To investigate the efficacy and safety of anlotinib combined with neoadjuvant chemotherapy (NAC) in elderly patients with triple-negative breast cancer (TNBC).

Elderly patients with TNBC who underwent NAC followed by modified radical mastectomy were enrolled and divided into control group and treatment group based on their treatment regimens. Control group received the TEC regimen as preoperative NAC, while treatment group received additional oral administration of anlotinib hydrochloride capsules (12 mg once daily, in a 2-weeks-on/1-week-off cycle) for 4 cycles. Carbohydrate antigen 153 (CA153), carcinoembryonic antigen (CEA), growth differentiation factor-3 (GdF3), carbohydrate antigen 19-9, Ki-67 positive rate, cyclooxygenase-2 (COX2), vascular endothelial growth factor (VGEF), bone sialoprotein, prolactin, insulin-like growth factor-1, clinical efficacy and long-term survival outcomes were compared between the two groups, and the safety was conducted.

A total of 93 patients were enrolled and divided into control group (n=48) and treatment group (n=45). After treatment, the objective response rates (ORR) were 43.75% (21 cases/48 cases) in control group and 64.44% (29 cases /45 cases) in treatment group, respectively; while the disease control rates (DCR) were 70.83% (34 cases /48 cases) and 88.89% (40 cases /45 cases), respectively; CA 153 levels were (24.59±3.57) and (22.21±3.86) μ·mL^-1, respectively; GdF3 levels were (117.53±18.29) and (102.24±15.47) ng·L^-1, respectively; CEA levels were (4.19±0.85) and (3.72±0.64) ng·L^-1, respectively; the Ki-67 positivity rates were 37.50% and 17.78%, respectively; COX-2 levels were (88.73±21.64) and (74.38±19.51) ng·L^-1, respectively; VEGF levels were (38.23±7.15) and (34.74±6.32) ng·L^-1, respectively; the progression-free survival (PFS) rates were 33.33% (16 cases/48 cases) and 46.67% (21 cases/45 cases), respectively. Statistically significant differences were observed in all the above indicators between the two groups (all P<0.05, P<0.01, P<0.001). The adverse drug reactions during chemotherapy in treatment group and control group included anemia, decreased appetite, neutropenia, leukopenia, thrombocytopenia, headache, hypertension, nausea and vomiting, fatigue, elevated thyroid hormones, diarrhea, constipation, infection, alopecia, impaired liver and kidney function, and hand-foot syndrome. The total incidence of adverse drug reactions was 64.58% (31 cases/48 cases) in control group and 71.11% (32 cases /45 cases) in treatment group, with no statistically significant difference between the groups (P>0.05). The overall survival (OS) rate was 60.42% (29 cases /48 cases) in control group and 68.89% (31 cases /45 cases) in treatment group, and the difference was not statistically significant (P>0.05).

Anlotinib combined with NAC regimen for elderly TNBC patients shows good efficacy, can improve Ki-67 positive rate and serum COX-2 and vascular endothelial growth factor levels, improve long-term survival, and has high safety.