, L., Jocolle, G., Bisagni, A., Antonuzzo, L., and Rossi, G.

Subjects
Molecular target, Fluorescence in situ hybridization, Biliary tract cancers, Biomarker, Immuno‑ histochemistry, ROS1 rearrangements, Articles
Abstract

Biliary tract cancers (BTCs) are a pool of diseases with poor prognosis and there is no orphan drug available. Currently, no molecular targets have been tested as druggable oncogenic drivers. C‑ros oncogene 1 (ROS1) rearrangements have been previously described in various tumors, including BTCs; however, data regarding their incidence and biological significance are controversial. Therefore, a retrospective multi‑ center study was performed to assess the incidence of ROS1 rearrangements in BTCs by means of immunohistochemistry and fluorescence in situ hybridization (FISH). The present study failed to demonstrate ROS1 expression in a multicenter series of 150 cases with BTCs and revealed that D4D6 was the most specific clone compared with other ROS1 primary antibodies, namely PA1‑30318 and EPMGHR2. Notably, nega‑ tive results obtained with D4D6 completely matched to data sorted out by FISH analysis, thus confirming a lack of ROS1 gene rearrangements in BTCs and false positive results when PA1‑30318 and EPMGHR2 clones were used. These results suggest that ROS1 rearrangements may not be targets for molecular therapy of BTCs with specific inhibitors.

Published
2020

18. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

19. Anthracycline-induced cardiotoxicity: A multicenter randomised trial comparing two strategies for guiding prevention with enalapril: The International CardioOncology Society-one trial

Author

Cardinale, D, Ciceri, F, Latini, R, Franzosi, M, Sandri, M, Civelli, M, Cucchi, G, Menatti, E, Mangiavacchi, M, Cavina, R, Barbieri, E, Gori, S, Colombo, A, Curigliano, G, Salvatici, M, Rizzo, A, Ghisoni, F, Bianchi, A, Falci, C, Aquilina, M, Rocca, A, Monopoli, A, Milandri, C, Rossetti, G, Bregni, M, Malossi, A, Nassiacos, D, Verusio, C, Giordano, M, Staszewsky, L, Barlera, S, Nicolis, E, Magnoli, M, Masson, S, Cipolla, C, Curigliano, Sicuro, M, Rossetti, Maggioni, A, Labianca, R, Tettamanti, M, Senni, M, Finzi, A, Grosso, F, Vago, T, Gramenzi, S, Balconi, G, Bernasconi, R, Buratti, M, Ojeda-Fernandez, M, Vasami, A, Thiebat, B, Bare, C, Corzani, A, Coccolo, F, Colecchia, S, Pellegrini, C, Appio, L, Caico, I, Mesenzani, O, Campana, C, Gilardoni, M, Scognamiglio, G, Corrado, G, Battagin, D, De Rosa, F, Carpino, C, Palazzo, S, Giannessi, P, Zipoli, G, Pastori, P, Callegari, S, Sesenna, C, Fodor, C, Guiducci, D, Mazza, R, Turazza, F, Vallerio, P, Marbello, L, Sala, E, Fragasso, G, Trinca, S, Farolfi, A, Andreis, D, Lanzoni, L, Marchetti, F, Mioranza, E, Banzato, A, Re, F, Gaibazzi, N, Gullo, M, Turina, M, Gervasi, E, Giaroli, F, Barco, B, Bertolini, A, Sinagra, G, Aleksova, A, Guglielmi, A, Pinotti, G, Gueli, R, Mongiardi, C, Vallini, I, Cardinale D., Ciceri F., Latini R., Franzosi M. G., Sandri M. T., Civelli M., Cucchi G., Menatti E., Mangiavacchi M., Cavina R., Barbieri E., Gori S., Colombo A., Curigliano G., Salvatici M., Rizzo A., Ghisoni F., Bianchi A., Falci C., Aquilina M., Rocca A., Monopoli A., Milandri C., Rossetti G., Bregni M., Malossi A., Nassiacos D., Verusio C., Giordano M., Staszewsky L., Barlera S., Nicolis E. B., Magnoli M., Masson S., Cipolla C. M., Sicuro M., Maggioni A. P., Labianca R., Tettamanti M., Senni M., Finzi A., Grosso F., Vago T., Gramenzi S., Balconi G., Bernasconi R., Nicolis E., Buratti M. G., Ojeda-Fernandez M. L., Vasami A., Thiebat B., Bare C., Corzani A., Coccolo F., Colecchia S., Pellegrini C., Appio L., Caico I., Mesenzani O., Campana C., Gilardoni M., Scognamiglio G., Corrado G., Battagin D., De Rosa F., Carpino C., Palazzo S., Giannessi P. G., Zipoli G., Pastori P., Callegari S., Sesenna C., Fodor C., Guiducci D., Mazza R., Turazza F. M., Vallerio P., Marbello L., Sala E., Fragasso G., Trinca S., Farolfi A., Andreis D., Lanzoni L., Marchetti F., Mioranza E., Banzato A., Re F., Gaibazzi N., Gullo M., Turina M. C., Gervasi E., Giaroli F., Barco B., Bertolini A., Sinagra G., Aleksova A., Guglielmi A., Pinotti G., Gueli R., Mongiardi C., Vallini I., Cardinale, D, Ciceri, F, Latini, R, Franzosi, M, Sandri, M, Civelli, M, Cucchi, G, Menatti, E, Mangiavacchi, M, Cavina, R, Barbieri, E, Gori, S, Colombo, A, Curigliano, G, Salvatici, M, Rizzo, A, Ghisoni, F, Bianchi, A, Falci, C, Aquilina, M, Rocca, A, Monopoli, A, Milandri, C, Rossetti, G, Bregni, M, Malossi, A, Nassiacos, D, Verusio, C, Giordano, M, Staszewsky, L, Barlera, S, Nicolis, E, Magnoli, M, Masson, S, Cipolla, C, Curigliano, Sicuro, M, Rossetti, Maggioni, A, Labianca, R, Tettamanti, M, Senni, M, Finzi, A, Grosso, F, Vago, T, Gramenzi, S, Balconi, G, Bernasconi, R, Buratti, M, Ojeda-Fernandez, M, Vasami, A, Thiebat, B, Bare, C, Corzani, A, Coccolo, F, Colecchia, S, Pellegrini, C, Appio, L, Caico, I, Mesenzani, O, Campana, C, Gilardoni, M, Scognamiglio, G, Corrado, G, Battagin, D, De Rosa, F, Carpino, C, Palazzo, S, Giannessi, P, Zipoli, G, Pastori, P, Callegari, S, Sesenna, C, Fodor, C, Guiducci, D, Mazza, R, Turazza, F, Vallerio, P, Marbello, L, Sala, E, Fragasso, G, Trinca, S, Farolfi, A, Andreis, D, Lanzoni, L, Marchetti, F, Mioranza, E, Banzato, A, Re, F, Gaibazzi, N, Gullo, M, Turina, M, Gervasi, E, Giaroli, F, Barco, B, Bertolini, A, Sinagra, G, Aleksova, A, Guglielmi, A, Pinotti, G, Gueli, R, Mongiardi, C, Vallini, I, Cardinale D., Ciceri F., Latini R., Franzosi M. G., Sandri M. T., Civelli M., Cucchi G., Menatti E., Mangiavacchi M., Cavina R., Barbieri E., Gori S., Colombo A., Curigliano G., Salvatici M., Rizzo A., Ghisoni F., Bianchi A., Falci C., Aquilina M., Rocca A., Monopoli A., Milandri C., Rossetti G., Bregni M., Malossi A., Nassiacos D., Verusio C., Giordano M., Staszewsky L., Barlera S., Nicolis E. B., Magnoli M., Masson S., Cipolla C. M., Sicuro M., Maggioni A. P., Labianca R., Tettamanti M., Senni M., Finzi A., Grosso F., Vago T., Gramenzi S., Balconi G., Bernasconi R., Nicolis E., Buratti M. G., Ojeda-Fernandez M. L., Vasami A., Thiebat B., Bare C., Corzani A., Coccolo F., Colecchia S., Pellegrini C., Appio L., Caico I., Mesenzani O., Campana C., Gilardoni M., Scognamiglio G., Corrado G., Battagin D., De Rosa F., Carpino C., Palazzo S., Giannessi P. G., Zipoli G., Pastori P., Callegari S., Sesenna C., Fodor C., Guiducci D., Mazza R., Turazza F. M., Vallerio P., Marbello L., Sala E., Fragasso G., Trinca S., Farolfi A., Andreis D., Lanzoni L., Marchetti F., Mioranza E., Banzato A., Re F., Gaibazzi N., Gullo M., Turina M. C., Gervasi E., Giaroli F., Barco B., Bertolini A., Sinagra G., Aleksova A., Guglielmi A., Pinotti G., Gueli R., Mongiardi C., and Vallini I.

Abstract

Background: Troponin changes over time have been suggested to allow for an early diagnosis of cardiac injury ensuing cancer chemotherapy; cancer patients with troponin elevation may benefit of therapy with enalapril. It is unknown whether a preventive treatment with enalapril may further increase the benefit. Methods: The International CardioOncology Society-one trial (ICOS-ONE) was a controlled, open-label trial conducted in 21 Italian hospitals. Patients were randomly assigned to two strategies: enalapril in all patients started before chemotherapy (CT; ‘prevention’ arm), and enalapril started only in patients with an increase in troponin during or after CT (‘troponin-triggered’ arm). Troponin was assayed locally in 2596 blood samples, before and after each anthracycline-containing CT cycle and at each study visit; electrocardiogram and echocardiogram were done at baseline, and at 1, 3, 6 and 12-month follow-up. Primary outcome was the incidence of troponin elevation above the threshold. Findings: Of the 273 patients, 88% were women, mean age 51 ± 12 years. The majority (76%) had breast cancer, 3% had a history of hypertension and 4% were diabetic. Epirubicin and doxorubicin were most commonly prescribed, with median cumulative doses of 360 [270–360] and 240 [240–240] mg/m2, respectively. The incidence of troponin elevation was 23% in the prevention and 26% in the troponin-triggered group (p = 0.50). Three patients (1.1%) -two in the prevention, one in the troponin-triggered group-developed cardiotoxicity, defined as 10% point reduction of LV ejection fraction, with values lower than 50%. Interpretation: Low cumulative doses of anthracyclines in adult patients with low cardiovascular risk can raise troponins, without differences between the two strategies of giving enalapril. Considering a benefit of enalapril in the prevention of LV dysfunction, a troponin-triggered strategy may be more convenient.

Published
2018

20. 1697P Cancer patients’ perceptions, opinions and feelings during the COVID-19 epidemic in the most affected Italian areas: Serial cross-sectional study

Author

Passalacqua, R., primary, Maglietta, G., additional, Ratti, M., additional, Gobbi, A., additional, Bonomi, M., additional, Saleri, J., additional, Grizzi, G., additional, Barbin, F., additional, Bonassi, L., additional, Buffoni, L., additional, Cavanna, L., additional, Gallina, F., additional, Gervasi, E., additional, Iridile, C., additional, Lonati, V., additional, Maddalena, R., additional, Meriggi, F.A., additional, Piloni, S., additional, Campione, F., additional, and Caminiti, C., additional

Published
2020
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22. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., Torri V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., and Torri V.

Abstract

Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.

Published
2017

26. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cazzaniga, M.E., primary, Airoldi, M., additional, Arcangeli, V., additional, Artale, S., additional, Atzori, F., additional, Ballerio, A., additional, Bianchi, G.V., additional, Blasi, L., additional, Campidoglio, S., additional, Ciccarese, M., additional, Cursano, M.C., additional, Piezzo, M., additional, Fabi, A., additional, Ferrari, L., additional, Ferzi, A., additional, Ficorella, C., additional, Frassoldati, A., additional, Fumagalli, A., additional, Garrone, O., additional, Gebbia, V., additional, Generali, D., additional, La Verde, N., additional, Maur, M., additional, Michelotti, A., additional, Moretti, G., additional, Musolino, A., additional, Palumbo, R., additional, Pistelli, M., additional, Porpiglia, M., additional, Sartori, D., additional, Scavelli, C., additional, Schirone, A., additional, Turletti, A., additional, Valerio, M.R., additional, Vici, P., additional, Zambelli, A., additional, Clivio, L., additional, Torri, V., additional, Alù, M., additional, Ancona, C., additional, Andreis, D., additional, Bajardi, E., additional, Benedetto, C., additional, Berardi, R., additional, Bordin, E., additional, Butti, C., additional, Capri, G., additional, Cicchiello, F., additional, Cocciolone, V., additional, Dester, M., additional, D'Onofrio, L., additional, Febbraro, A., additional, Ferrarini, I., additional, Fotia, V., additional, Gervasi, E., additional, Guaitoli, G., additional, Licata, L., additional, Liscia, N., additional, Mentuccia, L., additional, Miraglio, E., additional, Nicolini, M., additional, Paternò, E., additional, Pedani, F., additional, Pellegrini, D., additional, Petrucelli, L., additional, De Laurentiis, M., additional, Pizzuti, L., additional, Pogliani, C., additional, and Riva, F., additional

Published
2017
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29. Groin Pain Syndrome Italian Consensus Conference on terminology, clinical evaluation and imaging assessment in groin pain in athlete

Author

Bisciotti, G N, primary, Volpi, P, additional, Zini, R, additional, Auci, A, additional, Aprato, A, additional, Belli, A, additional, Bellistri, G, additional, Benelli, P, additional, Bona, S, additional, Bonaiuti, D, additional, Carimati, G, additional, Canata, G L, additional, Cassaghi, G, additional, Cerulli, S, additional, Delle Rose, G, additional, Di Benedetto, P, additional, Di Marzo, F, additional, Di Pietto, F, additional, Felicioni, L, additional, Ferrario, L, additional, Foglia, A, additional, Galli, M, additional, Gervasi, E, additional, Gia, L, additional, Giammattei, C, additional, Guglielmi, A, additional, Marioni, A, additional, Moretti, B, additional, Niccolai, R, additional, Orgiani, N, additional, Pantalone, A, additional, Parra, F, additional, Quaglia, A, additional, Respizzi, F, additional, Ricciotti, L, additional, Pereira Ruiz, M T, additional, Russo, A, additional, Sebastiani, E, additional, Tancredi, G, additional, Tosi, F, additional, and Vuckovic, Z, additional

Published
2016
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34. The “Bandalarga” project: School's concerts in oncology

Author

Pezzuolo, D., primary, Scarabelli, L., additional, Giovanardi, F., additional, Prati, G., additional, Montanari, S., additional, Vernizzi, R., additional, Darecchio, S., additional, Maramotti, G., additional, Codispoti, M., additional, Sforacchi, F., additional, Gervasi, E., additional, Codeluppi, G., additional, Carpi, G., additional, Manara, C., additional, Cavalca, M., additional, Brozzi, C., additional, Alberini, R., additional, Verona, C., additional, and Scaltriti, L., additional

Published
2015
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41. Production de chitine par les crustaces du zooplancton de la baie de Calvi (Corse)

Author

Gervasi, E, Jeuniaux, C, and Dauby, P

Subjects
Copepoda, Biological production, Zooplankton
Abstract

Chitin was estimated in samples of planktonic crustaceans living in Calvi Bay (Corsica). The percentages of chitin, with respect to dry weight, are comprised between 3.10% in Clausocalanus spp. and 12.22% in Cladocera (mainly Evadne ). The percentage of chitin remained approximatively constant during larval development in Calanus helgolandicus (3.26%). Using these results and the values of total biomass and production estimated by Dauby (1985) at the same place during a complete annual cycle (1983-1984), chitin biomass and production were calculated for every planktonic crustacean species (or group of species) and for the whole crustacean plankton. Daily chitin production was maximum during May (20.06 mg.m super(-2)/d). As far as the whole year is considered (March 1983 to February 1984), chitin planktonic production was estimated to 1.0014 g.m super(-2).

Published
1987

43. 421P Maintenance therapy with regorafenib (REGO) versus placebo after first-line (1L) platinum and fluoropyrimidines-based chemotherapy in HER2-negative advanced gastric (GC)/gastroesophageal junction (GEJ) cancer: Results of phase II randomized a-MANTRA study (GOIRC-05-2016)

Author

Damato, A., Bilancia, D., Iachetta, F., Strippoli, A., Filiali, F., Casaretti, R., Bernardini, I., Bellotti, G., Frassineti, G.L., Di Fabio, F., Aieta, M., Ghidini, M., Trentin, C., Cardellino, G., Gervasi, E., Romagnani, A., Cinieri, S., Normanno, N., Boni, L., and Pinto, C.

Subjects
*PLATINUM, *REGORAFENIB, *PLACEBOS, *CANCER chemotherapy
Published
2024
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44. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, Matteo, Butti, C., Liscia, N., Pogliani, C., Capri, Giorgia, Alu', Matteo, Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, Enrico, Guaitoli, G., Ferrarini, I., Gervasi, Elisea, Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, Anna, Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, Ruggero Astolfo, Clivio, L., Torri, V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cazzaniga, M. E, Bianchi, G. V, Cursano, M. C, Valerio, M. R, Torri, V., De Laurentiis, Michelino, Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, M., Butti, C., Liscia, N., Pogliani, C., Capri, G., Alù, M., Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, E., Guaitoli, G., Ferrarini, I., Gervasi, E., Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, A., Clivio, L., Cazzaniga, M., Ala, M., ARRIVAS BAJARDI, E., Paternã², E., Bianchi, G., Cursano, M., and Valerio, M.

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, chemistry.chemical_compound, ErbB-2, 0302 clinical medicine, Dose-intensity, Exemestane, 80 and over, Neoplasm Metastasis, Fulvestrant, Aged, 80 and over, education.field_of_study, Advanced breast cancer, Dose-intensity, Everolimus, Fulvestrant, Hormone-receptor positive, Advanced breast cancer, Everolimus, Hormone-receptor positive, Adult, Aged, Androstadienes, Breast Neoplasms, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Surgery, General Medicine, Everolimu, 030220 oncology & carcinogenesis, Receptor, medicine.drug, medicine.medical_specialty, Population, Socio-culturale, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Adverse effect, education, Gynecology, business.industry, fungi, Cancer, medicine.disease, Clinical trial, 030104 developmental biology, chemistry, business
Abstract

Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.

Published
2017

45. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmela Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone, Antonello Accurso, Biagio Agostara, Michele Aieta, Oscar Alabiso, Maria Grazia Alicicco, Dino Amadori, Laura Amaducci, Gianna Amiconi, Giustino Antuzzi, Mara Ardine, Antonio Ardizzoia, Caterina Aversa, Giuseppe Badalamenti, Sandro Barni, Carlo Basurto, Rossana Berardi, Cinzia Bergamasco, Paolo Bidoli, Claudia Bighin, Edoardo Biondi, Corrado Boni, Karen Borgonovo, Mario Botta, Stefano Bravi, Paolo Bruzzi, Giuseppe Buono, Alfredo Butera, Alessia Caldara, Giampiero Candeloro, Claudia Cappelletti, Cinzia Cardalesi, Elisabetta Carfora, Anna Cariello, Francesco Carrozza, Giacomo Cartenì, Michele Caruso, Virginia Casadei, Claudia Casanova, Luigi Castori, Luigi Cavanna, Giovanna Cavazzini, Marina Cazzaniga, Mario Chilelli, Paolo Chiodini, Silvia Chiorrini, Fortunato Ciardiello, Mariangela Ciccarese, Saverio Cinieri, Mario Clerico, Mariarosa Coccaro, Mario Comande, Claudia Corbo, Giuseppina Cortino, Stefania Cusenza, Gennaro Daniele, Alfonso Maria D'arco, Giuliana D'auria, Claudio Dazzi, Carmine De Angelis, Filippo de Braud, Gianfranco De Feo, Andrea De Matteis, Michele De Tursi, Anna Di Blasio, Giuseppe di Lucca, Liberato Di Lullo, Francesca Di Rella, Gianfranco Di Renzo, Pia Di Stefano, Aida Di Stefano, Anna Diana, Sara Donati, Agnese Fabbri, Alessandra Fabi, Marina Faedi, Gabriella Farina, Antonio Farris, Antonio Febbraro, Palma Fedele, Piera Federico, Francesco Ferraù, Gianluigi Ferretti, Antonella Ferro, Irene Floriani, Rosachiara Forcignanò, Samantha Forciniti, Valeria Forestieri, Gianni Fornari, Michela Frisinghelli, Vittorio Fusco, Giulia Gallizzi, Antonio Galvano, Antonio Gambardella, Angelo Gambi, Vittorio Gebbia, Erika Gervasi, Mara Ghilardi, Alice Giacobino, Giovanni Giardina, Francesco Giotta, Sara Giraudi, Mario Giuliano, Antonino Grassadonia, Donatella Grasso, Federica Grosso, Lorenzo Guizzaro, Pasquale Incoronato, Lorena Incorvaia, Giovanni Iodice, Nicla La Verde, Vincenzo Labonia, Gabriella Landi, Agnese Latorre, Vita Leonardi, Alessia Levaggi, Gennaro Limite, Linda Lina Bascialla, Lorenzo Livi, Evaristo Maiello, Daniela Mandelli, Ilaria Marcon, Daniela Menon, Michele Montedoro, Lucia Moraca, Anna Moretti, Maria Grazia Morritti, Patrizia Morselli, Antonella Mura, Silvia Mura, Michela Musacchio, Alberto Muzio, Donato Natale, Clara Natoli, Cinzia Nigro, Cecilia Nisticò, Antonio Nuzzo, Michele Orditura, Laura Orlando, Carmen Pacilio, Giuliano Palumbo, Raffaella Palumbo, Felice Pasini, Emanuela Paterno, Antonio Pazzola, Silvia Pelliccioni, Matilde Pensabene, Davide Perroni, Angela Pesenti Gritti, Fausto Petrelli, Maria Carmela Piccirillo, Graziella Pinotti, Claudia Pogliani, Davide Poli, Sonia Prader, Francesco Recchia, Daniele Rizzi, Carmen Romano, Rosalba Rossello, Chiara Rossini, Giuseppina Salvucci, Valeria Sanna, Alessandra Santini, Silvana Saracchini, Clementina Savastano, Giovanni Scambia, Francesco Schettini, Paola Schiavone, Alessio Schirone, Elena Seles, Simona Signoriello, Giuseppe Signoriello, Rosa Rita Silva, Antonia Silvestri, Vittorio Simeon, Ilaria Spagnoletti, Stefano Tamberi, Cristina Teragni, Verena Thalmann, Renato Thomas, Guglielmo Thomas, Amelia Tienghi, Nicola Tinari, Vincenza Tinessa, Federica Tomei, Giuseppe Tonini, Valter Torri, Divina Traficante, Marianna Tudini, Monica Turazza, Roberto Vignoli, Maria Giuseppa Vitale, Alessandra Zacchia, Pasquale Zagarese, Alda Zanni, Laura Zavallone, Maria Zavettieri, Alessandra Zoboli, De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M. G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A. A., Cognetti, F., Gori, S., Foglietta, J., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Verusio, C., Bernardo, A., Lorusso, V., Gravina, A., Moretti, G., Lauria, R., Lai, A., Mocerino, C., Rizzo, S., Nuzzo, F., Carlini, P., Perrone, F., Accurso, A., Agostara, B., Aieta, M., Alabiso, O., Alicicco, M. G., Amadori, D., Amaducci, L., Amiconi, G., Antuzzi, G., Ardine, M., Ardizzoia, A., Aversa, C., Badalamenti, G., Barni, S., Basurto, C., Berardi, R., Bergamasco, C., Bidoli, P., Bighin, C., Biondi, E., Boni, C., Borgonovo, K., Botta, M., Bravi, S., Bruzzi, P., Buono, G., Butera, A., Caldara, A., Candeloro, G., Cappelletti, C., Cardalesi, C., Carfora, E., Cariello, A., Carrozza, F., Carteni, G., Caruso, M., Casadei, V., Casanova, C., Castori, L., Cavanna, L., Cavazzini, G., Cazzaniga, M., Chilelli, M., Chiodini, P., Chiorrini, S., Ciardiello, F., Ciccarese, M., Cinieri, S., Clerico, M., Coccaro, M., Comande, M., Corbo, C., Cortino, G., Cusenza, S., Daniele, G., D'Arco, A. M., D'Auria, G., Dazzi, C., De Angelis, C., de Braud, F., De Feo, G., De Matteis, Ma., De Tursi, M., Di Blasio, A., di Lucca, G., Di Lullo, L., Di Rella, F., Di Renzo, G., Di Stefano, P., Di Stefano, A., Diana, A., Donati, S., Fabbri, A., Fabi, A., Faedi, M., Farina, G., Farris, A., Febbraro, A., Fedele, P., Federico, P., Ferrau, F., Ferretti, G., Ferro, A., Floriani, I., Forcignano, R., Forciniti, S., Forestieri, V., Fornari, G., Frisinghelli, M., Fusco, V., Gallizzi, G., Galvano, A., Gambardella, A., Gambi, A., Gebbia, V., Gervasi, E., Ghilardi, M., Giacobino, A., Giardina, G., Giotta, F., Giraudi, S., Giuliano, M., Grassadonia, A., Grasso, D., Grosso, F., Guizzaro, L., Incoronato, P., Incorvaia, L., Iodice, G., La Verde, N., Labonia, V., Landi, G., Latorre, A., Leonardi, V., Levaggi, A., Limite, G., Lina Bascialla, L., Livi, L., Maiello, E., Mandelli, D., Marcon, I., Menon, D., Montedoro, M., Moraca, L., Moretti, A., Morritti, M. G., Morselli, P., Mura, A., Mura, S., Musacchio, M., Muzio, A., Natale, D., Natoli, C., Nigro, C., Nistico, C., Nuzzo, A., Orditura, M., Orlando, L., Pacilio, C., Palumbo, G., Palumbo, R., Pasini, F., Paterno, E., Pazzola, A., Pelliccioni, S., Pensabene, M., Perroni, D., Pesenti Gritti, A., Petrelli, F., Piccirillo, M. C., Pinotti, G., Pogliani, C., Poli, D., Prader, S., Recchia, F., Rizzi, D., Romano, C., Rossello, R., Rossini, C., Salvucci, G., Sanna, V., Santini, A., Saracchini, S., Savastano, C., Scambia, G., Schettini, F., Schiavone, P., Schirone, A., Seles, E., Signoriello, S., Signoriello, G., Silva, R. R., Silvestri, A., Simeon, V., Spagnoletti, I., Tamberi, S., Teragni, C., Thalmann, V., Thomas, R., Thomas, G., Tienghi, A., Tinari, N., Tinessa, V., Tomei, F., Tonini, G., Torri, V., Traficante, D., Tudini, M., Turazza, M., Vignoli, R., Vitale, M. G., Zacchia, A., Zagarese, P., Zanni, A., Zavallone, L., Zavettieri, M., Zoboli, A., De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Bisagni, Giancarlo, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmen, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, Perrone, Francesco, Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, Mocerino, Carmela, D'Arco, Alfonso Maria, D'Auria, Giuliana, De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, and Zoboli, A

Subjects
Oncology, Receptor, ErbB-2, Settore MED/06 - Oncologia Medica, letrozole, law.invention, Adjuvant anastrozole, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Exemestane, law, exemestane, tamoxifen, breast cancer, Antineoplastic Combined Chemotherapy Protocols, 030212 general & internal medicine, Aromatase Inhibitors, Letrozole, Hazard ratio, Middle Aged, Receptors, Estrogen, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Receptors, Progesterone, Breast Neoplasm, Human, medicine.drug, medicine.medical_specialty, Socio-culturale, Anastrozole, Breast Neoplasms, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Aromatase Inhibitor, Humans, Aged, Antineoplastic Combined Chemotherapy Protocol, Androstadiene, business.industry, medicine.disease, Androstadienes, chemistry, business, Tamoxifen
Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is registered with the European Clinical Trials Database, number 2006-004018-42, and ClinicalTrials.gov, number NCT00541086. Findings: Between March 9, 2007, and July 31, 2012, 3697 patients were enrolled into the study. After a median follow-up of 60 months (IQR 46–72), 401 disease-free survival events were reported, including 211 (11%) of 1850 patients allocated to the switch strategy and 190 (10%) of 1847 patients allocated to upfront treatment. 5-year disease-free survival was 88·5% (95% CI 86·7–90·0) with the switch strategy and 89·8% (88·2–91·2) with upfront treatment (hazard ratio 0·89, 95% CI 0·73–1·08; p=0·23). 5-year disease-free survival was 90·0% (95% CI 87·9–91·7) with anastrozole (124 events), 88·0% (85·8–89·9) with exemestane (148 events), and 89·4% (87·3 to 91·1) with letrozole (129 events; p=0·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3–4 events, reported in 130 (7%) of 1761 patients who received the switch strategy and 128 (7%) of 1766 patients who received upfront treatment. Grade 1 musculoskeletal events were more frequent with the upfront schedule than with the switch schedule (924 [52%] of 1766 patients vs 745 [42%] of 1761 patients). All other grade 3–4 adverse events occurred in less than 2% of patients in either group. Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting. Funding: Italian Drug Agency.

Published
2018

46. Antiretroviral therapy in geriatric HIV patients: the GEPPO cohort study

Author

Nozza, Silvia, Malagoli, Andrea, Maia, Lilian, Calcagno, Andrea, Focã , Emanuele, De Socio, Giuseppe, Piconi, Stefania, Orofino, Giancarlo, Cattelan, Anna Maria, Celesia, Benedetto Maurizio, Gervasi, Elena, Guaraldi, Giovanni, Castagna, Antonella, Poli, Andrea, Galizzi, Nadia, Carli, Federica, Di Perri, Giovanni, Bonora, Stefano, Montrucchio, Chiara, Focã¡, Emanuele, Castelli, Francesco, Magro, Paola, Roldan, Eugenia Quiros, De Socio, Giuseppe Vittorio, Marinello, Serena, Farenga, Mariana, Cattela, Anna Maria, Marino, Andrea, Cacopardo, Bruno, Galli, Massimo, Riva, Agostino, Morena, Valeria, Nozza, S, Malagoli, A, Maia, L, Calcagno, A, Focà, E, De Socio, G, Piconi, S, Orofino, G, Cattelan, Am, Celesia, Bm, Gervasi, E, Guaraldi, G, on behalf the GEPPO Study, Group, and Castagna, A

Subjects
Male, 0301 basic medicine, Health Services for the Aged, Cross-sectional study, HIV Infections, Cohort Studies, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Pharmacology (medical), Multiple Chronic Conditions, Prospective Studies, 030212 general & internal medicine, Practice Patterns, Physicians', Prospective cohort study, Aged, 80 and over, Geriatrics, education.field_of_study, virus diseases, Middle Aged, Viral Load, Infectious Diseases, Italy, Cohort, Female, Cohort study, Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, Population, 03 medical and health sciences, Internal medicine, medicine, Humans, Tenofovir, education, Aged, Polypharmacy, Pharmacology, business.industry, DRUG-DRUG INTERACTIONS, INFECTED PATIENTS, OLDER-ADULTS, MYOCARDIAL-INFARCTION, TENOFOVIR, CRITERIA, RISK, POLYPHARMACY, IMPACT, TRIALS, Antiretroviral therapy, 030112 virology, Regimen, Cross-Sectional Studies, Logistic Models, Hiv patients, HIV-1, business
Abstract

Background GEPPO is a prospective observational multi-centric cohort including HIV-infected geriatric patients. We hypothesized that the GEPPO cohort may help characterize antiretroviral (ARV) prescribing criteria used in real life by Italian infectious disease (ID) physicians. Methods This was a cross-sectional study describing the current ARV regimen in a geriatric HIV population (≥65 years). Antiretroviral strategies were categorized as follows: (i) multidrug regimens (MDRs), which comprised triple or mega ART combinations; (ii) less drug regimens (LDRs), which comprised fewer than three ART compounds. Multi-morbidity (MM) was defined as the presence of three or more non-communicable diseases, and polypharmacy (PP) as the use of five or more medications in chronic use. Four alternative combinations (MM+PP+, MM+PP-, MM-PP+, MM-PP-) were used in logistic regression analyses. Results A total of 1222 HIV-positive patients were included (median age 70 years). Females composed 16% of the cohort. Median duration of HIV infection was 17 years; 335 population members had been infected for >20 years. MM was present in 64% and PP in 37% of the patients. Treatment consisted of triple therapy in 66.4%, dual therapy in 25.3%, monotherapy in 6.5% and 'mega-ART' with more than three drugs in 1.64% of the patients. In multivariate logistic regression MM and PP were predictive for mono-dual, NRTI-sparing and tenofovir disoproxil fumarate (TDF)-sparing combinations. Female gender and age were predictors of unboosted ARV regimens. Conclusions High prevalence of non-conventional ARV regimens in elderly HIV patients suggests that clinicians try to tailor ARV regimens according to age, HIV duration, MM and PP.

Published
2017

47. Efficacy of ceftazidime-avibactam in solid organ transplant recipients with bloodstream infections caused by carbapenemase-producing Klebsiella pneumoniae.

Author

Pérez-Nadales E, Fernández-Ruiz M, Natera AM, Gutiérrez-Gutiérrez B, Mularoni A, Russelli G, Pierrotti LC, Pinheiro Freire M, Falcone M, Tiseo G, Tumbarello M, Raffaelli F, Abdala E, Bodro M, Gervasi E, Fariñas MC, Seminari EM, Castón JJ, Marín-Sanz JA, Gálvez-Soto V, Rana MM, Loeches B, Martín-Dávila P, Pascual Á, Rodríguez-Baño J, Aguado JM, Martínez-Martínez L, and Torre-Cisneros J

Subjects
Humans, Anti-Bacterial Agents therapeutic use, Klebsiella pneumoniae, Retrospective Studies, Drug Combinations, Microbial Sensitivity Tests, Carbapenem-Resistant Enterobacteriaceae, Sepsis, Klebsiella Infections drug therapy
Abstract

We aimed to compare the efficacy of ceftazidime-avibactam (CAZ-AVI) versus the best available therapy (BAT) in solid organ transplant (SOT) recipients with bloodstream infection caused by carbapenemase-producing Klebsiella pneumoniae (CPKP-BSI). A retrospective (2016-2021) observational cohort study was performed in 14 INCREMENT-SOT centers (ClinicalTrials.gov identifier: NCT02852902; Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study). Outcomes were 14-day and 30-day clinical success (complete resolution of attributable manifestations, adequate source control, and negative follow-up blood cultures) and 30-day all-cause mortality. Multivariable logistic and Cox regression analyses adjusted for the propensity score to receive CAZ-AVI were constructed. Among 210 SOT recipients with CPKP-BSI, 149 received active primary therapy with CAZ-AVI (66/149) or BAT (83/149). Patients treated with CAZ-AVI had higher 14-day (80.7% vs 60.6%, P = .011) and 30-day (83.1% vs 60.6%, P = .004) clinical success and lower 30-day mortality (13.25% vs 27.3%, P = .053) than those receiving BAT. In the adjusted analysis, CAZ-AVI increased the probability of 14-day (adjusted odds ratio [aOR], 2.65; 95% confidence interval [CI], 1.03-6.84; P = .044) and 30-day clinical success (aOR, 3.14; 95% CI, 1.17-8.40; P = .023). In contrast, CAZ-AVI therapy was not independently associated with 30-day mortality. In the CAZ-AVI group, combination therapy was not associated with better outcomes. In conclusion, CAZ-AVI may be considered a first-line treatment in SOT recipients with CPKP-BSI., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Published
2023
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48. FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial.

Author

Damato A, Bergamo F, Antonuzzo L, Nasti G, Iachetta F, Romagnani A, Gervasi E, Larocca M, and Pinto C

Abstract

The NIVACOR trial is a phase II study assessing the efficacy and safety of nivolumab in combination with FOLFOXIRI/bevacizumab in first-line setting in patients affected by metastatic colorectal cancer (mCRC) RAS/BRAF mutated. We report safety run-in results in the first 10 patients enrolled. Patients received triplet chemotherapy with FOLFOXIRI scheme plus bevacizumab, in association with nivolumab every 2 weeks for 8 cycles (induction phase) followed by bevacizumab plus nivolumab every 2 weeks (maintenance phase), until progression of disease or unacceptable toxicities. The first ten patients were evaluated: 7 experienced at least one adverse event (AE) related to FOLFOXIRI/bevacizumab and 2 related to nivolumab. The most frequent grade 1-2 AEs related to FOLFOXIRI/bevacizumab were diarrhea and fatigue (71%), nausea and vomiting (57%); 3 (43%) had grade 3-4 neutropenia, and 2 (20%) patients developed grade 1-2 AEs nivolumab related: skin rash and salivary gland infection. Two patients delayed the dose because of serious AEs, proteinuria and salivary gland infection; one patient discontinued experimental treatment due to the ileo-urethral fistula and concurrent Clostridium infection diarrhea. No treatment- related death occurred. The safety run-in analysis of NIVACOR trial reassured using co-administration of FOLFOXIRI/bevacizumab and nivolumab was well tolerated with an acceptable toxicity profile., Clinical Trial Registration: https://clinicaltrials.gov/, (NCT04072198)., Competing Interests: CP reports outside the submitted work personal fees for advisory role, speaker engagements, and travel and accommodation expenses from Amgen, Astellas, Astra-Zeneca, Bayer, Bristol Meyer Squibb, Clovis Oncology, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, and Sanofi. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results., (Copyright © 2021 Damato, Bergamo, Antonuzzo, Nasti, Iachetta, Romagnani, Gervasi, Larocca and Pinto.)

Published
2021
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49. Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial.

Author

Pinto C, Zucali PA, Pagano M, Grosso F, Pasello G, Garassino MC, Tiseo M, Soto Parra H, Grossi F, Cappuzzo F, de Marinis F, Pedrazzoli P, Bonomi M, Gianoncelli L, Perrino M, Santoro A, Zanelli F, Bonelli C, Maconi A, Frega S, Gervasi E, Boni L, and Ceresoli GL

Subjects
Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors adverse effects, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Double-Blind Method, Drug Administration Schedule, Female, Humans, Italy, Male, Mesothelioma, Malignant diagnosis, Mesothelioma, Malignant mortality, Middle Aged, Pleural Neoplasms diagnosis, Pleural Neoplasms mortality, Progression-Free Survival, Time Factors, Gemcitabine, Ramucirumab, Angiogenesis Inhibitors administration & dosage, Antibodies, Monoclonal, Humanized administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Deoxycytidine analogs & derivatives, Mesothelioma, Malignant drug therapy, Pleural Neoplasms drug therapy
Abstract

Background: There is a preclinical rationale for inhibiting angiogenesis in mesothelioma. We aimed to assess the efficacy and safety of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated malignant pleural mesothelioma., Methods: RAMES was a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial done at 26 hospitals in Italy. Eligible patients were aged 18 years or older, had Eastern Cooperative Oncology Group performance status 0-2, and histologically proven malignant pleural mesothelioma progressing during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m 2 on days 1 and 8 every 3 weeks plus either intravenous placebo (gemcitabine plus placebo group) or ramucirumab 10 mg/kg (gemcitabine plus ramucirumab group) on day 1 every 3 weeks, until tumour progression or unacceptable toxicity. Central randomisation was done according to a minimisation algorithm method, associated with a random element using the following stratification factors: ECOG performance status, age, histology, and first-line time-to-progression. The primary endpoint was overall survival, measured from the date of randomisation to the date of death from any cause. Efficacy analyses were assessed in all patients who had been correctly randomised and received their allocated treatment, and safety analyses were assessed in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03560973, and with EudraCT, 2016-001132-36., Findings: Between Dec 22, 2016, and July 30, 2018, of 165 patients enrolled 161 were correctly assigned and received either gemcitabine plus placebo (n=81) or gemcitabine plus ramucirumab (n=80). At database lock (March 8, 2020), with a median follow-up of 21·9 months (IQR 17·7-28·5), overall survival was longer in the ramucirumab group (HR 0·71, 70% CI 0·59-0·85; p=0·028). Median overall survival was 13·8 months (70% CI 12·7-14·4) in the gemcitabine plus ramucirumab group and 7·5 months (6·9-8·9) in the gemcitabine plus placebo group. Grade 3-4 treatment-related adverse events were reported in 35 (44%) of 80 patients in the gemcitabine plus ramucirumab group and 24 (30%) of 81 in the gemcitabine plus placebo group. The most common treatment-related grade 3-4 adverse events were neutropenia (16 [20%] for gemcitabine plus ramucirumab vs ten [12%] for gemcitabine plus placebo) and hypertension (five [6%] vs none). Treatment-related serious adverse events were reported in five (6%) in the gemcitabine plus ramucirumab group and in four (5%) patients in the gemcitabine plus placebo group; the most common was thromboembolism (three [4%] for gemcitabine plus ramucirumab vs two [2%] for gemcitabine plus placebo). There were no treatment-related deaths., Interpretation: Ramucirumab plus gemcitabine significantly improved overall survival after first-line standard chemotherapy, with a favourable safety profile. This combination could be a new option in this setting., Funding: Eli Lilly Italy., Translation: For the Italian translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests CP reports advisory and speaker fees and travel and accommodation expenses from Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Clovis Oncology, Eisai, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, Sandoz, Sanofi, and Servier. PAZ reports advisory and speaker fees and travel and accommodation expenses from Merck Sharp and Dohme, Astellas, Janssen, Sanofi, Ipsen, Pfizer, Novartis, Bristol Myers Squibb, Amgen, AstraZeneca, Roche, and Bayer. FGrosso reports consultancy and speaker fees and travel and accommodation expenses from Merck Sharp and Dohme, Novocure, Bristol Myers Squibb, Boehringer Ingelheim, PharmaMar, and Novartis. GP reports advisory and speaker fees from AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Merck Sharp and Dohme, Roche, and Eli Lilly. MCG reports consultancy and advisory fees from AstraZeneca, Merck Sharp and Dohme, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Inivata, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati Threapeutics, Daiichi Sankyo, Bayer, GlaxoSmithKline, Sanofi-Aventis, Spectrum Pharmaceuticals, Blueprint Medicine, Janssen, Regeneron Pharmaceuticals; speaker fees from AstraZeneca, Merck Sharp and Dohme, and Takeda; travel and accommodation expenses from Roche; and a leadership or fiduciary role in European Society for Medical Oncology, American Society of Clinical Oncology, American Association for Cancer Research, Women for Oncology, and Italian collaborative group for thymic malignansies. MT reports advisory fees from AstraZeneca, Boehringer Ingelheim, Novartis, Roche, Takeda, and Eli Lilly; speaker fees from AstraZeneca, Boehringer Ingelheim, and Merck Sharp and Dohme; and research grants from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche. HSP reports advisory and speaker fees and travel and accommodation expenses from Amgen, AstraZeneca, Bristol Myers Squibb, Merck Sharp and Dohme, Novartis, Roche, Pfizer, and Sanofi. FGrossi reports advisory fees from AstraZeneca, Bristol Myers Squibb, Eli Lilly, Merck Sharp and Dohme, and Roche; speaker fees from Bristol Myers Squibb, AstraZeneca, Eli Lilly, Merck Sharp and Dohme, Roche, Amgen, Boehringer Ingelheim, Pierre Fabre, Pfizer, Takeda, Bayer, and Sotio; and a grant from Bristol Myers Squibb to their institution. FC reports speaker fees from Bristol Myers Squibb and advisory fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Eli Lilly, Mirati, Merck Sharp and Dohme, PharmaMar, Pfizer, and Roche. FdM reports advisory and speaker fees and travel and accommodation expenses from Merck Sharp and Dohme, Bristol Myers Squibb, Boehringer Ingelheim, Novartis, AstraZeneca, and Roche. AS reports consultancy fees from Arqule and Sanofi; speaker fees from Takeda, Bristol Myers Squibb, Roche, AbbVie, Amgen, Celgene, Servier, Gilead, AstraZeneca, Pfizer, Arqule, Eli Lilly, Sandoz, Eisai, Novartis, Bayer, and Merck Sharp and Dohme; and advisory fees from Bristol Myers Squibb, Servier, Gilead, Pfizer, Eisai, Bayer, and Merck Sharp and Dohme. GLC reports advisory speaker fees from Merck Sharp and Dohme, Astellas, and Novocure, and travel and accommodation expenses from Merck Sharp and Dohme, Astellas, and Novocure. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Published
2021
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50. Fluoroscopically Guided Subacromial Spacer Implantation for Massive Rotator Cuff Tears: Two Years of Prospective Follow-up.

Author

Gervasi E, Maman E, Dekel A, Markovitz E, and Cautero E

Abstract

Background: Massive rotator cuff tears (MRCTs) are common and have been estimated to account for nearly 40% of all rotator cuff tears. An evolving strategy for management of MRCTs has been the implantation of a degradable subacromial spacer balloon that attempts to restore normal shoulder biomechanics., Purpose: To assess the safety and efficacy of fluoroscopically guided balloon spacer implantation under local anesthesia in a cohort of patients with 2 years of postoperative follow-up., Study Design: Case series; Level of evidence, 4., Methods: The safety and efficacy of using fluoroscopically guided subacromial spacer implantation was assessed in 46 patients. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Constant and American Shoulder and Elbow Society (ASES) scores., Results: Overall, 87.5% (35/40) of patients saw clinically significant improvement in the total Constant and ASES scores from 6 weeks postoperatively, with improvement maintained up to 24 months postoperatively., Conclusion: The data suggest that fluoroscopically guided subacromial spacer implantation under local anesthesia is a low-risk, clinically effective option, especially for the elderly population and those patients who have multiple comorbidities or a contraindication to general anesthesia. Patients undergoing subacromial spacer implantation for the treatment of MRCTs had satisfactory outcomes at 2-year follow-up, with a low rate of complications., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: Devices for the surgical procedures in this study were provided by OrthoSpace. E. Maman is a paid consultant and member of the scientific advisory team for OrthoSpace and has stock options in OrthoSpace. A.D. is co-founder and medical director of OrthoSpace. E. Markovitz is an employee of OrthoSpace. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto., (© The Author(s) 2021.)

Published
2021
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