Efficacy of fulvestrant and capecitabine as maintenance therapy in patients with HR +/HER2 - metastatic breast cancer benefited from first-line chemotherapy.

It aimed to explore the distinction of efficacy between fulvestrant (FUL), capecitabine (CAP) alone, and combined treatment in maintenance therapy (MT) for patients with HR + /HER2 - metastatic breast cancer (MBC) who benefit from first-line chemotherapy. Ninety-five patients with HR + /HER2 - MBC who were in complete response (CR), partial response (PR), or stable disease (SD) after first-line chemotherapy were grouped: FUL group (FULG), CAP group (CAPG), and combined group (CG). The efficacy, adverse events (AEs), and short-term prognosis of MT were compared. The median time to progression (TTP) was 10, 14, and 18 months, respectively. The objective response rates (ORR) were 38.7%, 36.7%, and 61.8%, and the disease control rates (DCR) were 71.0%, 83.3%, and 97.1%, respectively. The progression-free survival (PFS) rates were 16.1%, 33.3%, and 44.1%, and the overall survival (OS) rates were 38.7%, 46.7%, and 58.8%, respectively. TTP, ORR, DCR, PFS, and OS in the CG were markedly higher against the other two groups; the incidence of thrombocytopenia and nausea/vomiting in the CG was higher against the FULG (all P < 0.05). There was no distinction in the incidence of other AEs (P > 0.05). The quality of life (QoL) score in the CG was markedly higher against the FULG and CAPG (P < 0.05). Metronomic CAP plus FUL can delay progressive disease (PD) and improve QoL in patients. Although these results are promising, they warrant further validation in larger, multicenter studies due to the limited sample size.