ObjectiveTo investigate the efficacy and safety of chidamide combined with paclitaxel liposome in the treatment of advanced breast cancer with negative HER2 expression.
MethodsA total of 41 patients with advanced HER2 negative breast cancer from May 2017 to November 2017, who failed in 2 regimens of chemotherapy were enrolled and randomly divided into observation group (n=20) and control group (n=21). Patients in observation group were given chidamide tablets (30 mg oral administration, twice per week for 2 months) and paclitaxel liposome (175 mg/m2 iv, 21 days was a cycle for 3 cycles). In addition to paclitaxel liposome, patients in control group were given placebo (30 mg oral administration, twice per week for 2 months). Response rate, disease control rate and progressionfree survival were analyzed.
ResultsAll patients were evaluable for the efficacy. In observation group, there were 5 cases of CR, 7 cases of PR, 5 cases of SD and 3 cases of PD. RR was 600% and DCR was 850%. In control group, there were 3 cases of CR, 3 cases of PR, 5 cases of SD and 10 cases of PD. RR was 286% and DCR was 524%. The RR and DCR in observation group were higher than those in control group (P<005). The median PFS was 52 months in observation group, higher than 31 months in control group (P<005). The main adverse reactions were gastrointestinal reactions and bone marrow suppression, mainly in grade 12. The incidences of leukopenia, thrombocytopenia and nausea/vomiting were higher in observation group than in control group (P<005).
ConclusionChidamide combined with paclitaxel liposome for advanced breast cancer with negative HER2 expression has good efficacy and the adverse effects are tolerable.