吉西他滨联合紫杉醇方案与长春瑞滨单药方案治疗蒽环类耐药的转移性乳腺癌的临床观察

目的：：评价吉西他滨联合紫杉醇方案与单药长春瑞滨方案在治疗蒽环类耐药的转移性乳腺癌患者中的疗效及不良反应。方法：2009年10月至2012年12月，我科收治的符合治疗条件的晚期乳腺癌患者共126例，随机分为吉西他滨联合紫杉醇组（GT 组）及单药长春瑞滨组（NVB 组），观察有效率（RR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及不良反应。采用χ2检验比较各组治疗有效率、疾病控制率及不良反应，采用Kaplan -Meier 法计算生存率，采用 Log -rank 检验进行生存率的比较。结果：GT 组较 NVB 组在 RR 及 OS 方面有优势（P ＝0.033；P ＝0.013），在 DCR、PFS 方面差异无统计学意义（P ＝0.440；P ＝0.159），在不良反应方面有较多的中重度白细胞减少（P ＝0.025）、轻度恶心呕吐（P ＝0.035）、便秘（P ＝0.030）、肌肉关节疼痛（P ＝0.000）及疲乏无力（P ＝0.003）。结论：对于身体状况较好的患者，使用吉西他滨联合紫杉醇方案较单药长春瑞滨方案有助于提高患者的 RR 及 OS，但需注意不良反应的监测及相应的处理。

Gemcitabine plus Paclitaxel Regimen and Vinorelbine Single Agent Regimen for Anthracycline-resistant Metastatic Breast Cancer

Objective:To evaluate the difference in curative effect and adverse events between gemcitabine plus paclitaxel regimen and vinorelbine single agent regimen in treating anthracycline-resistant metastatic breast cancer patients. Methods:From Oct.2009 to Dec.2012,126 cases of metastatic breast cancer who met the criterion we established for this study were collected and randomized into gemcitabine plus paclitaxel group (GT group)and vinorelbine group (NVB group).The observation end points included response rate (RR),disease control rate (DCR),progression-free survival (PFS),overall survival (OS)and adverse events.Chi-square test was used to compare the RR,DCR and adverse events in both groups and Kaplan-Meier method was used to estimate the survival rate in both arms.Log-rank test was used to compare the survival rate of each group.Results:GT group,compared with NVB group,had better results in RR and OS and the differences were statistically significant (P =0.033;P =0.013).The results in DCR and PFS,however,had no statistically significant difference (P =0.440;P =0.159).GT group had more grade 3 ~4 adverse events of leucopenia (P=0.025),more grade 1 ~2 adverse events of nausea and vomiting (P =0.035),constipation (P =0.030),myalgia or arthralgia (P =0.000)and fatigue (P =0.003).Conclusion:Compared to NVB regimen,GT regimen may increase the RR and OS in patients of better physical condition but we should pay more attention to the adverse events.