恩替诺特联合卡培他滨治疗晚期三阴型乳腺癌的疗效及安全性

Efficacy and Safety of Entinostat Combined with Capecitabine in Treatment of Advanced Triple-Negative Breast Cancer

目的探讨恩替诺特联合卡培他滨治疗晚期三阴型乳腺癌的疗效及安全性。方法选取晚期三阴性乳腺癌患者59例,按随机数字表法将其分为观察组(n=29)和对照组(n=30)。观察组予恩替诺特(5 mg,po,每周1次)联合卡培他滨(1250 mg·m^(-2),po,每天2次,连续口服2周,休息1周,共3个疗程治疗)。对照组予同等剂量卡培他滨联合安慰剂治疗。比较2组的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、1年生存率和毒副反应。结果观察组的ORR、DCR分别为31.0%和44.8%,显著高于对照组10.0%和20.0%(χ^(2)=4.03、4.16,P<0.05)。观察组中位PFS和1年生存率分别为4.76个月和57.0%,显著高于对照组的0.79个月和30.1%(χ^(2)=4.29、4.60,P<0.05)。观察组白细胞下降率为79.3%,血小板下降率79.4%,胃肠道反应率为62.1%。观察组白细胞下降、血小板下降、胃肠道反应发生率高于对照组(P<0.05),但毒副反应以1—2级为主。结论恩替诺特联合卡培他滨治疗晚期三阴性乳腺癌疗效较好,不良反应主要为骨髓抑制、消化道反应等,且可耐受。

Objective To investigate the efficacy and safety of entinostat combined with capecitabine in the treatment of advanced triple-negative breast cancer(TNBC).Methods Fifty-nine patients with advanced TNBC were randomly divided into two groups.The observation group(n=29)was treated with entinostat(5 mg,po,once a week)and capecitabine(1250 mg·m^(-2),po,twice a day for 2 consecutive weeks followed by a 1-week rest,3 courses of treatment).The control group was given the same doses of capecitabine and placebo.Objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),1-year survival rate and adverse reactions were compared between the two groups.Results The ORR and DCR in the observation group(31.0%and 44.8%,respectively)were higher than those in the control group(10.0%and 20.0%,respectively)(χ^(2)=4.03 and 4.16,respectively;P<0.05).The median PFS and 1-year survival rate in the observation group were respectively 4.76 months and 57.0%,which were higher than those in the control group(0.79 months and 30.1%,respectively)(χ^(2)=4.29 and 4.60,respectively;P<0.05).In addition,the rates of leukocyte decline,platelet decline and gastrointestinal reactions in the observation group(79.3%,79.4%and 62.1%,respectively)were higher than those in the control group(P<0.05).However,the main toxic and side reactions were grade 1-2 in the observation group.Conclusion The combination of entinostat and capecitabine,an effective treatment for advanced TNBC,led to a leukocyte decline rate of 79.3%,a platelet decline rate of 79.4%and a gastrointestinal reaction rate of 62.1%.The main toxic and side reactions were bone marrow suppression and digestive tract reaction,which could be tolerated.