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

L. Moscetti, M. A. Fabbri, C. Natoli, P. Vici, T. Gamucci, I. Sperduti, L. Iezzi, E. Iattoni, L. Pizzuti, C. Roma, A. Vaccaro, G. D'Auria, M. Mauri, L. Mentuccia, A. Grassadonia, M. Barba, E. M. Ruggeri

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Abstract

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.
Original languageEnglish
Pages (from-to)54528-54536
JournalOncotarget
Volume8
Issue number33
DOIs
Publication statusPublished - Apr 20 2017

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Breast Neoplasms
Disease-Free Survival
Survival
Estrogen Receptors
Therapeutics
fulvestrant
Multivariate Analysis
Neoplasm Metastasis
Safety

Keywords

  • endocrine resistance
  • endocrine therapy
  • fulvestrant
  • metastatic breast cancer

Cite this

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial. / Moscetti, L.; Fabbri, M. A.; Natoli, C.; Vici, P.; Gamucci, T.; Sperduti, I.; Iezzi, L.; Iattoni, E.; Pizzuti, L.; Roma, C.; Vaccaro, A.; D'Auria, G.; Mauri, M.; Mentuccia, L.; Grassadonia, A.; Barba, M.; Ruggeri, E. M.

In: Oncotarget, Vol. 8, No. 33, 20.04.2017, p. 54528-54536.

Research output: Contribution to journalArticle

Moscetti, L, Fabbri, MA, Natoli, C, Vici, P, Gamucci, T, Sperduti, I, Iezzi, L, Iattoni, E, Pizzuti, L, Roma, C, Vaccaro, A, D'Auria, G, Mauri, M, Mentuccia, L, Grassadonia, A, Barba, M & Ruggeri, EM 2017, 'Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial', Oncotarget, vol. 8, no. 33, pp. 54528-54536. https://doi.org/10.18632/oncotarget.17262 [doi]
Moscetti, L. ; Fabbri, M. A. ; Natoli, C. ; Vici, P. ; Gamucci, T. ; Sperduti, I. ; Iezzi, L. ; Iattoni, E. ; Pizzuti, L. ; Roma, C. ; Vaccaro, A. ; D'Auria, G. ; Mauri, M. ; Mentuccia, L. ; Grassadonia, A. ; Barba, M. ; Ruggeri, E. M. / Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial. In: Oncotarget. 2017 ; Vol. 8, No. 33. pp. 54528-54536.
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abstract = "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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T1 - Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

AU - Moscetti, L.

AU - Fabbri, M. A.

AU - Natoli, C.

AU - Vici, P.

AU - Gamucci, T.

AU - Sperduti, I.

AU - Iezzi, L.

AU - Iattoni, E.

AU - Pizzuti, L.

AU - Roma, C.

AU - Vaccaro, A.

AU - D'Auria, G.

AU - Mauri, M.

AU - Mentuccia, L.

AU - Grassadonia, A.

AU - Barba, M.

AU - Ruggeri, E. M.

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PY - 2017/4/20

Y1 - 2017/4/20

N2 - 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.

AB - 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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KW - endocrine therapy

KW - fulvestrant

KW - metastatic breast cancer

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