Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Feb;15(1):30-37.
doi: 10.1159/000495469. Epub 2019 Apr 17.

Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Marina Elena Cazzaniga  1   2 , Claudio Verusio  3 , Mariangela Ciccarese  4 , Alberto Fumagalli  5 , Donata Sartori  6 , Maria Rosaria Valerio  7 , Mario Airoldi  8 , Gabriella Moretti  9 , Corrado Ficorella  10 , Lorenzo Gianni  11 , Andrea Michelotti  12 , Alberto Zambelli  13 , Antonio Febbraro  14 , Daniele Generali  15 , Mirco Pistelli  16 , Ornella Garrone  17 , Antonino Musolino  18 , Patrizia Vici  19 , Michela Maur  20 , Lucia Mentuccia  21 , Nicla La Verde  22 , Giulia Valeria Bianchi  23 , Salvatore Artale  24 , Livio Blasi  25 , Michelino De Laurentiis  26 , Francesco Atzori  1 , Anna Turletti  2 , Mauro Porpiglia  3 , Daniele Santini  4 , Alessandra Fabi  5 , Vittorio Gebbia  6 , Alessio Schirone  7 , Raffaella Palumbo  8 , Antonella Ferzi  9 , Antonio Frassoldati  10 , Claudio Scavelli  11 , Luca Clivio  12 , Monica Giordano  13 , Michela Donadio  14 , Laura Biganzoli  15 , Lucia Del Mastro  16 , Giancarlo Bisagni  17 , Lorenzo Livi  18 , Clara Natoli  19 , Filippo Montemurro  20 , Ferdinando Riccardi  21 , Emanuela Romagnoli  22 , Paolo Marchetti  23 , Valter Torri  12 , Paolo Pronzato  24 , Giorgio Mustacchi  25
Affiliations

Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Marina Elena Cazzaniga et al. Breast Care (Basel). 2020 Feb.

Abstract

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting.

Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies).

Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35-82) for the EVA and 57.8 years (range 35.0-82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1-48) and 12.4 months (range 2.9-70.0) in the two data sets, respectively.

Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Keywords: Advanced breast cancer; First-line setting; Fulvestrant; Hormone receptor positive.

PubMed Disclaimer

Conflict of interest statement

The Authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
CONSORT flow chart.
Fig. 2
Fig. 2
Plot sections of PFS and TTC (AMBRA GIM-13 data set).
See this image and copyright information in PMC

References

    1. Lim E, Metzger-Filho O, Winer EP. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park) 2012;26:688–694. 96. - PubMed
    1. Cardoso F, Costa A, Senkus E, Aapro M, André F, Barrios CH, et al. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3) Ann Oncol. 2017 Dec;28((12)):3111. - PMC - PubMed
    1. Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug;51((15)):3867–73. - PubMed
    1. Howell A, Robertson JF, Vergote I. A review of the efficacy of anastrozole in postmenopausal women with advanced breast cancer with visceral metastases. Breast Cancer Res Treat. 2003 Dec;82((3)):215–22. - PubMed
    1. Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, et al. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002 Aug;20((16)):3386–95. - PubMed