Research Papers:

This article has been corrected. Correction in: Oncotarget. 2018; 9:36720-21.

Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study

Marina Cazzaniga _, Claudio Verusio, Mariangela Ciccarese, Alberto Fumagalli, Donata Sartori, Maria Rosaria Valerio, Mario Airoldi, Gabriella Moretti, Corrado Ficorella, Valentina Arcangeli, Lucrezia Diodati, Alberto Zambelli, Antonio Febbraro, Daniele Generali, Mirco Pistelli, Ornella Garrone, Antonino Musolino, Patrizia Vici, Michela Maur, Lucia Mentuccia, Nicla La Verde, Giulia Bianchi, Salvatore Artale, Livio Blasi, Matilde Piezzo, Francesco Atzori, Anna Turletti, Chiara Benedetto, Maria Concetta Cursano, Alessandra Fabi, Vittorio Gebbia, Alessio Schirone, Raffaella Palumbo, Antonella Ferzi, Antonio Frassoldati, Claudio Scavelli, Luca Clivio and Valter Torri on behalf of The EVA Study Group

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Oncotarget. 2018; 9:31877-31887. https://doi.org/10.18632/oncotarget.25874

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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


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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