多西他赛联合吉西他滨治疗复发转移性乳腺癌临床疗效及预后影响因素

Clinical effect of docetaxel combined with gemcitabine for patients with recurrent or metastatic breast cancer and its prognostic factors

目的探讨多西他赛联合吉西他滨治疗复发转移性乳腺癌的临床疗效及预后影响因素。方法复发转移性乳腺癌患者46例，给予多西他赛联合吉西他滨治疗，具体方案为：多西他赛75mg／m2，静脉滴注1h，第1天；吉西他滨1000mg／m2，静脉滴注30min，第1、8天；21d为1个周期，评价患者近期疗效并随访患者总生存时间和无进展生存时间。采用单因素x2检验和多因素Cox风险比例模型分析患者临床病理特征与总有效率和总生存时间的关系。结果46例复发转移性乳腺癌患者均接受3—6个周期的联合化疗治疗，完全缓解4例（8．7％），部分缓解22例（47．8％），稳定12例（26．1％），进展8例（17．4％），总有效率为56．5％（26／46），疾病控制率为82．6％（38／46）；中位总生存时间为16．0个月（95％CI为6．5～25．5个月），中位无进展生存时间为8．0个月（95％CI为6．2～9．8个月）；单因素分析结果显示，患者年龄、绝经状态、行为状况（Ps）评分、肿瘤转移数目均与患者总有效率相关（P〈0．05），多因素Cox风险比例模型分析显示，患者年龄、绝经状态、Ps评分、肿瘤转移数目均与患者的总生存时间相关，是患者预后的影响因素（P〈0．05）；主要不良反应以骨髓抑制、胃肠道反应、皮疹、脱发及乏力为主，大多数为I-Ⅱ级。结论多西他赛联合吉西他滨治疗复发转移性乳腺癌的临床疗效好，安全性高；患者年龄、绝经状态、Ps评分、肿瘤转移数目可作为该方案预后的影响因素。

Objective To explore the efficacy and the prognostic factors of docetaxel combined with gemcitabine for patients with recurrent or metastatic breast cancer. Methods Forty-six patients with recurrent or metastatic breast cancer received docetaxel combined with gemcitabine regimen （docetaxel 75 mg/m2, intra- venous drip, dl; gemcitabine 1000 mg/m2, intravenous drip, dl,d8; The regimen was repeated every three- weeks for 3-6 cycles）. The response rate （RR） was evaluated after 2 cycles, and the overall survival （OS） and progress-free survival （PFS） were recorded. Single factor chi square test and multivariate Cox proportion hazard model were used to evaluate the relationship between clinic pathologic features and RR, OS. Results All patients completed 3-6 cycls chemotherapy. The overall response rate was 56. 5% （26/46） and disease control rate was 82.6% （38/46）, with 4 patients of complete remission （ 8.7% ）, 22 patients of partial remis- sion （47.8%）, 12 patients of stable disease （26.1%） and 8 patients of progressive disease （ 17.4% ）. The median OS of 46 patients was 16.0 months （95% CI： 6.5-25.5 months） and PFS was 8.0 months （95 % CI： 6：2-9.8 months）. Single factor analysis showed that age, menopausal status, PS score, the number of metasta- sis had correlations with RR（P 〈 O. 05）; Cox proportion hazard model also showed that age, menopausal status, PS score, the number of metastasis had correlations with OS, and were the prognostic factors （P 〈 0.05）. The most frequent treatment-related adverse events were myelosuppression, gastrointestinal reaction, rash, alopecia, fatigue, and were tolerable （ I - II level）. Conclusion Docetaxel combined with gemcitabine is effective and safe in the treatment of recurrent or metastatic breast cancer. Age, menopausal status, PS score and the number of metastasis are the prognostic factors for efficacy of docetaxel combined with gemcitabine regimen.