22 results on '"Laudadio, Lucio"'
Search Results
2. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial
- Author
-
Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Bisagni, Giancarlo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmela, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, and Perrone, Francesco
- Published
- 2018
- Full Text
- View/download PDF
3. Identification of Subgroups of Early Breast Cancer Patients at High Risk of Nonadherence to Adjuvant Hormone Therapy: Results of an Italian Survey
- Author
-
Tinari, Nicola, Fanizza, Caterina, Romero, Marilena, Gambale, Elisabetta, Moscetti, Luca, Vaccaro, Angela, Seminara, Patrizia, Longo, Flavia, Gori, Stefania, Vici, Patrizia, Gamucci, Teresa, Mauri, Mariella, Laudadio, Lucio, Nuzzo, Antonio, Fabbri, Maria Agnese, Fattoruso, Silvia Ileana, Mazzilli, Lorenzo, Grassadonia, Antonino, Cianchetti, Ettore, and Natoli, Clara
- Published
- 2015
- Full Text
- View/download PDF
4. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study
- Author
-
Arpino, Grazia, Michelotti, Andrea, Truini, Mauro, Montemurro, Filippo, Russo, Stefania, Palumbo, Raffaella, Zamagni, Claudio, Latorre, Agnese, Bruzzese, Dario, Riccardi, Ferdinando, De Laurentiis, Michelino, Beano, Alessandra, Biganzoli, Laura, Zaniboni, Alberto, Laudadio, Lucio, Malagoli, Maria, Bilancia, Domenico, Schettini, Francesco, Giuliano, Mario, Cazzaniga, Marina Elena, and De Placido, Sabino
- Published
- 2016
- Full Text
- View/download PDF
5. Letrozole combined with gonadotropin-releasing hormone analog for metastatic male breast cancer
- Author
-
Di Lauro, Luigi, Vici, Patrizia, Del Medico, Pietro, Laudadio, Lucio, Tomao, Silverio, Giannarelli, Diana, Pizzuti, Laura, Sergi, Domenico, Barba, Maddalena, and Maugeri-Saccà, Marcello
- Published
- 2013
- Full Text
- View/download PDF
6. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience
- Author
-
Pizzuti, Laura, Giordano, Antonio, Michelotti, Andrea, Mazzotta, Marco, Natoli, Clara, Gamucci, Teresa, De Angelis, Claudia, Landucci, Elisabetta, Diodati, Lucrezia, Iezzi, Laura, Mentuccia, Lucia, Fabbri, Agnese, Barba, Maddalena, Sanguineti, Giuseppe, Marchetti, Paolo, Tomao, Silverio, Mariani, Luciano, Paris, Ida, Lorusso, Vito, Vallarelli, Simona, Cassano, Alessandra, Airoldi, Francesca, Orlandi, Armando, Moscetti, Luca, Sergi, Domenico, Sarobba, Maria Giuseppina, Tonini, Giuseppe, Santini, Daniele, Sini, Valentina, Veltri, Enzo, Vaccaro, Angela, Ferrari, Laura, De Tursi, Michele, Tinari, Nicola, Grassadonia, Antonino, Greco, Filippo, Botticelli, Andrea, La Verde, Nicla, Zamagni, Claudio, Rubino, Daniela, Cortesi, Enrico, Magri, Valentina, Pomati, Giulia, Scagnoli, Simone, Capomolla, Elisabetta, Kayal, Ramy, Scinto, Angelo Fedele, Corsi, Domenico Cristiano, Cazzaniga, Marina, Laudadio, Lucio, Forciniti, Samantha, Mancini, Maria, Carbognin, Luisa, Seminara, Patrizia, Barni, Sandro, Samaritani, Riccardo, Roselli, Mario, Portarena, Ilaria, Dello Russo, Antonio, Ficorella, Corrado, Cannita, Katia, Carpano, Silvia, Pistelli, Mirco, Berardi, Rossana, De Maria Marchiano, Ruggero, Sperduti, Isabella, Ciliberto, Gennaro, Vici, Patrizia, Cassano, Alessandra (ORCID:0000-0002-3311-7163), Orlandi, Armando (ORCID:0000-0001-5253-4678), Corsi, Domenico, De Maria Marchiano, Ruggero (ORCID:0000-0003-2255-0583), Pizzuti, Laura, Giordano, Antonio, Michelotti, Andrea, Mazzotta, Marco, Natoli, Clara, Gamucci, Teresa, De Angelis, Claudia, Landucci, Elisabetta, Diodati, Lucrezia, Iezzi, Laura, Mentuccia, Lucia, Fabbri, Agnese, Barba, Maddalena, Sanguineti, Giuseppe, Marchetti, Paolo, Tomao, Silverio, Mariani, Luciano, Paris, Ida, Lorusso, Vito, Vallarelli, Simona, Cassano, Alessandra, Airoldi, Francesca, Orlandi, Armando, Moscetti, Luca, Sergi, Domenico, Sarobba, Maria Giuseppina, Tonini, Giuseppe, Santini, Daniele, Sini, Valentina, Veltri, Enzo, Vaccaro, Angela, Ferrari, Laura, De Tursi, Michele, Tinari, Nicola, Grassadonia, Antonino, Greco, Filippo, Botticelli, Andrea, La Verde, Nicla, Zamagni, Claudio, Rubino, Daniela, Cortesi, Enrico, Magri, Valentina, Pomati, Giulia, Scagnoli, Simone, Capomolla, Elisabetta, Kayal, Ramy, Scinto, Angelo Fedele, Corsi, Domenico Cristiano, Cazzaniga, Marina, Laudadio, Lucio, Forciniti, Samantha, Mancini, Maria, Carbognin, Luisa, Seminara, Patrizia, Barni, Sandro, Samaritani, Riccardo, Roselli, Mario, Portarena, Ilaria, Dello Russo, Antonio, Ficorella, Corrado, Cannita, Katia, Carpano, Silvia, Pistelli, Mirco, Berardi, Rossana, De Maria Marchiano, Ruggero, Sperduti, Isabella, Ciliberto, Gennaro, Vici, Patrizia, Cassano, Alessandra (ORCID:0000-0002-3311-7163), Orlandi, Armando (ORCID:0000-0001-5253-4678), Corsi, Domenico, and De Maria Marchiano, Ruggero (ORCID:0000-0003-2255-0583)
- Abstract
Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.
- Published
- 2019
7. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: A real‐world experience
- Author
-
Pizzuti, Laura, primary, Giordano, Antonio, additional, Michelotti, Andrea, additional, Mazzotta, Marco, additional, Natoli, Clara, additional, Gamucci, Teresa, additional, De Angelis, Claudia, additional, Landucci, Elisabetta, additional, Diodati, Lucrezia, additional, Iezzi, Laura, additional, Mentuccia, Lucia, additional, Fabbri, Agnese, additional, Barba, Maddalena, additional, Sanguineti, Giuseppe, additional, Marchetti, Paolo, additional, Tomao, Silverio, additional, Mariani, Luciano, additional, Paris, Ida, additional, Lorusso, Vito, additional, Vallarelli, Simona, additional, Cassano, Alessandra, additional, Aroldi, Francesca, additional, Orlandi, Armando, additional, Moscetti, Luca, additional, Sergi, Domenico, additional, Sarobba, Maria Giuseppina, additional, Tonini, Giuseppe, additional, Santini, Daniele, additional, Sini, Valentina, additional, Veltri, Enzo, additional, Vaccaro, Angela, additional, Ferrari, Laura, additional, De Tursi, Michele, additional, Tinari, Nicola, additional, Grassadonia, Antonino, additional, Greco, Filippo, additional, Botticelli, Andrea, additional, La Verde, Nicla, additional, Zamagni, Claudio, additional, Rubino, Daniela, additional, Cortesi, Enrico, additional, Magri, Valentina, additional, Pomati, Giulia, additional, Scagnoli, Simone, additional, Capomolla, Elisabetta, additional, Kayal, Ramy, additional, Scinto, Angelo Fedele, additional, Corsi, Domenico, additional, Cazzaniga, Marina, additional, Laudadio, Lucio, additional, Forciniti, Samantha, additional, Mancini, Maria, additional, Carbognin, Luisa, additional, Seminara, Patrizia, additional, Barni, Sandro, additional, Samaritani, Riccardo, additional, Roselli, Mario, additional, Portarena, Ilaria, additional, Russo, Antonio, additional, Ficorella, Corrado, additional, Cannita, Katia, additional, Carpano, Silvia, additional, Pistelli, Mirco, additional, Berardi, Rossana, additional, De Maria, Ruggero, additional, Sperduti, Isabella, additional, Ciliberto, Gennaro, additional, and Vici, Patrizia, additional
- Published
- 2018
- Full Text
- View/download PDF
8. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial
- Author
-
De Placido, Sabino, primary, Gallo, Ciro, additional, De Laurentiis, Michelino, additional, Bisagni, Giancarlo, additional, Arpino, Grazia, additional, Sarobba, Maria Giuseppa, additional, Riccardi, Ferdinando, additional, Russo, Antonio, additional, Del Mastro, Lucia, additional, Cogoni, Alessio Aligi, additional, Cognetti, Francesco, additional, Gori, Stefania, additional, Foglietta, Jennifer, additional, Frassoldati, Antonio, additional, Amoroso, Domenico, additional, Laudadio, Lucio, additional, Moscetti, Luca, additional, Montemurro, Filippo, additional, Verusio, Claudio, additional, Bernardo, Antonio, additional, Lorusso, Vito, additional, Gravina, Adriano, additional, Moretti, Gabriella, additional, Lauria, Rossella, additional, Lai, Antonella, additional, Mocerino, Carmela, additional, Rizzo, Sergio, additional, Nuzzo, Francesco, additional, Carlini, Paolo, additional, Perrone, Francesco, additional, Accurso, Antonello, additional, Agostara, Biagio, additional, Aieta, Michele, additional, Alabiso, Oscar, additional, Alicicco, Maria Grazia, additional, Amadori, Dino, additional, Amaducci, Laura, additional, Amiconi, Gianna, additional, Antuzzi, Giustino, additional, Ardine, Mara, additional, Ardizzoia, Antonio, additional, Aversa, Caterina, additional, Badalamenti, Giuseppe, additional, Barni, Sandro, additional, Basurto, Carlo, additional, Berardi, Rossana, additional, Bergamasco, Cinzia, additional, Bidoli, Paolo, additional, Bighin, Claudia, additional, Biondi, Edoardo, additional, Boni, Corrado, additional, Borgonovo, Karen, additional, Botta, Mario, additional, Bravi, Stefano, additional, Bruzzi, Paolo, additional, Buono, Giuseppe, additional, Butera, Alfredo, additional, Caldara, Alessia, additional, Candeloro, Giampiero, additional, Cappelletti, Claudia, additional, Cardalesi, Cinzia, additional, Carfora, Elisabetta, additional, Cariello, Anna, additional, Carrozza, Francesco, additional, Cartenì, Giacomo, additional, Caruso, Michele, additional, Casadei, Virginia, additional, Casanova, Claudia, additional, Castori, Luigi, additional, Cavanna, Luigi, additional, Cavazzini, Giovanna, additional, Cazzaniga, Marina, additional, Chilelli, Mario, additional, Chiodini, Paolo, additional, Chiorrini, Silvia, additional, Ciardiello, Fortunato, additional, Ciccarese, Mariangela, additional, Cinieri, Saverio, additional, Clerico, Mario, additional, Coccaro, Mariarosa, additional, Comande, Mario, additional, Corbo, Claudia, additional, Cortino, Giuseppina, additional, Cusenza, Stefania, additional, Daniele, Gennaro, additional, D'arco, Alfonso Maria, additional, D'auria, Giuliana, additional, Dazzi, Claudio, additional, De Angelis, Carmine, additional, de Braud, Filippo, additional, De Feo, Gianfranco, additional, De Matteis, Andrea, additional, De Tursi, Michele, additional, Di Blasio, Anna, additional, di Lucca, Giuseppe, additional, Di Lullo, Liberato, additional, Di Rella, Francesca, additional, Di Renzo, Gianfranco, additional, Di Stefano, Pia, additional, Di Stefano, Aida, additional, Diana, Anna, additional, Donati, Sara, additional, Fabbri, Agnese, additional, Fabi, Alessandra, additional, Faedi, Marina, additional, Farina, Gabriella, additional, Farris, Antonio, additional, Febbraro, Antonio, additional, Fedele, Palma, additional, Federico, Piera, additional, Ferraù, Francesco, additional, Ferretti, Gianluigi, additional, Ferro, Antonella, additional, Floriani, Irene, additional, Forcignanò, Rosachiara, additional, Forciniti, Samantha, additional, Forestieri, Valeria, additional, Fornari, Gianni, additional, Frisinghelli, Michela, additional, Fusco, Vittorio, additional, Gallizzi, Giulia, additional, Galvano, Antonio, additional, Gambardella, Antonio, additional, Gambi, Angelo, additional, Gebbia, Vittorio, additional, Gervasi, Erika, additional, Ghilardi, Mara, additional, Giacobino, Alice, additional, Giardina, Giovanni, additional, Giotta, Francesco, additional, Giraudi, Sara, additional, Giuliano, Mario, additional, Grassadonia, Antonino, additional, Grasso, Donatella, additional, Grosso, Federica, additional, Guizzaro, Lorenzo, additional, Incoronato, Pasquale, additional, Incorvaia, Lorena, additional, Iodice, Giovanni, additional, La Verde, Nicla, additional, Labonia, Vincenzo, additional, Landi, Gabriella, additional, Latorre, Agnese, additional, Leonardi, Vita, additional, Levaggi, Alessia, additional, Limite, Gennaro, additional, Lina Bascialla, Linda, additional, Livi, Lorenzo, additional, Maiello, Evaristo, additional, Mandelli, Daniela, additional, Marcon, Ilaria, additional, Menon, Daniela, additional, Montedoro, Michele, additional, Moraca, Lucia, additional, Moretti, Anna, additional, Morritti, Maria Grazia, additional, Morselli, Patrizia, additional, Mura, Antonella, additional, Mura, Silvia, additional, Musacchio, Michela, additional, Muzio, Alberto, additional, Natale, Donato, additional, Natoli, Clara, additional, Nigro, Cinzia, additional, Nisticò, Cecilia, additional, Nuzzo, Antonio, additional, Orditura, Michele, additional, Orlando, Laura, additional, Pacilio, Carmen, additional, Palumbo, Giuliano, additional, Palumbo, Raffaella, additional, Pasini, Felice, additional, Paterno, Emanuela, additional, Pazzola, Antonio, additional, Pelliccioni, Silvia, additional, Pensabene, Matilde, additional, Perroni, Davide, additional, Pesenti Gritti, Angela, additional, Petrelli, Fausto, additional, Piccirillo, Maria Carmela, additional, Pinotti, Graziella, additional, Pogliani, Claudia, additional, Poli, Davide, additional, Prader, Sonia, additional, Recchia, Francesco, additional, Rizzi, Daniele, additional, Romano, Carmen, additional, Rossello, Rosalba, additional, Rossini, Chiara, additional, Salvucci, Giuseppina, additional, Sanna, Valeria, additional, Santini, Alessandra, additional, Saracchini, Silvana, additional, Savastano, Clementina, additional, Scambia, Giovanni, additional, Schettini, Francesco, additional, Schiavone, Paola, additional, Schirone, Alessio, additional, Seles, Elena, additional, Signoriello, Simona, additional, Signoriello, Giuseppe, additional, Silva, Rosa Rita, additional, Silvestri, Antonia, additional, Simeon, Vittorio, additional, Spagnoletti, Ilaria, additional, Tamberi, Stefano, additional, Teragni, Cristina, additional, Thalmann, Verena, additional, Thomas, Renato, additional, Thomas, Guglielmo, additional, Tienghi, Amelia, additional, Tinari, Nicola, additional, Tinessa, Vincenza, additional, Tomei, Federica, additional, Tonini, Giuseppe, additional, Torri, Valter, additional, Traficante, Divina, additional, Tudini, Marianna, additional, Turazza, Monica, additional, Vignoli, Roberto, additional, Vitale, Maria Giuseppa, additional, Zacchia, Alessandra, additional, Zagarese, Pasquale, additional, Zanni, Alda, additional, Zavallone, Laura, additional, Zavettieri, Maria, additional, and Zoboli, Alessandra, additional
- Published
- 2018
- Full Text
- View/download PDF
9. A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: A real-world experience
- Author
-
Vici, Patrizia, Pizzuti, Laura, Michelotti, Andrea, Sperduti, Isabella, Natoli, Clara, Mentuccia, Lucia, Di Lauro, Luigi, Sergi, Domenico, Marchetti, Paolo, Santini, Daniele, Magnolfi, Emanuela, Iezzi, Laura, Moscetti, Luca, Fabbri, Agnese, Cassano, Alessandra, Grassadonia, Antonino, Omarini, Claudia, Piacentini, Federico, Botticelli, Andrea, Bertolini, Ilaria, Scinto, Angelo Fedele, Zampa, Germano, Mauri, Maria, D'Onofrio, Loretta, Sini, Valentina, Barba, Maddalena, Maugeri-saccã , Marcello, Rossi, Ernesto, Landucci, Elisabetta, Tomao, Silverio, Alberti, Antonio Maria, Giotta, Francesco, Ficorella, Corrado, Adamo, Vincenzo, Russo, Antonio, Lorusso, Vito, Cannita, Katia, Barni, Sandro, Laudadio, Lucio, Greco, Filippo, Garrone, Ornella, Della Giulia, Marina, Marolla, Paolo, Sanguineti, Giuseppe, Di Cocco, Barbara, Ciliberto, Gennaro, De Maria, Ruggero, Gamucci, Teresa, Vici, P., Pizzuti, L., Michelotti, A., Sperduti, I., Natoli, C., Mentuccia, L., Di Lauro, L., Sergi, D., Marchetti, P., Santini, D., Magnolfi, E., Iezzi, L., Moscetti, L., Fabbri, A., Cassano, A., Grassadonia, A., Omarini, C., Piacentini, F., Botticelli, A., Bertolini, I., Scinto, A., Zampa, G., Mauri, M., D'Onofrio, L., Sini, V., Barba, M., Maugeri-Saccà , M., Rossi, E., Landucci, E., Tomao, S., Alberti, A., Giotta, F., Ficorella, C., Adamo, V., Russo, A., Lorusso, V., Cannita, K., Barni, S., Laudadio, L., Greco, F., Garrone, O., Della Giulia, M., Marolla, P., Sanguineti, G., Di Cocco, B., Ciliberto, G., De Maria, R., and Gamucci, T.
- Subjects
0301 basic medicine ,Oncology ,HER2 positive ,real-world ,medicine.medical_specialty ,T-DM1 ,metastatic breast cancer ,previous pertuzumab ,Metastatic breast cancer ,Previous pertuzumab ,Real-world ,oncology ,ECOG Performance Status ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Settore MED/04 - PATOLOGIA GENERALE ,law ,Internal medicine ,Medicine ,Univariate analysis ,Settore MED/06 - ONCOLOGIA MEDICA ,business.industry ,Cancer ,medicine.disease ,Log-rank test ,trastuzumab ,030104 developmental biology ,chemistry ,Trastuzumab emtansine ,030220 oncology & carcinogenesis ,HER2 positive, Metastatic breast cancer, Previous pertuzumab, Real-world, T-DM1, Oncology ,Pertuzumab ,business ,medicine.drug ,Research Paper - Abstract
We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab-pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab-pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival benefit (p < 0.0001), while overall survival was positively affected by lower ECOG PS (p < 0.0001), absence of brain metastases (p 0.05), and clinical benefit (p < 0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to confirm and interpret our data on apparently lower T-DM1 efficacy when given as second-line treatment after pertuzumab, and on the optimal sequence order.
- Published
- 2017
10. A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience
- Author
-
Vici, Patrizia, primary, Pizzuti, Laura, additional, Michelotti, Andrea, additional, Sperduti, Isabella, additional, Natoli, Clara, additional, Mentuccia, Lucia, additional, Lauro, Luigi Di, additional, Sergi, Domenico, additional, Marchetti, Paolo, additional, Santini, Daniele, additional, Magnolfi, Emanuela, additional, Iezzi, Laura, additional, Moscetti, Luca, additional, Fabbri, Agnese, additional, Cassano, Alessandra, additional, Grassadonia, Antonino, additional, Omarini, Claudia, additional, Piacentini, Federico, additional, Botticelli, Andrea, additional, Bertolini, Ilaria, additional, Scinto, Angelo Fedele, additional, Zampa, Germano, additional, Mauri, Maria, additional, D’Onofrio, Loretta, additional, Sini, Valentina, additional, Barba, Maddalena, additional, Maugeri-Saccà, Marcello, additional, Rossi, Ernesto, additional, Landucci, Elisabetta, additional, Tomao, Silverio, additional, Alberti, Antonio Maria, additional, Giotta, Francesco, additional, Ficorella, Corrado, additional, Adamo, Vincenzo, additional, Russo, Antonio, additional, Lorusso, Vito, additional, Cannita, Katia, additional, Barni, Sandro, additional, Laudadio, Lucio, additional, Greco, Filippo, additional, Garrone, Ornella, additional, Giulia, Marina Della, additional, Marolla, Paolo, additional, Sanguineti, Giuseppe, additional, Cocco, Barbara Di, additional, Ciliberto, Gennaro, additional, Maria, Ruggero De, additional, and Gamucci, Teresa, additional
- Published
- 2017
- Full Text
- View/download PDF
11. Correction: The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
- Author
-
Gori, Stefania, primary, Inno, Alessandro, additional, Fiorio, Elena, additional, Foglietta, Jennifer, additional, Ferro, Antonella, additional, Gulisano, Marcella, additional, Pinotti, Graziella, additional, Gubiotti, Marta, additional, Cavazzini, Maria Giovanna, additional, Turazza, Monica, additional, Duranti, Simona, additional, De Simone, Valeria, additional, Iezzi, Laura, additional, Bisagni, Giancarlo, additional, Spazzapan, Simon, additional, Cavanna, Luigi, additional, Saggia, Chiara, additional, Bria, Emilio, additional, Cretella, Elisabetta, additional, Vici, Patrizia, additional, Santini, Daniele, additional, Fabi, Alessandra, additional, Garrone, Ornella, additional, Frassoldati, Antonio, additional, Amaducci, Laura, additional, Saracchini, Silvana, additional, Evangelisti, Lucia, additional, Barni, Sandro, additional, Gamucci, Teresa, additional, Mentuccia, Lucia, additional, Laudadio, Lucio, additional, Zoboli, Alessandra, additional, Marchetti, Fabiana, additional, Bogina, Giuseppe, additional, Lunardi, Gianluigi, additional, and Boni, Luca, additional
- Published
- 2015
- Full Text
- View/download PDF
12. The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
- Author
-
Gori, Stefania, primary, Inno, Alessandro, additional, Fiorio, Elena, additional, Foglietta, Jennifer, additional, Ferro, Antonella, additional, Gulisano, Marcella, additional, Pinotti, Graziella, additional, Gubiotti, Marta, additional, Cavazzini, Maria Giovanna, additional, Turazza, Monica, additional, Duranti, Simona, additional, De Simone, Valeria, additional, Iezzi, Laura, additional, Bisagni, Giancarlo, additional, Spazzapan, Simon, additional, Cavanna, Luigi, additional, Saggia, Chiara, additional, Bria, Emilio, additional, Cretella, Elisabetta, additional, Vici, Patrizia, additional, Santini, Daniele, additional, Fabi, Alessandra, additional, Garrone, Ornella, additional, Frassoldati, Antonio, additional, Amaducci, Laura, additional, Saracchini, Silvana, additional, Evangelisti, Lucia, additional, Barni, Sandro, additional, Gamucci, Teresa, additional, Mentuccia, Lucia, additional, Laudadio, Lucio, additional, Zoboli, Alessandra, additional, Marchetti, Fabiana, additional, Bogina, Giuseppe, additional, Lunardi, Gianluigi, additional, and Boni, Luca, additional
- Published
- 2015
- Full Text
- View/download PDF
13. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study
- Author
-
Arpino, Grazia, primary, Michelotti, Andrea, additional, Truini, Mauro, additional, Montemurro, Filippo, additional, Russo, Stefania, additional, Palumbo, Raffaella, additional, Zamagni, Claudio, additional, Latorre, Agnese, additional, Bruzzese, Dario, additional, Riccardi, Ferdinando, additional, De Laurentiis, Michelino, additional, Beano, Alessandra, additional, Biganzoli, Laura, additional, Zaniboni, Alberto, additional, Laudadio, Lucio, additional, Malagoli, Maria, additional, Bilancia, Domenico, additional, Schettini, Francesco, additional, Giuliano, Mario, additional, Cazzaniga, Marina Elena, additional, and De Placido, Sabino, additional
- Published
- 2015
- Full Text
- View/download PDF
14. Abstract P5-18-05: The Promher Study: An observational Italian study on HER2+ve, pT1a-b, pN0, M0 breast cancer (BC) patients (pts)
- Author
-
Gori, Stefania, primary, Turazza, Monica, additional, Duranti, Simona, additional, Fiorio, Elena, additional, Foglietta, Jennifer, additional, Gulisano, Marcella, additional, Marcon, Ilaria, additional, Gubbiotti, Marta, additional, Cavazzini, Maria Giovanna, additional, Spazzapan, Simon, additional, De Simone, Valeria, additional, Bisagni, Giancarlo, additional, Saggia, Chiara, additional, Cavanna, Luigi, additional, Bria, Emilio, additional, Iezzi, Laura, additional, Cretella, Elisabetta, additional, Vici, Patrizia, additional, Santini, Daniele, additional, Fabi, Alessandra, additional, Garrone, Ornella, additional, Ferro, Antonella, additional, Saracchini, Silvana, additional, Evangelisti, Lucia, additional, Barni, Sandro, additional, Mentuccia, Lucia, additional, Laudadio, Lucio, additional, Inno, Alessandro, additional, Lunardi, Gianluigi, additional, Coati, Francesca, additional, and Boni, Luca, additional
- Published
- 2015
- Full Text
- View/download PDF
15. Gemcitabine-induced posterior reversible encephalopathy syndrome: A case report
- Author
-
Cioffi, Pasquale, primary, Laudadio, Lucio, additional, Nuzzo, Antonio, additional, Belfiglio, Maurizio, additional, Petrelli, Fabio, additional, and Grappasonni, Iolanda, additional
- Published
- 2011
- Full Text
- View/download PDF
16. Paralytic Ileus Associated with Capecitabine
- Author
-
Laudadio, Lucio, primary, Biondi, Edoardo, additional, D'Ostilio, Nicola, additional, Cesta, Alisia, additional, Di Giandomenico, Francesca, additional, Forciniti, Samantha, additional, and Nuzzo, Antonio, additional
- Published
- 2008
- Full Text
- View/download PDF
17. Letrozole combined with gonadotropin-releasing hormone analog for metastatic male breast cancer.
- Author
-
Lauro, Luigi, Vici, Patrizia, Medico, Pietro, Laudadio, Lucio, Tomao, Silverio, Giannarelli, Diana, Pizzuti, Laura, Sergi, Domenico, Barba, Maddalena, and Maugeri-Saccà, Marcello
- Abstract
The role of aromatase inhibitors combined with gonadotropin-releasing hormone analog in metastatic male breast cancer patients remains unknown. In this retrospective study we evaluated the activity of letrozole combined with a gonadotropin-releasing hormone analog as a first- or second-line therapy for metastatic male breast cancer patients. 19 men entered the study. We did not observe any grade 3 or 4 adverse events. 2 patients (10.5 %) had complete response, 7 patients (36.8 %) experienced a partial response, 7 patients (36.8 %) had stable disease lasting ≥6 months, and 3 patients (15.8 %) had progressive disease. Overall, the disease control rate was 84.2 %. Median progression-free survival was 12.5 months (95 % CI 8.2-16.9), median overall survival was 35.8 months (95 % CI 24.4-49.2), 1- and 2-year survival rates were 89.5 and 67 %, respectively. Interestingly, 3 out of 4 patients treated with the combination following disease progression while on aromatase inhibitor monotherapy confirmed or improved the best overall response observed in the first-line setting. The combination of letrozole and gonadotropin-releasing hormone analog is effective and safe in hormone-receptor positive, metastatic male breast cancer patients. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
18. Gemcitabine-induced posterior reversible encephalopathy syndrome: A case report.
- Author
-
Cioffi, Pasquale, Laudadio, Lucio, Nuzzo, Antonio, Belfiglio, Maurizio, Petrelli, Fabio, and Grappasonni, Iolanda
- Subjects
- *
ANTIMETABOLITES , *BLOOD testing , *CEREBRAL anoxia , *ELECTROCARDIOGRAPHY , *MAGNETIC resonance imaging , *PHYSICAL diagnosis , *SOCIAL services case management , *EARLY medical intervention , *DISEASE risk factors - Abstract
Gemcitabine is a commonly used chemotherapeutic agent for a variety of tumors. Although this nucleoside analog antineoplastic agent is similar in structure to cytarabine, central nervous system toxicities have rarely been attributed to gemcitabine. The posterior reversible encephalopathy syndrome (PRES) is a condition characterized by reversible neurological and radiological findings that has been associated with use of chemotherapeutic and more recently novel targeted therapies. We describe one case of a 41-year-old woman with PRES under treatment for leiomyosarcoma because of the probable association with gemcitabine. Our case, to our knowledge, represents the seventh published report of this particular toxicity. Naranjo algorithm, efficacious method for assessing the causality of adverse drug reactions (ADRs) from a case report, suggests a direct casual relationship. PRES is probably a rare complication of gemcitabine, but the oncologist should take it into careful consideration, because PRES is reversible with treatment of current hypertension or removal of the causative agent. However, failure to quickly recognize the syndrome and discontinue the offending agent may result in profound and permanent central nervous system dysfunction or death. [ABSTRACT FROM PUBLISHER]
- Published
- 2012
- Full Text
- View/download PDF
19. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience
- Author
-
Michele De Tursi, Marco Mazzotta, Armando Orlandi, Marina Elena Cazzaniga, Enrico Cortesi, Maddalena Barba, Laura Iezzi, Giuseppe Tonini, E. Landucci, Lucio Laudadio, Domenico Sergi, Alessandra Cassano, Giuseppe Sanguineti, Nicla La Verde, Riccardo Samaritani, Patrizia Seminara, Antonio Russo, Claudio Zamagni, Simone Scagnoli, Valentina Magri, Ramy Kayal, Enzo Veltri, Francesca Aroldi, Clara Natoli, Ilaria Portarena, Samantha Forciniti, Laura Ferrari, Lucia Mentuccia, Gennaro Ciliberto, Daniele Santini, Teresa Gamucci, Filippo Greco, Silvia Carpano, Mario Roselli, Sandro Barni, A. Fabbri, Isabella Sperduti, A. Vaccaro, Ida Paris, Daniela Rubino, Ruggero De Maria, Patrizia Vici, Claudia De Angelis, Giulia Pomati, Luisa Carbognin, Simona Vallarelli, Antonino Grassadonia, Mirco Pistelli, A.F. Scinto, Katia Cannita, Andrea Michelotti, Domenico Corsi, E. Capomolla, Corrado Ficorella, Nicola Tinari, Vito Lorusso, Rossana Berardi, Andrea Botticelli, Antonio Giordano, Silverio Tomao, Laura Pizzuti, Paolo Marchetti, Maria Giuseppina Sarobba, Valentina Sini, Luca Moscetti, Lucrezia Diodati, Maria Vincenza Mancini, Luciano Mariani, Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti, Laura, Giordano, Antonio, Michelotti, Andrea, Mazzotta, Marco, Natoli, Clara, Gamucci, Teresa, De Angelis, Claudia, Landucci, Elisabetta, Diodati, Lucrezia, Iezzi, Laura, Mentuccia, Lucia, Fabbri, Agnese, Barba, Maddalena, Sanguineti, Giuseppe, Marchetti, Paolo, Tomao, Silverio, Mariani, Luciano, Paris, Ida, Lorusso, Vito, Vallarelli, Simona, Cassano, Alessandra, Airoldi, Francesca, Orlandi, Armando, Moscetti, Luca, Sergi, Domenico, Sarobba, Maria Giuseppina, Tonini, Giuseppe, Santini, Daniele, Sini, Valentina, Veltri, Enzo, Vaccaro, Angela, Ferrari, Laura, De Tursi, Michele, Tinari, Nicola, Grassadonia, Antonino, Greco, Filippo, Botticelli, Andrea, La Verde, Nicla, Zamagni, Claudio, Rubino, Daniela, Cortesi, Enrico, Magri, Valentina, Pomati, Giulia, Scagnoli, Simone, Capomolla, Elisabetta, Kayal, Ramy, Scinto, Angelo Fedele, Corsi, Domenico, Cazzaniga, Marina, Laudadio, Lucio, Forciniti, Samantha, Mancini, Maria, Carbognin, Luisa, Seminara, Patrizia, Barni, Sandro, Samaritani, Riccardo, Roselli, Mario, Portarena, Ilaria, Russo, Antonio, Ficorella, Corrado, Cannita, Katia, Carpano, Silvia, Pistelli, Mirco, Berardi, Rossana, De Maria, Ruggero, Sperduti, Isabella, Ciliberto, Gennaro, and Vici, Patrizia
- Subjects
Male ,0301 basic medicine ,Oncology ,Pyridines ,Receptor, ErbB-2 ,Physiology ,Clinical Biochemistry ,Piperazines ,chemistry.chemical_compound ,0302 clinical medicine ,Exemestane ,Antineoplastic Combined Chemotherapy Protocols ,advanced breast cancer ,hormonal therapy ,endocrine resistance ,palbociclib ,real-world setting ,Breast ,Aged, 80 and over ,advanced breast cancer, hormonal therapy ,Middle Aged ,Treatment Outcome ,Receptors, Estrogen ,030220 oncology & carcinogenesis ,Toxicity ,Female ,Receptors, Progesterone ,medicine.drug ,Adult ,Cell Biology ,medicine.medical_specialty ,Breast Neoplasms ,Palbociclib ,Neutropenia ,Disease-Free Survival ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Aged ,Everolimus ,Settore MED/06 - ONCOLOGIA MEDICA ,business.industry ,Cancer ,medicine.disease ,Confidence interval ,030104 developmental biology ,chemistry ,MED/06 - ONCOLOGIA MEDICA ,business ,Hormone - Abstract
Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.
- Published
- 2019
20. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial
- Author
-
Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmela Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone, Antonello Accurso, Biagio Agostara, Michele Aieta, Oscar Alabiso, Maria Grazia Alicicco, Dino Amadori, Laura Amaducci, Gianna Amiconi, Giustino Antuzzi, Mara Ardine, Antonio Ardizzoia, Caterina Aversa, Giuseppe Badalamenti, Sandro Barni, Carlo Basurto, Rossana Berardi, Cinzia Bergamasco, Paolo Bidoli, Claudia Bighin, Edoardo Biondi, Corrado Boni, Karen Borgonovo, Mario Botta, Stefano Bravi, Paolo Bruzzi, Giuseppe Buono, Alfredo Butera, Alessia Caldara, Giampiero Candeloro, Claudia Cappelletti, Cinzia Cardalesi, Elisabetta Carfora, Anna Cariello, Francesco Carrozza, Giacomo Cartenì, Michele Caruso, Virginia Casadei, Claudia Casanova, Luigi Castori, Luigi Cavanna, Giovanna Cavazzini, Marina Cazzaniga, Mario Chilelli, Paolo Chiodini, Silvia Chiorrini, Fortunato Ciardiello, Mariangela Ciccarese, Saverio Cinieri, Mario Clerico, Mariarosa Coccaro, Mario Comande, Claudia Corbo, Giuseppina Cortino, Stefania Cusenza, Gennaro Daniele, Alfonso Maria D'arco, Giuliana D'auria, Claudio Dazzi, Carmine De Angelis, Filippo de Braud, Gianfranco De Feo, Andrea De Matteis, Michele De Tursi, Anna Di Blasio, Giuseppe di Lucca, Liberato Di Lullo, Francesca Di Rella, Gianfranco Di Renzo, Pia Di Stefano, Aida Di Stefano, Anna Diana, Sara Donati, Agnese Fabbri, Alessandra Fabi, Marina Faedi, Gabriella Farina, Antonio Farris, Antonio Febbraro, Palma Fedele, Piera Federico, Francesco Ferraù, Gianluigi Ferretti, Antonella Ferro, Irene Floriani, Rosachiara Forcignanò, Samantha Forciniti, Valeria Forestieri, Gianni Fornari, Michela Frisinghelli, Vittorio Fusco, Giulia Gallizzi, Antonio Galvano, Antonio Gambardella, Angelo Gambi, Vittorio Gebbia, Erika Gervasi, Mara Ghilardi, Alice Giacobino, Giovanni Giardina, Francesco Giotta, Sara Giraudi, Mario Giuliano, Antonino Grassadonia, Donatella Grasso, Federica Grosso, Lorenzo Guizzaro, Pasquale Incoronato, Lorena Incorvaia, Giovanni Iodice, Nicla La Verde, Vincenzo Labonia, Gabriella Landi, Agnese Latorre, Vita Leonardi, Alessia Levaggi, Gennaro Limite, Linda Lina Bascialla, Lorenzo Livi, Evaristo Maiello, Daniela Mandelli, Ilaria Marcon, Daniela Menon, Michele Montedoro, Lucia Moraca, Anna Moretti, Maria Grazia Morritti, Patrizia Morselli, Antonella Mura, Silvia Mura, Michela Musacchio, Alberto Muzio, Donato Natale, Clara Natoli, Cinzia Nigro, Cecilia Nisticò, Antonio Nuzzo, Michele Orditura, Laura Orlando, Carmen Pacilio, Giuliano Palumbo, Raffaella Palumbo, Felice Pasini, Emanuela Paterno, Antonio Pazzola, Silvia Pelliccioni, Matilde Pensabene, Davide Perroni, Angela Pesenti Gritti, Fausto Petrelli, Maria Carmela Piccirillo, Graziella Pinotti, Claudia Pogliani, Davide Poli, Sonia Prader, Francesco Recchia, Daniele Rizzi, Carmen Romano, Rosalba Rossello, Chiara Rossini, Giuseppina Salvucci, Valeria Sanna, Alessandra Santini, Silvana Saracchini, Clementina Savastano, Giovanni Scambia, Francesco Schettini, Paola Schiavone, Alessio Schirone, Elena Seles, Simona Signoriello, Giuseppe Signoriello, Rosa Rita Silva, Antonia Silvestri, Vittorio Simeon, Ilaria Spagnoletti, Stefano Tamberi, Cristina Teragni, Verena Thalmann, Renato Thomas, Guglielmo Thomas, Amelia Tienghi, Nicola Tinari, Vincenza Tinessa, Federica Tomei, Giuseppe Tonini, Valter Torri, Divina Traficante, Marianna Tudini, Monica Turazza, Roberto Vignoli, Maria Giuseppa Vitale, Alessandra Zacchia, Pasquale Zagarese, Alda Zanni, Laura Zavallone, Maria Zavettieri, Alessandra Zoboli, De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M. G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A. A., Cognetti, F., Gori, S., Foglietta, J., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Verusio, C., Bernardo, A., Lorusso, V., Gravina, A., Moretti, G., Lauria, R., Lai, A., Mocerino, C., Rizzo, S., Nuzzo, F., Carlini, P., Perrone, F., Accurso, A., Agostara, B., Aieta, M., Alabiso, O., Alicicco, M. G., Amadori, D., Amaducci, L., Amiconi, G., Antuzzi, G., Ardine, M., Ardizzoia, A., Aversa, C., Badalamenti, G., Barni, S., Basurto, C., Berardi, R., Bergamasco, C., Bidoli, P., Bighin, C., Biondi, E., Boni, C., Borgonovo, K., Botta, M., Bravi, S., Bruzzi, P., Buono, G., Butera, A., Caldara, A., Candeloro, G., Cappelletti, C., Cardalesi, C., Carfora, E., Cariello, A., Carrozza, F., Carteni, G., Caruso, M., Casadei, V., Casanova, C., Castori, L., Cavanna, L., Cavazzini, G., Cazzaniga, M., Chilelli, M., Chiodini, P., Chiorrini, S., Ciardiello, F., Ciccarese, M., Cinieri, S., Clerico, M., Coccaro, M., Comande, M., Corbo, C., Cortino, G., Cusenza, S., Daniele, G., D'Arco, A. M., D'Auria, G., Dazzi, C., De Angelis, C., de Braud, F., De Feo, G., De Matteis, Ma., De Tursi, M., Di Blasio, A., di Lucca, G., Di Lullo, L., Di Rella, F., Di Renzo, G., Di Stefano, P., Di Stefano, A., Diana, A., Donati, S., Fabbri, A., Fabi, A., Faedi, M., Farina, G., Farris, A., Febbraro, A., Fedele, P., Federico, P., Ferrau, F., Ferretti, G., Ferro, A., Floriani, I., Forcignano, R., Forciniti, S., Forestieri, V., Fornari, G., Frisinghelli, M., Fusco, V., Gallizzi, G., Galvano, A., Gambardella, A., Gambi, A., Gebbia, V., Gervasi, E., Ghilardi, M., Giacobino, A., Giardina, G., Giotta, F., Giraudi, S., Giuliano, M., Grassadonia, A., Grasso, D., Grosso, F., Guizzaro, L., Incoronato, P., Incorvaia, L., Iodice, G., La Verde, N., Labonia, V., Landi, G., Latorre, A., Leonardi, V., Levaggi, A., Limite, G., Lina Bascialla, L., Livi, L., Maiello, E., Mandelli, D., Marcon, I., Menon, D., Montedoro, M., Moraca, L., Moretti, A., Morritti, M. G., Morselli, P., Mura, A., Mura, S., Musacchio, M., Muzio, A., Natale, D., Natoli, C., Nigro, C., Nistico, C., Nuzzo, A., Orditura, M., Orlando, L., Pacilio, C., Palumbo, G., Palumbo, R., Pasini, F., Paterno, E., Pazzola, A., Pelliccioni, S., Pensabene, M., Perroni, D., Pesenti Gritti, A., Petrelli, F., Piccirillo, M. C., Pinotti, G., Pogliani, C., Poli, D., Prader, S., Recchia, F., Rizzi, D., Romano, C., Rossello, R., Rossini, C., Salvucci, G., Sanna, V., Santini, A., Saracchini, S., Savastano, C., Scambia, G., Schettini, F., Schiavone, P., Schirone, A., Seles, E., Signoriello, S., Signoriello, G., Silva, R. R., Silvestri, A., Simeon, V., Spagnoletti, I., Tamberi, S., Teragni, C., Thalmann, V., Thomas, R., Thomas, G., Tienghi, A., Tinari, N., Tinessa, V., Tomei, F., Tonini, G., Torri, V., Traficante, D., Tudini, M., Turazza, M., Vignoli, R., Vitale, M. G., Zacchia, A., Zagarese, P., Zanni, A., Zavallone, L., Zavettieri, M., Zoboli, A., De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Bisagni, Giancarlo, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmen, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, Perrone, Francesco, Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, Mocerino, Carmela, D'Arco, Alfonso Maria, D'Auria, Giuliana, De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, and Zoboli, A
- Subjects
Oncology ,Receptor, ErbB-2 ,Settore MED/06 - Oncologia Medica ,letrozole ,law.invention ,Adjuvant anastrozole ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Exemestane ,law ,exemestane ,tamoxifen ,breast cancer ,Antineoplastic Combined Chemotherapy Protocols ,030212 general & internal medicine ,Aromatase Inhibitors ,Letrozole ,Hazard ratio ,Middle Aged ,Receptors, Estrogen ,Tolerability ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,Receptors, Progesterone ,Breast Neoplasm ,Human ,medicine.drug ,medicine.medical_specialty ,Socio-culturale ,Anastrozole ,Breast Neoplasms ,Disease-Free Survival ,Drug Administration Schedule ,03 medical and health sciences ,Breast cancer ,Internal medicine ,medicine ,Aromatase Inhibitor ,Humans ,Aged ,Antineoplastic Combined Chemotherapy Protocol ,Androstadiene ,business.industry ,medicine.disease ,Androstadienes ,chemistry ,business ,Tamoxifen - Abstract
Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is registered with the European Clinical Trials Database, number 2006-004018-42, and ClinicalTrials.gov, number NCT00541086. Findings: Between March 9, 2007, and July 31, 2012, 3697 patients were enrolled into the study. After a median follow-up of 60 months (IQR 46â72), 401 disease-free survival events were reported, including 211 (11%) of 1850 patients allocated to the switch strategy and 190 (10%) of 1847 patients allocated to upfront treatment. 5-year disease-free survival was 88·5% (95% CI 86·7â90·0) with the switch strategy and 89·8% (88·2â91·2) with upfront treatment (hazard ratio 0·89, 95% CI 0·73â1·08; p=0·23). 5-year disease-free survival was 90·0% (95% CI 87·9â91·7) with anastrozole (124 events), 88·0% (85·8â89·9) with exemestane (148 events), and 89·4% (87·3 to 91·1) with letrozole (129 events; p=0·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3â4 events, reported in 130 (7%) of 1761 patients who received the switch strategy and 128 (7%) of 1766 patients who received upfront treatment. Grade 1 musculoskeletal events were more frequent with the upfront schedule than with the switch schedule (924 [52%] of 1766 patients vs 745 [42%] of 1761 patients). All other grade 3â4 adverse events occurred in less than 2% of patients in either group. Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting. Funding: Italian Drug Agency.
- Published
- 2018
21. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study
- Author
-
Grazia Arpino, Claudio Zamagni, Ferdinando Riccardi, Laura Biganzoli, Mario Giuliano, Alessandra Beano, Michelino De Laurentiis, Lucio Laudadio, Sabino De Placido, Dario Bruzzese, Andrea Michelotti, Stefania Russo, Francesco Schettini, Domenico Bilancia, Alberto Zaniboni, Mauro Truini, Marina Cazzaniga, Maria Malagoli, Filippo Montemurro, Raffaella Palumbo, A. Latorre, Arpino, Grazia, Michelotti, Andrea, Truini, Mauro, Montemurro, Filippo, Russo, Stefania, Palumbo, Raffaella, Zamagni, Claudio, Latorre, Agnese, Bruzzese, Dario, Riccardi, Ferdinando, DE LAURENTIIS, Michelino, Beano, Alessandra, Biganzoli, Laura, Zaniboni, Alberto, Laudadio, Lucio, Malagoli, Maria, Bilancia, Domenico, Schettini, Francesco, Giuliano, Mario, Cazzaniga, Marina Elena, DE PLACIDO, Sabino, Arpino, G, Michelotti, A, Truini, M, Montemurro, F, Russo, S, Palumbo, R, Zamagni, C, Latorre, A, Bruzzese, D, Riccardi, F, De Laurentiis, M, Beano, A, Biganzoli, L, Zaniboni, A, Laudadio, L, Malagoli, M, Bilancia, D, Schettini, F, Giuliano, M, Cazzaniga, M, and De Placido, S
- Subjects
Adult ,Oncology ,Cancer Research ,medicine.medical_specialty ,Receptor, ErbB-2 ,Breast Neoplasms ,Clinical practice ,Adjuvant therapy ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Meta-Analysis as Topic ,Randomized controlled trial ,law ,Trastuzumab ,Internal medicine ,HER2 ,medicine ,Humans ,030212 general & internal medicine ,Practice Patterns, Physicians' ,skin and connective tissue diseases ,Prospective cohort study ,neoplasms ,Aged ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,clinical trials, clinical practice, early breast cancer ,Hematology ,business.industry ,Early breast cancer ,General Medicine ,Middle Aged ,medicine.disease ,Clinical Practice ,Clinical trial ,Italy ,030220 oncology & carcinogenesis ,Physical therapy ,Female ,business ,medicine.drug - Abstract
Background: Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC. Patients and methods: From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics. Results: Versus RCT patients, CP patients were more likely to be older than 50years (65 vs. 49%; p2cm (T≥2cm 39 vs. 59%; p 
- Published
- 2016
22. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience.
- Author
-
Pizzuti L, Giordano A, Michelotti A, Mazzotta M, Natoli C, Gamucci T, De Angelis C, Landucci E, Diodati L, Iezzi L, Mentuccia L, Fabbri A, Barba M, Sanguineti G, Marchetti P, Tomao S, Mariani L, Paris I, Lorusso V, Vallarelli S, Cassano A, Aroldi F, Orlandi A, Moscetti L, Sergi D, Sarobba MG, Tonini G, Santini D, Sini V, Veltri E, Vaccaro A, Ferrari L, De Tursi M, Tinari N, Grassadonia A, Greco F, Botticelli A, La Verde N, Zamagni C, Rubino D, Cortesi E, Magri V, Pomati G, Scagnoli S, Capomolla E, Kayal R, Scinto AF, Corsi D, Cazzaniga M, Laudadio L, Forciniti S, Mancini M, Carbognin L, Seminara P, Barni S, Samaritani R, Roselli M, Portarena I, Russo A, Ficorella C, Cannita K, Carpano S, Pistelli M, Berardi R, De Maria R, Sperduti I, Ciliberto G, and Vici P
- Subjects
- Adult, Aged, Aged, 80 and over, Breast metabolism, Breast pathology, Breast Neoplasms metabolism, Disease-Free Survival, Female, Humans, Middle Aged, Receptors, Estrogen drug effects, Receptors, Estrogen metabolism, Receptors, Progesterone drug effects, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms pathology, Piperazines pharmacology, Pyridines pharmacology, Receptor, ErbB-2 metabolism
- Abstract
Data from 423 human epidermal growth factor receptor 2-negative (HER2-), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6-35.4) and clinical benefit was 52.7% (95% CI, 48-57.5). ORR was negatively affected by prior exposure to everolimus/exemestane ( p = 0.002) and favorably influenced by early line-treatment ( p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8-16) and median overall survival was 24 months (95% CI, 17-30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2-, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained., (© 2018 Wiley Periodicals, Inc.)
- Published
- 2019
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.