16 results on '"Cogoni, Alessio Aligi"'
Search Results
2. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study
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Celio, Luigi, Cortinovis, Diego, Cogoni, Alessio Aligi, Cavanna, Luigi, Martelli, Olga, Carnio, Simona, Collovà, Elena, Bertolini, Federica, Petrelli, Fausto, Cassano, Alessandra, Chiari, Rita, Zanelli, Francesca, Pisconti, Salvatore, Vittimberga, Isabella, Letizia, Antonietta, Misino, Andrea, Gernone, Angela, Bonizzoni, Erminio, Pilotto, Sara, De Placido, Sabino, and Bria, Emilio
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- 2022
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3. Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study
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Pinto, Carmine, primary, Orlandi, Armando, additional, Normanno, Nicola, additional, Maiello, Evaristo, additional, Calegari, Maria A., additional, Antonuzzo, Lorenzo, additional, Bordonaro, Roberto, additional, Zampino, Maria G., additional, Pini, Sara, additional, Bergamo, Francesca, additional, Tonini, Giuseppe, additional, Avallone, Antonio, additional, Latiano, Tiziana P., additional, Rosati, Gerardo, additional, Cogoni, Alessio Aligi, additional, Ballestrero, Alberto, additional, Zaniboni, Alberto, additional, Roselli, Mario, additional, Tamberi, Stefano, additional, and Barone, Carlo, additional
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- 2024
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4. Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®)
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Caminiti, Caterina, primary, Bryce, Jane, additional, Riva, Silvia, additional, Ng, Diane, additional, Diodati, Francesca, additional, Iezzi, Elisa, additional, Sparavigna, Lucia, additional, Novello, Silvia, additional, Porta, Camillo, additional, Del Mastro, Lucia, additional, Procopio, Giuseppe, additional, Cinieri, Saverio, additional, Falzetta, Amalia, additional, Calabrò, Fabio, additional, Lorusso, Vito, additional, Cogoni, Alessio Aligi, additional, Tortora, Giampaolo, additional, Maruzzo, Marco, additional, Passalacqua, Rodolfo, additional, Cognetti, Francesco, additional, Adamo, Vincenzo, additional, Capelletto, Enrica, additional, Ferrari, Alessandra, additional, Bagnalasta, Michela, additional, Bassi, Maurizio, additional, Nicelli, Annalisa, additional, De Persis, Davide, additional, D’Acunti, Alessia, additional, Iannelli (patient), Elisabetta, additional, Perrone, Francesco, additional, and Mitchell, Sandra A., additional
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- 2022
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5. sj-pdf-1-tmj-10.1177_03008916221099558 – Supplemental material for Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®)
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Caminiti, Caterina, Bryce, Jane, Riva, Silvia, Ng, Diane, Diodati, Francesca, Iezzi, Elisa, Sparavigna, Lucia, Novello, Silvia, Porta, Camillo, Del Mastro, Lucia, Procopio, Giuseppe, Cinieri, Saverio, Falzetta, Amalia, Calabrò, Fabio, Lorusso, Vito, Cogoni, Alessio Aligi, Tortora, Giampaolo, Maruzzo, Marco, Passalacqua, Rodolfo, Cognetti, Francesco, Adamo, Vincenzo, Capelletto, Enrica, Ferrari, Alessandra, Bagnalasta, Michela, Bassi, Maurizio, Nicelli, Annalisa, De Persis, Davide, D’Acunti, Alessia, Iannelli (patient), Elisabetta, Perrone, Francesco, and Mitchell, Sandra A.
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Medicine - Abstract
Supplemental material, sj-pdf-1-tmj-10.1177_03008916221099558 for Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®) by Caterina Caminiti, Jane Bryce, Silvia Riva, Diane Ng, Francesca Diodati, Elisa Iezzi, Lucia Sparavigna, Silvia Novello, Camillo Porta, Lucia Del Mastro, Giuseppe Procopio, Saverio Cinieri, Amalia Falzetta, Fabio Calabrò, Vito Lorusso, Alessio Aligi Cogoni, Giampaolo Tortora, Marco Maruzzo, Rodolfo Passalacqua, Francesco Cognetti, Vincenzo Adamo, Enrica Capelletto, Alessandra Ferrari, Michela Bagnalasta, Maurizio Bassi, Annalisa Nicelli, Davide De Persis, Alessia D’Acunti, Elisabetta Iannelli (patient), Francesco Perrone and Sandra A. Mitchell in Tumori Journal
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- 2022
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6. Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®)
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Caminiti, Caterina, Bryce, Jane, Riva, Silvia, Ng, Diane, Diodati, Francesca, Iezzi, Elisa, Sparavigna, Lucia, Novello, Silvia, Porta, Camillo, Del Mastro, Lucia, Procopio, Giuseppe, Cinieri, Saverio, Falzetta, Amalia, Calabrò, Fabio, Lorusso, Vito, Cogoni, Alessio Aligi, Tortora, Giampaolo, Maruzzo, Marco, Passalacqua, Rodolfo, Cognetti, Francesco, Adamo, Vincenzo, Capelletto, Enrica, Ferrari, Alessandra, Bagnalasta, Michela, Bassi, Maurizio, Nicelli, Annalisa, De Persis, Davide, D’Acunti, Alessia, Iannelli (patient), Elisabetta, Perrone, Francesco, and Mitchell, Sandra A.
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Introduction: US National Cancer Institute’s (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and describe the content validity and reliability in a diverse sample of Italian-speaking patients.Methods: All PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was explored and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was explored in a second sample (n=135).Results: Four rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94).Discussion: Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary descriptive evidence of content validity and reliability.
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- 2023
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7. Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system
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Riva, Silvia, primary, Arenare, Laura, additional, Di Maio, Massimo, additional, Efficace, Fabio, additional, Montesarchio, Vincenzo, additional, Frontini, Luciano, additional, Giannarelli, Diana, additional, Bryce, Jane, additional, Del Campo, Laura, additional, De Lorenzo, Francesco, additional, Iannelli, Elisabetta, additional, Traclò, Francesca, additional, Gitto, Lara, additional, Jommi, Claudio, additional, Vaccaro, Concetta Maria, additional, Barberio, Daniela, additional, Cinieri, Saverio, additional, Porta, Camillo, additional, Del Mastro, Lucia, additional, Zagonel, Vittorina, additional, Cogoni, Alessio Aligi, additional, Bordonaro, Roberto, additional, Gimigliano, Anna, additional, Piccirillo, Maria Carmela, additional, Guizzaro, Lorenzo, additional, Gallo, Ciro, additional, and Perrone, Francesco, additional
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- 2021
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8. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study
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Celio, Luigi, primary, Cortinovis, Diego, additional, Cogoni, Alessio Aligi, additional, Cavanna, Luigi, additional, Martelli, Olga, additional, Carnio, Simona, additional, Collovà, Elena, additional, Bertolini, Federica, additional, Petrelli, Fausto, additional, Cassano, Alessandra, additional, Chiari, Rita, additional, Zanelli, Francesca, additional, Pisconti, Salvatore, additional, Vittimberga, Isabella, additional, Letizia, Antonietta, additional, Misino, Andrea, additional, Gernone, Angela, additional, Bonizzoni, Erminio, additional, Pilotto, Sara, additional, De Placido, Sabino, additional, and Bria, Emilio, additional
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- 2021
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9. Final analysis of the PROMISE-GIM6 phase III trial assessing GnRH agonist use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer.
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Lambertini, Matteo, primary, Boni, Luca, additional, Michelotti, Andrea, additional, Magnolfi, Emanuela, additional, Cogoni, Alessio Aligi, additional, Mosconi, Anna Maria, additional, Giordano, Monica, additional, Garrone, Ornella, additional, Arpino, Grazia, additional, Poggio, Francesca, additional, Cinacchi, Paola, additional, Bighin, Claudia, additional, Fregatti, Piero, additional, Pronzato, Paolo, additional, Blondeaux, Eva, additional, and Del Mastro, Lucia, additional
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- 2021
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10. Long-Term Outcomes With Pharmacological Ovarian Suppression During Chemotherapy in Premenopausal Early Breast Cancer Patients.
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Lambertini, Matteo, Boni, Luca, Michelotti, Andrea, Magnolfi, Emanuela, Cogoni, Alessio Aligi, Mosconi, Anna Maria, Giordano, Monica, Garrone, Ornella, Arpino, Grazia, Poggio, Francesca, Cinacchi, Paola, Bighin, Claudia, Fregatti, Piero, Pronzato, Paolo, Blondeaux, Eva, Mastro, Lucia Del, group, the GIM study, Del Mastro, Lucia, and GIM study group
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ADJUVANT chemotherapy ,PERIMENOPAUSE ,RESEARCH ,RESEARCH methodology ,ANTINEOPLASTIC agents ,EVALUATION research ,COMPARATIVE studies ,OVARIAN diseases ,BREAST tumors - Abstract
Background: Although use of gonadotropin-releasing hormone agonist (GnRHa) during chemotherapy is an established strategy to protect ovarian function in premenopausal breast cancer patients, no long-term safety data are available, raising some concerns in women with hormone receptor-positive disease. There are controversial data on its fertility preservation potential.Methods: The Prevention of Menopause Induced by Chemotherapy: a Study in Early Breast Cancer Patients-Gruppo Italiano Mammella 6 (PROMISE-GIM6) trial is a multicenter, randomized, open-label, phase III superiority trial conducted at 16 Italian centers from October 2003 to January 2008. Eligible patients were randomly assigned to (neo)adjuvant chemotherapy alone (control arm) or combined with the GnRHa triptorelin (GnRHa arm). The primary planned endpoint was incidence of chemotherapy-induced premature ovarian insufficiency. Post hoc endpoints were disease-free survival (DFS), overall survival (OS), and post-treatment pregnancies. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated.Results: Of 281 randomly assigned patients, 80.4% had hormone receptor-positive breast cancer. Median follow-up was 12.4 years (interquartile range = 11.3-13.2 years). No differences in 12-year DFS (65.7% [95% CI = 57.0% to 73.1%] in the GnRHa arm vs 69.2% [95% CI = 60.3% to 76.5%] in the control arm; HR = 1.16, 95% CI = 0.76 to 1.77) or in 12-year OS (81.2% [95% CI = 73.6% to 86.8%] in the GnRHa arm vs 81.3% [95% CI = 73.1% to 87.2%] in the control arm; HR = 1.17, 95% CI = 0.67 to 2.03) were observed. In patients with hormone receptor-positive disease, the hazard ratio was 1.02 (95% CI = 0.63 to 1.63) for DFS and 1.12 (95% CI = 0.59 to 2.11) for OS. In the GnRHa and control arms, 9 and 4 patients had a posttreatment pregnancy, respectively (HR = 2.14, 95% CI = 0.66 to 6.92).Conclusions: Final analysis of the PROMISE-GIM6 trial provides reassuring results on the safety of GnRHa use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer, including those with hormone receptor-positive disease. [ABSTRACT FROM AUTHOR]- Published
- 2022
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11. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study).
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Celio, Luigi, Cortinovis, Diego, Cogoni, Alessio Aligi, Cavanna, Luigi, Martelli, Olga, Carnio, Simona, Collovà, Elena, Bertolini, Federica, Petrelli, Fausto, Cassano, Alessandra, Chiari, Rita, Zanelli, Francesca, Pisconti, Salvatore, Vittimberga, Isabella, Letizia, Antonietta, Misino, Andrea, Gernone, Angela, Bonizzoni, Erminio, Pilotto, Sara, and De Placido, Sabino
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FOOD consumption ,WEIGHT loss ,VOMITING ,PREVENTIVE medicine ,INGESTION ,CISPLATIN - Abstract
We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA, a netupitant/palonosetron fixed combination, for preventing chemotherapy-induced nausea and vomiting (CINV) caused by cisplatin. This pre-planned exploratory analysis assessed the effect of the DEX-sparing regimen on a patient's food intake. Chemotherapy-naïve patients undergoing cisplatin (≥ 70 mg/m
2 ) were given NEPA and DEX (12 mg) on day 1 and randomized to receive either no further DEX (DEX1), or oral DEX (4 mg BID) on days 2–4 (DEX4). Patient-reported endpoint maintenance of usual daily food intake was assessed during the 5-days post-chemotherapy. The relationship between usual daily food intake and CINV control, pre-chemotherapy self-rated food intake and BMI-adjusted weight loss (WL) were evaluated. One-hundred fifty-two patients (76/group) were assessable. The proportion of patients reporting maintenance of usual daily food intake was similar in both groups: 69.7% (95% CI, 58.6–78.9) for DEX1 vs. 72.4% (95% CI, 61.4–81.2) for DEX4. Only CINV control was significantly associated with maintenance of usual daily food intake (P ≤ 0.001) during the overall phase. The DEX-sparing regimen does not adversely affect patient-reported daily food intake post-chemotherapy. The current analysis adds further insights into antiemetic efficacy of DEX sparing beyond day 1 in the challenging setting of cisplatin. Trial registration: The parent study was registered on ClinicalTrials.gov (NCT04201769). [ABSTRACT FROM AUTHOR]- Published
- 2022
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12. 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
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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
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- 2018
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13. P3.02c-092 Nivolumab in Multi-Treated Patients with Advanced Sq-NSCLC: Data from the Italian Cohort of Expanded Access Programme (EAP)
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Tiseo, Marcello, primary, Crinò, Lucio, additional, Galetta, Domenico, additional, Abbate, Maria Ida, additional, Delmonte, Angelo, additional, Grossi, Francesco, additional, De Marinis, Filippo, additional, Ricciardi, Serena, additional, Manzo, Anna, additional, Palla, Antonio, additional, Tondini, Carlo, additional, Tassinari, Davide, additional, Frassoldati, Antonio, additional, Verderame, Francesco, additional, Cogoni, Alessio Aligi, additional, Cognetti, Francesco, additional, Palmiotti, Gennaro, additional, Illiano, Alfonso, additional, Silvestris, Franco, additional, and Soto Parra, Hector Josè, additional
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- 2017
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14. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study
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Federica Bertolini, Antonietta Letizia, Simona Carnio, Emilio Bria, A. Misino, Olga Martelli, Salvatore Pisconti, Sabino De Placido, Luigi Cavanna, F. Zanelli, Alessio Aligi Cogoni, Fausto Petrelli, Sara Pilotto, Isabella Vittimberga, Luigi Celio, Elena Collovà, Angela Gernone, Erminio Bonizzoni, Rita Chiari, Alessandra Cassano, Diego Cortinovis, Celio, Luigi, Cortinovis, Diego, Cogoni, Alessio Aligi, Cavanna, Luigi, Martelli, Olga, Carnio, Simona, Collovà, Elena, Bertolini, Federica, Petrelli, Fausto, Cassano, Alessandra, Chiari, Rita, Zanelli, Francesca, Pisconti, Salvatore, Vittimberga, Isabella, Letizia, Antonietta, Misino, Andrea, Gernone, Angela, Bonizzoni, Erminio, Pilotto, Sara, De Placido, Sabino, and Bria, Emilio
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0301 basic medicine ,Cancer Research ,Quinuclidines ,Nausea ,medicine.drug_class ,Pyridines ,Vomiting ,Pyridine ,Dexamethasone ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,polycyclic compounds ,Netupitant ,Antiemetic ,Humans ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,Palonosetron ,Quinuclidine ,Regimen ,030104 developmental biology ,Oncology ,chemistry ,Symptom Management and Supportive Care ,030220 oncology & carcinogenesis ,Anesthesia ,Antiemetics ,Chemotherapy-induced nausea and vomiting ,medicine.symptom ,Cisplatin ,business ,hormones, hormone substitutes, and hormone antagonists ,medicine.drug ,Chemotherapy‐induced nausea and vomiting ,Human - Abstract
Background To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin‐based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low‐dose DEX on days 2 and 3, combined with an oral fixed‐dose combination of netupitant and palonosetron (NEPA), compared with the guideline‐consistent use of 4‐day DEX. Patients and Methods In this open‐label, multicenter study, chemotherapy‐naïve patients undergoing high‐dose cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2–3 (DEX3), or (c) DEX (4 mg twice daily) on days 2–4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5‐day overall phase. The noninferiority margin was set at −15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea). Results Two‐hundred twenty‐eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX‐sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, −12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups. Conclusion A simplified regimen of NEPA plus single‐dose DEX offers comparable chemotherapy‐induced nausea and vomiting prevention throughout 5 days post‐chemotherapy with the advantage of sparing patients additional doses of DEX in the high–emetic‐risk setting of cisplatin‐based chemotherapy. Implications for Practice Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy‐induced emesis. Although generally considered safe, even short‐term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapies. This study demonstrates comparable antiemetic control during the 5 days post‐chemotherapy with a simplified regimen of netupitant/palonosetron plus single‐dose DEX versus the standard 4‐day DEX reference treatment in high‐dose cisplatin. This represents a clinically relevant achievement as it not only simplifies antiemetic prophylaxis but also offers an opportunity to appropriately use in patients where caution with corticosteroid use is advised., This study was designed to test whether two different dexamethasone‐sparing regimens, when administered with NEPA, might provide the opportunity to reduce the total corticosteroid dose while maintaining the same degree of chemotherapy‐induced nausea and vomiting control in patients undergoing cisplatin‐based chemotherapy.
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- 2021
15. 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
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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.
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- 2018
16. Long-Term Outcomes With Pharmacological Ovarian Suppression During Chemotherapy in Premenopausal Early Breast Cancer Patients.
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Lambertini M, Boni L, Michelotti A, Magnolfi E, Cogoni AA, Mosconi AM, Giordano M, Garrone O, Arpino G, Poggio F, Cinacchi P, Bighin C, Fregatti P, Pronzato P, Blondeaux E, and Del Mastro L
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemotherapy, Adjuvant adverse effects, Female, Gonadotropin-Releasing Hormone, Humans, Pregnancy, Premenopause, Breast Neoplasms, Primary Ovarian Insufficiency chemically induced, Primary Ovarian Insufficiency prevention & control
- Abstract
Background: Although use of gonadotropin-releasing hormone agonist (GnRHa) during chemotherapy is an established strategy to protect ovarian function in premenopausal breast cancer patients, no long-term safety data are available, raising some concerns in women with hormone receptor-positive disease. There are controversial data on its fertility preservation potential., Methods: The Prevention of Menopause Induced by Chemotherapy: a Study in Early Breast Cancer Patients-Gruppo Italiano Mammella 6 (PROMISE-GIM6) trial is a multicenter, randomized, open-label, phase III superiority trial conducted at 16 Italian centers from October 2003 to January 2008. Eligible patients were randomly assigned to (neo)adjuvant chemotherapy alone (control arm) or combined with the GnRHa triptorelin (GnRHa arm). The primary planned endpoint was incidence of chemotherapy-induced premature ovarian insufficiency. Post hoc endpoints were disease-free survival (DFS), overall survival (OS), and post-treatment pregnancies. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated., Results: Of 281 randomly assigned patients, 80.4% had hormone receptor-positive breast cancer. Median follow-up was 12.4 years (interquartile range = 11.3-13.2 years). No differences in 12-year DFS (65.7% [95% CI = 57.0% to 73.1%] in the GnRHa arm vs 69.2% [95% CI = 60.3% to 76.5%] in the control arm; HR = 1.16, 95% CI = 0.76 to 1.77) or in 12-year OS (81.2% [95% CI = 73.6% to 86.8%] in the GnRHa arm vs 81.3% [95% CI = 73.1% to 87.2%] in the control arm; HR = 1.17, 95% CI = 0.67 to 2.03) were observed. In patients with hormone receptor-positive disease, the hazard ratio was 1.02 (95% CI = 0.63 to 1.63) for DFS and 1.12 (95% CI = 0.59 to 2.11) for OS. In the GnRHa and control arms, 9 and 4 patients had a posttreatment pregnancy, respectively (HR = 2.14, 95% CI = 0.66 to 6.92)., Conclusions: Final analysis of the PROMISE-GIM6 trial provides reassuring results on the safety of GnRHa use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer, including those with hormone receptor-positive disease., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2022
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