Everolimus Plus Exemestane in Advanced Breast Cancer: Safety Results of the BALLET Study on Patients Previously Treated Without and with Chemotherapy in the Metastatic Setting. (21st April 2017)

• Record Type: Journal Article
• Authors: Generali, Daniele; Montemurro, Filippo; Bordonaro, Roberto; Mafodda, Antonino; Romito, Sante; Michelotti, Andrea; Piovano, Pierluigi; Ionta, Maria Teresa; Bighin, Claudia; Sartori, Donata; Frassoldati, Antonio; Cazzaniga, Marina Elena; Riccardi, Ferdinando; Testore, Franco; Vici, Patrizia; Barone, Carlo Antonio; Schirone, Alessio; Piacentini, Federico; Nolè, Franco; Molino, Annamaria; Latini, Luciano; Simoncini, Edda Lucia; Roila, Fausto; Cognetti, Francesco; Nuzzo, Francesco; Foglietta, Jennifer; Minisini, Alessandro Marco; Goffredo, Francesca; Portera, Giuseppe; Ascione, Gilda; Mariani, Gabriella;
• Other Names: Elena Piazza investigator.; Rita Ceccherini investigator.; Gabriella Farina investigator.; Mauro Moroni investigator.; Alberto Tondini Carlo investigator.; Saverio Cinieri investigator.; Giuseppe Cairo investigator.; Salvatore Pisconti investigator.; Gennaro Palmiotti investigator.; Francesco Giotta investigator.; Anna Rizzi investigator.; Massimiliano Spada investigator.; Graziella Pinotti investigator.; Francesco Caruso investigator.; Rodolfo Mattioli investigator.; Michele Aieta investigator.; Claudio Graiff investigator.; Claudio Verusio investigator.; Carlo Aschele investigator.; Felettino Sede investigator.; Giovanni Vicario investigator.; Antonella Ferro investigator.; Oscar Alabiso investigator.; Lorenzo Pavesi investigator.; Sergio Fava investigator.; Antonio Pazzola investigator.; Maria Ruggeri Enzo investigator.; Paolo Tralongo investigator.; Monica Giordano investigator.; Maria D'Arco Alfonso investigator.; Vincenza Tinessa investigator.; Teresa Gamucci Maria investigator.; Paolo Marchetti investigator.; Enrico Cortesi investigator.; Ilaria Portarena investigator.; Saverio Danese investigator.; Domenico Amoroso investigator.; Eugenio Cammilluzzi investigator.; Armando Santoro investigator.; Sergio Bretti investigator.; Daniele Farci investigator.; Pietro Ianniello Giovanni investigator.; Salvatore Palazzo investigator.; Antonio Russo investigator.; Giovanni Rosti investigator.; Nicola Marzano investigator.; Evaristo Maiello investigator.; Lorenza Mairone investigator.; Roberto Maisano investigator.; Caterina Battaglia investigator.; Donatella Grasso investigator.; Cesare Gridelli investigator.; Ornella Garrone investigator.; Giuseppe Serravezza investigator.; Laura Merlini investigator.; Cristina Ghiotto investigator.; Silvana Saracchini investigator.; Gianfranco Filippelli investigator.; Andrea De Censi investigator.; Corrado Ficorella investigator.; Corrado Boni investigator.; Pia Di Stefano investigator.; Michela Donadio investigator.; Pierosandro Tagliaferri investigator.; Angelo Di Leo investigator.; Sabino De Placido investigator.; Giuseppina Sarobba investigator.; Federico Castiglione investigator.; Agata Pisano investigator.; Luisa Fioretto investigator.; Hèctor Soto Parra investigator.; Germano Zampa investigator.; Carmelo Iacono investigator.; Vincenzo Montesarchio investigator.; Mario Barduagni investigator.; Marco Benasso investigator.; Lucio Giustini investigator.; Salvatore Siena investigator.; Sandro Barni investigator.; Sergio Bracarda investigator.; Fedele Scinto investigator.; Marilena Visini investigator.; Lorenzo Gianni investigator.; Salvatore Artale investigator.; Luca Gianni investigator.; Fortunato Ciardiello investigator.; Amelia Tienghi investigator.; Giampaolo Tortora investigator.; Alba Brandes investigator.; Felice Pasini investigator.; Vincenzo Adamo investigator.; Mario Clerico investigator.; Giovanna Cavazzini investigator.; Fernando Gaion investigator.; Giovanni Scambia investigator.; Mario Airoldi investigator.;
• Is Part Of: Oncologist. Volume 22:Number 6(2017)
• Page Start: 648
• Page End: 654
• Publication Date: 2017-04-21
• Subjects: Advanced breast cancer -- Safety -- Everolimus -- Hormone‐receptor positive -- Real life; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2016-0461
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract : Background: The BALLET study was an open‐label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor‐positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). Patients and Methods: One thousand one hundred and fifty‐one Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). Results: One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus‐related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus‐related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. Conclusion: Real‐life data of the Italian patients BALLET‐related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. Abstract : This study presents results of the BALLET study, which focused on the use of everolimus/exemestane combination in postmenopausal women with ER+ locally advanced or metastatic breast cancer after recurrence or progression after nonsteroidal aromatase inhibitor treatment. Real‐life data of the cohort are reported.