A real-world, retrospective, observational study to evaluate the safety and effectiveness of Fulvestrant (Eranfu) monotherapy in HR+/HER2- advanced breast cancer patients
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Abstract
Background: Fulvestrant, a selective estrogen receptor degrader (SERD), is a standard endocrine therapy for HR-positive, HER2-negative advanced breast cancer (ABC). Despite the recent approval of combination regimens with targeted therapies, fulvestrant monotherapy remains widely used. However, real-world data from high-burden, resource-limited settings like Thailand are scarce. Objective: To evaluate the real-world safety and clinical effectiveness of generic fulvestrant (Eranfu) monotherapy in Thai patients with HR+/HER2- ABC across treatment lines. Methods: A retrospective review of 74 medical records of postmenopausal women (≥18 years) treated with fulvestrant between 1 January 2022 and 31 January 2024 was conducted. Of these, 29 patients met inclusion criteria: no prior endocrine therapy, relapse on/after adjuvant anti-estrogen therapy, or progression on anti-estrogen therapy, with ≥6 months of follow-up. Patients received Eranfu monotherapy as 1st line (n=4), 2nd line (n=15), or ≥3rd line (n=10). Safety was evaluated using CTCAE v5.0. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). Results: Median age was 61 years (range 43–89); 86.2% had ECOG performance status 0–1. Bone metastases were present in 55.2%, and 51.7% had visceral involvement. Patients had received up to two prior lines of endocrine or chemotherapy. Fulvestrant was well-tolerated, with only eight grade ≥4 adverse events. Median PFS was 3.67 months overall, longer in 1st line (6.73 months) than 2nd (3.27 months) or later lines (4.27 months). Median OS was 30.77 months. ORR was 14.2% overall and 50% with 1st line fulvestrant monotherapy. Conclusion: Fulvestrant demonstrated favorable safety and efficacy in Thai HR+/HER2- ABC patients, including those with visceral metastases and prior endocrine therapy. Improved results with 1st line use underscore the value of early initiation, supporting its continued role across treatment lines, especially in resource-limited settings.
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บทความทีตีพิมพ์ในวารสารโรคมะเร็งนี้ถือว่าเป็นลิขสิทธิ์ของมูลนิธิสถาบันมะเร็งแห่งชาติ และผลงานวิชาการหรือวิจัยของคณะผู้เขียน ไม่ใช่ความคิดเห็นของบรรณาธิการหรือผู้จัดทํา
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