替吉奥联合多西紫杉醇治疗蒽环类耐药的复发转移性乳腺癌38例

Clinical effects of docetaxel combined with compound tegafur capsule in the treatment of 38 patients with anthracycline-refractory recurrent metastatic breast cancer

目的研究替吉奥联合多西紫杉醇治疗蒽环类耐药复发转移性乳腺癌（ARMBC）的疗效及患者不良反应。方法回顾性分析38例ARMBC患者接受替吉奥联合多西紫杉醇方案的治疗情况。其中多西紫杉醇70mg／m2，替吉奥60mg／m2，口服，每天2次，第1天至第14天。每3周为1个周期，至少2个周期。结果38例患者治疗后，完全缓解（CR）2例（5．3％）、部分缓解（PR）20例（52．6％）、稳定（SD）10例（26．3％）、进展（PD）6例（15．8％）；客观有效率57．9％（95％CI42．6％～74．2％），临床获益率73．7％（95％凹58．4％～89．1％），中位疾病进展时间（1rrP）7．8个月（95％ CI6．7～8．9个月），中位生存期（OS）15．7个月（95％口12．9～18．8个月）。患者主要不良反应为骨髓抑制，其中Ⅲ～Ⅳ度白细胞减少占21．1％。Ⅰ～Ⅱ度不良反应主要为手足综合征、恶心呕吐、腹泻、肝损害、口腔黏膜炎，均可耐受。结论替吉奥联合多西紫杉醇治疗ARMBC疗效好，不良反应可耐受。

Objective To investigate the efficacy and toxicity of docetaxel combined with compound tegafur capsule （S-I） on anthracycline-refractory recurrent metastatic breast cancer （ARMBC）. Methods Thirty-eight ARMBC patients were given intravenous 70 mg/m2 docetaxel at day 1, and oral 60 mg/m2 S-1 twice every day at day 1 to 14. Every 3 weeks was one cycle and each patient received at least two cycles. Results After treatment, among these 38 patients, there was 2 complete response （CR） （5.3 %）, 20 partial response （PR） （52.6 %）, 10 stable disease （SD） （26.3 %）, and 6 progressive disease （PD） （15.8 %）. Overall objective response rate was 57.9 % （95 % confidence interval： 42.6 %-74.2 %） while clinical benefit response rate was 73.7 % （95% confidence interval： 58.4 %-89.1%）. The median time to progression （TFP） was 7.8 months （95 % confidence interval： 6.7-8.9 months）, and median overall survival time （OS） was 15.7 months （95 % confidence interval： 12.9-18.8 months）. The main toxic reaction was myelosuppression, and grade Ⅲ and Ⅳ adverse events including leueopenia occurred in 21.1% of all cases. Most common grade Ⅰ and Ⅱ adverse events, such as hand-foot syndrome, nausea, vomiting, diarrhea, liver dysfunction, and oral mueositis, were tolerable. Conclusion Good clinical efficacy is achieved in the therapy of metastatic breast cancer with docetaxel and S-1 combination regimen and toxic reaction is tolerable.