吉西他滨联合奈达铂治疗人表皮生长因子受体2阴性晚期乳腺癌的疗效和安全性

Evaluation of the efficacy and safety of combination of gemcitabine and nedaplatin for patients with HER-2 negative metastatic breast cancer

目的评估吉西他滨联合奈达铂(GN方案)治疗人表皮生长因子受体2(HER-2)阴性晚期乳腺癌的疗效及安全性。方法选择既往接受过蒽环类和(或)紫杉类药物辅助或新辅助治疗的HER-2阴性复发转移性乳腺癌患者45例,2014年1月至2019年2月在中国医学科学院肿瘤医院接受GN方案治疗。根据实体瘤的疗效评价标准(RECIST)1.1进行疗效评价,根据通用不良事件评价标准(CTCAE)进行不良反应的评估和监测。随访患者的无进展生存时间(PFS)和总生存时间(OS),分析预后影响因素。结果45例患者接受中位4个周期的治疗,其中1例完全缓解,21例部分缓解,客观缓解率为48.9%(95%CI:33.7%~64.1%)。10例(22.2%)患者出现3~4级白细胞减少,13例(28.9%)出现3~4级中性粒细胞减少,8例(17.8%)出现3~4级血小板减少。3~4级非血液学不良反应主要为恶心呕吐,发生率为4.4%(2/45)。45例患者中,34例死亡,中位PFS为5.1个月(95%CI:3.9~6.1个月),中位OS为17.6个月(95%CI:13.1~20.9个月)。结论对于既往接受过蒽环类和(或)紫杉类药物治疗的HER-2阴性复发转移性晚期乳腺癌患者,GN方案是一种有效且耐受性较好的化疗方案。

Objective To assess the therapeutic efficacy and safety of the gemcitabine combined with nedaplatin(GN)chemotherapy for metastatic human epidermal growth factor receptor-2(HER-2)negative breast cancer patients.Methods Forty-five patients with HER-2 negative recurrent metastatic breast cancer who had received prior adjuvant or neoadjuvant therapy with anthracycline and/or taxanes were enrolled.All the patients received GN regime from January 2014 to February 2019.The therapeutic efficacy was evaluated according to response evaluation criteria in solid tumors(RECIST)1.1.The adverse response was evaluated and monitored according to common terminology criteria for adverse events(CTCAE).The progression-free survival(PFS)and overall survival(OS)and prognostic factors were also analyzed.Results All of the 45 patients received 4 course GN,1 of them achieved complete response,21 achieved partial response.The objective response rate was 48.9(95%CI:33.7%-64.1%).Grade 3-4 hematological toxicities include leukopenia occurred in 10(22.2%)of patients,neutropenia in 13(28.9%)patients,and thrombocytopenia in 8(17.6%)patients.The grade 3-4 hematological toxicities mainly manifested as nausea and vomiting,and the incidence was 4.4%(2/45).Among the 45 patients,34 died,the median PFS was 5.1(95%CI:3.9-6.1)months and the median OS was 17.6(95%CI:13.1-20.9)months.Conclusion The combination of gemcitabine and nedaplatin is an effective and tolerable treatment for metastatic breast cancer patients previously treated with anthracyclines and/or taxanes.