西达本胺联合PD-1抑制剂治疗晚期三阴型乳腺癌的疗效及安全性

Efficacy and safety of chidamide combined with PD-1 inhibitors in the treatment of advanced triple negative breast cancer

目的:探讨西达本胺联合PD-1抑制剂治疗晚期三阴型乳腺癌的疗效及安全性。方法:选取我院2019年1月至2020年11月接受过至少2个化疗方案后出现肿瘤进展的晚期三阴型乳腺癌患者61例,随机分为观察组(西达本胺+帕博利珠单抗)和对照组(帕博利珠单抗+安慰剂),比较两组患者中位无进展生存期(Progression-free survival,PFS)、客观缓解率(Objective response rate,ORR)、疾病控制率(Disease control rate,DCR)、1年生存率和不良反应。结果:观察组客观缓解率(ORR)为20.0%高于对照组3.2%,差异无统计学意义(P>0.05),疾病控制率(DCR)为40.0%高于对照组16.1%(P<0.05);观察组中位无进展生存期(4.21个月)高于对照组(0.75个月),1年生存率(57%)高于对照组(33%),差异均有统计学意义(P<0.05)。观察组白细胞下降、血红蛋白下降、血小板下降、胃肠道反应发生率高于对照组(P<0.05),但主要以1~2级不良反应为主,3~4级经积极对症治疗后均恢复正常,不良反应可耐受。结论:西达本胺联合PD-1抑制剂治疗晚期三阴型乳腺癌疗效肯定,不良反应较轻,可耐受。

Objective:To explore the efficacy and safety of chidamide combined with PD-1 inhibitors in the treatment of advanced triple negative breast cancer(TNBC).Methods:Sixty-one patients with advanced triple negative breast cancer who had received at least 2 chemotherapy regiments and developed tumor progression in our hospital from January 2019 to November 2020 were include in the study.They were randomly divided into observation group(chidamide+pembrolizumab)and control group(pembrolizumab+placebo).The primary endpoint was progression-free survival(PFS),and secondary endpoints included objective response rate(ORR=CR+PR),disease control rate(DCR=CR+PR+SD),1-year survival rate and adverse events.Results:In the observation group the objective remission rate(ORR=CR+PR)was 20.0%,higher than that in the control group(3.2%),with no statistical significance(P>0.05).The disease control rate(DCR=CR+PR+SD)in the control group(40.0%)was higher than that of the control group(16.1%)(P<0.05).The median PFS of the observation group was 4.21 months and the 1-year survival rate was 57%,and the median PFS of the control group was 0.75 months and the 1-year survival rate was 33%,with statistical significance(P<0.05).In the observation group,the decreases rate of white blood cells,hemoglobin,thrombocytopenia,and the incidence of gastrointestinal reaction were higher than those in the control group(P<0.05).The main adverse reactions were grade 1-2,grade 3-4 was recovered after effective treatment.The adverse reaction was tolerable.Conclusion:The efficacy and safety of chidamide combined with PD-1 inhibitors in the treatment of advanced triple negative breast cancer is positive,and the adverse reactions are mild and tolerable.