摘要
The purpose of this study was to investigate the efficacy and safety of chidamide combined with paclitaxel liposome in the treatment of advanced HER-2-negative breast cancer.First,41 patients with advanced HER-2-negative breast cancer who had received two chemotherapy regimens from May 2017 to November 2017 were randomly selected to receive chidamide combined with paclitaxel liposome treatment(observation group,n=20)or placebo combined with paclitaxel liposome treatment(control group,n=21).The treatment scheme of the observation group was oral chidamide 30mg twice a week for 2 months.In addition,on day 1,the patients were given paclitaxel liposome orally and intravenously administered with 175 mg/m2 for 1 cycle for 21 days and 3 cycles of chemotherapy.The treatment scheme of the control group was oral placebo 30 mg twice a week for 2 months.In addition,the method of paclitaxel liposome administration was the same as the observation group.The response rate(RR),disease control rate(DCR),and progression-free survival(PFS)were compared between the two groups.The results showed that all the 41 patients could be evaluated.In the observation group,CR5,PR7,SD5 and PD3 were obtained.RR was 60.0%and DCR was 85.0%.In the control group,CR3,PR3,SD5 and PD10 were obtained.RR was 28.6%and DCR was 52.4%.RR and DCR in the observation group were better than those in the control group,and the difference was statistically significant(P<0.05).The median PFS of the observation group was 5.2 months,longer than that of the control group(3.1 months,P<0.05).The main adverse reactions in the two groups were gastrointestinal reactions and bone marrow suppression,with grade 1~2 as the main ones.The incidence of leukopenia,thrombocytopenia and nausea and vomiting in the observation group was higher than that in the control group(P<0.05).Therefore,the chidamide combined with paclitaxel liposome is effective in the treatment of advanced HER-2-negative breast cancer,and the adverse reactions can be tolerated.
