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, Claudio Verusio, Mariangela Ciccarese, Alberto Fumagalli, Donata Sartori, Maria Rosaria Valerio, Mario Airoldi, Gabriella Moretti, Corrado Ficorella, Lorenzo Gianni, Andrea Michelotti, Alberto Zambelli, Antonio Febbraro, Daniele Generali, Mirco Pistelli, Ornella Garrone, Antonino Musolino, Patrizia Vici, Michela Maur, Lucia MentucciaNicla La Verde, Giulia Valeria Bianchi, Salvatore Artale, Livio Blasi, Michelino De Laurentiis, Francesco Atzori, Anna Turletti, Mauro Porpiglia, Daniele Santini, Alessandra Fabi, Vittorio Gebbia, Alessio Schirone, Raffaella Palumbo, Antonella Ferzi, Antonio Frassoldati, Claudio Scavelli, Luca Clivio, Monica Giordano, Michela Donadio, Laura Biganzoli, Lucia Del Mastro, Giancarlo Bisagni, Lorenzo Livi, Clara Natoli, Filippo Montemurro, Ferdinando Riccardi, Emanuela Romagnoli, Paolo Marchetti, Valter Torri, Paolo Pronzato, Giorgio Mustacchi

Research output: Contribution to journalArticle

Abstract

<bold><italic>Background:</italic></bold> 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. <bold><italic>Methods:</italic></bold> 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). <bold><italic>Results:</italic></bold> 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. <bold><italic>Conclusion:</italic></bold> These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Original languageEnglish
JournalBreast Care
DOIs
Publication statusPublished - Jan 1 2019

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Extravehicular Activity
Breast Neoplasms
Therapeutics
Aromatase Inhibitors
Datasets
fulvestrant
Italy
Neoplasm Metastasis
Bone and Bones

ASJC Scopus subject areas

  • Surgery
  • Oncology

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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. / Cazzaniga, Marina Elena; Verusio, Claudio; Ciccarese, Mariangela; Fumagalli, Alberto; Sartori, Donata; Valerio, Maria Rosaria; Airoldi, Mario; Moretti, Gabriella; Ficorella, Corrado; Gianni, Lorenzo; Michelotti, Andrea; Zambelli, Alberto; Febbraro, Antonio; Generali, Daniele; Pistelli, Mirco; Garrone, Ornella; Musolino, Antonino; Vici, Patrizia; Maur, Michela; Mentuccia, Lucia; La Verde, Nicla; Bianchi, Giulia Valeria; Artale, Salvatore; Blasi, Livio; De Laurentiis, Michelino; Atzori, Francesco; Turletti, Anna; Porpiglia, Mauro; Santini, Daniele; Fabi, Alessandra; Gebbia, Vittorio; Schirone, Alessio; Palumbo, Raffaella; Ferzi, Antonella; Frassoldati, Antonio; Scavelli, Claudio; Clivio, Luca; Giordano, Monica; Donadio, Michela; Biganzoli, Laura; Del Mastro, Lucia; Bisagni, Giancarlo; Livi, Lorenzo; Natoli, Clara; Montemurro, Filippo; Riccardi, Ferdinando; Romagnoli, Emanuela; Marchetti, Paolo; Torri, Valter; Pronzato, Paolo; Mustacchi, Giorgio.

In: Breast Care, 01.01.2019.

Research output: Contribution to journalArticle

Cazzaniga, ME, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, MR, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, GV, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P & Mustacchi, G 2019, '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', Breast Care. https://doi.org/10.1159/000495469
Cazzaniga, Marina Elena ; Verusio, Claudio ; Ciccarese, Mariangela ; Fumagalli, Alberto ; Sartori, Donata ; Valerio, Maria Rosaria ; Airoldi, Mario ; Moretti, Gabriella ; Ficorella, Corrado ; Gianni, Lorenzo ; Michelotti, Andrea ; Zambelli, Alberto ; Febbraro, Antonio ; Generali, Daniele ; Pistelli, Mirco ; Garrone, Ornella ; Musolino, Antonino ; Vici, Patrizia ; Maur, Michela ; Mentuccia, Lucia ; La Verde, Nicla ; Bianchi, Giulia Valeria ; Artale, Salvatore ; Blasi, Livio ; De Laurentiis, Michelino ; Atzori, Francesco ; Turletti, Anna ; Porpiglia, Mauro ; Santini, Daniele ; Fabi, Alessandra ; Gebbia, Vittorio ; Schirone, Alessio ; Palumbo, Raffaella ; Ferzi, Antonella ; Frassoldati, Antonio ; Scavelli, Claudio ; Clivio, Luca ; Giordano, Monica ; Donadio, Michela ; Biganzoli, Laura ; Del Mastro, Lucia ; Bisagni, Giancarlo ; Livi, Lorenzo ; Natoli, Clara ; Montemurro, Filippo ; Riccardi, Ferdinando ; Romagnoli, Emanuela ; Marchetti, Paolo ; Torri, Valter ; Pronzato, Paolo ; Mustacchi, Giorgio. / 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. In: Breast Care. 2019.
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title = "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",
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.",
author = "Cazzaniga, {Marina Elena} and Claudio Verusio and Mariangela Ciccarese and Alberto Fumagalli and Donata Sartori and Valerio, {Maria Rosaria} and Mario Airoldi and Gabriella Moretti and Corrado Ficorella and Lorenzo Gianni and Andrea Michelotti and Alberto Zambelli and Antonio Febbraro and Daniele Generali and Mirco Pistelli and Ornella Garrone and Antonino Musolino and Patrizia Vici and Michela Maur and Lucia Mentuccia and {La Verde}, Nicla and Bianchi, {Giulia Valeria} and Salvatore Artale and Livio Blasi and {De Laurentiis}, Michelino and Francesco Atzori and Anna Turletti and Mauro Porpiglia and Daniele Santini and Alessandra Fabi and Vittorio Gebbia and Alessio Schirone and Raffaella Palumbo and Antonella Ferzi and Antonio Frassoldati and Claudio Scavelli and Luca Clivio and Monica Giordano and Michela Donadio and Laura Biganzoli and {Del Mastro}, Lucia and Giancarlo Bisagni and Lorenzo Livi and Clara Natoli and Filippo Montemurro and Ferdinando Riccardi and Emanuela Romagnoli and Paolo Marchetti and Valter Torri and Paolo Pronzato and Giorgio Mustacchi",
year = "2019",
month = "1",
day = "1",
doi = "10.1159/000495469",
language = "English",
journal = "Breast Care",
issn = "1661-3791",
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TY - JOUR

T1 - 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

T2 - The EVA and GIM-13 AMBRA Studies

AU - Cazzaniga, Marina Elena

AU - Verusio, Claudio

AU - Ciccarese, Mariangela

AU - Fumagalli, Alberto

AU - Sartori, Donata

AU - Valerio, Maria Rosaria

AU - Airoldi, Mario

AU - Moretti, Gabriella

AU - Ficorella, Corrado

AU - Gianni, Lorenzo

AU - Michelotti, Andrea

AU - Zambelli, Alberto

AU - Febbraro, Antonio

AU - Generali, Daniele

AU - Pistelli, Mirco

AU - Garrone, Ornella

AU - Musolino, Antonino

AU - Vici, Patrizia

AU - Maur, Michela

AU - Mentuccia, Lucia

AU - La Verde, Nicla

AU - Bianchi, Giulia Valeria

AU - Artale, Salvatore

AU - Blasi, Livio

AU - De Laurentiis, Michelino

AU - Atzori, Francesco

AU - Turletti, Anna

AU - Porpiglia, Mauro

AU - Santini, Daniele

AU - Fabi, Alessandra

AU - Gebbia, Vittorio

AU - Schirone, Alessio

AU - Palumbo, Raffaella

AU - Ferzi, Antonella

AU - Frassoldati, Antonio

AU - Scavelli, Claudio

AU - Clivio, Luca

AU - Giordano, Monica

AU - Donadio, Michela

AU - Biganzoli, Laura

AU - Del Mastro, Lucia

AU - Bisagni, Giancarlo

AU - Livi, Lorenzo

AU - Natoli, Clara

AU - Montemurro, Filippo

AU - Riccardi, Ferdinando

AU - Romagnoli, Emanuela

AU - Marchetti, Paolo

AU - Torri, Valter

AU - Pronzato, Paolo

AU - Mustacchi, Giorgio

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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U2 - 10.1159/000495469

DO - 10.1159/000495469

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JO - Breast Care

JF - Breast Care

SN - 1661-3791

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