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. This study assessed the efficacy of fulvestrant in women with mBC in early-versus later-line therapy.

Methods: This retrospective cohort study assessed Saskatchewan women with HR+ mBC who received fulvestrant between 2003-2019. A multivariate Cox proportional survival analysis was performed.

Results: One hundred and eighty-six 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. Our results show that women with clinical benefit from fulvestrant, who received post-fulvestrant chemotherapy, or had non-visceral disease, had better survival.

Keywords: fulvestrant; hormone receptor positive breast cancer; hormone-resistant; survival; visceral metastases.

Figure 1

Flowchart of study participants who received fulvestrant.

Figure 2

(A) Kaplan–Meier survival curves for time to progression stratified by line of therapy with a median TTP of 12 months (9.4–14.6) in women starting fulvestrant after ≤2 lines of therapy, versus 6 months (5.1–6.9) in women with ≥3 lines of therapy (p = 0.015). (B) Kaplan–Meier survival curves for overall survival (OS) stratified by line of therapy with a median OS of 26 months (16.0–36.0) in women starting fulvestrant after ≤2 lines of therapy, versus 16 months (10.5–21.5) in women with ≥3 lines of therapy (p = 0.067).

Figure 3

(A) Kaplan–Meier survival curves for time to progression (TTP) stratified by the presence of visceral metastasis. Patients who had visceral metastasis had a TTP of 7 months (5.1–8.9), versus 11 months (7.9–14.1) without visceral metastasis (p = 0.142). (B) Kaplan–Meier survival curves for overall survival (OS) stratified by the presence of visceral metastasis. Patients who had visceral metastasis had a lower OS of 18 months (14.1–21.9), versus 32 months (23.0–41.0) without visceral metastasis (p = 0.029).