7 results on '"Seles, Elena"'
Search Results
2. Factors influencing 5-year persistence to adjuvant endocrine therapy in young women with breast cancer
- Author
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Pagan, Eleonora, Ruggeri, Monica, Bianco, Nadia, Bucci, Eraldo Oreste, Graffeo, Rossella, Borner, Markus, Giordano, Monica, Gianni, Lorenzo, Rabaglio, Manuela, Freschi, Andrea, Cretella, Elisabetta, Seles, Elena, Farolfi, Alberto, Simoncini, Edda, Ciccarese, Mariangela, Rauch, Daniel, Favaretto, Adolfo, Honecker, Friedemann, Berardi, Rossana, Franzetti-Pellanda, Alessandra, Gelber, Shari, Partridge, Ann H., Goldhirsch, Aron, Bagnardi, Vincenzo, Pagani, Olivia, and Ribi, Karin
- Published
- 2024
- Full Text
- View/download PDF
3. Employment trajectories of young women with breast cancer: an ongoing prospective cohort study in Italy and Switzerland
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Ribi, Karin, primary, Pagan, Eleonora, additional, Sala, Isabella, additional, Ruggeri, Monica, additional, Bianco, Nadia, additional, Bucci, Eraldo Oreste, additional, Graffeo, Rossella, additional, Borner, Markus, additional, Giordano, Monica, additional, Gianni, Lorenzo, additional, Rabaglio, Manuela, additional, Freschi, Andrea, additional, Cretella, Elisabetta, additional, Seles, Elena, additional, Farolfi, Alberto, additional, Simoncini, Edda, additional, Ciccarese, Mariangela, additional, Rauch, Daniel, additional, Favaretto, Adolfo, additional, Glaus, Agnes, additional, Berardi, Rossana, additional, Franzetti-Pellanda, Alessandra, additional, Bagnardi, Vincenzo, additional, Gelber, Shari, additional, Partridge, Ann H., additional, Goldhirsch, Aron, additional, and Pagani, Olivia, additional
- Published
- 2022
- Full Text
- View/download PDF
4. Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant.
- Author
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UCL - (MGD) Service d'oncologie médicale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, Malorni, Luca, Tyekucheva, Svitlana, Hilbers, Florentine S, Ignatiadis, Michail, Neven, Patrick, Colleoni, Marco, HENRY, Stéphanie, Ballestrero, Alberto, Bonetti, Andrea, Jerusalem, Guy, Papadimitriou, Konstantinos, Bernardo, Antonio, Seles, Elena, Duhoux, Francois, MacPherson, Iain R, Thomson, Alastair, Davies, David Mark, Bergqvist, Mattias, Migliaccio, Ilenia, Gebhart, Géraldine, Zoppoli, Gabriele, Bliss, Judith M, Benelli, Matteo, McCartney, Amelia, Kammler, Roswitha, De Swert, Heidi, Ruepp, Barbara, Fumagalli, Debora, Maibach, Rudolf, Cameron, David, Loi, Sherene, Piccart, Martine, Regan, Meredith M, International Breast Cancer Study Group, Breast International Group and PYTHIA Collaborators, UCL - (MGD) Service d'oncologie médicale, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, Malorni, Luca, Tyekucheva, Svitlana, Hilbers, Florentine S, Ignatiadis, Michail, Neven, Patrick, Colleoni, Marco, HENRY, Stéphanie, Ballestrero, Alberto, Bonetti, Andrea, Jerusalem, Guy, Papadimitriou, Konstantinos, Bernardo, Antonio, Seles, Elena, Duhoux, Francois, MacPherson, Iain R, Thomson, Alastair, Davies, David Mark, Bergqvist, Mattias, Migliaccio, Ilenia, Gebhart, Géraldine, Zoppoli, Gabriele, Bliss, Judith M, Benelli, Matteo, McCartney, Amelia, Kammler, Roswitha, De Swert, Heidi, Ruepp, Barbara, Fumagalli, Debora, Maibach, Rudolf, Cameron, David, Loi, Sherene, Piccart, Martine, Regan, Meredith M, International Breast Cancer Study Group, and Breast International Group and PYTHIA Collaborators
- Abstract
Biomarkers for cyclin-dependent kinase 4/6 inhibitors, such as palbociclib, for patients with hormone receptor-positive/HER2-negative metastatic breast cancer are lacking. Thymidine kinase is a proliferation marker downstream of the cyclin-dependent kinase 4/6 pathway. We prospectively investigated the prognostic role of serum thymidine kinase activity (sTKa), in patients treated with Palbociclib + fulvestrant. PYTHIA was a phase II, single-arm, multicentre, trial that enrolled 124 post-menopausal women with endocrine-resistant hormone receptor-positive/HER2-negative metastatic breast cancer. Serum samples were collected pre-treatment (pre-trt; n = 122), at day 15 of cycle 1 (D15; n = 108), during the one week-off palbociclib before initiating cycle 2 (D28; n = 108) and at end of treatment (n = 76). sTKa was determined centrally using Divitum®, a refined ELISA-based assay with a limit of detection of 20 Divitum Units (Du)/L. The primary study endpoint was progression-free survival, assessed for its association with pre- and on-treatment sTKa. Data from 122 women were analysed. Pre-treatment sTKa was not associated with clinical characteristics and moderately correlated with tissue Ki-67. Palbociclib + fulvestrant markedly suppressed sTKa levels at D15, with 83% of patients recording levels below limit of detection. At D28, sTKa showed a rebound in 60% of patients. At each timepoint, higher sTKa was associated with shorter progression-free survival (each p < 0.001), with the strongest effect at D15. STKa is an independent prognostic biomarker in patients treated with palbociclib. High pre-treatment sTKa and its incomplete suppression during treatment may identify patients with poorer prognosis and primary resistance. This warrants validation in prospective comparative trials. CLINICALTRIALS. NCT02536742; EudraCT 2014-005387-15.
- Published
- 2022
5. Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant
- Author
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Malorni, Luca, primary, Tyekucheva, Svitlana, additional, Hilbers, Florentine S., additional, Ignatiadis, Michail, additional, Neven, Patrick, additional, Colleoni, Marco, additional, Henry, Stéphanie, additional, Ballestrero, Alberto, additional, Bonetti, Andrea, additional, Jerusalem, Guy, additional, Papadimitriou, Konstantinos, additional, Bernardo, Antonio, additional, Seles, Elena, additional, Duhoux, Francois P., additional, MacPherson, Iain R., additional, Thomson, Alastair, additional, Davies, David Mark, additional, Bergqvist, Mattias, additional, Migliaccio, Ilenia, additional, Gebhart, Géraldine, additional, Zoppoli, Gabriele, additional, Bliss, Judith M., additional, Benelli, Matteo, additional, McCartney, Amelia, additional, Kammler, Roswitha, additional, De Swert, Heidi, additional, Ruepp, Barbara, additional, Fumagalli, Debora, additional, Maibach, Rudolf, additional, Cameron, David, additional, Loi, Sherene, additional, Piccart, Martine, additional, and Regan, Meredith M., additional
- Published
- 2022
- Full Text
- View/download PDF
6. 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
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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
7. 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
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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
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