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.
Pizzuti, L., Natoli, C., Gamucci, T., Mauri, M., Sergi, D., Di Lauro, L., … Vici, P. (2017). 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. Oncotarget, 8(40). https://doi.org/10.18632/oncotarget.16982