氟尿嘧啶持续输注联合表柔比星和顺铂治疗转移性和局部晚期乳腺癌的II期研究：一种有效的新方案
Phase II study of continuous infusion fluorouracil with epirubicin and cisplatin in patients with metastatic and locally advanced breast cancer: an active new regimen.
作者信息
Jones A L, Smith I E, O'Brien M E, Talbot D, Walsh G, Ramage F, Robertshaw H, Ashley S
机构信息
Department of Medicine, Royal Marsden Hospital, London, United Kingdom.
出版信息
J Clin Oncol. 1994 Jun;12(6):1259-65. doi: 10.1200/JCO.1994.12.6.1259.
PURPOSE
To investigate the efficacy and toxicity of continuous infusion fluorouracil (5-FU) with every-3-weeks epirubicin and cisplatin (ECF) in advanced breast cancer in a phase II study.
PATIENTS AND METHODS
Forty-three patients with metastatic (n = 29) or locally advanced/inflammatory (n = 14) breast cancer were treated with 5-FU 200 mg/m2/d via a Hickman line using an ambulatory pump for 6 months with epirubicin 50 mg/m2 intravenously (IV) and cisplatin 60 mg/m2 IV every 3 weeks, for eight courses.
RESULTS
The overall response rate (complete plus partial) was 84% (95% confidence interval [Cl], 76% to 96%), with a complete response rate of 24% (95% Cl, 9% to 40%) in patients with metastatic disease and 36% (95% Cl, 11% to 61%) in patients with locally advanced disease. The main World Health Organization [WHO] grade 3 or 4 toxicities included leukopenia, emesis, and alopecia.
CONCLUSION
Infusional ECF is a highly active regimen in advanced breast cancer and warrants evaluation in high-risk early breast cancer.
目的
在一项II期研究中，调查持续输注氟尿嘧啶（5 - FU）联合每3周一次的表柔比星和顺铂（ECF）方案治疗晚期乳腺癌的疗效和毒性。
患者与方法
43例转移性（n = 29）或局部晚期/炎性（n = 14）乳腺癌患者，通过Hickman导管使用便携式输液泵以200 mg/m²/d的剂量持续输注5 - FU 6个月，同时每3周静脉注射（IV）表柔比星50 mg/m²和顺铂60 mg/m²，共8个疗程。
结果
总缓解率（完全缓解加部分缓解）为84%（95%置信区间[Cl]，76%至96%），转移性疾病患者的完全缓解率为24%（95% Cl，9%至40%），局部晚期疾病患者的完全缓解率为36%（95% Cl，11%至61%）。主要的世界卫生组织（WHO）3级或4级毒性反应包括白细胞减少、呕吐和脱发。
结论
持续输注ECF方案在晚期乳腺癌中具有高活性，值得在高危早期乳腺癌中进行评估。
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