Efficacy of Fulvestrant in Women with Hormone-Resistant Metastatic Breast Cancer (mBC): A Canadian Province Experience

Abstract Introduction: Fulvestrant has demonstrated efficacy in hormone receptor positive (HR+) metastatic breast cancer (mBC), both in first- and second-line settings. In clinical practice, however, fulvestrant has been used as a later-line therapy. The study aimed to assess the efficacy of fulvestrant in women with mBC in early- versus later-line therapy. Methods: In this retrospective cohort study, women with HR+ mBC who received fulvestrant between 2003–2019 in Saskatchewan were assessed. A multivariate Cox proportional survival analysis was performed. Results: 186 women with a median age of 63.5 years were identified; 178 (95.6%) had hormone resistant mBC, 57.5% had visceral disease, and 43.0% had received chemotherapy before fulvestrant. 102 (54.8%) women received ≤ 2-line-therapy, and 84 (45.2%) received ≥ 3 line-therapy before fulvestrant. The median time to progression (TTP) was 12 months in the early-treatment vs. 6 months in the later-treatment group, p = 0.015. Overall survival (OS) from the start of fulvestrant was 26 months in the early-treatment group vs. 16 months in the later-treatment group, p = 0.067. On multivariate analysis, absence of visceral metastasis, HR: 0.70 (0.50–0.99), was significantly correlated with better TTP, whereas post-fulvestrant chemotherapy, HR: 0.32 (0.23–0.47), clinical benefit from fulvestrant, HR: 0.44 (0.30–0.65) and absence of visceral metastasis, HR: 0.70 (0.50–0.97), were correlated with better OS. Conclusions: Fulvestrant has demonstrated efficacy as both early- and later-line therapy in hormone-resistant mBC. Women with clinical benefit from fulvestrant, who received post-fulvestrant chemotherapy, or had non-visceral disease had better survival.