He Kewen, Wang Xinzhao, Guan Xiyun, Yu Qian, Ma Qinghua, Liu Zhaoyun, Yu Zhiyong
School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Science, Jinan, P.R. China.
Department of Surgery, Shandong Cancer Hospital Affiliated to Shandong University, Shandong Academy of Medical Science, Jinan, P.R. China.
Anticancer Res. 2017 Oct;37(10):5647-5653. doi: 10.21873/anticanres.12000.
To evaluate the efficacy and toxicity of vinorelbine and gemcitabine (NG) versus vinorelbine and cisplatin (NP) in anthracycline- and taxane-pretreated patients with HER2-negative advanced breast cancer.
Patients were randomly assigned on a 1:1 schedule to receive no more than six cycles of NG or NP. Dosing for the NG group was 25 mg/m vinorelbine and 1,000 mg/m gemcitabine, given on days 1 and 8 every 3 weeks; for the NP group,25 mg/m vinorelbine was given on days 1 and 8, and 75 mg/m cisplatin was given on day 1 every 3 weeks. The primary endpoint was disease control rate (DCR). The secondary endpoints were the progression-free survival (PFS), overall survival (OS) and safety.
The full analysis set comprised of 37 patients receiving NG and 37 receiving NP. The DCR was 70.3% with NG and 64.9% with NP (p=0.619). Median PFS were 7 months (95% CI=5.88-8.12) and 6 months (95% CI=5.29-6.71) respectively in NG and NP group [hazard ratio (HR)=1.696; 95% confidence interval (CI)=0.73-3.93; p=0.217)]. Corresponding median OS was 18 (95% CI=10.35-13.65) months and 12 (95% CI=15.83-20.17) months (HR=1.219; 95% CI=0.67-2.23; p=0.521). For adverse events, neutropenia and nausea/vomiting were milder in the NG group than in the NP group (all p<0.05).
Although no significant differences were observed in terms of DCR, PFS and OS, with milder toxicity, NG appeared to be a more valuable first-line treatment regimen than NP in anthracycline- and taxane-pretreated patients with HER2-negative advanced breast cancer.
评估长春瑞滨联合吉西他滨（NG方案）与长春瑞滨联合顺铂（NP方案）用于蒽环类和紫杉类治疗失败的HER2阴性晚期乳腺癌患者的疗效和毒性。
患者按1:1比例随机分配，接受不超过6个周期的NG方案或NP方案治疗。NG组给药方案为：长春瑞滨25mg/m²，吉西他滨1000mg/m²，每3周第1天和第8天给药；NP组给药方案为：长春瑞滨25mg/m²，每3周第1天和第8天给药，顺铂75mg/m²，每3周第1天给药。主要终点为疾病控制率（DCR）。次要终点为无进展生存期（PFS）、总生存期（OS）和安全性。
全分析集包括37例接受NG方案治疗的患者和37例接受NP方案治疗的患者。NG方案组的DCR为70.3%，NP方案组为64.9%（p = 0.619）。NG组和NP组的中位PFS分别为7个月（95%CI = 5.88 - 8.12）和6个月（95%CI = 5.29 - 6.71）[风险比（HR）= 1.696；95%置信区间（CI）= 0.73 - 3.93；p = 0.217]。相应的中位OS分别为18个月（95%CI = 10.35 - 13.65）和12个月（95%CI = 15.83 - 20.17）（HR = 1.219；95%CI = 0.67 - 2.23；p = 0.521）。在不良事件方面，NG组的中性粒细胞减少和恶心/呕吐比NP组更轻（所有p < 0.05）。
尽管在DCR、PFS和OS方面未观察到显著差异，但NG方案毒性较轻，对于蒽环类和紫杉类治疗失败的HER2阴性晚期乳腺癌患者，NG方案似乎是比NP方案更有价值的一线治疗方案。
