Research Papers:
Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study
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Abstract
Marina Cazzaniga1,2, Claudio Verusio3, Mariangela Ciccarese4, Alberto Fumagalli5, Donata Sartori6, Maria Rosaria Valerio7, Mario Airoldi8, Gabriella Moretti9, Corrado Ficorella10, Valentina Arcangeli11, Lucrezia Diodati12, Alberto Zambelli13, Antonio Febbraro14, Daniele Generali15, Mirco Pistelli16, Ornella Garrone17, Antonino Musolino18, Patrizia Vici19, Michela Maur20, Lucia Mentuccia21, Nicla La Verde22, Giulia Bianchi23, Salvatore Artale24, Livio Blasi25, Matilde Piezzo26, Francesco Atzori27, Anna Turletti28, Chiara Benedetto29, Maria Concetta Cursano30, Alessandra Fabi31, Vittorio Gebbia32, Alessio Schirone33, Raffaella Palumbo34, Antonella Ferzi35, Antonio Frassoldati36, Claudio Scavelli37, Luca Clivio38 and Valter Torri on behalf of The EVA Study Group38
1Research Unit Phase I trials, ASST Monza, Monza, Italy
2Oncology Unit, ASST Monza, Monza, Italy
3Oncology Unit, ASST della Valle Olona-Presidio Ospedaliero di Saronno, Saronno, Italy
4Oncology Unit, Ospedale "Vito Fazzi" di Lecce, Lecce, Italy
5Oncology Unit, Ospedale Moriggia Pelascini, Gravedona, Italy
6Oncology Unit, AULSS 3, Mirano, Italy
7Oncology Department, Policlinico di Palermo Paolo Giaccone, Palermo, Italy
8Oncology Unit 2-Città della Salute e della Scienza di Torino, Torino, Italy
9Oncology Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy
10Dipartimento di Scienze Cliniche Applicate e Biotecnologiche (DISCAB)-Università Degli Studi Dell’Aquila, L’Aquila, Italy
11Oncology Unit Rimini Azienda USL Romagna, Rimini, Italy
12Oncology Unit 2, Azienda Osp edaliera Universitaria Pisa via Roma 67, Pisa, Italy
13Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy
14Oncology Unit, Ospedale Sacro Cuore di Gesù, Fatebenefratelli, Benevento, Italy
15Brest Unit, ASST di Cremona, Cremona, Italy
16Oncology Unit, AOU Ospedali Riuniti Umberto I-GM Lancisi-G Salesi, Ancona, Italy
17Oncology Unit, AOS Croce e Carle Ospedale di Insegnamento, Cuneo, Italy
18Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
19Oncology Unit 2, Istituto Nazionale Tumori Regina Elena–IFO, Roma, Italy
20Oncology Unit, Policlinico University Hospital of Modena, Modena, Italy
21Oncology Unit, ASL di Frosinone Osp. "SS. Trinità", Sora, Italy
22Oncology Unit, ASST Fatebenefratelli Sacco Presidio Ospedaliero Fatebenefratelli, Milano, Italy
23Oncology Unit 1, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy
24Oncology Departement, Ospedale di Gallarate ASST Valle Olona, Gallarate, Italy
25Oncology Unit, ARNAS Civico Palermo, Palermo, Italy
26National Cancer Institute "Fondazione Giovanni Pascale", Napoli, Italy
27Struttura Complessa di Oncologia Medica Azienda Ospedaliero-Universitaria Cagliari, Italy
28Oncology Unit, Ospedale Martini della ASL Città di Torino, Torino, Italy
29Dipartimento Universitario Ginecologia e Ostetricia 1, Ospedale S. Anna Torino, Turin, Italy
30Oncology Unit, Università Campus Bio-Medico, Roma, Italy
31Oncology Unit 1, Istituto Regina Elena–IFO, Roma, Italy
32Oncology Unit, Ospedale La Maddalena, Palermo, Italy
33Oncolgy Department, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy
34Oncology Unit, IRCCS ICS Maugeri, Pavia, Italy
35Oncology Unit, ASST OVEST Milanese, Presidio di Legnano, Legnano, Italy
36Oncology Unit, Az Ospedaliero Universitaria di Ferrara, Ferrara, Italy
37Oncology Unit, Ospedale "S. Cuore di Gesù", Gallipoli, Italy
38IRCCS-Istituto di Ricerche Farmacologiche “Mario Negri”, Milano, Italy
Correspondence to:
Marina Cazzaniga, email: [email protected]
Keywords: elderly; everolimus; exemestane; hormone-receptor positive; advanced breast cancer
Received: April 02, 2018 Accepted: July 12, 2018 Published: October 02, 2018
ABSTRACT
BACKGROUND: The present analysis focuses on real-world data of Everolimus-Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years.
METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and {greater than or equal to} 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel-Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model.
RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged {greater than or equal to} 65 years, of whom 87 were {greater than or equal to} 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged {greater than or equal to} 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (>7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3–4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged {greater than or equal to} 70 years. Five treatment-related deaths were collected (3,2%).
CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.
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PII: 25874