PHASE-II STUDY OF CONTINUOUS INFUSIONAL 5-FLUOROURACIL WITH EPIRUBICIN AND CARBOPLATIN (INSTEAD OF CISPLATIN) IN PATIENTS WITH METASTATIC LOCALLY ADVANCED BREAST-CANCER (INFUSIONAL ECARBOF) - A VERY ACTIVE ANDWELL-TOLERATED OUTPATIENT REGIMEN

Infusional 5-fluorouracil (F) with cisplatin (C) and epirubicin (E), s o-called infusional ECF, is a highly active new schedule against local ly advanced or metastatic breast cancer. Cisplatin, however, is a majo r contributor to toxicity and usually requires inpatient treatment. In an attempt to overcome this, we have investigated the effect of subst ituting carboplatin for cisplatin in our original infusional ECF regim en. Fifty-two patients with metastatic (n = 36) or locally advanced/in flammatory (n = 16) breast cancer were treated with 5-fluorouracil 200 mg m(-2) day(-1) via a Hickman line using an ambulatory pump for 6 mo nths, with epirubicin 50 mg m(-2) intravenously (i.v.) and carboplatin AUC5 i.v. every 4 weeks, for six courses (infusional ECarboF). The ov erall response rate (complete plus partial) was 81% (95% CI 67%-90%), with a complete response rate of 17% (95% CI 6-33%) in patients with m etastatic disease and 56% (95% CI 30-80%) in patients with locally adv anced disease. Median response duration and survival for metastatic di sease was 8 and 14 months respectively, and two patients with locally advanced disease have relapsed. These results are very similar to thos e previously achieved with infusional ECF. Severe grade 3/4 toxicity w as low. Infusional ECarboF is a highly active, well-tolerated, outpati ent regimen effective against advanced/metastatic breast cancer and no w warrants evaluation against conventional chemotherapy in high-risk e arly breast cancer.