Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. Italian Multicentre Breast Study with Epirubicin.

Abstract

From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.

Paclitaxel, Epirubicin and Cyclophosphamide Combination in First-Line Treatment of Metastatic Breast Cancer: A Dose Escalation Study

“…The response rate compares favourably with more standard FAC/FEC chemotherapy regimens, where responses of 44–57% have been reported [1, 2, 3], and is in keeping with response rates reported for combinations of paclitaxel/epirubicin (54–84%) and paclitaxel/cyclophosphamide (50%) [12, 16, 17, 18, 20]. …”

“…Despite clinical responses of 44–57% achieved with standard combination regimens comprising 5-fluorouracil, an anthracycline (doxorubicin or epirubicin) and cyclophosphamide (FAC/FEC), the prognosis remains poor [1, 2, 3]. One approach to improve the outcome of patients with metastatic breast cancer is the introduction of new chemotherapeutic agents and the development of novel combination strategies.…”

Cardiotoxicity of anthracycline agents for the treatment of cancer: Systematic review and meta-analysis of randomised controlled trials

“…The majority of the studies were on women with advanced or metastatic breast cancer [38,40,51-57], three were on women with ovarian cancer [28,58,59], and one studied patients with non-Hodgkin's lymphoma [60]. Some participants had cardiac risk factors at baseline, mainly due to prior treatment with an anthracycline or radiotherapy (Additional file 6; Table S4).…”

A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study

“…To minimize toxic effects, doxorubicin has often been replaced by epirubicin (EPI), known to be as active as the parent compound and with lower toxicity, particularly cardiac toxicity [3-6]. As dose-response concerns, higher EPI doses, both as single agent and in combination regimens, seem to be more efficacious than lower doses [7-10].…”