M E Cazzaniga1, M Airoldi2, V Arcangeli3, S Artale4, F Atzori5, A Ballerio6, G V Bianchi7, L Blasi8, S Campidoglio9, M Ciccarese10, M C Cursano11, M Piezzo12, A Fabi13, L Ferrari14, A Ferzi15, C Ficorella16, A Frassoldati17, A Fumagalli18, O Garrone19, V Gebbia20, D Generali21, N La Verde22, M Maur23, A Michelotti24, G Moretti25, A Musolino26, R Palumbo27, M Pistelli28, M Porpiglia29, D Sartori30, C Scavelli31, A Schirone32, A Turletti33, M R Valerio34, P Vici35, A Zambelli36, L Clivio37, V Torri37. 1. Research Unit Phase I Trials, ASST Monza, Monza, Italy; Oncology Unit, ASST Monza, Monza, Italy. Electronic address: marina.cazzaniga@asst-monza.it. 2. Oncology Unit 2 - Città della Salute e della Scienza di Torino, Torino, Italy. 3. Oncology Unit Rimini Azienda USL Romagna, Rimini, Italy. 4. Oncology Department, Ospedale di Gallarate ASST Valle Olona, Gallarate, Italy. 5. Oncology Unit, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy. 6. Oncology Unit, ASST della Valle Olona - Presidio Ospedaliero di Saronno, Saronno, Italy. 7. Oncology Unit 1, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy. 8. Oncology Unit, ARNAS Civico Palermo, Palermo, Italy. 9. Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli, Benevento, Italy. 10. Oncology Unit, Ospedale "Vito Fazzi" di Lecce, Lecce, Italy. 11. Oncology Unit, Università Campus Bio-Medico, Roma, Italy. 12. National Cancer Institute "Fondazione Giovanni Pascale", Napoli, Italy. 13. Oncology Unit 1, Istituto Regina Elena - IFO, Roma, Italy. 14. Oncology Unit, ASL di Frosinone Osp. "SS. Trinità", Italy. 15. Oncology Unit, ASST OVEST Milanese - Presidio di Legnano, Legnano, Italy. 16. Dipartimento di Scienze Cliniche Applicate e Biotecnologiche (DISCAB) - Università Degli Studi Dell'Aquila, L'Aquila, Italy. 17. Oncology Unit, Az Ospedaliero Universitaria di Ferrara, Ferrara, Italy. 18. Oncology Unit, Ospedale Moriggia Pelascini, Gravedona, Italy. 19. Oncology Unit, A.O. S. Croce e Carle Ospedale di Insegnamento, Cuneo, Italy. 20. Oncology Unit, Osp. La Maddalena, Palermo, Italy. 21. Brest Unit, ASST di Cremona, Italy. 22. Oncology Unit, ASST Fatebenefratelli Sacco, Milano, Italy. 23. Oncology and Haematology Department, A.O.U Policlinico di Modena, Modena, Italy. 24. Oncology Unit I, Ospedale S. Chiara, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. 25. Oncology Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy. 26. Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 27. Oncology Unit, IRCCS ICS Maugeri, Pavia, Italy. 28. Oncology Unit, AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi, Ancona, Italy. 29. Oncology Unit, Presidio Ospedaliero S. Anna, Torino, Italy. 30. Oncology Unit, AULSS 3, Mirano, Italy. 31. Oncology Unit, Ospedale "S. Cuore di Gesù", Gallipoli, Italy. 32. Oncology Department, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 33. Oncology Unit, Ospedale Martini della ASL "Città di Torino", Torino, Italy. 34. Oncology Department, Policlinico di Palermo Paolo Giaccone, Palermo, Italy. 35. Oncology Unit, Istituto Nazionale Tumori Regina Elena - IFO, Roma, Italy. 36. Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy. 37. IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
Abstract
BACKGROUND: The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. PATIENTS AND METHODS: This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. RESULTS: From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33-83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1-7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4-58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). CONCLUSIONS: The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
BACKGROUND: The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. PATIENTS AND METHODS: This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. RESULTS: From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33-83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1-7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4-58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). CONCLUSIONS: The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
Authors: Hossein Taghizadeh; Robert M Mader; Leonhard Müllauer; Stefanie Aust; Stephan Polterauer; Heinz Kölbl; Veronika Seebacher; Christoph Grimm; Alexander Reinthaller; Gerald W Prager Journal: Oncologist Date: 2020-05-08
Authors: Marina Elena Cazzaniga; Romano Danesi; Corrado Girmenia; Pietro Invernizzi; Alessandra Elvevi; Massimo Uguccioni Journal: Breast Cancer Res Treat Date: 2019-05-07 Impact factor: 4.872