PHASE-II STUDY OF CONTINUOUS-INFUSION FLUOROURACIL WITH EPIRUBICIN AND CISPLATIN IN PATIENTS WITH METASTATIC AND LOCALLY ADVANCED BREAST-CANCER - AN ACTIVE NEW REGIMENT

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 [CI], 76% to 96%), with a complete response rate of 24% (95% CI, 9% to 40%) in patients with metastatic disease and 36% (95% CI, 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.