Real-World Efficacy of Fulvestrant Monotherapy as the First Treatment or Maintenance Treatment in Patients with Metastatic Breast Cancer

Background: Fulvestrant 500 mg monotherapy is recommended as the first-line endocrine treatment in postmenopausal women with hormone receptor-positive metastatic breast cancer (MBC). It is also used in MBC maintenance treatment. However, few studies have compared the efficacy of fulvestrant during the initial treatment with that during maintenance treatment. Patients and Methods: MBC patients who were treated with fulvestrant either as initial therapy for metastatic disease or after progression following one line of chemotherapy between January 2016 and December 2017 were identified from the database of the Affiliated Hospital of Qingdao University. The primary end point was progression-free survival (PFS). Results: The study included 135 MBC patients who were treated with fulvestrant; 116 patients who received fulvestrant as first-line treatment were divided into 2 groups: the no-chemotherapy treatment (NCT) group received fulvestrant as initial therapy during disease progression, and the chemotherapy treatment (CT) group received fulvestrant as maintenance following disease stabilization or response to previous chemotherapy. The median PFS was 16 months in NCT patients and 8 months in the CT group. Patients who had a longer disease-free survival, no visceral metastasis and one metastasis site, benefited from fulvestrant as first-line treatment during disease progression. Patients with 2 or more metastasis sites benefited from chemotherapy as first-line treatment and fulvestrant as maintenance treatment. Conclusions: Fulvestrant monotherapy showed good clinical activity and safety in patients with MBC who were treated upon disease progression and in those receiving maintenance therapy.