临床肿瘤学杂志 ›› 2018, Vol. 23 ›› Issue (8): 721-724.

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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#
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  1. 南昌南昌市第三医院肿瘤内科
  • 出版日期:2018-08-31 发布日期:2018-09-07

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

  1. Department of Oncology, the Third Hospital of Nanchang
  • Online:2018-08-31 Published:2018-09-07

摘要: 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。


关键词: 乳腺癌, HER2阴性, 西达本胺, 紫杉醇脂质体

Abstract: 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.


Key words: Breast cancer, Negative HER2 expression, Chidamide, Paclitaxel liposome

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