西达本胺联合紫杉醇脂质体治疗HER 2阴性晚期乳腺癌的临床研究#br# #br#

目的探讨西达本胺联合紫杉醇脂质体治疗HER 2阴性晚期乳腺癌的疗效及安全性。 方法收集2017年5月至2017年11月41例接受过2种化疗方案后出现进展的HER 2阴性晚期乳腺癌患者41例，随机接受西达本胺联合紫杉醇脂质体治疗（观察组，n=20）或安慰剂联合紫杉醇脂质体治疗（对照组，n=21）。观察组：西达本胺30 mg口服，每周2次，服用2个月；第1天口服西达本胺的同时给予紫杉醇脂质体175 mg／m2静滴，21天为1个周期，化疗3个周期。对照组：安慰剂30 mg口服，每周2次，服用2个月；紫杉醇脂质体给药方法同观察组。比较两组的有效率（RR）、疾病控制率（DCR）和无进展生存期（PFS）。 结果41例患者均可评价疗效。观察组获CR 5例、PR 7 例、SD 5例和PD 3例；RR为 600％，DCR为 850％；对照组获CR 3例、PR 3例、SD 5例和PD 10例；RR为 286％，DCR为 524％。观察组RR和DCR均优于对照组，差异有统计学意义（P＜005）。观察组的中位PFS为 52个月，长于对照组的 31个月（P＜005）。两组主要不良反应为消化道反应和骨髓抑制，以1～2级为主。观察组白细胞减少、血小板减少和恶心呕吐的发生率高于对照组（P＜005）。 结论西达本胺联合紫杉醇脂质体治疗HER 2阴性晚期乳腺癌的疗效较好，且不良反应可耐受。

Clinical study of chidamide combined with paclitaxel liposome in the treatment of advanced breast cancer with negative HER 2 expression

ObjectiveTo investigate the efficacy and safety of chidamide combined with paclitaxel liposome in the treatment of advanced breast cancer with negative HER 2 expression. MethodsA total of 41 patients with advanced HER 2 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 progression free 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 600％ and DCR was 850％. In control group， there were 3 cases of CR， 3 cases of PR， 5 cases of SD and 10 cases of PD. RR was 286％ and DCR was 524％. The RR and DCR in observation group were higher than those in control group （P＜005）. The median PFS was 52 months in observation group， higher than 31 months in control group （P＜005）. The main adverse reactions were gastrointestinal reactions and bone marrow suppression， mainly in grade 1 2. The incidences of leukopenia， thrombocytopenia and nausea／vomiting were higher in observation group than in control group （P＜005）. ConclusionChidamide combined with paclitaxel liposome for advanced breast cancer with negative HER 2 expression has good efficacy and the adverse effects are tolerable.