Fulvestrant in hormone-positive advanced breast cancer: Real-world outcome

Background: Fulvestrant has been shown to improve survival in hormone-positive, HER2-negative advanced breast cancer (ABC). There is no study on fulvestrant from India. Objectives: This study was done to assess the prognostic factors and outcome of patients with ABC treated with fulvestrant. Materials and Methods: This was a retrospective study from the case records of patients who received fulvestrant for hormone receptor (HR)-positive breast cancer from May 2011 to July 2019. Results: A total of 37 women were included in this analysis, with a median follow-up of 9 months. The median age was 63 years. The Eastern Cooperative Oncology Group performance status (ECOG PS) was 0–2 (78%) and 3–4 (22%). The sites of metastasis were bone (59%), lung (43%), liver (32%), lymph node (24%), and bone only (20%). Patients with visceral metastasis and visceral crisis constituted 60% and 13%, respectively. The median number of lines of prior systemic therapy for metastatic disease was 2 (range, 0–6). The dose of fulvestrant used was 500 mg in 76% and 250 mg in 24%. There were no Grade 3 or 4 toxicities due to fulvestrant. The median progression-free survival and overall survival were 10 months (95% confidence interval [CI], 4–15.9 months) and 21 months (95% CI, 8.9–33.1 months), respectively. Univariate analysis showed that patients with ECOG PS 3–4 had a worse survival as compared to patients with PS 0–2. Conclusion: This is the first study on the outcomes of fulvestrant in advanced breast cancer from India. Fulvestrant is safe, well-tolerated, and effective in patients with hormone-positive ABC. Fulvestrant can be recommended even in heavily pretreated HR-positive advanced breast cancer and in those with a poor general condition (ECOG PS 3 or 4) who are ineligible for chemotherapy.