Clinical Research Papers:

Anthropometric, clinical and molecular determinants of treatment outcomes in postmenopausal, hormone receptor positive metastatic breast cancer patients treated with fulvestrant: Results from a real word setting

Laura Pizzuti, Clara Natoli, Teresa Gamucci, Mariella Mauri, Domenico Sergi, Luigi Di Lauro, Giancarlo Paoletti, Enzo Ruggeri, Laura Iezzi, Isabella Sperduti, Lucia Mentuccia, Agnese Fabbri, Marcello Maugeri-Saccà, Luca Moscetti, Maddalena Barba _ and Patrizia Vici

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Oncotarget. 2017; 8:69025-69037. https://doi.org/10.18632/oncotarget.16982

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Laura Pizzuti1, Clara Natoli2, Teresa Gamucci3, Mariella Mauri4, Domenico Sergi1, Luigi Di Lauro1, Giancarlo Paoletti1, Enzo Ruggeri5, Laura Iezzi2, Isabella Sperduti6, Lucia Mentuccia3, Agnese Fabbri5, Marcello Maugeri-Saccà1,7, Luca Moscetti8, Maddalena Barba1,7 and Patrizia Vici1

1 Division of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy

2 Department of Medical,Oral and Biotechnological Sciences, Centro Scienzedell’ Invecchiamento e Medicina Traslazionale-CeSI-MeT, Chieti, Italy

3 Medical Oncology Unit, SS Trinità Hospital, Loc. San Marciano, Sora, Frosinone, Italy

4 Division of Oncology, San Giovanni Hospital, Rome, Italy

5 Division of Oncology, Complesso Ospedaliero Belcolle, AUSL Viterbo, Strada S. Martinese, Viterbo, Italy

6 Biostatistics Unit, Regina Elena National Cancer Institute, Rome, Italy

7 Scientific Direction, Regina Elena National Cancer Institute, Rome, Italy

8 Department of Medical and Surgical Sciences for Children and Adults, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy

Correspondence to:

Maddalena Barba, email:

Keywords: fulvestrant, hormone receptor positive metastatic breast cancer, endocrine sensitivity, endocrine resistance

Received: January 10, 2017 Accepted: March 15, 2017 Published: April 09, 2017


To characterize determinants of treatment outcome in a real world population of 161 post-menopausal hormone receptor-positive metastatic breast cancer patients treated with fulvestrant. Descriptive statistics for demographics, anthropometrics, clinical and molecular characteristic were compared across subgroups of sensitivity/resistance to prior endocrine therapy and tested in uni/multivariate models. Clinical benefit was more common in sensitive patients with higher estrogen receptor expression and when fulvestrant was given in first line (p=0.02 and 0.046). In resistant patients, PFS was longer with lower BMI (p=0.01). Among endocrine sensitive women, longer PFS was associated with fulvestrant in first-line, single metastasis and no visceral involvement (p=0.01, 0.003 and 0.01). OS was shorter in resistant patients with HER2-positive disease and if fulvestrant was given in second and subsequent line (p=0.03). In sensitive patients, we observed worse OS with multiple metastases (p=0.008). Multivariate analyses confirmed longer PFS in resistant patients with lower BMI and older age (p=0.002 and 0.007). OS in resistant patients was negatively influenced by HER2 positivity and fulvestrant in second and subsequent line (p=0.04). In sensitive women, multiple metastases were associated with poorer survival (p=0.002). This evidence encourages considering patient and disease characteristics in decision making and outcome interpretation for patients candidate to fulvestrant.

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