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22 results on '"Leo, Luigi"'

1. First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study— ENCORE

Author

Le Tourneau, Christophe, primary, Ghiani, Massimo, additional, Cau, Maria Chiara, additional, Depenni, Roberta, additional, Ronzino, Graziana, additional, Bonomo, Pierluigi, additional, Montesarchio, Vincenzo, additional, Leo, Luigi, additional, Schulten, Jeltje, additional, Salmio, Satu, additional, Messinger, Diethelm, additional, Sbrana, Andrea, additional, Borcoman, Edith, additional, and Ghi, Maria Grazia, additional

Published
2023
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2. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Di Maggio, Gabriele, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, Aieta, Michele, Ciardiello, F., Normanno, N., Martinelli, E., Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A.R., Rachiglio, M., Lambiase, M., Latiano, T.P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., and Maiello, E.

Published
2016
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3. Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial

Author

Martinelli, E., Cardone, C., Troiani, T., Normanno, N., Pisconti, S., Sforza, V., Bordonaro, A.R., Rachiglio, A.M., Lambiase, M., Latiano, T.P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., Maiello, E., Ciardiello, F., Iaffaioli, Vincenzo, Nasti, Guglielmo, Nappi, Anna, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Maggio, GabrieleDi, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, and Aieta, Michele

Published
2016
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4. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Ciardiello, F., Normanno, N., Martinelli, E., Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A. R., Rachiglio, M., Lambiase, M., Latiano, T. P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., Maiello, E., Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Di Maggio, Gabriele, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, and Aieta, Michele

Published
2016
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6. Eribulin in combination with bevacizumab as second-line treatment for HER2–negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI)

Author

DE ANGELIS, CARMINE, primary, Bruzzese, Dario, additional, Bernardo, Antonio, additional, Baldini, Editta, additional, Leo, Luigi, additional, Fabi, Alessandra, additional, Gamucci, Teresa, additional, De Placido, Pietro, additional, Poggio, Francesca, additional, Russo, Stefania, additional, Forestieri, Valeria, additional, Lauria, Rossella, additional, De Santo, Irene, additional, Michelotti, Andrea, additional, Mastro, Lucia Del, additional, De Laurentiis, Michelino, additional, Giuliano, Mario, additional, De Placido, Sabino, additional, and Arpino, Grazia, additional

Published
2020
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12. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study

Author

Del Prete, Salvatore, primary, Cennamo, Gregorio, additional, Leo, Luigi, additional, Montella, Liliana, additional, Vincenzi, Bruno, additional, Biglietto, Maria, additional, Andreozzi, Francesca, additional, Prudente, Antonella, additional, Iodice, Patrizia, additional, Savastano, Clementina, additional, Nappi, Anna, additional, Montesarchio, Vincenzo, additional, and Addeo, Raffaele, additional

Published
2017
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13. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): A randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Ciardiello, F, Normanno, N., Martinelli, Enrica, Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A. R., Rachiglio, M., Lambiase, Marianna, Latiano, Tiziana Pia, Modoni, G., Cordio, S., Giuliani, Franca, Biglietto, M., Montesarchio, V., Barone, Carlo Antonio, Tonini, Giuliana Bianca, Cinieri, S., Febbraro, A., Rizzi, Davide, Vita, F. De, Orditura, M., Colucci, Fabiola Giulia, Maiello, E., Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Maggio, Gabriele Di, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, Aieta, Michele, Cassano, Alessandra (ORCID:0000-0002-3311-7163), Ciardiello, F, Normanno, N., Martinelli, Enrica, Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A. R., Rachiglio, M., Lambiase, Marianna, Latiano, Tiziana Pia, Modoni, G., Cordio, S., Giuliani, Franca, Biglietto, M., Montesarchio, V., Barone, Carlo Antonio, Tonini, Giuliana Bianca, Cinieri, S., Febbraro, A., Rizzi, Davide, Vita, F. De, Orditura, M., Colucci, Fabiola Giulia, Maiello, E., Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Maggio, Gabriele Di, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, Aieta, Michele, and Cassano, Alessandra (ORCID:0000-0002-3311-7163)

Abstract

Background: Cetuximab plus chemotherapy is a first-line treatment option in metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients. No data are currently available on continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression. Patients and methods: We did this open-label, 1:1 randomized phase II trial at 25 hospitals in Italy to evaluate the efficacy of cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) as second-line treatment of KRAS exon 2 wild-type metastatic CRC patients treated in first line with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab. Patients received FOLFOX plus cetuximab (arm A) or FOLFOX (arm B). Primary end point was progressionfree survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis. Results: Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B). Median PFS was 6.4 [95% confidence interval (CI) 4.7-8.0] versus 4.5 months (95% CI 3.3-5.7); [hazard ratio (HR), 0.81; 95% CI 0.58-1.12; P = 0.19], respectively. NGS was performed in 117/153 (76.5%) cases; 66/117 patients (34 in arm A and 32 in arm B) had KRAS, NRAS, BRAF and PIK3CA wild-type tumours. For these patients, PFS was longer in the FOLFOX plus cetuximab arm [median 6.9 (95% CI 5.5-8.2) versus 5.3 months (95% CI 3.7-6.9); HR, 0.56 (95% CI 0.33-0.94); P = 0.025]. There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056]. Conclusions: Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials.

Published
2016

17. Impact of anemia management with EPO on psychologic distress in cancer patients: results of a multicenter patient survey

Author

Del Prete, Salvatore, primary, Cinieri, Saverio, additional, Lorusso, Vito, additional, Maiorino, Luigi, additional, Pizza, Carmine, additional, Pisano, Agata, additional, Montesarchio, Vincenzo, additional, Leo, Luigi, additional, Savastano, Clementina, additional, Pistolese, Giuseppe, additional, Bianco, Maddalena, additional, Mabilia, Roberto, additional, Tonachella, Riccardo, additional, Febbraro, Antonio, additional, Manzione, Luigi, additional, Palazzo, Salvatore, additional, Filippelli, Gianfranco, additional, Vincenzi, Bruno, additional, Barbato, Enrico, additional, Cennamo, Gregorio, additional, Riccardi, Ferdinando, additional, Misso, Gabriella, additional, Caraglia, Michele, additional, and Addeo, Raffaele, additional

Published
2014
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18. Beta-erythropoietin in clinical practice: GOIM 2705 multicenter observational study

Author

Addeo, Raffaele, primary, Cennamo, Gregorio, additional, Maiorino, Luigi, additional, Pizza, Carmine, additional, Pisano, Agata, additional, Leo, Luigi, additional, Bianco, Maddalena, additional, Lambiase, Nicola, additional, Vincenzi, Bruno, additional, Cinieri, Saverio, additional, Lorusso, Vito, additional, Gebbia, Vittorio, additional, Filippelli, Giancarlo, additional, Barbato, Enrico, additional, Febbraro, Antonio, additional, Mabilia, Roberto, additional, Savastano, Clementina, additional, Pistolese, Giuseppe, additional, Manzione, Luigi, additional, Montesarchio, Vincenzo, additional, Giotta, Francesco, additional, and Del Prete, Salvatore, additional

Published
2008
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22. Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial.

Author

Martinelli E, Cardone C, Troiani T, Normanno N, Pisconti S, Sforza V, Bordonaro AR, Rachiglio AM, Lambiase M, Latiano TP, Modoni G, Cordio S, Giuliani F, Biglietto M, Montesarchio V, Barone C, Tonini G, Cinieri S, Febbraro A, Rizzi D, De Vita F, Orditura M, Colucci G, Maiello E, Ciardiello F, Iaffaioli V, Nasti G, Nappi A, Botti G, Tatangelo F, Chicchinelli N, Montrone M, Sebastio A, Guarino T, Simone G, Graziano P, Chiarazzo C, Maggio G, Longhitano L, Manusia M, Cartenì G, Nappi O, Micheli P, Leo L, Rossi S, Cassano A, Tommaselli E, Giordano G, Sponziello F, Marino A, Rinaldi A, Romito S, Muda AO, Lorusso V, Leo S, Barni S, Grimaldi G, and Aieta M

Abstract

Background: In the cetuximab after progression in KRAS wild-type colorectal cancer patients (CAPRI) trial patients with metastatic colorectal cancer (mCRC) received 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) and cetuximab in first line followed by 5-Fluorouracil, folinic acid, oxaliplatin (FOLFOX) with or without cetuximab until progression. Limited data are available on the efficacy and safety of anti-epidermal growth factor receptor (anti-EGFR) agents on elderly patients with mCRC. In the current study we evaluated the efficacy and safety of FOLFIRI plus cetuximab in age-defined subgroups., Methods: A post-hoc analysis was performed in CAPRI trial patients; outcomes (progression-free survival (PFS), overall response rate (ORR), safety) were analysed by age-groups and stratified according to molecular characterisation. 3 age cut-offs were used to define the elderly population (≥65; ≥70 and ≥75 years)., Results: 340 patients with mCRC were treated in first line with FOLFIRI plus cetuximab. Among those, 154 patients were >65 years, 86 >70 years and 35 >75 years. Next-generation sequencing (NGS) was performed in 182 patients. Among them, 87 patients were >65 years, 46 >70 and 17 >75. 104 of 182 patients were wild type (WT) for KRAS, NRAS, BRAF, PIK3CA genes. In the quadruple WT group, 51 patients were ≥65 years; 29 were ≥70; 9 were ≥75. Median PFS was similar within the age-subgroups in the intention-to-treat population, NGS cohort and quadruple WT patients, respectively. Likewise, ORR was not significantly different among age-subgroups in the 3 populations. Safety profile was acceptable and similarly reported among all age-groups, with the exception of grade ≥3 diarrhoea (55% vs 25%, p=0.04) and neutropaenia (75% vs 37%, p=0.03) in patients ≥75 years and grade ≥3 fatigue (31% vs 20%, p=0.01) in patients <75 years., Conclusions: Tolerability of cetuximab plus FOLFIRI was acceptable in elderly patients. Similar ORR and PFS were observed according to age-groups. No differences in adverse events were reported among the defined subgroups with the exception of higher incidence of grade ≥3 diarrhoea and neutropaenia in patients ≥75 years and grade ≥3 fatigue in patients <75 years., Trial Registration Number: 2009-014041-81., Competing Interests: Competing interests: None declared.

Published
2017
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