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1,053 results on '"Torri, V"'

1. Efficacy and safety of ramucirumab plus carboplatin and paclitaxel in untreated metastatic thymic carcinoma: RELEVENT phase II trial (NCT03921671)

Author

Proto, C., Ganzinelli, M., Manglaviti, S., Imbimbo, M., Galli, G., Marabese, M., Zollo, F., Alvisi, M.F., Perrino, M., Cordua, N., Borea, F., de Vincenzo, F., Chella, A., Cappelli, S., Pardini, E., Ballatore, Z., Lucarelli, A., Ambrosini, E., Giuliano, M., Pietroluongo, E., Mulargiu, C., Fabbri, A., Prelaj, A., Occhipinti, M., Brambilla, M., Mazzeo, L., Beninato, T., Vigorito, R., Ruggirello, M., Greco, F.G., Calareso, G., Miliziano, D., Rulli, E., De Simone, I., Torri, V., de Braud, F.G.M., Pasello, G., De Placido, P., Berardi, R., Petrini, I., Zucali, P., Garassino, M.C., and Lo Russo, G.

Published
2024
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3. Final results of the real-life observational VICTOR-6 study on metronomic chemotherapy in elderly metastatic breast cancer (MBC) patients

Author

Trevisan, B., Pepe, F. F., Vallini, I., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Baldelli, A., Fontana, A., Gambaro, A. R., Garrone, O., Gebbia, V., Generali, D., Gianni, L., Giovanardi, F., Grassadonia, A., Leonardi, V., Sarti, S., Musolino, A., Nicolini, M., Putzu, C., Riccardi, F., Santini, D., Sarobba, M. G., Schintu, M. G., Scognamiglio, G., Spadaro, P., Taverniti, C., Toniolo, D., Tralongo, P., Turletti, A., Valenza, R., Valerio, M. R., Vici, P., Clivio, L., Torri, V., and Cazzaniga, M. E.

Published
2023
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5. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group

Author

Lacas, Benjamin, Carmel, Alexandra, Landais, Cécile, Wong, Stuart J, Licitra, Lisa, Tobias, Jeffrey S, Burtness, Barbara, Ghi, Maria Grazia, Cohen, Ezra EW, Grau, Cai, Wolf, Gregory, Hitt, Ricardo, Corvò, Renzo, Budach, Volker, Kumar, Shaleen, Laskar, Sarbani Ghosh, Mazeron, Jean-Jacques, Zhong, Lai-Ping, Dobrowsky, Werner, Ghadjar, Pirus, Fallai, Carlo, Zakotnik, Branko, Sharma, Atul, Bensadoun, René-Jean, Redda, Maria Grazia Ruo, Racadot, Séverine, Fountzilas, George, Brizel, David, Rovea, Paolo, Argiris, Athanassios, Nagy, Zoltán Takácsi, Lee, Ju-Whei, Fortpied, Catherine, Harris, Jonathan, Bourhis, Jean, Aupérin, Anne, Blanchard, Pierre, Pignon, Jean-Pierre, Group, MACH-NC Collaborative, Adelstein, DJ, Alfonsi, M, Belkacemi, Y, Bar-Ad, V, Bernier, J, Bratland, Å, Calais, G, Campbell, B, Caudell, J, Chabaud, S, Chamorey, E, Chaukar, D, Choi, KN, Choussy, O, Collette, L, Cruz, JJ, Dani, C, Dauzier, E, Forastiere, AA, Garaud, P, Gregoire, V, Hackshaw, A, Haddad, E, Haffty, BG, Hansen, A, Hayoz, S, Horiot, JC, Jeremic, B, Karrison, TG, Langendijk, JA, Lapeyre, M, Lartigau, E, Leong, T, Le, QT, Lee, PPY, Lewin, F, Lin, A, Lopes, A, Mehta, S, Moon, J, Moyal, E, Occéan, BV, Olmi, P, Orecchia, R, O'Sullivan, B, Overgaard, J, Petit, C, Quon, H, Sanguineti, G, Satar, T, Simes, J, Simon, C, Sire, C, Staar, S, Stromberger, C, Strojan, P, Temam, S, Thomson, D, Timochenko, A, Torri, V, and Tseroni, V

Subjects
Cancer, Clinical Trials and Supportive Activities, Rare Diseases, Clinical Research, 6.5 Radiotherapy and other non-invasive therapies, Evaluation of treatments and therapeutic interventions, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Chemotherapy, Adjuvant, Head and Neck Neoplasms, Humans, Induction Chemotherapy, Randomized Controlled Trials as Topic, Meta-analysis, Review, Individual Patient Data, Randomised Clinical Trials, Chemotherapy, Radiotherapy, Head and Neck Cancer, MACH-NC Collaborative Group, Other Physical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Background and purposeThe Meta-Analysis of Chemotherapy in squamous cell Head and Neck Cancer (MACH-NC) demonstrated that concomitant chemotherapy (CT) improved overall survival (OS) in patients without distant metastasis. We report the updated results.Materials and methodsPublished or unpublished randomized trials including patients with non-metastatic carcinoma randomized between 1965 and 2016 and comparing curative loco-regional treatment (LRT) to LRT + CT or adding another timing of CT to LRT + CT (main question), or comparing induction CT + radiotherapy to radiotherapy + concomitant (or alternating) CT (secondary question) were eligible. Individual patient data were collected and combined using a fixed-effect model. OS was the main endpoint.ResultsFor the main question, 101 trials (18951 patients, median follow-up of 6.5 years) were analyzed. For both questions, there were 16 new (2767 patients) and 11 updated trials. Around 90% of the patients had stage III or IV disease. Interaction between treatment effect on OS and the timing of CT was significant (p

Published
2021

7. Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey

Author

Reni, Michele, Macchini, Marina, Orsi, Giulia, Peretti, Umberto, Valente, Mariamaddalena, Giommoni, Elisa, Antonuzzo, Lorenzo, Di Costanzo, Francesco, Bergamo, Francesca, Zagonel, Vittorina, Lonardi, Sara, Buggin, Federica, Milella, Michele, Palmerio, Silvia, Cavanna, Luigi, Di Nunzio, Camilla, Di Marco, Maria Cristina, Grassi, Elisa, Spada, Massimiliano, Messina, Marco, Cordio, Stefano, Avola, Francesco, Aprile, Giuseppe, Pagano, Salvatore, Simionato, Francesca, Cardellino, Giovanni Gerardo, Majer, Federica, Maiello, Evaristo, Latiano, Tiziana Pia, Chiarazzo, Cinzia, Artioli, Fabrizio, Razzini, Giorgia, Pasqualini, Antonella, Ghidini, Michele, Binda, Elisa, Lazzarelli, Silvia, Bozzarelli, Silvia, Sala, Simona, Luppi, Gabriele, Pettorelli, Elisa, Spallanzani, Andrea, Vicario, Giovanni, Salmaso, Flavia, Basso, Marco, Silvestris, Nicola, Del Curatolo, Sabina, Zustovich, Fable, Bongiovanni, Francesca, Longobardi, Ciro, Sandi, Ilenia, Fontanella, Caterina, Montelatici, Silvia, Giordano, Monica, Luchena, Giovanna, Gilardoni, Micol, Tamburini, Emiliano, Rudnas, Britt, Venturini, Barbara, Merelli, Barbara, Negrini, Giorgia, Vici, Elio Maria, Marabese, Alessandra, Garetto, Cristina, Curcio, Paola, Cinieri, Saverio, Cinefra, Margherita, Ferrara, Pasqualinda, Cantore, Maurizio, Morselli, Patrizia, Fumi, Guglielmo, Isidori, Agnese, Ciccarese, Giovanni, Paolo Frassineti, Giovanni Luca, Pagan, Flavia, Vaccaro, Vanja, Spoto, Chiara, Ferrara, Marianna, Garufi, Carlo, Caporale, Marta, Vasile, Enrico, Salani, Francesca, Barone, Elisa, Berardi, Rossana, Onofri, Azzurra, Ballatore, Zelmira, Lucarelli, Alessandra, Barucca, Alessandra, Pancotti, Amedeo, Scipioni, Teresa, Bencardino, Katia, Marrapese, Giovanna, Idotta, Laura, Petrelli, Fausto, Lonati, Veronica, Ceribelli, Anna, Giuli, Angelo, Zannori, Cristina, Bassanelli, Maria, Mambrini, Andrea, Ginocchi, Laura, Orlandi, Massimo, Celio, Luigi, Niger, Monica, Biamonte, Lavinia, Tamberi, Stefano, Piancastelli, Alessandra, Papiani, Giorgio, Valli, Irene, Allione, Paolo, Boe, Maria Giovanna, Scartozzi, Mario, Lai, Eleonora, Pireddu, Annagrazia, Ziranu, Pina, Demurtas, Laura, Puzzoni, Marco, Mariani, Stefano, Pretta, Andrea, Liscia, Nicole, Savastano, Clementina, Malaspina, Valentina, Tonini, Giuseppe, Grassani, Teresa, Barco, Barbara, Pierosandro, Tagliaferri, Ciliberto, Domenico, Ierardi, Antonella, Calandruccio, Natale Daniele, Minotti, Vincenzo, Matocci, Roberta, Torri, Valter, Porcu, Luca, Rulli, Erica, De Simone, Irene, Carlucci, Luciano, Rulli, Eliana, Poli, Davide, Tonto, Paola, Scellato, Francesca, Pinto, Carmine, Reni, M., Giommoni, E., Bergamo, F., Milella, M., Cavanna, L., Di Marco, M.C., Spada, M., Cordio, S., Aprile, G., Cardellino, G.G., Maiello, E., Bernardini, I., Ghidini, M., Bozzarelli, S., Macchini, M., Orsi, G., De Simone, I., Rulli, Er., Porcu, L., Torri, V., and Pinto, C.

Published
2023
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8. PEOPLE (NCT03447678), a first-line phase II pembrolizumab trial, in negative and low PD-L1 advanced NSCLC: clinical outcomes and association with circulating immune biomarkers

Author

Lo Russo, G., Sgambelluri, F., Prelaj, A., Galli, F., Manglaviti, S., Bottiglieri, A., Di Mauro, R.M., Ferrara, R., Galli, G., Signorelli, D., De Toma, A., Occhipinti, M., Brambilla, M., Rulli, E., Triulzi, T., Torelli, T., Agnelli, L., Brich, S., Martinetti, A., Dumitrascu, A.D., Torri, V., Pruneri, G., Fabbri, A., de Braud, F., Anichini, A., Proto, C., Ganzinelli, M., Mortarini, R., and Garassino, M.C.

Published
2022
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9. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Cortinovis, D., Canova, S., Colonese, F., Abbate, M.I., Sala, L., Sala, E., Perez Gila, M., Bono, F., Pagni, F., Ceresoli, G.L., D’Aveni, A., Bonomi, M., Grosso, F., De Angelis, A., Ugo, F., Belletti, M., Zucali, P.A., Perrino, M., De Vincenzo, F., Santoro, A., Gelsomino, F., Ardizzoni, A., Pasello, G., Frega, S., Mencoboni, M., Carlucci, L., De Simone, I., D’Incalci, M., Galli, F., Poli, D., Rulli, E., Torri, V., and Cortinovis, D.L.

Published
2022
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10. Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (GOETH STUDY)—a collaborative randomized controlled trial by ACOI, FONDAZIONE AIOM, SIC, SICE, and SICO

Author

Di Giorgio, A., Gerardi, C., Abatini, C., Melotti, G., Bonavina, L., Torri, V., Santullo, F., Garattini, S., De Luca, M., Rulli, Erica, Rulli, Eliana, and Pacelli, F.

Published
2022
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11. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis

Author

Adelstein, D.J., Agarwal, J., Alfonsi, M., Argiris, A., Aupérin, A., Bacigalupo, A., Bar-Ad, V., Bartelink, H., Beadle, B., Belkacemi, Y., Bensadoun, R.J., Bernier, J., Blanchard, P., Bourhis, J., Bratland, Å., Brizel, D., Budach, V., Budach, W., Burtness, B., Calais, G., Campbell, B., Caudell, J., Chabaud, S., Chamorey, E., Chaukar, D., Cheugoua-Zanetsie, M., Cho, K.H., Choussy, O., Cruz Hernandez, J.J., Denham, J.W., Dobrowsky, W., Dominello, M.M, Driessen, C.M.L., Fallai, C., Forastiere, A.A., Fortpied, C., Fountzilas, G., Garaud, P., Garden, A.S., Gery, B., Ghadjar, P., Ghi, M.G., Ghosh Laskar, S., Graff-Cailleaud, P., Grau, C., Gregoire, V., Hackshaw, A., Haddad, E, Haffty, B.G., Hansen, A., Hay, J.H., Hayoz, S., Horiot, J.C., Hitt, R., Jeremic, B., Johansen, J., Jones, C., Julieron, M., Kristensen, C.A., Kumar, S., Lacas, B., Langendijk, J.A., Lapeyre, M., Lartigau, E., Licitra, L., Le, Q.T., Lee, J.W., Lee, P., Lewin, F., Li, Y., Lopes, A., Lotayef, M., Maciejewski, B., Mazeron, J.J., Mehta, S., Michalski, W., Moon, J., Moon, S.H., Moyal, E., Nankivell, M., Nilsson, P., Olmi, P., Orecchia, R., O'Sullivan, B., Overgaard, J., Parmar, M.K.B., Petit, C., Pignon, J.P., Pointreau, Y., Posner, M.R., Poulsen, M.G., Quon, H., Racadot, S., Rosenthal, D.I., Rovea, P., Ruo Redda, M.G., Sanguineti, G., Shenouda, G., Simes, J., Sharma, A., Simon, C., Sire, C., Skladowski, K., Spencer, S., Staar, S., Strojan, P., Stromberger, C., Suwinski, R., Szutkowski, Z., Takácsi-Nagy, Z., Tao, Y.G., Temam, S., Thomson, D., Tobias, J.S., Torres-Saavedra, P., Torri, V., Tripcony, L., Trotti, A., Tseroni, V., van Herpen, C., van Tinteren, H., Vermorken, J., Viegas, C.M.P., Vokes, E.E., Waldron, J., Wernecke, K.D, Widder, J., Wolf, G.T., Wong, S.J., Wu, J.S., Yamazaki, H., Zaktonik, B., Zackrisson, B., Zhong, L.P., Petit, Claire, Lacas, Benjamin, Pignon, Jean-Pierre, Le, Quynh Thu, Grégoire, Vincent, Grau, Cai, Hackshaw, Allan, Zackrisson, Björn, Parmar, Mahesh K B, Lee, Ju-Whei, Ghi, Maria Grazia, Sanguineti, Giuseppe, Temam, Stéphane, Cheugoua-Zanetsie, Maurice, O'Sullivan, Brian, Posner, Marshall R, Vokes, Everett E, Cruz Hernandez, Juan J, Szutkowski, Zbigniew, Lartigau, Eric, Budach, Volker, Suwiński, Rafal, Poulsen, Michael, Kumar, Shaleen, Ghosh Laskar, Sarbani, Mazeron, Jean-Jacques, Jeremic, Branislav, Simes, John, Zhong, Lai-Ping, Overgaard, Jens, Fortpied, Catherine, Torres-Saavedra, Pedro, Bourhis, Jean, Aupérin, Anne, and Blanchard, Pierre

Published
2021
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12. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cicchiello, F., Riva, F., Vallini, I., Mazza, M., Bonfadini, C., Bordin, E., Canicattì, M., Cappuccio, F., Collovà, E., De Angelis, C., Desorte, R., Donati, S., Drudi, G., Galanti, D., Mocerino, C., Orlando, L., Pellegrino, B., Pizzuti, L., Ridolfi, C., Rocca, A., Sarti, D., Spagnoletti, I., Tinari, N., Vandone, A., Vizzini, L., Cazzaniga, M.E., Pinotti, G., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Fiorentini, G., Fontana, A., Gambaro, A.R., Garrone, O., Gebbia, V., Generali, D., Gianni, L., Giovanardi, F., Grassadonia, A., Leonardi, V., Marchetti, P., Melegari, E., Musolino, A., Nicolini, M., Putzu, C., Riccardi, F., Santini, D., Saracchini, S., Sarobba, M.G., Schintu, M.G., Scognamiglio, G., Spadaro, P., Taverniti, C., Toniolo, D., Tralongo, P., Turletti, A., Valenza, R., Valerio, M.R., Vici, P., Clivio, L., and Torri, V.

Published
2019
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13. Final results of the real-life observational VICTOR-6 study on metronomic chemotherapy in elderly metastatic breast cancer (MBC) patients

Author

Trevisan, B, Pepe, F, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cazzaniga, M, Trevisan B., Pepe F. F., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cazzaniga M. E., Trevisan, B, Pepe, F, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cazzaniga, M, Trevisan B., Pepe F. F., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., and Cazzaniga M. E.

Abstract

Nowadays, treatment of metastatic breast cancer (MBC) has been enriched with novel therapeutical strategies. Metronomic chemotherapy (mCHT) is a continuous and frequent administration of chemotherapy at a lower dose and so whit less toxicity. Thus, this strategy could be attractive for elderly MBC patients. Aim of this analysis is to provide insights into mCHT’s activity in a real-life setting of elderly MBC patients. Data of patients ≥ 75 years old included in VICTOR-6 study were analyzed. VICTOR-6 is a multicentre, Italian, retrospective study, which collected data on mCHT in MBC patients treated between 2011 and 2016. A total of 112 patients were included. At the beginning of mCHT, median age was 81 years (75–98) and in 33% of the patients mCHT was the first line choice. Overall Response Rate (ORR) and Disease Control Rate (DCR) were 27.9% and 79.3%, respectively. Median PFS ranged between 7.6 and 9.1 months, OS between 14.1 and 18.5 months. The most relevant toxicity was the hematological one (24.1%); severe toxicity (grade 3–4) ranged from 0.9% for skin toxicity up to 8% for hematologic one. This is a large study about mCHT in elderly MBC patients, providing insights to be further investigated in this subgroup of frail patients.

Published
2023

14. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial)

Author

Sposito, C, Pietrantonio, F, Maspero, M, Di Benedetto, F, Vivarelli, M, Tisone, G, De Carlis, L, Romagnoli, R, Gruttadauria, S, Colledan, M, Agnes, S, Ettorre, G, Baccarani, U, Torzilli, G, Di Sandro, S, Pinelli, D, Caccamo, L, Sartore Bianchi, A, Spreafico, C, Torri, V, Mazzaferro, V, Sposito C., Pietrantonio F., Maspero M., Di Benedetto F., Vivarelli M., Tisone G., De Carlis L., Romagnoli R., Gruttadauria S., Colledan M., Agnes S., Ettorre G., Baccarani U., Torzilli G., Di Sandro S., Pinelli D., Caccamo L., Sartore Bianchi A., Spreafico C., Torri V., Mazzaferro V., Sposito, C, Pietrantonio, F, Maspero, M, Di Benedetto, F, Vivarelli, M, Tisone, G, De Carlis, L, Romagnoli, R, Gruttadauria, S, Colledan, M, Agnes, S, Ettorre, G, Baccarani, U, Torzilli, G, Di Sandro, S, Pinelli, D, Caccamo, L, Sartore Bianchi, A, Spreafico, C, Torri, V, Mazzaferro, V, Sposito C., Pietrantonio F., Maspero M., Di Benedetto F., Vivarelli M., Tisone G., De Carlis L., Romagnoli R., Gruttadauria S., Colledan M., Agnes S., Ettorre G., Baccarani U., Torzilli G., Di Sandro S., Pinelli D., Caccamo L., Sartore Bianchi A., Spreafico C., Torri V., and Mazzaferro V.

Abstract

Background: Patients with unresectable Colorectal Liver Metastases (CLM) receiving palliative chemotherapy have a 5-year overall survival (OS) of less than 30%. Liver transplantation (LT) can improve OS up to 60%-83% (SECA-I and SECA-II trials). The aim of the study is to assess the efficacy of LT in liver-only metastatic CRC compared with a matched cohort of patients included in a phase III trial on triplet chemotherapy + antiEGFR. Patients and Methods: The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial (ClinicalTrials.gov NCT03803436). Hyperselected patients with liver-limited unresectable CLM, RAS and BRAF wild-type and curatively removed primary colon cancer are included. The observed post-transplant outcomes will be prospectively compared 1:5 with those obtained in a matched cohort from the TRIPLETE trial (NCT03231722). Results: Primary endpoint is to compare the 3 and 5-years OS of patients enrolled in the COLT trial with COLT-eligible population enrolled in the TRIPLETE trial. An expected gain in OS of 40% at 5-years is predicted for the COLT population (the expected OS at 5-years in COLT vs. TRIPLETE is 70% vs. 30%). Secondary endpoints are to compare the 5-years disease-free survival and to assess the safety of LT (Dindo-Clavien Classification and the Comprehensive Complication Index). Conclusion: LT offers the longest OS reported in selected patients with CLM. Improving the selection strategies can give patients a 5-year OS similar to other indications for LT and a better outcome than those undergoing chemotherapy alone.

Published
2023

17. 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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18. Best practices for the management of local-regional recurrent chordoma: a position paper by the Chordoma Global Consensus Group

Author

Stacchiotti, S., Gronchi, A., Fossati, P., Akiyama, T., Alapetite, C., Baumann, M., Blay, J.Y., Bolle, S., Boriani, S., Bruzzi, P., Capanna, R., Caraceni, A., Casadei, R., Colia, V., Debus, J., Delaney, T., Desai, A., Dileo, P., Dijkstra, S., Doglietto, F., Flanagan, A., Froelich, S., Gardner, P.A., Gelderblom, H., Gokaslan, Z.L., Haas, R., Heery, C., Hindi, N., Hohenberger, P., Hornicek, F., Imai, R., Jeys, L., Jones, R.L., Kasper, B., Kawai, A., Krengli, M., Leithner, A., Logowska, I., Martin Broto, J., Mazzatenta, D., Morosi, C., Nicolai, P., Norum, O.J., Patel, S., Penel, N., Picci, P., Pilotti, S., Radaelli, S., Ricchini, F., Rutkowski, P., Scheipl, S., Sen, C., Tamborini, E., Thornton, K.A., Timmermann, B., Torri, V., Tunn, P.U., Uhl, M., Yamada, Y., Weber, D.C., Vanel, D., Varga, P.P., Vleggeert-Lankamp, C.L.A., Casali, P.G., and Sommer, J.

Published
2017
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19. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Canova, S, Ceresoli, G, Grosso, F, Zucali, P, Gelsomino, F, Pasello, G, Mencoboni, M, Rulli, E, Galli, F, De Simone, I, Carlucci, L, De Angelis, A, Belletti, M, Bonomi, M, D'Aveni, A, Perrino, M, Bono, F, Cortinovis, D, Colonese, F, Abbate, M, Sala, L, Sala, E, Perez Gila, M, Pagni, F, Ugo, F, De Vincenzo, F, Santoro, A, Ardizzoni, A, Frega, S, D'Incalci, M, Poli, D, Torri, V, Canova S., Ceresoli G. L., Grosso F., Zucali P. A., Gelsomino F., Pasello G., Mencoboni M., Rulli E., Galli F., De Simone I., Carlucci L., De Angelis A., Belletti M., Bonomi M., D'Aveni A., Perrino M., Bono F., Cortinovis D. L., Cortinovis D., Colonese F., Abbate M. I., Sala L., Sala E., Perez Gila M., Pagni F., Ugo F., De Vincenzo F., Santoro A., Ardizzoni A., Frega S., D'Incalci M., Poli D., Torri V., Canova, S, Ceresoli, G, Grosso, F, Zucali, P, Gelsomino, F, Pasello, G, Mencoboni, M, Rulli, E, Galli, F, De Simone, I, Carlucci, L, De Angelis, A, Belletti, M, Bonomi, M, D'Aveni, A, Perrino, M, Bono, F, Cortinovis, D, Colonese, F, Abbate, M, Sala, L, Sala, E, Perez Gila, M, Pagni, F, Ugo, F, De Vincenzo, F, Santoro, A, Ardizzoni, A, Frega, S, D'Incalci, M, Poli, D, Torri, V, Canova S., Ceresoli G. L., Grosso F., Zucali P. A., Gelsomino F., Pasello G., Mencoboni M., Rulli E., Galli F., De Simone I., Carlucci L., De Angelis A., Belletti M., Bonomi M., D'Aveni A., Perrino M., Bono F., Cortinovis D. L., Cortinovis D., Colonese F., Abbate M. I., Sala L., Sala E., Perez Gila M., Pagni F., Ugo F., De Vincenzo F., Santoro A., Ardizzoni A., Frega S., D'Incalci M., Poli D., and Torri V.

Abstract

Background: Malignant pleural mesothelioma (MPM) is a cancer with a high mortality rate and few therapeutic options. After platinum–pemetrexed combination, no further promising drug seems to be effective. Immune checkpoint inhibitors may have some activity in pretreated patients and no data are available in this population about durvalumab. Materials and methods: DIADEM was a multicenter, open-label, single-arm, phase II trial aimed at evaluating the efficacy and safety of durvalumab. Patients with locally advanced/metastatic MPM who progressed after platinum–pemetrexed chemotherapy were enrolled to receive durvalumab (1500 mg, intravenously Q4W) for 12 months or until evidence of disease progression or unacceptable toxicity. The primary endpoint was the proportion of patients alive and free from progression at 16 weeks (PFS16wks) calculated from treatment initiation. Secondary endpoints were progression-free survival, overall survival, overall response rate, and safety. Results: Sixty-nine patients with a median age of 69 years (range 44-82 years) were enrolled; 62 patients (89.9%) had epithelioid histotype. As first-line treatment, all patients received platinum derivatives–pemetrexed combination (60.9% with carboplatin and 39.1% with cisplatin). As of March 2021, the median follow-up was 9.2 months (interquartile range 5.2-11.1 months). Six patients (8.7%) completed the 12-month treatment; 60 patients discontinued, of whom 42 for progressive disease, and 4 died. Seventeen patients (28.3%; 95% confidence interval 17.5% to 41.4%) were alive or free from progression at 16 weeks. Eleven patients (18.6%) had a grade 3 or 4 treatment-related adverse event (AE), and one (1.4%) had a grade ≥3 immune-related, treatment-related AE. There was one drug-related death. Conclusion: Durvalumab alone in pretreated non-selected MPM did not reach a meaningful clinical activity, showing any new major safety issue signals.

Published
2022

20. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer

Author

Colombo, N, Tomao, F, Benedetti Panici, P, Nicoletto, M, Tognon, G, Bologna, A, Lissoni, A, Decensi, A, Lapresa, M, Mancari, R, Palaia, I, Tasca, G, Tettamanzi, F, Alvisi, M, Rulli, E, Poli, D, Carlucci, L, Torri, V, Fossati, R, Biagioli, E, Colombo N., Tomao F., Benedetti Panici P., Nicoletto M. O., Tognon G., Bologna A., Lissoni A. A., DeCensi A., Lapresa M., Mancari R., Palaia I., Tasca G., Tettamanzi F., Alvisi M. F., Rulli E., Poli D., Carlucci L., Torri V., Fossati R., Biagioli E., Colombo, N, Tomao, F, Benedetti Panici, P, Nicoletto, M, Tognon, G, Bologna, A, Lissoni, A, Decensi, A, Lapresa, M, Mancari, R, Palaia, I, Tasca, G, Tettamanzi, F, Alvisi, M, Rulli, E, Poli, D, Carlucci, L, Torri, V, Fossati, R, Biagioli, E, Colombo N., Tomao F., Benedetti Panici P., Nicoletto M. O., Tognon G., Bologna A., Lissoni A. A., DeCensi A., Lapresa M., Mancari R., Palaia I., Tasca G., Tettamanzi F., Alvisi M. F., Rulli E., Poli D., Carlucci L., Torri V., Fossati R., and Biagioli E.

Abstract

Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone. Methods: BAROCCO trial randomized 123 patients: 80 mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300 mg tablets twice daily together with 20 mg cediranib daily (continuous schedule) or with 20 mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5). Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50–1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68–1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm. Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population. Clinical trial identification: IRFMN-OVA-7289, EudraCT: 2016–003964-38, NCT03314740.

Published
2022

22. 26P ctDNA prognostic and diagnostic value for recurrence in patients with early-stage breast cancer: A systematic review and meta-analysis

Author

Marta, G. Nader, primary, Monforte, M., additional, Cinquini, M., additional, Agostinetto, E., additional, Branco, D. Martins, additional, Fontsa, M. Langouo, additional, Ignatiadis, M., additional, Torri, V., additional, Apolone, G., additional, Cappelletti, V., additional, Pruneri, G., additional, de Azambuja, E., additional, and Di Cosimo, S., additional

Published
2023
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25. A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma

Author

Rosati, G., Ambrosini, G., Barni, S., Andreoni, B., Corradini, G., Luchena, G., Daniele, B., Gaion, F., Oliverio, G., Duro, M., Martignoni, G., Pinna, N., Sozzi, P., Pancera, G., Solina, G., Pavia, G., Pignata, S., Johnson, F., Labianca, R., Apolone, G., Zaniboni, A., Monteforte, M., Negri, E., Torri, V., Mosconi, P., and Fossati, R.

Published
2016
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26. Signs and symptoms of COVID-19 in patients with multiple sclerosis

Author

Schiavetti I., Carmisciano L., Ponzano M., Cordioli C., Cocco E., Marfia G. A., Inglese M., Filippi M., Radaelli M., Bergamaschi R., Immovilli P., Capobianco M., De Rossi N., Brichetto G., Scandellari C., Cavalla P., Pesci I., Confalonieri P., Perini P., Trojano M., Lanzillo R., Tedeschi G., Comi G., Battaglia M. A., Patti F., Salvetti M., Sormani M. P., Abbadessa G., Aguglia U., Allegorico L., Rossi Allegri B. M., Alteno A., Amato M. P., Annovazzi P., Antozzi C., Appendino L., Arena S., Baione V., Balgera R., Barcella V., Baroncini D., Barrila C., Bellacosa A., Bellucci G., Bergamaschi V., Bezzini D., Biolzi B., Bisecco A., Bonavita S., Borriello G., Bosa C., Bosco A., Bovis F., Bozzali M., Brambilla L., Brescia Morra V., Buccafusca M., Bucciantini E., Bucello S., Buscarinu M. C., Cabboi M. P., Calabrese M., Calabria F., Caleri F., Camilli F., Caniatti L. M., Cantello R., Capra R., Capuano R., Carta P., Celani M. G., Cellerino M., Cerqua R., Chisari C., Clerici R., Clerico M., Cola G., Conte A., Conti M. Z., Cordano C., Cordera S., Corea F., Correale C., Cottone S., Crescenzo F., Curti E., d'Ambrosio A., D'Amico E., Danni M. C., d'Arma A., Dattola V., de Biase S., De Luca G., De Mercanti S. F., De Mitri P., De Stefano N., Della Cava F. M., Cava M. D., Di Lemme S., di Napoli M., Di Sapio A., Docimo R., Dutto A., Evangelista L., Fanara S., Fantozzi R., Ferraro D., Ferro M. T., Fioretti C., Fratta M., Frau J., Fronza M., Furlan R., Gajofatto A., Gallo A., Gallo P., Gasperini C., Ghazaryan A., Giometto B., Gobbin F., Govone F., Granella F., Grange E., Grasso M. G., Grimaldi L. M. E., Guareschi A., Guaschino C., Guerrieri S., Guidetti D., Juergenson I. B., Iaffaldano P., Ianniello A., Iasevoli L., Imperiale D., Infante M. T., Iodice R., Iovino A., Konrad G., Landi D., Lapucci C., Lavorgna L., L'Episcopo M. R., Leva S., Liberatore G., Lo Re M., Longoni M., Lopiano L., Lorefice L., Lucchini M., Lus G., Maimone D., Malentacchi M., Mallucci G., Malucchi S., Mancinelli C. R., Mancinelli L., Manganotti P., Maniscalco G. T., Mantero V., Marangoni S., Marastoni D., Marinelli F., Marti A., Boneschi Martinelli F., Masserano Z. F., Matta F., Mendozzi L., Meucci G., Miante S., Miele G., Milano E., Mirabella M., Missione R., Moccia M., Moiola L., Montepietra S., MontiBragadin M., Montini F., Motta R., Nardone R., Gabri Nicoletti C., Nobile-Orazio E., Nozzolillo A., Onofrj M., Orlandi R., Palmieri A., Paolicelli D., Pasquali L., Pasto L., Pedrazzoli E., Petracca M., Petrone A., Piantadosi C., Pietroboni A. M., Pinardi F., Portaccio E., Pozzato M., Pozzilli C., Prosperini L., Protti A., Ragonese P., Rasia S., Realmuto S., Repice A., Rigoni E., Rilla M. T., Rinaldi F., Romano C. M., Ronzoni M., Rovaris M., Ruscica F., Sabattini L., Salemi G., Saraceno L., Sartori A., Sbragia E., Scarano G. I., Scarano V., Sessa M., Sgarito C., Sibilia G., Siciliano G., Signori A., Signoriello E., Sinisi L., Sireci F., Sola P., Solaro C., Sotgiu S., Sparaco M., Stromillo M. L., Strumia S., Susani E. L., Tabiadon G., Teatini F., Tomassini V., Tonietti S., Torri V., Tortorella C., Toscano S., Totaro R., Trotta M., Turano G., Ulivelli M., Valentino M., Vaula G., Vecchio D., Vercellino M., Verrengia E. P., Vianello M., Virgilio E., Vitetta F., Vollaro S., Zaffaroni M., Zampolini M., Zarbo I. R., Zito A., Zuliani L., Schiavetti, Irene, Carmisciano, Luca, Ponzano, Marta, Cordioli, Cinzia, Cocco, Eleonora, Marfia, Girolama Alessandra, Inglese, Matilde, Filippi, Massimo, Radaelli, Marta, Bergamaschi, Roberto, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Confalonieri, Paolo, Perini, Paola, Trojano, Maria, Lanzillo, Roberta, Tedeschi, Gioacchino, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria Pia, Gianmarco, Abbadessa, Umberto, Aguglia, Allegorico, Lia, Beatrice Maria Rossi Allegri, Anastasia, Alteno, Amato, MARIA PIA, Pietro, Annovazzi, Carlo, Antozzi, Lucia, Appendino, Sebastiano, Arena, Viola, Baione, Roberto, Balgera, Valeria, Barcella, Damiano, Baroncini, Caterina, Barrilà, Alessandra, Bellacosa, Gianmarco, Bellucci, Valeria, Bergamaschi, Daiana, Bezzini, Beatrice, Biolzi, Bisecco, Alvino, Simona, Bonavita, Giovanna, Borriello, Chiara, Bosa, Antonio, Bosco, Francesca, Bovi, Marco, Bozzali, Laura, Brambilla, BRESCIA MORRA, Vincenzo, Maria, Buccafusca, Elisabetta, Bucciantini, Sebastiano, Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano, Calabrese, Francesca, Calabria, Francesca, Caleri, Federico, Camilli, Luisa Maria Caniatti, Roberto, Cantello, Ruggero, Capra, Rocco, Capuano, Patrizia, Carta, Maria Grazia Celani, Maria, Cellerino, Raffaella, Cerqua, Clara, Chisari, Raffaella, Clerici, Marinella, Clerico, Gaia, Cola, Antonella, Conte, Marta Zaffira Conti, Christian, Cordano, Susanna, Cordera, Francesco, Corea, Claudio, Correale, Salvatore, Cottone, Francesco, Crescenzo, Erica, Curti, Alessandro, D’Ambrosio, Emanuele, D’Amico, Maura Chiara Danni, Alessia, D’Arma, Vincenzo, Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Stefano, Fabio Maria Della Cava, Marco Della Cava, Sonia Di Lemme, Mario di Napoli, Alessia Di Sapio, Renato, Docimo, Anna, Dutto, Luana, Evangelista, Salvatore, Fanara, Roberta, Fantozzi, Diana, Ferraro, Maria Teresa Ferrò, Cristina, Fioretti, Mario, Fratta, Jessica, Frau, Marzia, Fronza, Roberto, Furlan, Alberto, Gajofatto, Gallo, Antonio, Paolo, Gallo, Claudio, Gasperini, Anna, Ghazaryan, Bruno, Giometto, Francesca, Gobbin, Flora, Govone, Franco, Granella, Erica, Grange, Grasso, MARIA GRAZIA, Grimaldi, Luigi M. E., Angelica, Guareschi, Clara, Guaschino, Simone, Guerrieri, Donata, Guidetti, Ina Barbara Juergenson, Pietro, Iaffaldano, Ianniello, Antonio, Luigi, Iasevoli, Daniele, Imperiale, Maria Teresa Infante, Iodice, Rosa, Iovino, Aniello, Giovanna, Konrad, Doriana, Landi, Caterina, Lapucci, Luigi, Lavorgna, Maria Rita L’Episcopo, Serena, Leva, Giuseppe, Liberatore, Marianna Lo Re, Marco, Longoni, Leonardo, Lopiano, Lorena, Lorefice, Matteo, Lucchini, Lus, Giacomo, Maimone, Davide, Maria, Malentacchi, Giulia, Mallucci, Simona, Malucchi, Chiara Rosa Mancinelli, Luca, Mancinelli, Paolo, Manganotti, Giorgia Teresa Maniscalco, Vittorio, Mantero, Sabrina, Marangoni, Damiano, Marastoni, Fabiana, Marinelli, Marti, NICOLA ALESSANDRO, Filippo Boneschi Martinelli, Zoli Federco Masserano, Francesca, Matta, Laura, Mendozzi, Giuseppe, Meucci, Silvia, Miante, Giuseppina, Miele, Eva, Milano, Massimiliano, Mirabella, Rosanna, Missione, Moccia, Marcello, Lucia, Moiola, Sara, Montepietra, Margherita, Montibragadin, Federico, Montini, Roberta, Motta, Raffaele, Nardone, Carolina Gabri Nicoletti, Eduardo, Nobile‐orazio, Nozzolillo, Agostino, Marco, Onofrj, Riccardo, Orlandi, Anna, Palmieri, Damiano, Paolicelli, Livia, Pasquali, Luisa, Pastò, Elisabetta, Pedrazzoli, Petracca, Maria, Alfredo, Petrone, Carlo, Piantadosi, Pietroboni, Anna M., Federica, Pinardi, Emilio, Portaccio, Mattia, Pozzato, Pozzilli, Carlo, Luca, Prosperini, Alessandra, Protti, Paolo, Ragonese, Sarah, Rasia, Sabrina, Realmuto, Anna, Repice, Eleonora, Rigoni, Maria Teresa Rilla, DELLA RATTA RINALDI, Francesca, Calogero Marcello Romano, Marco, Ronzoni, Marco, Rovari, Francesca, Ruscica, Loredana, Sabattini, Giuseppe, Salemi, Lorenzo, Saraceno, Alessia, Sartori, Arianna, Sartori, Elvira, Sbragia, Giuditta Ilaria Scarano, Valentina, Scarano, Maria, Sessa, Caterina, Sgarito, Sibilia, Grazia, Gabriele, Siciliano, Alessio, Signori, Signoriello, Elisabetta, Sinisi, Leonardo, Francesca, Sireci, Patrizia, Sola, Claudio, Solaro, Stefano, Sotgiu, Maddalena, Sparaco, Maria Laura Stromillo, Silvia, Strumia, Emanuela Laura Susani, Giulietta, Tabiadon, Francesco, Teatini, Valentina, Tomassini, Simone, Tonietti, Valentina, Torri, Tortorella, Carla, Simona, Toscano, Rocco, Totaro, Maria, Trotta, Gabriella, Turano, Monica, Ulivelli, Manzo, Valentino, Giovanna, Vaula, Domizia, Vecchio, Marco, Vercellino, Elena Pinuccia Verrengia, Marika, Vianello, Eleonora, Virgilio, Francesca, Vitetta, Vollaro, Stefano, Mauro, Zaffaroni, Mauro, Zampolini, Ignazio Roberto Zarbo, Antonio, Zito, and Luigi Zuliani, Schiavetti, I., Carmisciano, L., Ponzano, M., Cordioli, C., Cocco, E., Marfia, G. A., Inglese, M., Filippi, M., Radaelli, M., Bergamaschi, R., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Scandellari, C., Cavalla, P., Pesci, I., Confalonieri, P., Perini, P., Trojano, M., Lanzillo, R., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Abbadessa, G., Aguglia, U., Allegorico, L., Rossi Allegri, B. M., Alteno, A., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia Morra, V., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cola, G., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, F. M., Cava, M. D., Di Lemme, S., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Fantozzi, R., Ferraro, D., Ferro, M. T., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Furlan, R., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Grimaldi, L. M. E., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Juergenson, I. B., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Iodice, R., Iovino, A., Konrad, G., Landi, D., Lapucci, C., Lavorgna, L., L'Episcopo, M. R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, M., Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, G. T., Mantero, V., Marangoni, S., Marastoni, D., Marinelli, F., Marti, A., Boneschi Martinelli, F., Masserano, Z. F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, M., Missione, R., Moccia, M., Moiola, L., Montepietra, S., Montibragadin, M., Montini, F., Motta, R., Nardone, R., Gabri Nicoletti, C., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scarano, G. I., Scarano, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, E. L., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., and Zuliani, L.

Subjects
Multiple Sclerosis, Anosmia, Clinical Sciences, neurological disorders, Neurodegenerative, Settore MED/26, demyelinating disease, COVID-19, demyelinating diseases, disease-modifying treatment, multiple sclerosis, Humans, neurological disorder, Aged, Neurology & Neurosurgery, SARS-CoV-2, Pain Research, Neurosciences, Brain Disorders, Settore MED/26 - NEUROLOGIA, Good Health and Well Being, Neurology, multiple sclerosi, Neurology (clinical), MuSC-19 Study Group, Ageusia, Human
Abstract

Background and purpose: Clinical outcomes of multiple sclerosis (MS) patients affected by coronavirus disease 2019 (COVID-19) have been thoroughly investigated, but a further analysis on main signs and symptoms and their risk factors still needs attention. The objective of this study was to group together and describe based on similarity the most common signs and symptoms of COVID-19 in MS patients and identify all factors associated with their manifestation. Method: Logistic and linear regression models were run to recognize factors associated with each pooled group of symptoms and their total number. Results: From March 2020 to November 2021, data were collected from 1354 MS patients with confirmed infection of COVID-19. Ageusia and anosmia was less frequent in older people (odds ratio [OR] 0.98; p=0.005) and more in smoker patients (OR 1.39; p=0.049). Smoke was also associated with an incremental number of symptoms (OR 1.24; p=0.031), substance abuse (drugs or alcohol), conjunctivitis and rash (OR 5.20; p=0.042) and the presence of at least one comorbidity with shortness of breath, tachycardia or chest pain (OR 1.24; p=0.008). Some disease-modifying therapies were associated with greater frequencies of certain COVID-19 symptoms (association between anti-CD20 therapies and increment in the number of concomitant symptoms: OR 1.29; p=0.05). Differences in frequencies between the three waves were found for flu-like symptoms (G1, p=0.024), joint or muscle pain (G2, p=0.013) and ageusia and anosmia (G5, p < 0.001). All cases should be referred to variants up to Delta. Conclusion: Several factors along with the choice of specific therapeutic approaches might have a different impact on the occurrence of some COVID-19 symptoms.

Published
2022

27. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Canova, S., primary, Ceresoli, G.L., additional, Grosso, F., additional, Zucali, P.A., additional, Gelsomino, F., additional, Pasello, G., additional, Mencoboni, M., additional, Rulli, E., additional, Galli, F., additional, De Simone, I., additional, Carlucci, L., additional, De Angelis, A., additional, Belletti, M., additional, Bonomi, M., additional, D’Aveni, A., additional, Perrino, M., additional, Bono, F., additional, Cortinovis, D.L., additional, Cortinovis, D., additional, Canova, S., additional, Colonese, F., additional, Abbate, M.I., additional, Sala, L., additional, Sala, E., additional, Perez Gila, M., additional, Pagni, F., additional, Ugo, F., additional, De Vincenzo, F., additional, Santoro, A., additional, Ardizzoni, A., additional, Frega, S., additional, D’Incalci, M., additional, Poli, D., additional, and Torri, V., additional

Published
2022
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29. 1232P Assessing uncertainty and vulnerability of clinical trials with immune-checkpoint inhibitors and chemotherapy (ICI+CT) in early stage non-small cell lung cancer (NSCLC) by informative censoring and survival inferred fragility index (SIFI)

Author

Nuccio, A., Salomone, F., Viscardi, G., Venanzi, F.M., Bulotta, A., Ogliari, F.R., Oresti, S., Riva, S.T., Mollica, L., Viganò, M.G., Passaretti, F., Ravasi, M., Papotto, L., Ferrara, M., Ricciuti, B., Veronesi, G., Cascone, T., Garassino, M.C., Torri, V., and Ferrara, R.

Published
2024
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30. Trabectedin in Malignant Pleural Mesothelioma: Results From the Multicentre, Single Arm, Phase II ATREUS Study

Author

Cortinovis, D, Grosso, F, Carlucci, L, Zucali, P, Pasello, G, Tiseo, M, Sperandi, F, Hollander, L, Galli, F, Torri, V, Rulli, E, Canova, S, Maconi, A, Bidoli, P, Ceresoli, G, D'Incalci, M, Cortinovis D., Grosso F., Carlucci L., Zucali P. A., Pasello G., Tiseo M., Sperandi F., Hollander L., Galli F., Torri V., Rulli E., Canova S., Maconi A., Bidoli P., Ceresoli G. L., D'Incalci M., Cortinovis, D, Grosso, F, Carlucci, L, Zucali, P, Pasello, G, Tiseo, M, Sperandi, F, Hollander, L, Galli, F, Torri, V, Rulli, E, Canova, S, Maconi, A, Bidoli, P, Ceresoli, G, D'Incalci, M, Cortinovis D., Grosso F., Carlucci L., Zucali P. A., Pasello G., Tiseo M., Sperandi F., Hollander L., Galli F., Torri V., Rulli E., Canova S., Maconi A., Bidoli P., Ceresoli G. L., and D'Incalci M.

Abstract

ATREUS was a phase II, single arm, multicenter study aimed at exploring the activity and safety of trabectedin in 78 epithelioid patients and 67 nonepithelioid patients with unresectable malignant pleural mesothelioma. Trabectedin showed modest clinical activity, at the expense of relevant liver toxicity. Introduction: New therapeutic approaches in unresectable malignant pleural mesothelioma (MPM) are eagerly awaited. Trabectedin is an antitumor agent with an effect on cancer cell proliferation and a modulating action on tumor microenvironment. The ATREUS study explored the activity and safety of trabectedin in patients with unresectable MPM. Methods: Epithelioid patients with MPM received trabectedin as second-line while biphasic/sarcomatoid patients with MPM as first- or second-line therapy. Treatment was given intravenously at an initially planned dose of 1.3 mg/m(2) every 3 weeks, until progression or unacceptable toxicity. The primary endpoint was progression-free survival rate at 12 weeks (PFS12wks). Results: Overall, 78 patients (54%) had epithelioid and 67 (46%) nonepithelioid MPM. PFS12wks in 62 evaluable patients with epithelioid MPM was 43.5% (80% confidence interval 34.9%-52.5%); median progression-free and overall survival were 2.4 and 9.0 months, respectively. PFS12wks in 52 evaluable patients with nonepithelioid MPM was 30.8% (90% confidence interval 20.3%-42.9%); median progression-free and overall survival were 1.7 and 5.4 months. Trabectedin starting dose was amended due to excess of liver toxicity. Eighty-four (64%) and 48 (36%) patients received 1.3 mg/m(2 )and 1.1. mg/m(2), respectively. The most common grade 3-4 toxicities were hepatotoxicity, leukopenia/neutropenia, and fatigue. Grade 3-4 hepatotoxicity was reported in 59 (70%) patients treated at 1.3 mg/m(2), and in 19 (40%) treated at 1.1 mg/m(2). Conclusions: Trabectedin showed modest clinical activity, at the expense of relevant liver toxicity. Further development of this drug in MPM at fu

Published
2021

31. Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study

Author

Cazzaniga, M, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Di Mauro, P, Cogliati, V, Capici, S, Clivio, L, Torri, V, Cazzaniga M. E., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Di Mauro P., Cogliati V., Capici S., Clivio L., Torri V., Cazzaniga, M, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Di Mauro, P, Cogliati, V, Capici, S, Clivio, L, Torri, V, Cazzaniga M. E., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Di Mauro P., Cogliati V., Capici S., Clivio L., and Torri V.

Abstract

Purpose: Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods: We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%). Results: Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9–7.2) and 12.1 months (95% CI: 9.6–16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0–18.4), 6.1 months (95% CI: 4.0–8.9) for CTX-based and 5.3 months (95% CI: 4.1–9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3–16.7 and CTX-based ones (95%CI: 8.7–52.8). Tumour response, PFS and OS decreased proportionally in later lines. Conclusion: This analysis represents the largest series of TNBC patients treated with mCHT in

Published
2021

32. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., Torri V., Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., and Torri V.

Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study. Results: Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98–1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12–1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26–1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96–1.70; p = 0.089) for CSS. Conclusions: Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.

Published
2021

33. Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., Mustacchi G., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., and Mustacchi G.

Abstract

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35-82) for the EVA and 57.8 years (range 35.0-82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1-48) and 12.4 months (range 2.9-70.0) in the two data sets, respectively. Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Published
2020

34. Implementing clinical practice guidelines: time to assess it

Author

Sessa, C, Colombo, N, Creutzberg, C, Concin, N, Wimberger, P, Curigliano, G, Marinoni, K, Douillard, J, Pentheroudakis, G, Torri, V, Rauh, S, Sessa C., Colombo N., Creutzberg C. L., Concin N., Wimberger P., Curigliano G., Marinoni K., Douillard J. -Y., Pentheroudakis G., Torri V., Rauh S., Sessa, C, Colombo, N, Creutzberg, C, Concin, N, Wimberger, P, Curigliano, G, Marinoni, K, Douillard, J, Pentheroudakis, G, Torri, V, Rauh, S, Sessa C., Colombo N., Creutzberg C. L., Concin N., Wimberger P., Curigliano G., Marinoni K., Douillard J. -Y., Pentheroudakis G., Torri V., and Rauh S.

Published
2020

35. How Age, Comorbidities and Concomitant Medications Influence Ibrutinib Management and Survival in Waldenstrom Macroglobulinemia

Author

Frustaci, A, Piazza, F, Ferrero, S, Reda, G, Rizzi, R, Orsucci, L, Ferrarini, I, Deodato, M, Laurenti, L, Puccini, B, Barate, C, Varettoni, M, Merli, M, Cencini, E, Greco, A, Gini, G, Ferrari, A, Borella, C, Lista, E, Gentile, M, Murru, R, Motta, M, Rezzonico, F, Tani, M, Sportoletti, P, Zamprogna, G, Torri, V, Cairoli, R, Tedeschi, A, Frustaci, A, Piazza, F, Ferrero, S, Reda, G, Rizzi, R, Orsucci, L, Ferrarini, I, Deodato, M, Laurenti, L, Puccini, B, Barate, C, Varettoni, M, Merli, M, Cencini, E, Greco, A, Gini, G, Ferrari, A, Borella, C, Lista, E, Gentile, M, Murru, R, Motta, M, Rezzonico, F, Tani, M, Sportoletti, P, Zamprogna, G, Torri, V, Cairoli, R, and Tedeschi, A

Published
2022

36. Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis: short-term and long-term outcomes from the CHECK study - protocol for a randomised, multicentre, phase 3 trial

Author

Pacelli, Fabio, Gerardi, C., Rulli, Eleonora, Abatini, C., Rotolo, S., Garattini, Silvio, Melotti, G., Torri, V., Galli, F., Di Giorgio, Andrea, Pacelli F. (ORCID:0000-0002-2013-6525), Rulli E., Garattini S., Di Giorgio A., Pacelli, Fabio, Gerardi, C., Rulli, Eleonora, Abatini, C., Rotolo, S., Garattini, Silvio, Melotti, G., Torri, V., Galli, F., Di Giorgio, Andrea, Pacelli F. (ORCID:0000-0002-2013-6525), Rulli E., Garattini S., and Di Giorgio A.

Abstract

Introduction Up to one-fifth of patients with colorectal cancer will develop peritoneal metastases, frequently without other districts' involvement. Despite the recent unsuccesses of hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer peritoneal metastases treatment, the rationale in the prophylactic setting remains strong. Several clinical and pharmacokinetic data suggest that the efficacy of intraperitoneal chemotherapy is highest when the disease is microscopic. However, robust evidence demonstrating whether the addition of HIPEC for high-risk colorectal cancers offers better control of local recurrence is lacking. Methods and analysis This is a multicentre randomised phase 3 trial comparing prophylactic surgery plus HIPEC CO2 with mitomycin, over standard surgical excision in patients with colorectal cancer at high risk of peritoneal carcinomatosis; 388 patients will be included in this study. The primary objective is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 with mitomycin and standard surgery in terms of local recurrence-free survival. The main secondary endpoints are disease-free survival (DFS), overall survival (OS) and safety. The primary endpoint will be described with a cumulative incidence function and will be analysed with Grey test to take account of the competing risks. DFS and OS will be described with the Kaplan-Meier method. Ethics and dissemination This trial has been evaluated by the Italian Medicines Agency, local ethics committees and will be submitted to the Ministry of Health to notify the start of the trial according to the regulation of trials on devices with CE mark/certification. The results will be submitted for presentation at academic meetings and for publication in a peer-reviewed journal, whatever the findings. Trial registration number NCT03914820.

Published
2022

37. Signs and symptoms of COVID-19 in patients with multiple sclerosis

Author

Schiavetti, I., Carmisciano, L., Ponzano, M., Cordioli, C., Cocco, E., Marfia, G. A., Inglese, M., Filippi, M., Radaelli, M., Bergamaschi, R., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Scandellari, C., Cavalla, P., Pesci, I., Confalonieri, P., Perini, P., Trojano, M., Lanzillo, R., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Abbadessa, G., Aguglia, U., Allegorico, L., Rossi Allegri, B. M., Alteno, A., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia Morra, V., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cola, G., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, F. M., Cava, M. D., Di Lemme, S., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Fantozzi, R., Ferraro, D., Ferro, M. T., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Furlan, R., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Grimaldi, L. M. E., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Juergenson, I. B., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Iodice, R., Iovino, A., Konrad, G., Landi, D., Lapucci, C., Lavorgna, L., L'Episcopo, M. R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, G. T., Mantero, V., Marangoni, S., Marastoni, D., Marinelli, F., Marti, A., Boneschi Martinelli, F., Masserano, Z. F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Moiola, L., Montepietra, S., Montibragadin, M., Montini, F., Motta, R., Nardone, R., Gabri Nicoletti, C., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scarano, G. I., Scarano, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, E. L., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), Mirabella M. (ORCID:0000-0002-7783-114X), Schiavetti, I., Carmisciano, L., Ponzano, M., Cordioli, C., Cocco, E., Marfia, G. A., Inglese, M., Filippi, M., Radaelli, M., Bergamaschi, R., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Scandellari, C., Cavalla, P., Pesci, I., Confalonieri, P., Perini, P., Trojano, M., Lanzillo, R., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Abbadessa, G., Aguglia, U., Allegorico, L., Rossi Allegri, B. M., Alteno, A., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia Morra, V., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cola, G., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, F. M., Cava, M. D., Di Lemme, S., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Fantozzi, R., Ferraro, D., Ferro, M. T., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Furlan, R., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Grimaldi, L. M. E., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Juergenson, I. B., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Iodice, R., Iovino, A., Konrad, G., Landi, D., Lapucci, C., Lavorgna, L., L'Episcopo, M. R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, G. T., Mantero, V., Marangoni, S., Marastoni, D., Marinelli, F., Marti, A., Boneschi Martinelli, F., Masserano, Z. F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Moiola, L., Montepietra, S., Montibragadin, M., Montini, F., Motta, R., Nardone, R., Gabri Nicoletti, C., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scarano, G. I., Scarano, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, E. L., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), and Mirabella M. (ORCID:0000-0002-7783-114X)

Abstract

Background and purpose Clinical outcomes of multiple sclerosis (MS) patients affected by coronavirus disease 2019 (COVID-19) have been thoroughly investigated, but a further analysis on main signs and symptoms and their risk factors still needs attention. The objective of this study was to group together and describe based on similarity the most common signs and symptoms of COVID-19 in MS patients and identify all factors associated with their manifestation. Method Logistic and linear regression models were run to recognize factors associated with each pooled group of symptoms and their total number. Results From March 2020 to November 2021, data were collected from 1354 MS patients with confirmed infection of COVID-19. Ageusia and anosmia was less frequent in older people (odds ratio [OR] 0.98; p = 0.005) and more in smoker patients (OR 1.39; p = 0.049). Smoke was also associated with an incremental number of symptoms (OR 1.24; p = 0.031), substance abuse (drugs or alcohol), conjunctivitis and rash (OR 5.20; p = 0.042) and the presence of at least one comorbidity with shortness of breath, tachycardia or chest pain (OR 1.24; p = 0.008). Some disease-modifying therapies were associated with greater frequencies of certain COVID-19 symptoms (association between anti-CD20 therapies and increment in the number of concomitant symptoms: OR 1.29; p = 0.05). Differences in frequencies between the three waves were found for flu-like symptoms (G1, p = 0.024), joint or muscle pain (G2, p = 0.013) and ageusia and anosmia (G5, p < 0.001). All cases should be referred to variants up to Delta. Conclusion Several factors along with the choice of specific therapeutic approaches might have a different impact on the occurrence of some COVID-19 symptoms.

Published
2022

41. Corrigendum to “International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer”

Author

Novello, S., primary, Torri, V., additional, Grohe, C., additional, Kurz, S., additional, Serke, M., additional, Wehler, T., additional, Meyer, A., additional, Ladage, D., additional, Geissler, M., additional, Colantonio, I., additional, Cauchi, C., additional, Stoelben, E., additional, Ceribelli, A., additional, Kropf-Sanchen, C., additional, Valmadre, G., additional, Borra, G., additional, Schena, M., additional, Morabito, A., additional, Santo, A., additional, Gregorc, V., additional, Chiari, R., additional, Reck, M., additional, Schmid-Bindert, G., additional, Folprecht, G., additional, Griesinger, F., additional, Follador, A., additional, Pedrazzoli, P., additional, Bearz, A., additional, Caffo, O., additional, Dickgreber, N.J., additional, Irtelli, L., additional, Wiest, G., additional, Monica, V., additional, Porcu, L., additional, Manegold, C., additional, and Scagliotti, G.V., additional

Published
2022
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42. COVID-19 in patients with thoracic malignancies (TERAVOLT): first results of an international, registry-based, cohort study

Author

Garassino, M.C., Whisenant, J.G., Huang, L.C., Trama, A., Torri, V., Agustoni, F., Baena, J., Banna, G., Berardi, R., Bettini, A.C., Bria, E., Brighenti, M., Cadranel, J., Toma, A. De, Chini, C., Cortellini, A., Felip, E., Finocchiaro, G., Garrido, P., Genova, C., Giusti, R., Gregorc, V., Grossi, F., Grosso, F., Intagliata, S., Verde, N. La, Liu, S.V., Mazieres, J., Mercadante, E., Michielin, O., Minuti, G., Moro-Sibilot, D., Pasello, G., Passaro, A., Scotti, V., Solli, P., Stroppa, E., Tiseo, M., Viscardi, G., Voltolini, L., Wu, Y.L., Zai, S., Pancaldi, V., Dingemans, A.M., Meerbeeck, J. Van, Barlesi, F., Wakelee, H., Schuurbiers, O.C.J., Peters, S., Horn, L., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Pulmonologie, MUMC+: MA Med Staf Spec Longziekten (9), Pulmonary Medicine, TERAVOLT investigators, and TERAVOLT Investigators

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Aged, Betacoronavirus, Cause of Death, Coronavirus Infections, Cross-Sectional Studies, Female, Hospitalization, Humans, Longitudinal Studies, Middle Aged, Pandemics, Pneumonia, Viral, Registries, Risk Factors, Thoracic Neoplasms, COVID-19, Pneumonia, Viral, SARS-CoV-2, Article, 03 medical and health sciences, 0302 clinical medicine, Disease registry, Intensive care, Internal medicine, medicine, Medical history, Risk factor, Lung cancer, business.industry, Mortality rate, Cancer, Coronavirus Infections/epidemiology, Coronavirus Infections/mortality, Coronavirus Infections/pathology, Hospitalization/statistics & numerical data, Pneumonia, Viral/epidemiology, Pneumonia, Viral/mortality, Pneumonia, Viral/pathology, Registries/statistics & numerical data, Thoracic Neoplasms/epidemiology, Thoracic Neoplasms/mortality, Thoracic Neoplasms/pathology, Thoracic Neoplasms/therapy, medicine.disease, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Human medicine, business, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], Cohort study
Abstract

Contains fulltext : 229846.pdf (Publisher’s version ) (Closed access) BACKGROUND: Early reports on patients with cancer and COVID-19 have suggested a high mortality rate compared with the general population. Patients with thoracic malignancies are thought to be particularly susceptible to COVID-19 given their older age, smoking habits, and pre-existing cardiopulmonary comorbidities, in addition to cancer treatments. We aimed to study the effect of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on patients with thoracic malignancies. METHODS: The Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry is a multicentre observational study composed of a cross-sectional component and a longitudinal cohort component. Eligibility criteria were the presence of any thoracic cancer (non-small-cell lung cancer [NSCLC], small-cell lung cancer, mesothelioma, thymic epithelial tumours, and other pulmonary neuroendocrine neoplasms) and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms. Patients of any age, sex, histology, or stage were considered eligible, including those in active treatment and clinical follow-up. Clinical data were extracted from medical records of consecutive patients from Jan 1, 2020, and will be collected until the end of pandemic declared by WHO. Data on demographics, oncological history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes were collected. Associations between demographic or clinical characteristics and outcomes were measured with odds ratios (ORs) with 95% CIs using univariable and multivariable logistic regression, with sex, age, smoking status, hypertension, and chronic obstructive pulmonary disease included in multivariable analysis. This is a preliminary analysis of the first 200 patients. The registry continues to accept new sites and patient data. FINDINGS: Between March 26 and April 12, 2020, 200 patients with COVID-19 and thoracic cancers from eight countries were identified and included in the TERAVOLT registry; median age was 68.0 years (61.8-75.0) and the majority had an Eastern Cooperative Oncology Group performance status of 0-1 (142 [72%] of 196 patients), were current or former smokers (159 [81%] of 196), had non-small-cell lung cancer (151 [76%] of 200), and were on therapy at the time of COVID-19 diagnosis (147 [74%] of 199), with 112 (57%) of 197 on first-line treatment. 152 (76%) patients were hospitalised and 66 (33%) died. 13 (10%) of 134 patients who met criteria for ICU admission were admitted to ICU; the remaining 121 were hospitalised, but were not admitted to ICU. Univariable analyses revealed that being older than 65 years (OR 1.88, 95% 1.00-3.62), being a current or former smoker (4.24, 1.70-12.95), receiving treatment with chemotherapy alone (2.54, 1.09-6.11), and the presence of any comorbidities (2.65, 1.09-7.46) were associated with increased risk of death. However, in multivariable analysis, only smoking history (OR 3.18, 95% CI 1.11-9.06) was associated with increased risk of death. INTERPRETATION: With an ongoing global pandemic of COVID-19, our data suggest high mortality and low admission to intensive care in patients with thoracic cancer. Whether mortality could be reduced with treatment in intensive care remains to be determined. With improved cancer therapeutic options, access to intensive care should be discussed in a multidisciplinary setting based on cancer specific mortality and patients' preference. FUNDING: None.

Published
2020
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46. International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer

Author

Novello, S., primary, Torri, V., additional, Grohe, C., additional, Kurz, S., additional, Serke, M., additional, Wehler, T., additional, Meyer, A., additional, Ladage, D., additional, Geissler, M., additional, Colantonio, I., additional, Cauchi, C., additional, Stoelben, E., additional, Ceribelli, A., additional, Kropf-Sanchen, C., additional, Valmadre, G., additional, Borra, G., additional, Schena, M., additional, Morabito, A., additional, Santo, A., additional, Gregorc, V., additional, Chiari, R., additional, Reck, M., additional, Schmid-Bindert, G., additional, Folprecht, G., additional, Griesinger, F., additional, Follador, A., additional, Pedrazzoli, P., additional, Bearz, A., additional, Caffo, O., additional, Dickgreber, N.J., additional, Irtelli, L., additional, Wiest, G., additional, Monica, V., additional, Porcu, L., additional, Manegold, C., additional, and Scagliotti, G.V., additional

Published
2022
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49. 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
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50. Pan-European Expert Meeting on the Use of Metronomic Chemotherapy in Advanced Breast Cancer Patients: The PENELOPE Project

Author

Cazzaniga, M, Munzone, E, Bocci, G, Afonso, N, Gomez, P, Langkjer, S, Petru, E, Pivot, X, Sanchez Rovira, P, Wysocki, P, Torri, V, Cazzaniga M. E., Munzone E., Bocci G., Afonso N., Gomez P., Langkjer S., Petru E., Pivot X., Sanchez Rovira P., Wysocki P., Torri V., Cazzaniga, M, Munzone, E, Bocci, G, Afonso, N, Gomez, P, Langkjer, S, Petru, E, Pivot, X, Sanchez Rovira, P, Wysocki, P, Torri, V, Cazzaniga M. E., Munzone E., Bocci G., Afonso N., Gomez P., Langkjer S., Petru E., Pivot X., Sanchez Rovira P., Wysocki P., and Torri V.

Abstract

Introduction: Metronomic chemotherapy (mCHT) is a treatment regimen in which drugs are administered frequently or continuously and that maintains low, prolonged, and pharmacologically active plasma concentrations of drugs to avoid toxicity associated with traditional chemotherapy regimens, while achieving tumor response. Despite the increasing use of mCHT in patients with metastatic breast cancer (MBC) and the endorsement of mCHT in guidelines, no consensus exists about which patients may substantially benefit from mCHT, which agents can be recommended, and in which treatment setting mCHT is most appropriate. Methods: In October 2017, ten international experts in the management of breast cancer convened to develop a report describing the current status of the use of mCHT for the treatment of advanced breast cancer, based not only on current literature but also on their opinion. The Delphi method was used to reach consensus. Results: A full consensus was reached concerning the acknowledgement that mCHT is not simply a different way of administering chemotherapy but a truly new treatment option. The best-known effect of mCHT is on angiogenesis inhibition, but exciting new data are on the way regarding potential activity on immune system activation. The experts strongly suggest that the ideal patients for mCHT are those with hormone receptor (HR)-positive tumors or those with triple-negative disease. Independently of HR status, mCHT could be an advantageous option for elderly patients, who are often under-treated simply because of their age. Conclusion: Current data support the use of mCHT in selected patients with MBC. Funding: Pierre Fabre.

Published
2019

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