西达本胺联合吉西他滨三线治疗晚期三阴性乳腺癌

Chidemide combined with gemcitabine as third-line treatment for advanced triple negative breast cancer

目的探讨西达本胺联合吉西他滨三线治疗晚期三阴性乳腺癌的疗效及安全性。方法晚期三阴性乳腺癌患者63例,随机分为观察组(n=31)和对照组(n=32)。观察组给予西达本胺(30 mg,po,每周2次)联合吉西他滨(1 000 mg·m^-2,静脉滴注,每3周1次,共3个疗程)治疗。对照组给予同等剂量吉西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年生存率和不良反应。结果观察组的ORR和DCR分别为29%和45%,显著高于对照组的9%和22%(P <0.05)。观察组患者的中位PFS为4.46个月(95%CI:0.19~17.85),优于对照组患者的0.82个月(95%CI:0.13~13.98)。观察组1年生存率为58%,对照组为31%,有显著差异(P <0.05)。2组不良反应以Ⅰ~Ⅱ级为主,观察组白细胞、血小板下降及胃肠道反应发生率明显高于对照组(P <0.05)。结论西达本胺联合吉西他滨治疗晚期三阴性乳腺癌疗效较好,不良反应较轻微,患者可耐受。

AIM To investigate the efficacy and safety of chidemide combined with gemcitabine as third-line treatment for advanced triple negative breast cancer(TNBC). METHODS Sixty-three patients with advanced TNBC were randomly divided into observation group(n = 31) and control group(n = 32).The observation group was treated with chidamide(30 mg, po, twice a week) combined with gemcitabine(1 000 mg·m^-2, ivgtt, once every 3 weeks for 3 courses). The control group was treated with the same dose of gemcitabine combined with placebo. The objective response rate(ORR), disease control rate(DCR), progression-free survival(PFS), one-year survival rate and adverse reactions were compared between the two groups. RESULTS The ORR and DCR of the observation group were 29% and 45%,which were significantly higher than those of the control group(9% and 22%, P < 0.05). The median PFS of the observation group was 4.46 months(95%CI: 0.19 to 17.85), which was better than that of the control group(0.82 months, 95%CI: 0.13 to 13.98). The one-year survival rate was 58% in the observation group and 31% in the control group, with a significant difference(P < 0.05). The adverse reactions of the two groups were mainly grade Ⅰ-Ⅱ, and the incidence of leukocytes, platelets and gastrointestinal reactions in the observation group was significantly higher than that in the control group(P < 0.05). CONCLUSION Chidamide combined with gemcitabine is effective in the treatment of advanced triple negative breast cancer. The adverse reactions are mild and the patient can tolerate it.