Research Papers:

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

Luca Moscetti _, Maria Agnese Fabbri, Clara Natoli, Patrizia Vici, Teresa Gamucci, Isabella Sperduti, Laura Iezzi, Elena Iattoni, Laura Pizzuti, Carmine Roma, Angela Vaccaro, Giuliana D’Auria, Mariella Mauri, Lucia Mentuccia, Antonino Grassadonia, Maddalena Barba and Enzo Maria Ruggeri

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Oncotarget. 2017; 8:54528-54536. https://doi.org/10.18632/oncotarget.17262

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Luca Moscetti1,8, Maria Agnese Fabbri1, Clara Natoli2, Patrizia Vici3, Teresa Gamucci4, Isabella Sperduti5, Laura Iezzi6, Elena Iattoni8, Laura Pizzuti3, Carmine Roma7, Angela Vaccaro4, Giuliana D’Auria1, Mariella Mauri7, Lucia Mentuccia4, Antonino Grassadonia2, Maddalena Barba3 and Enzo Maria Ruggeri1

1Division of Medical Oncology, AUSL Viterbo, Belcolle Hospital Strada Sammartinese, 01100 Viterbo, Italy

2Department of Medical, Oral and Biotechnological Sciences and CeSI-MeT University G. D'Annunzio, Chieti-Pescara, 66100 Chieti, Italy

3Division of Medical Oncology 2, Regina Elena National Cancer Institute, 00144 Roma, Italy

4Medical Oncology Unit, ASL Frosinone, 03100 Frosinone, Italy

5Biostatistics Unit, Istituto Regina Elena, 00144 Rome, Italy

6Medical Oncology Unit, SS. Annunziata Hospital, 66100 Chieti, Italy

7Division of Oncology, Azienda Ospedaliera San Giovanni Addolorata, 00184 Rome, Italy

8Department of Oncology and Haematology, Azienda Ospedaliero Universitaria Policlinico di Modena, 41124 Modena, Italy

Correspondence to:

Luca Moscetti, email: [email protected]

Keywords: fulvestrant, metastatic breast cancer, endocrine therapy, endocrine resistance

Received: October 11, 2016    Accepted: March 04, 2017    Published: April 20, 2017


The observational prospective trial herein presented aimed at evaluating the efficacy of fulvestrant 500 mg in the treatment of endocrine sensitive advanced breast cancer patients from the real world setting. The primary end point was clinical benefit rate (CBR). Secondary end points were overall survival (OS), progression free survival (PFS) and tolerability. One hundred sixty three patients were enrolled. At a median follow up of 20 months, the 61% of patients reached CBR, whose median duration was 10.8 months. Median PFS and OS were 7 and 35 months, respectively. Endocrine sensitive patients showed better PFS and OS. No relevant toxicity appeared when analyzing safety data. In multivariate analysis, visceral involvement, endocrine sensitivity and previous endocrine therapy were prognostic factor for PFS, whereas endocrine sensitivity and metastasis at diagnosis had prognostic relevance for OS. Estrogen receptor expression >50%, single metastatic site, and no prior endocrine therapy for advanced disease were predictive of CBR. In this prospective trial, fulvestrant 500 mg appeared to be a safe and active treatment and confirmed its efficacy in the daily clinical practice. A high percent expression of estrogen receptors (above 50%) was associated with higher CBR. Treatment was very well tolerated. Endocrine sensitivity had a major impact on treatment outcome. As expected, patients who had received first-line endocrine therapy for advanced disease exhibited worse outcome and a lower CBR.

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